ACOG Guideline PDF
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Somali National University
Dr;Alfatih Aadaik
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This document is a summary of comprehensive guidelines for Obstetrics and Gynecology, revised and updated until March 2016. It covers various topics such as classification of evidence levels, understanding audit, risk management, contraception, and many other important areas of women's health care.
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COMPREHENSIVE GUIDELINES SUMMARY GAfatih COMPREHENSIVE GUIDELINES SUMMARY Dr;Alfatih Aadaik [REVISED AND UPDATED UPTO MARCH 2016] CONTENTS Page No. 1 CLASSI...
COMPREHENSIVE GUIDELINES SUMMARY GAfatih COMPREHENSIVE GUIDELINES SUMMARY Dr;Alfatih Aadaik [REVISED AND UPDATED UPTO MARCH 2016] CONTENTS Page No. 1 CLASSIFICATION OF EVIDENCE LEVELS 8 2 UNDERSTANDING AUDIT 9 3 RISK MANAGEMENT FOR MATERNITY AND GYNAECOLOGY 14 4 CONTRACEPTION 20 5 UK MEDICAL ELIGIBILITY CRITERIA FOR: CONTRACEPTIVE USE 35 6 LONG-ACTING REVERSIBLE CONTRACEPTION 44 7 MANAGEMENT OF UNSCHEDULED BLEEDING IN WOMEN USING HORMONAL 51 CONTRACEPTION 8 MALE & FEMALE STERILIZATION 60 9 FEMALE STERILIZATION 62 10 CHRONIC PELVIC PAIN 66 11 PELVIC INFLAMMATORY DISEASE 69 12 ENDOMETRIOSIS 73 13 PREVETION OF INJURIES DURING LAPAROSCOPIC ENTERY 76 14 MANAGEMENT OF PREMENSTRUAL SYNDROME 80 15 LONG TERM CONSEQUANCE OF PCOS 84 16 METFORMIN FOR THE MANAGEMENT OF INFERTILITY IN WOMEN WITH PCOS 85 17 HEAVY MENSTRUAL BLEEDING 91 18 INITIAL MANAGEMENT OF MENORRAHGIA 92 19 MANAGEMENT OF MENORRAHGIA IN SECONDARY CARE 94 1 20 MANAGEMENT OF ENDOMETRIAL HYPERPLASIA 101 21 ASYMPTOMATIC ENDOMETRIAL THICKENING 103 22 BEST PRACTICE IN OUTPATIENT HYSTEROSCOPY 105 23 FERTILITY : ASSESSMENT AND TREATMENT 115 24 IMMUNOLOGICAL TESTING AND INTERVENTIONS FOR REPRODUCTIVE FAILURE 119 25 PERINATAL RISKS ASSOCIATED WITH IVF 122 26 OVARIAN HYPERSTIMULATION SYNDROME 128 27 MULTIPLE PREGNANCY 134 28 MANAGEMENT OF MONOCHORIONIC TWIN 137 29 ABORTION 140 30 THE MANAGEMENT OF EARLY PREGNANCY LOSS 146 31 GESTATIONALTROPHOBLASTIC DISEASE (GTD) 150 32 RECURRENT 1ST TRIMESTER AND 2ND TRIMESTER MISCARRIAGE 154 33 CERVICAL CERCLAGE 157 34 THE MANAGEMENT OF TUBAL PREGNANCY 159 35 AMNIOCENTESIS AND CHORIONIC VILLUS SAMPLING 161 36 AMNIOCENTESIS 162 2 37 NONINVASIVE PRENATAL DIAGNOSIS USING CFFDNA 164 38 ANTENATAL SCREENING FOR DOWN SYNDROME 165 39 PERICONCEPTIONAL FOLIC ACID AND FOOD FORTIFICATION IN THE PREVENTION OF NEURAL 166 TUBE DEFECTS 40 REVIEW CARDIAC DISEASE IN PREGNANCY. PART 1: CONGENITAL HEART DISEASE 177 41 REVIEW CARDIAC DISEASE IN PREGNANCY. PART 2: ACQUIRED HEART DISEASE 181 42 MANAGEMENT OF SICKLE CELL DISEASE IN PREGNANCY 188 43 MANAGEMENT OF BETA THALASSAEMIA IN PREGNANCY 196 44 DIABETES IN PREGNANCY 203 45 DIAGNOSIS AND TREATMENT OF GESTATIONAL DIABETES 204 46 HYPERTENSION IN PREGNANCY 217 47 THE MANAGEMENT OF SEVERE PRE ECLAMPSIA /ECLAMPSIA 221 48 INVESTIGATION AND MANAGEMENT OF THE SGA 228 49 REDUCED FETAL MOVEMENTS 232 50 LATE INTRAUTERINE FETAL DEATH AND STILLBIRTH 240 51 PREGNANCY IN WOMEN WITH EPILEPSY 243 52 RENAL DISEASE IN PREGNANCY 245 53 MANAGEMENT OF WOMEN WITH OBESITY IN PREGNANCY 250 3 54 OBSTETRIC CHOLESTASIS 253 55 ANTENATAL CARE 264 56 ANTENATAL CORTICOSTEROIDS 266 57 ANTI-D IMMUNOGLOBULIN FOR RHESUS D PROPHYLAXIS 270 58 THE MANAGEMENT OF WOMEN WITH RED CELL ANTIBODIES DURING PREGNANCY 279 59 ANTEPARTUM HAEMORRHAGE 280 60 PLACENTA PRAEVIA , PLACENTA ACCRETA AND VASA PRAEVIA 290 61 THE MANAGEMENT OF ANAEMIA IN PREGNANCY AND POSTNATALLY 294 62 BLOOD TRANSFUSION IN OBSTETRICS 298 63 PREGNANCY AND BREAST CANCER 302 64 THE PREVENTION OF MALARIA IN PREGNANCY 310 65 BACTERIAL SEPSIS IN PREGNANCY 313 66 BACTERIAL SEPSIS FOLLOWING PREGNANCY 319 67 PREVENTION OF EARLY ONSET NEONATAL GBS DISEASE 326 68 CHICKEN POX IN PREGNANCY 330 69 MANAGEMENT OF HIV IN PREGNANCY 334 70 MANAGEMENT OF GENITAL HERPES IN PREGNANCY 338 4 71 PARVOVIRUS B 19 INFECTION 340 72 EXERCISE IN PREGNANCY 342 73 FEMALE GENITAL MUTILATION 344 74 IMPROVING PATIENT HANDOVER 349 75 THE MANAGEMENT OF BREECH PRESENTATION 351 76 EXTERNAL CEPHALIC VERSION 353 77 HOME BIRTHS 355 78 BIRTH AFTER PREVIOUS CAESAREAN BIRTH 356 79 PRETERM PRELABOUR RUPTURE OF MEMBRANES 359 80 MAGNESIUM SULPHATE TO PREVENT CEREBRAL PALSY FOLLOWING PRETERM BIRTH 362 81 TOCOLYSIS FOR WOMEN IN PRETERM LABOUR 363 82 INDUCTION OF LABOUR 366 83 INTRAPARTUM CARE 371 84 ELECTRONIC FETAL MONITORING 387 85 UMBILICAL CORD PROLAPSE 394 86 OPERATIVE VAGINAL DELIVERY 397 87 CONSENT ADVICE.OPERATIVE VAGINAL DELIVERY 402 5 88 SHOULDER DYSTOCIA 404 89 3RD AND 4TH DEGREE PERINEAL TEARS 408 90 SECONDARY SUTURING COMPARED TO NON-SUTURING FOR BROKEN DOWN PERINEAL 412 WOUNDS FOLLOWING CHILDBIRTH 91 CAESAREAN SECTION 413 92 CLAMPING OF UMBILICAL CORD 418 93 PERITONEAL CLOSURE 420 94 PREVENTION AND MANAGEMENT OF PPH 421 95 ELECTIVE INTERVENTIONAL RADIOLOGY IN PPH 430 96 MATERNAL COLLAPSE IN PREGNANCY AND THE PUERPERIUM 431 97 CRITICAL AND MATERNITY CARE 438 98 ANTENATAL AND POSTNATAL MENTAL HEALTH 445 99 OVARIAN CYSTS IN POSTMENOPAUSAL WOMEN 447 100 SUSPECTED OVARIAN MASSES IN PREMENOPAUSAL WOMEN 450 101 TARGETED THERAPIES FOR MANAGEMENT OF OVARIAN CANCER 453 103 POP-Q SYSTEM FOR THE ASSESSMENT OF PELVIC ORGAN PROLAPSE 454 104 POST HYSTERECTOMY VAGINAL VAULT PROLAPSE 460 105 URINARY INCONTINENCE 464 6 106 SURGICAL TREATMENT OF URODYNAMIC STRESS INCONTINENCE 470 107 VACCINATION AGAINST CERVICAL CANCER 471 108 REDUCING THE RISK OF THROMBOSIS AND EMBOLISM DURING PREGNANCY AND THE 473 PUERPERIUM 109 THE ACUTE MANAGEMENT OF THROMBOSIS AND EMBOLISM DURING PREGNANCY AND 489 THE PUERPERIUM 110 VENOUS THROMBOEMBOLISM AND HORMONE REPLACEMENT THERAPY 495 111 VTE AND HORMONAL CONTRACEPTION 499 112 THEMANAGEMENT OF VULVAL SKIN DISORDERS 503 7 CLASSIFICATION OF EVIDENCE LEVELS 8 UNDERSTANDING AUDIT Definition Clinical audit is a quality improvement process that improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. What can be audited? Audit may evaluate: 1. the structure of services, 2. the process of care 3. the outcome of care. Measure of structure or service provision For example, research evidence shows that outcome for patients with ovarian cancer is better if they are operated by trained gynaecologist and managed within multidisciplinary team. An audit of the referral and management of patients with ovarian cancer can provide an overview of service provision in this area. Process measure Process measures are clinical practices evaluated by research and shown to influence outcome. For example, research evidence shows that the use of antenatal steroids improve perinatal outcome. Evaluation of this process of care is by measuring the proportion of appropriate women who received antenatal steroids. Process measures may be used to assess the quality of care and have some advantages over outcome measures: 1. provide more direct measure of the quality of care 2. they occur more frequently, so smaller samples are needed 3. the findings are easier to interpret 4. as smaller audits are needed, they cost less. Outcome measure Outcome measure is the response to an intervention; for example, the health status (dead or alive), cure following surgery for stress incontinence Outcomes can be : 1. desirable; improvement in the patient‟s condition or quality of life, 2. undesirable, adverse effects of a treatment. the use of outcomes alone in assessing quality of care has limitations: 1. outcomes are not a direct measure of the care provided. 2. not all patients who experience substandard care will have a poor outcome 3. many factors contribute to eventual outcome (e.g. disease severity, health status and social and health inequalities) 4. outcomes may be delayed 5. research evidence about the impact of some care processes on outcome is limited 6. adverse outcomes occur less frequently so larger samples will be needed. Despite all the difficulties with outcome measures, mortality and morbidity measures are important 9 „Critical incident‟ or „adverse event‟ reporting involves the identification of patients where an adverse event has occurred, such as the Confidential Enquiries into Maternal Deaths (CEMD). The audit cycle Steps of Audit (audit cycle): 1. selection of a topic 2. identification of an appropriate standard 3. data collection to assess performance against the prespecified standard 4. implementation of changes to improve care if necessary 5. data collection for a second, time to determine whether care has improved. Selection of a topic In selecting a topic for audit, priority should be given to : 1. common health concerns, 2. areas associated with high rates of mortality, morbidity or disability, 3. where good research evidence is available to inform practice. It is important to involve those who will be implementing change at this stage of the audit process. 11 Identification of an appropriate standard 1) Review criteria The criterion is the reference point against which current practice is measured. High-quality evidence-based guidelines can be used as criteria. Where this is not possible, criteria should be agreed by a multidisciplinary group including those involved in providing care and those who use the service. Review criteria should be explicit rather than implicit and need to: 1. lead to valid judgements about the quality of care, and therefore should be based on research evidence 2. relate to aspects of care that are important either to patients or clinical outcome 3. be measurable. 2) Standard and target level of performance defined as „the percentage of events that should comply with the criterion‟ (e.g. the proportion of women undergoing induced abortion who were screened for lower genital tract organisms, the proportion of women delivered by caesarean section who received thromboprophylaxis, Target levels of performance should be examined periodically. setting target levels of performance is by: 1. informal agreement among the group leading the audit or among health professionals. 2. external standards Target levels of performance have been most used in screening programmes. For example, in screening for cervical cancer there are quality criteria to be met, such as the proportion of cervical smears that have endocervical cells. 3) Benchmarking it is the „process of defining a level of care set as a goal to be attained‟. benchmarking techniques help participants in audit to avoid setting unnecessarily low or unrealistically high target levels of performance. Data collection to assess performance against the pre-specified standard the following points need to be considered: 1) What data items to collect? Definitions need to be clear so that there is no confusion about what is being collected. For example, if collecting data on rupture of membranes, it may need to be specified whether this is spontaneous or artificial. Data collectors should be aware of their responsibilities to the Data Protection Act and any locally agreed guidelines. Nationally agreed guidelines, known as the Caldicott Principles: 11 1. Justify the purpose(s). 2. Do not use patient-identifiable information unless it is absolutely necessary. 3. Use the minimum necessary patient-identifiable information. 4. Access to patient-identifiable information should be on a strict need-to-know basis. Only those individuals who need access to patient-identifiable information should have access. 5. Everyone should be aware of their responsibilities and obligations to respect patient confidentiality. 6. Understand and comply with the law. 2) How to collect the data Sources of data include: 1. routinely collected data if available (e.g. birth registers); 2. clinical records 3. data collection through direct observation or from questionnaire surveys or patients. 3) Who will collect the data? In small audit projects the principal investigators can go through clinical notes for data abstraction. In larger projects, it may be appropriate for those involved in the care of the woman to fill in standard data collection sheets. 4) Data management 5) Data analysis Simple statistics are often all that is required. Other useful statistical software packages include Epi Info, SAS, SPSS, STATA and Minitab. 5.4 Implementation of changes to improve care if necessary Data analysis and interpretation will lead to identification of clinical areas that should be addressed. There are many methods by which this can be done. The feedback of audit findings is most commonly used; Simple methods were occasionally effective, for example: 1. feedback of data collected 2. provision of clear data, perhaps using modern information systems, supported by active teamwork 3. support from the organisation for teamwork 4. use of several methods together within the context of an implementation plan. Change does not always occur in audit due to: 1. Resistance to change among local professionals or in the organisational environment or team 2. Patients themselves may have preferences for care that make change difficult. Organisation of audit The following features are associated with successful audit: 1. Good planning with structured programmes with realistic aims and objectives 2. leadership and attitude of senior management 3. nondirective, hands-on approach 4. support of staff, strategy groups and regular discussions 5. emphasis on team working and support 6. environment conducive to conducting audit. 12 7. multidisciplinary approach with the involvement of stakeholders (including consumers or users of the service provided) and the local audit department 8. resources. Common reasons why audits fail 1. Failure to participate and attitudes to audit. Involving all stakeholders (including service users) in the project can encourage participation. 2. Failure to continue and complete the audit cycle. 3. Failure to provide a supportive environment for audit. 4. Lack of resources, especially time. 5. Lack of training in audit methodology and evidence-based skills. 6. Cost. 13 RISK MANAGEMENT FOR MATERNITY AND GYNAECOLOGY Patient safety, risk management and quality of care Standards for Better Health, published by the UK Department of Health, outlined seven domains of health care the first of which is safety. Managing risk Definition of risk management: „theculture, processes and structures that are directed towards realizing potential opportunities whilst managing adverse effects‟. some misconceptionsregarding risk management: 1. Risk management is not primarily about avoiding or mitigating claims; rather, it is a tool for improving the quality of care.Risk management is also as much about learning from claims as it is about mitigating claims. 2. Risk management is not simply the reporting of patient safety incidents. Incident reporting is only one aspect of the identification of risk. incident reporting is on the reactive side of risk management. More the proactive side is more effective when resources are used to minimise the occurrence of patient safety incidents instead of „fire fighting‟ after wrong. fire drill is one example of proactive risk management. 3. risk management is the business of service managers and of little concern to working clinicians. Risk management is actually the business of all stakeholders in the organisation, clinicians and non-clinicians. Basic questions addressed by risk management A holistic view of patient safety The term „clinical risk management‟ is sometimes used to refer to the application of risk management in the clinical setting 14 The demarcation between clinical and non-clinical risk is not always clear-cut. Application of risk management 4. Organisational requirements for risk management 15 Integrated framework Risk is best managed within a framework that integrates all aspects of clinical governance including clinical audit, education and training, complaints and claims handling, health and safety, research and service development. The organisation should provide a safety culture which is more likely if there is strong leadership, teamwork, communication, user involvement and training. Linked with hospital-wide strategies and initiatives Risk management at the specialty or subspecialty level should be linked with hospital-wide strategies and initiatives. Each department should have a written risk management strategy and a designated risk lead. Strategic direction and leadership should be provided by a multidisciplinary risk management or clinical governance committee. For a maternity unit ( senior obstetrician, training-grade doctor, a midwife, an anaesthetist, a neonatologist and the unit manager). 5. The risk management process 1) Risk identification either prospectively by checking possible sources of patient safety incidents before happened or retrospectively by looking back at things that did go wrong. 16 1. Incident reporting Each unit should have a list of reporting incidents (trigger list) for maternity and gynaecology To optimise the reporting of incidents, staff should be aware and motivated.. 17 2. Identifying prospective risk by using a tool called Failure Mode and Effects Analysis (FMEA). this tool has been more extensively used in aviation, aerospace and automobile industries but is applicable to health care. 3. Looking at what went wrong By using system analysis or „root cause analysis‟. It is a structured and systematic approach to invistigate clinical incidents. The key steps are: Identify incident and take decision to investigate. Select members of the investigation team. Gather data (such as records, interviews, protocols) and relevant physical items. Determine the chronology of the incident. Identify care delivery problems (unsafe acts; for example, failure to act or incorrect decision). Identify contributory factors (such as inadequate training, lack of supervision). Devise an action plan. Avoid two fallacies: professionals who try hard enough will not make any errors (the perfection fallacy) and people will make fewer errors if they get punished for any error (thepunishment fallacy). It is important to distinguish between „active‟ and „latent‟ failures and also between error and violation, because the aim is not to apportion blame but to reduce the risk of similar incidents again. active failure is the immediate cause of incident while a latent failure is a more remote but important cause. In the evolution of risk management, a unit is more likely to start by looking back at incidents that have happened („root cause analysis‟) rather than prophylactically examining processes (FMEA) but either or both approaches can be used. Generally, FMEA is more time consuming and should be reserved for high-priority processes. 2) Risk analysis and evaluation risk score matrix helps to identify risks or incidents that require in-depth investigation or those that require immediate action. 18 The risk score is commonly derived by multiplying the severity of the incident by the likelihood of its occurrence. Levels of severity will be locally defined, taking into account the extent of harm caused to the patient and the organisation. The likelihood rating the probability of occurrence (for A risk with a score of 20 or higher is deemed an unacceptable risk. 3) Risk treatment Options for dealing with the risk(s) may be elimination, substitution, reduction or acceptance of the risk, is Selection of the appropriate treatment will be influenced by the risk rating and there may be significant resource implications. Lessons learned from the identification and treatment of risk should be shared with other parts of the hospital/trust and with the wider community through channels such as multidisciplinary team meetings, ward meetings, safety alerts, newsletters, intranet and educational meetings. 4) Risk registers Each clinical area should have a risk register. Risks identified through the processes described above should be entered in the register. A risk register is not a static document. Ideally, a risk register should be in electronic format. 6. The national context A useful tool produced by the NPSA is the Incident Decision Tree, The decision tree helps distinguish between cases requiring disciplinary action and those attributable to system failure. It takes the user through a series of structured questions about the individual‟s action, motive and behaviour at the time of the incident. These questions consider whether deliberate harm was intended, whether illness or substance misuse was contributory, whether local guidelines were in place and followed. 19 Family Planning: NICE & FSRH Sept 2012 CONTRACEPTION introdution Uptake of contraception in the UK (women aged 16-49 years),Oral contraception 25% ,Male / female sterilisation 24%,Sheath 18%,IUCD 4% COMBINED ORAL CONTRACEPTIVE PILL DOSE; Oestrogen: Contain 35, 30 or 20mcg (Loestrin 20 / Mercilon / Femodette) ethinyl oestradiol (pills containing 50mcg ethinyl oestradiol are rarely used) Progestogen: 2nd generation ;1\Norethisterone 1mg 2\Levonorgestrel 150mcg 3rd generation ;1\Desogestrel 150mcg 2\Gestodene 150mcg 3\Norgestimate 250mcg Spironolactone derivative ; Drospirenone 3mg Failure rate (Pearl index – failure rate per 100 woman year) = 0.1 if correctly taken. Mode of action: 1\Suppress ovulation 2\Disrupt endometrium 3\Thicken cervical mucus RISKS / COMPLICATIONS Venous thrombo-embolism (VTE) Increased risk of VTE associated with COCP – related to dose of oestrogen and the type of progestogen. 10 fold increase in VTE risk in women taking OCP containing over 50mcg ethinyl oestradiol, 7 fold increase with 50mcg and 4 fold increase with < 50mcg Risk of VTE as follows: 1) Healthy woman not taking COCP - 5 / 100,000 2) Second generation COCP user - 15 / 100,000 3) Third generation COCP user (desogestrel or gestodene) - 25 / 100,000 4) Pregnancy - 60 / 100,000 Women with a family history of VTE, severe varicose veins, immobility or obesity should not be prescribed third generation COCP. COCP use associated with a decrease in antithrombin III and an increase in fibrinogen, prothrombin, factors VII, IX, X, XII. Low dose COCP (160/100 7. Severe diabetes mellitus 8. Focal migraine 9. Thrombophilia 10. 4 weeks before major surgery – 2 weeks after full mobility 11. Active liver disease 12. Severe inflammatory bowel disease 13. Undiagnosed genital tract bleeding / pregnancy 14. Acute porphyria / SLE 15. Uncorrected valvular heart disease 16. TIAs / cerebral haemorrhage 17. Altitude > 4500m 18. Trophoblastic disease – until HCG undetectable 19. Hyper-prolactinaemia (seek specialist advice) PRESCRIBING COCP Detailed history – exclude pregnancy / contra-indications Ensure most appropriate method for woman – compliance / life-style Weight / BP Discuss alternatives Discuss benefits (non-contraceptive) and risks Outline symptoms to look out for / minor side effects Teach pill-taking including missed pill advice Provide written information / help-line Make appointment for review COCP is NOT associated with an increased incidence of secondary amenorrhoea. Type of progestogen 23 1) NORGESTIMATE 19-Nortestosterone derivative Minimal androgenic activity; associated with a marked increase in SHBG Mono-phasic and tri-phasic combinations of EE and norgestimate offer contraceptive efficacy similar to other COCP with good cycle control. There is a favourable lipid profile and no effect on carbohydrate metabolism 2) DESOGESTREL 19-Nortestosterone derivative with minimal androgenic activity Contraceptive efficacy similar to other COCP. Favourable effect on lipid profile Evidence that COCP containing desogestrel or gestodene associated with an increased risk of VTE compared to those containing levonorgestrel 3) DROSPIRENONE Spironolactone derivative with some anti-androgenic effects Effect on VTE risk unknown Initial trend towards weight loss in early cycles is offset by a slight weight gain with long-term use (by cycle 13) Contraceptive efficacy is similar to other COCP Headache is the most frequently reported side-effect Hyperkalaemia is a theoretical possibility and therefore this pill is contra-indicated in renal and adrenal insufficiency and hepatic dysfunction Serum potassium should be checked during the first treatment cycle in women treated with NSAIDs, potassium sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, heparin, aldosterone antagonists and potassium supplements Delivery systems 1) INJECTABLE COMBINED CONTRACEPTIVE Contains 25mg medroxyprogesterone acetate + 5mg oestradiol cypionate Administered once monthly by intra-muscular injection (should be administered every 28-33 days) Contraceptive efficacy similar to long-term systemic or intra-uterine progesterone- only methods or the modern copper IUCD Has advantage over 3 monthly progesterone-only regimen as improved bleeding patterns and swifter return of fertility on discontinuation Majority of women (~75%) report satisfactory monthly bleeding patterns 2) CONTRACEPTIVE PATCH 20 cm squared trans-dermal system Contains 6.0mg norelgestromin, the primary active metabolite of norgestimate and 0.75mg ethinyl oestradiol Hormones released at a rate of 150mcg norelgestromin and 20mcg EE per day for 7 days during which the patch is worn. The patch is changed every 7 days for 3 weeks with a drug-free 7 day interval Patient compliance is significantly higher with the contraceptive patch compared to oral contraceptive pills 24 Pearl Index = 0.88. In comparative trials, efficacy better than COCP Side-effects similar to COCP with the addition of application site reaction. Nausea, headache, breast tenderness and break-through bleeding usually decrease by the third cycle in most women PROGESTERONE-ONLY PILLS Delivery systems 1. Progeaterone – only pills (POP) 2. Injettables 3. Implants Suitable for women with VTE, migraine, older women who smoke, women with hypertension, valvular heart disease, diabetes mellitus. Modes of action Suppress ovulation Reduce fallopian tube motility Reduce endometrial receptiveness Thicken cervical mucus and reduce sperm penetrability Pearl index - 1.2 / 100 woman year Efficacy increases with age and may be reduced if increased weight > 70kg – consider double dose. Main action is on cervical mucus with maximal effect 4 hours after dose Suppress ovulation in ~ 40%, this is unpredictable and varies between cycles resulting in irregular menstruation 10% - 15% of women have complete inhibition of ovarian activity and are amenorrhoeic. ~50% have regular ovulatory cycles with a normal luteal phase and a normal menstrual cycle. 35–40% have inconsistent suppression of ovarian activity with variable follicular development, and occasional ovulation often characterized by short or inadequate luteal phases. Associated with increased incidence of ovarian follicular cysts and increased risk of ectopic pregnancy (compared to COCP, but decreased compared to sexually active non-contraceptive user) Efficacy is reduced by hepatic enzyme-inducing drugs. Needs to be taken strictly on time to maximise efficacy. Readily reversible method of contraception – no effect on subsequent fertility, suited for breast-feeding mothers, older smokers, diabetics, hypertensives and avoids oestrogenic side-effects of COCP. Contra-indications 1. Pregnancy. 2. Undiagnosed vaginal bleeding. 3. Severe arterial disease. 4. Liver adenoma. 5. Porphyria. 6. after evacuation of molar pregnancy until HCG levels return to normal Starting routine 25 One tablet daily taken from day 1 of the cycle and taken continuously Should be taken at the same time every day and within 3 hours at the most Additional precautions not required when starting treatment When switching from COCP, start on the day following completion of COCP without a break (omit inactive tablets if ED regimen) Following delivery – start at any time after 3 weeks post-partum – risk of break- through bleeding If pill missed for more than 3 hours, additional precautions needed for 7 days Vomiting within 3 hours of dose or severe diarrhoea – additional precautions for 7 days after recovery Formulations 1. Etynodiol diacetate 500mcg 2. Norethisterone 350mcg 3. Levonorgestrel 30mcg 4. Norgestrel 75mcg INJECTABLES Depo-medroxyprogesterone acetate 150mg (depo-provera, every 84-90 days) Norethisterone oenanthate 200mg (Noristerat, every 8 weeks) Main effect is inhibition of ovulation Endometrial and cervical mucus effects also Pearl index0.25 – 0.5 / 100 woman years (depo-provera)0.4 – 2.0 / 100 woman years (Noristerat) Depo-provera commonly used in UK Menstrual irregularity is common – amenorrhoea becomes more likely with repeated doses (30% after 1st dose, 55% after 4th dose). Associated with a delay in return to normal fertility of about 8 months after last injection, may be as long as 24 months. Weight gain - ~6lb(35kg) in the first year Associated with lower risk of ectopic pregnancy (compared to POP but higher than COCP), PID, endometrial cancer. Menstrual blood loss is reduced with a reduction in iron deficiency anaemia and need for hystsrectomy in women with fibroids Heavy bleeding reported in women given depo-provera immediately after delivery and treatment should be delayed for at least 6 weeks. If the woman is not breast- feeding and has been counselled, may be administered within 5 days of delivery Depo-provera and osteoporosis There is evidence that depo-provera causes a significant reduction in bone mineral density. This effect may be more important in adolescents. This reduction appears to be partly reversible after discontinuation and resumption of ovarian activity 1) In adolescents, depo-provera should only be used after other methods have been considered and found to be unsuitable or unacceptable 2) In women with risk factors for osteoporosis, other methods should be Considered prior to use of depo-provera 3) In all women, careful re-evaluation of risks and benefits of treatment should be undertaken in those who wish to continue use for longer than 2 years IMPLANTS 26 Implanon (68mg etonorgestrel – ACTIVE METABOLITE OF DESOGESTREL) Pearl index 0-1 / 100 woman years Ovarian suppression, endometrial effects, cervical mucus thickening Lasts 3 years – efficacy may be lower during the third year in overweight women Rapid return of fertility – 90% of women ovulate within 30 days Associated with irregular bleeding initially, amenorrhoea rate ~ 50% Prolonged use of injectables / implants has raised concerns about hypo- oestrogenaemia in amenorrhoeic women and loss of bone mineral density although there are no data to substantiate these concerns Broad-spectrum antibiotics do not affect the efficacy of injectables / implants. Hepatic enzyme-inducing drugs may reduce efficacy and in long-term users, the dose interval of depo-provera should be reduced to 10 weeks INTRA-UTERINE CONTRACEPTION Act by preventing fertilisation and implantation. The progesterone releasing intra-uterine system has local progestogenic effects on the endometrium and cervical mucus. Disadvantages; are difficulties with insertion, pain and vaginal bleeding, risk of pelvic Infection, expulsion. CONTRAINDICATIONS Relative (WHO 3) I. Immunosupression including HIV / AIDS II. High risk of sexually transmitted disease III. Menorrhagia (except IUS) IV. Benign trophoblastic disease V. Up to 4 weeks post-partum - risk of perforation / expulsion VI. Ovarian cancer awaiting treatment Absolute (WHO 4) 1\ Current or recent sexually transmitted infection or PID, including post-partum and Post-TOP endometritis 2\ Distorted uterine cavity 3\ possible pregnancy 4\ undiagnosed vaginal bleeding 5\ Pelvic tuberculosis 6\ Cervical or endometrial cancer awaiting treatment 7\ Malignant gestational trophoblastic disease * Women at risk of bacterial endocarditis should have prophylactic antibiotics prior to IUCD fitting* The following conditions are NOT contraindications to the use of IUDs 1) Past history of PID or sexually transmitted disease if the woman is now at low risk 2) Previous ectopic pregnancy 3) Previous expulsion 4) Previous caesarean section 5) Nulliparity 6) Cervical intra-epithelial neoplasia 7) Past or current breast cancer 8) Uterine fibroids without distortion of the endometrial cavity THE MIRENA INTRA-UTERINE SYSTEM Contains 52mg Levonorgestrel released at the rate of 20mcg / day. The frame is rendered radio-opaque by impregnation with barium sulphate. 27 Licensed for contraception for 5 years. Levonorgestrel – induced endometrial changes are established within three cycles with atrophy of endometrial glands, decidualisation of the stroma, inactivation of the epithelium, supression of spiral arterioles and an inflammatory response. The endometrium becomes unresponsive to oestrogen. After removal, endometrial morphology returns to normal with menstruation within 30 days NON-CONTRACEPTIVE USES / BENEFITS i. Management of menorrhagia - Reduction in menstrual blood loss of up to 97% after 12 months of use with an increase in serum ferritin and Hb concentrations. 35% amenorrhoea rate at 1 year ii. Dysmenorrhoea - There is evidence that this may be improved. iii. Progestogenic opposition for oestrogen replacement therapy / oestrogen therapy for PMS iv. Low rate of ectopic pregnancy (0.02/100 woman years compared to 0.25/100 woman years for the Nova T and 1.2-1.6/100 woman years for sexually active women not using contraception). v. Protection against PID – thickening of cervical mucus, inactivation of the endometrium and reduced bleeding. vi. Management of endometrial hyperplasia vii. Some evidence that the incidence of uterine fibroids and their growth is reduced viii. Cost-effectiveness – compare to cost of hysterectomy / medical treatment for menorrhagia. SIDE-EFFECTS / COMPLICATIONS a) Difficulties with insertion – especially in nulliparous women, cervical dilatation required under para-cervical block / NSAID. b) Irregular bleeding – takes 3 months for endometrial atrophy – good counselling required prior to insertion c) Increased incidence of functional ovarian cysts compared to copper IUD users d) Amenorrhoea – unless appropriately counselled, some women may regard this as abnormal e) Progestogenic side-effects – oedema / headache / breast tenderness / acne – subside after a few months f) Expulsion - commonly occurs during first month following insertion. CONTRA-INDICATIONS 1. Pregnancy 2. Undiagnosed genital tract bleeding 3. Severe distortion of the uterine cavity 4. Acute or recurrent PID 5. Leukaemia 6. Valvular heart disease 7. Severe arterial disease 8. Liver disease 9. Sensitivity to levonorgestrel 10. Histories of ovarian cysts / thrombo-embolic disease are relative contra-indications. COMPLICATIONS OF IUCD USE Expulsion Most occur in the first year, and especially in the first 3 months. 28 Increased risk of expulsion in women with heavy painful periods, with insertion within 6 weeks post-partum, previous expulsion and with inexperienced operator. Perforation Risk 1.2 / 1000 insertions Pregnancy Remove device gently if possible, as soon as pregnancy is diagnosed - reduces the risk of spontaneous miscarriage by 50%. Exclude ectopic pregnancy (risk 1:25 with IUCD). Pelvic infection Six fold increase in risk of developing PID in the first 20 days following insertion compared with any other time Thereafter the risk of infection remains constant at 1.4 / 1000 women Increased menstrual loss Abdominal pain / dysmenorrhoea PERSONA Natural family planning – measures levels of LH and oestron-3-glucuronide in early morning urine. Needs to be programmed for three months (test urine for 16 days in the first month and 8 days in subsequent months) before device can be relied upon. Not suitable for the following groups of women: 1- Cycle length 35 days 2- PCOS 3- Breastfeeding 4- Menopausal symptoms 5- Women taking hormonal medication Needs to be re-programmed after post-coital contraception Failure rate ~ 6/100 woman years with perfect use. Much higher for „typical‟ user. FSRH- Emergency Contraception:Updated January 2012 Methods: CU- IUD (1st line), levonorgestrel (LNG), ulipristal acetate (UPA). IUD & UPA: up to 5 days. LNG isn‟t licenced beyond 3 days despite demonstrated efficacy up to 4 days. If woman needs to continue CC after oral EC; offer CHC (excluding co-cyprindiol), POP or implant + inform to do Preg-Test after 3 wks after UPSI (unprotected sexual intercource) has occurred. DMPA should be started immediately only if other methods are not appropriate or acceptable, because it should ideally be offered only after pregnancy can be excluded. Following administration of LNG, women continuing to use a hormonal method of contraception should be advised to use additional contraceptive precautions for 7 days (2 days for POP, 9 days for Qlaira®). Following administration of UPA, women continuing to use a hormonal method of contraception should be advised to use additional contraceptive precautions for 14 days (9 days for POP, 16 days for Qlaira). 29 Women taking liver enzyme-inducing drugs (or who have stopped taking this medication within the last 28 days) should be advised that a Cu-IUD is the only method of EC not affected by these drugs. They should be advised not to use UPA during or within 28 days of stopping taking this medication. Women taking liver enzyme-inducing drugs, including post-exposure HIV prophylaxis after sexual exposure (or who have stopped within the last 28 days), and who decline or are not eligible for a Cu-IUD, should be advised to take a dose of 3 mg LNG (two Levonelle ® tablets) as soon as possible within 120 hours of UPSI (outside the product licence). The efficacy of LNG after 96 hours is uncertain. Women should be advised not to use UPA if they are currently taking drugs that increase gastric pH (e.g. antacids, histamine H 2 antagonists and proton pump inhibitors). Women should be advised to seek medical advice if they vomit within 2 hours of taking LNG or 3 hours of UPA administration. A repeat dose of the same method or a Cu-IUD may be offered if appropriate. LNG can be used more than once in a cycle or for a recent indication even if there has been an earlier episode of UPSI outside the treatment window (>120 hours). UPA isn‟t currently supported for such use or concomitantly with LNG. The CEU advises that if further UPSI occurs within 12 hours of a dose of LNG, further EC treatment is not required. It is not known if UPA reduces the efficacy of LNG or how long after UPA administration any such interaction has an effect. Women choosing a Cu-IUD for EC may opt to continue using the Cu-IUD for ongoing contraception. If the woman does not require contraception or prefers another method, the Cu-IUD can be removed after pregnancy has been excluded and providing there has been no UPSI in the 7 days prior to removal and guidance for switching methods is followed. No studies have specifically looked at the effect of body weight on the efficacy of oral EC. contraindication : LNG: there are no medical contraindications to LNG, including breastfeeding. UPA: severe uncontrolled asthma, hepatic dysfunction, hereditary problems of galactose intolerance, the lactase deficiency or glucose-galactose malabsorption and peptic ulcer. Postnatal Sexual and Reproductive Health Available evidence suggests that use of progestogen- only contraception while breastfeeding does not affect breast milk volume. Currently insufficient evidence for COCS. Progestogen-only contraception has been shown to have no effect on infant growth. Women may be advised that if they are 48 hrs) OR starting the pack two or more days late (more than 48 hours late). If you have missed one pill, anywhere in the pack: Take the last pill you missed now even if it means taking two pills in one day Continue taking the rest of the pack as usual No additional contraception needed Take your 7-day break as normal. If you have missed two or more pills (i.e. more than 48 hours late), anywhere in the pack: 31 Take the last pill you missed now even if it means taking two pills in one day Leave any earlier missed pills Continue taking the rest of the pack as usual and use an extra method of contraception for the next 7 days EC should be considered if unprotected sex occurred in the pill-free interval or in the first week of pill-taking. OMIT THE PILL-FREE INTERVAl If pills are missed in the third week. Qlaira ®: 20 µg estradiol valerate/dienogest containing pill (quadriphasic pill). -Missed white tablet? (2 tablets at the end of the wallet): you do not need to take it later. -If you have forgotten any of the active tablets in a wallet, and you have no bleeding at the end of a wallet, you may be pregnant. Contact your doctor before you start the next wallet. (45 days in case of micronor) Missed 1 micronor? Take the most recently misse pill [but leave earlier one if > 1] & take the next one on time. (ie may be 2 pills on same night) + 2days extra protection. If you lose a pill, just take a pill from a spare strip. Then take all the other pills from your current strip as usual. Marvilon(Desogestrel 150 micrograms +Ethinyl estradiol 30 micrograms): Missed pill roles apply if > 12hrs. Take the most recently misse pill [but leave earlier one if > 1] & take the next one on time. (Ie may be 2 pills on same night). 32 If you start a new strip of pills late, or make your “week off” longer than seven days EC + 7d extra protection. If you lose a pill, either takes one from a spare strip; or take the last pill of the strip in place of the lost pill & continue. Your cycle will be one day shorter. For POP & COCs: If you are sick within the window period, take a spare pill. If sickenss > window, follow missed pil roles. Cerazette: desogestrel (75 microgram) < 12hrs, take as soon you remember & no more action needed. > 12 hrs: Take a tablet as soon as you remember and take the next one at the usual time (This may mean taking two in one day) + EC + 7days extra protection. Yasmin: (0.030 milligrams ethinylestradiol and 3 milligrams drospirenone); 21 tablets. Missed 1 pill (or > 12hrs): 1st weak: Take the forgotten tablet as soon as you remember + next one on time +EC + 7 days extra protections. 2nd wk: as above but NO extra or EC unless > 1pill missed. 3rd wk: NO extra prec or EC if you do one of the following: either take the forgotten tablet as soon as you remember & slip pill free period; OR stop the tablets and go directly to the tablet-free period. For COCs: You can also start the pill up to, and including, the fifth day of your period and you will be protected from pregnancy immediately. EFFECTS OF CONTRACEPTION ON FUTURE FERTILITY(REVERSE FERTILITY Combined oral contraceptive pill Prompt return to ovulation with 70% of women ovulating in the first cycle and 98% by the third cycle Reduced risk of PID due to progestogen Reduced risk of ectopic pregnancy Higher Hb and ferritin levels may be associated with improved reproductive outcomes No effect on early pregnancy loss, sex ratio or congenital anomalies if inadvertently taken in early pregnancy 1% of women would remain amenorrhoeic 6 months after stopping the pill – similar to rate of secondary amenorrhoea in general population. Women who lose weight on the pill are at increased risk. If persists for over 6 months, investigation warranted to exclude PCOS, hyperprolactinaemia, premature ovarian failure Progesterone-only methods Prompt return to normal fertility with POP and implants POP – less protection from ectopic pregnancy than the combined pill and may be associated with a slight increase in risk Implanon – return to normal ovulation within 6 weeks Depo-progestogens: No permanent impact on fertility Ovulation returns on average 4-5 months following last injection with a median conception time of 5-7 months 33 Women should be warned that conception may be delayed for up to 2 years after the last injection and alternative methods should be used in women who may wish to get pregnant sooner Thought to be due to delayed metabolism of the drug from micro-crystalline deposits in muscle tissue IUCD Risk of PID confined to the first 3 weeks following insertion and thereafter related to life-style Levonorgestrel releasing IUS associated with lower risk of ectopic pregnancy compared to copper IUCD Barrier methods Associated with lower risk of PID No evidence that spermicides are associated with an increased risk of congenital anomalies 34 CONTRACEPTIVE USE 35 36 37 38 39 41 41 42 43 LONG-ACTING REVERSIBLE CONTRACEPTION Counselling and provision of information Women requiring contraception should be given information and offered all methods including LARC that will enable them to choose a method and use it effectively. This information include: efficacy duration risks and side effects non-contraceptive benefits the procedure for initiation and removal/discontinuation when to seek help while using the method. Training of healthcare professionals in contraceptive care Healthcare professionals should be competent to: help women to consider and compare the pros and cons of all methods relevant to their individual needs manage common side effects and problems. Contraceptive providers who do not provide LARC should have mechanism for referring women for LARC. Healthcare professionals providing intrauterine or subdermal contraceptives should receive training to develop and maintain the relevant skills to provide these methods. Cost effectiveness LARC methods are more cost effective than the COC even at 1 year of use. IUDs, the IUS and the implant are more cost effective than injectable contraceptives. Increasing the use of LARC will reduce unwanted pregnancies. Informed consent for special groups Information should take into account the woman‟s needs. Be aware of the law on providing contraceptives for young and people with learning disabilities. If a woman is unable to understand and take responsibility for decisions about contraception, carers and others should meet to agree a care plan. 44 Appendix A: Features of the LARC methods to discuss with women 45 IUD IUS DMPA IMP 46 47 Choice of method for different groups of women All LARC methods are suitable for: nulliparous women breastfeeding women who have had an abortion – at time of abortion or later women with BMI > 30 women with HIV – encourage safer sex women with diabetes women with migraine with or without aura – all progestogen-only methods may be used women with contraindication to oestrogen Choices for adolescents IUD, IUS, implants: no specific restrictions to use DMPA: care needed; use only if other methods unacceptable or not suitable2 Choices for women more than 40 years old IUD, IUS, implants: no specific restrictions to use 48 DMPA: care needed, but generally benefits outweigh risks Choices for women post-partum, including breastfeeding IUD, IUS: can be inserted from 4 weeks after childbirth (see page 9) DMPA, implants: any time after childbirth Choices for women taking other medication IUS, DMPA: no evidence that effectiveness of other medication reduced Implants: not recommended for women taking enzyme-inducing drugs Choices for women with epilepsy IUD, IUS, DMPA: no specific contraindications; DMPA use may be associated with reduced seizure frequency Implants: not recommended for women taking enzyme-inducing drugs Choices for women at risk of sexually transmitted infection (STI) IUD, IUS: tests may be needed before insertion DMPA, implants: no specific contraindications Provide advice on safer sex Practical details of LARC methods Copper intrauterine devices and the intrauterine system Assessing and managing STIs and other infections Before inserting an IUD or IUS, test for: Chlamydia trachomatis and Neisseria gonorrhoeae in women at risk of STIs For woman at increased risk of STIs, give prophylactic antibiotics before inserting an IUD or IUS if testing has not been completed. For women with risks of uterine or systemic infection, arrange investigations and give appropriate prophylaxis or treatment before inserting an IUD or IUS. When fitting The risk of uterine perforation is related to the skill of the healthcare professional. IUDs:the most effective IUDs contain at least 380 mm2 of copper and have banded copper on arms. Provided that the woman is not pregnant, an IUD or IUS may be inserted: at any time during the cycle (but, for the IUS, if the woman is amenorrhoeic or it is > 5 days since her period started, she should use barrier contraception for 7 days after insertion) immediately after first or second trimester abortion from 4 weeks post-partum, irrespective of the mode of delivery. If the woman has epilepsy, seizure risk increase at the time of fitting an IUD or IUS. Women with a history of venous thromboembolism (VTE) may use the IUS. Managing problems For heavier and/or prolonged bleeding associated with use of an IUD: Treat with NSAIDs and tranexamic acid Suggest changing to the IUS if the woman finds bleeding unacceptable. If Actinomyces-like organisms are seen on a cervical smear: assess for pelvic infection, remove the IUD or IUS if there are signs of infection. If a woman becomes pregnant with an IUP, remove the IUD or IUS before 12 weeks‟ gestation. Injectable contraceptives When administering Given by deep intramuscular injection into the gluteal or deltoid muscle or the lateral thigh. Provided that the woman is not pregnant, use may be started: Up to the 5th day of the cycle without the need for additional contraceptives 49 After the 5th day of the cycle, with barrier contraception for the first 7 days after injection Immediately after first or second trimester abortion. At any time post-partum. Managing problems DMPA may be given up to 2 weeks late without the need for additional contraceptives. Treat persistent bleeding associated with DMPA with mefenamic acid or ethinylestradiol. When considering DMPA use beyond 2 years, review the woman‟s clinical situation, discuss the benefits and risks, and support her choice. There is no evidence of congenital malformation to the fetus if pregnancy occurs during DMPA. Implants Inform women that etonogestrel implants have a very low failure rate (less than 1 pregnancy per 1000 implants fitted over 3 years). Inform women that vaginal bleeding patterns are likely to change while using an etonogestrel implant. Vaginal bleeding may stop, become more or less frequent, or be prolonged during implant use. Inform women that dysmenorrhoea may reduce during etonogestrel implant use. Inform women that there is no evidence showing a delay in return to fertility after an etonogestrel implant is removed. Inform women that complications with etonogestrel implant insertion and removal are uncommon. (Possible complications are listed in the summary ofproduct characteristics.) When fitting Provided that the woman is not pregnant, Implanon may be inserted: At any time (but use barrier methods for first 7 days if the woman is amenorrhoeic or it is more than 5 days since menstrual bleeding started) Immediately after abortion in any trimester At any time post-partum. Managing problems Treat irregular bleeding with mefenamic acid or ethinylestradiol. Remove the implant if a woman becomes pregnant and continues with the pregnancy, although there is no evidence of a teratogenic effect. 51 MANAGEMENT OF UNSCHEDULED BLEEDING IN WOMEN USING HORMONAL CONTRACEPTION 51 SUMMARY FOR THE MANAGEMENT OF WOMEN USING HORMONAL CONTRACEPTION PRESENT WITH UNSCHEDULED BLEEDINGP RE-METHOD COUNSELLING 1. advise women Before starting hormonal contraception about the expected bleeding patterns, both initially and in the longer term. INITIAL MANAGEMENT 2. A clinical history should be taken from women with unscheduled bleeding to identify the possibility of an underlying cause. 3. women with unscheduled bleeding who are at risk of STIs (aged 8 trailing coils (i.e. coils protruding inside the uterine cavity). unusual post-procedural pain. if X-ray or TVUSS is equivocal or unsatisfactory. The confirmatory imaging test should be undertaken 3 months after the insertion. Women who do not attend for confirmatory testing should be informed that they need to continue using additional contraception until tubal occlusion is confirmed. Hysteroscopic sterilisation-Failure: intra-fallopian micro-insert has a low associated failure rate which is approximately 1 in 500 at 5 years Limited available evidence suggests that intra-fallopian micro-insert insertion can be carried out in combination with endometrial ablation. C/I to Hysteroscopic sterilisation (by manuafcturer): uncertainty about ending fertility pregnancy or suspected pregnancy delivery or abortion of a second-trimester pregnancy 38°C abnormal vaginal bleeding (intermenstrual, postcoital) deep dyspareunia positive cervical excitation adnexal tenderness with or without a palpable mass. laparoscopy may also lack sensitivity, but enables: sampling from the fallopian tubes and the pouch of Douglas provide information on the severity of the condition exclude alternative pathologies. Transvaginal ultrasound scanning may be helpful When supported by power Doppler, it can identify inflamed and dilated tubes and tubo-ovarian masses. May differentiate PID from acute appendicitis. There is insufficient evidence to support its routine use. CT and MRI can assist in diagnosis but the evidence is limited. Blood leucocytosis, elevated ESR or C-reactive protein support the diagnosis and severity of the disease. leucocytosis on a wet-mount vaginal smear lack sensitivity as it is also found in isolated lower genital infection. There is insufficient evidence to support endometrial biopsy as a routine diagnostic test. 2) Microbiological Women with suspected PID should be tested for gonorrhoea and chlamydia. A positive result support the clinical diagnosis of PID. Gonorrhea and chlamydia should be tested with an endocervical specimen for: 1. Culture (direct inoculation on to a culture plate) 2. Nucleic acid amplification test (NAAT). women at high risk of gonorrhea: 1. the woman‟s partner has gonorrhoea, 2. clinically severe disease, 3. sexual contact abroad. 66 Additional sample from the urethra is recommended if NAAT is not available to enforce the diagnosis. Screening is not yet justified for other organisms, including M. genitalium because of limited information on prevalence, natural history, treatment and cost effectiveness. Starting treatment 1) Management in the outpatient setting for mild or moderate PID Interactions between antibiotic and hormonal contraception and other medications should be assessed. Antibiotic should be commenced as soon as the diagnosis is suspected. Outpatient antibiotic regimens: 1. oral ofloxacin 400 mg twice daily + oral metronidazole 400 mg twice daily for 14 days. 2. intramuscular ceftriaxone 250 mg single dose + oral doxycycline 100 mg twice daily + metronidazole 400 mg twice daily for 14 days. Cefoxitin is better for the treatment of PID than ceftriaxone but is not easily available in the UK. Metronidazole may be discontinued with mild or moderate PID if not tolerate. Alternative treatments with less strong evidence than above: 1. intramuscular ceftriaxone 250 mg immediately, followed by azithromycin 1 g/week for 2 weeks. Women should be counseled verbally and written informations provided their condition and the long-term implications for their health and their partner(s) including: Treatment and its possible adverse effects Repeat episodes of PID are associated with high increase in the risk of infertility Future use of barrier contraception will significantly reduce the risk of PID The need for tracing of sexual partners Clinically more severe disease is associated with a greater risk of sequelae the earlier treatment is given the lower the risk of future fertility problems. 2) Management in the hospital setting for severePID Indication for admission: Surgical emergency cannot be excluded Clinically severe disease Tubo-ovarian abscess PID in pregnancy Incompliance or lack of response to oral therapy Hospital antibiotic regimens based on IV therapy which should be continued until 24 hours after clinical improvement and followed by oral therapy: 1. ceftriaxone 2 g by IV daily + doxycycline 100 mg IV twice daily, followed by oral doxycycline 100 mg twice daily + oral metronidazole 400 mg twice daily for a total of 14 days. 2. clindamycin 900 mg IV three times daily + gentamicin IV followed by either: oral clindamycin 450 mg four times daily to complete 14 days OR oral doxycycline 100 mg twice daily plus oral metronidazole 400 mg twice daily to complete 14 days. Gentamicin should be given as a 2 mg/kg loading dose followed by 1.5 mg/kg three times daily or a single daily dose of 7 mg/kg/day. 3. Ofloxacin 400 mg IV twice daily + metronidazole 500 mg IV three times daily for 14 days. 3) Treatment in pregnancy and in young women A pregnancy test should be done in all women suspected of having PID to exclude an ectopic pregnancy. 67 When the risk of EP clinically is high, repeat pregnancy test 21 days after the last unprotected intercourse. The risk of giving any of the antibiotic regimens in early pregnancy(before a positive pregnancy test) is low. PID is rare in women with an intrauterine pregnancy except in the case of septic abortion. Drugs known to be toxic in pregnancy, such as tetracyclines, should be avoided. A combination of cefotaxime, azithromycin and metronidazole for 14 days may be used. Ofloxacin should be avoided, in young women, when bone development is still occurring. Doxycycline can be safely used over the age of 12 years. 4) Treatment in a woman with an intrauterine contraceptive device Remove IUD in women presenting with PID, especially if symptoms not resolved within 72 hrs. 5) Other modes of treatment Surgical treatment in severe cases or where there is clear evidence of a pelvic abscess. Identify the origin of the abscess, as the abscess may have arisen from the appendix or colon. Ultrasound-guided aspiration of pelvic fluid collections is less invasive and equally effective. Management of sexual partner(s) of women with PID Referral woman and her partner to a genitourinary medicine/sexual health clinic to facilitate contact tracing and infection screening. With STIs, the sexual partner(s) should be contacted and offered advice and screening. Tracing of sexual partners should be within a 6- month period of the onset of symptoms. The risk of STIs in the partners of women with PID is high. Women should avoid intercourse until they and their partner complete treatment course. Review of women with PID In the outpatient setting, review at 72 hours, particularly those with a moderate or severe presentation. Further review 4–6 weeks after therapy may be useful to ensure: Adequate response to treatment Compliance with oral antibiotics Screening and treatment of sexual contacts Awareness of the significance of PID and its sequelae Negative pregnancy test, if clinically indicated. Repeat testing for chlamydia and gonorrhoea in: persisting symptoms, tracing of sexual contacts indicate the persisting or recurrent infection. Women who are infected with HIV Women with PID who are also infected with HIV should be treated with same antibiotic regimens Women with HIV should be managed in conjunction with their HIV physician. Contraception options and PID Women on hormonal contraception presenting with breakthrough bleeding should be screened for genital tract infection, especially C. trachomatis. COC pill is protective against symptomatic PID. IUD only increases the risk of developing PID in the first few weeks after insertion. If a woman is at risk of future PID and requests an IUD for contraception, the LNG- IUS is appropriate. 68 ENDOMETRIOSIS Purpose and scope Endometriosis is defined as the presence of endometrial-like tissue outside the uterus, which induces a chronic, inflammatory reaction. The condition is predominantly found in women of reproductive age. The associated symptoms can impact on general physical, mental and social wellbeing. Some women have no symptoms at all and finding endometriosis in them may be coincidental. Pain persist despite adequate medical and/or surgical treatment of the disease may suggest another source of pain, such as adenomyosis, interstitial cystitis or musculoskeletal (pelvic floor muscle spasm). In such conditions, a multidisciplinary approach involving pain clinic and counselling should be considered. Localisation and appearance of endometriosis The most commonly affected sites are pelvic organs and peritoneum, bowel or lungs are occasionally affected. The extent of the disease varies from a few, small lesions to large, ovarian endometriotic cysts. There can be extensive fibrosis in structures such as the uterosacral ligaments and adhesion causing marked distortion of pelvic anatomy. Disease severity is assessed by describing the findings at surgery or quantitatively by a classification system. Endometriosis typically appears as: 1. superficial „powder-burn‟ or „gunshot‟ lesions on the ovaries, serosal surfaces and peritoneum: 2. black, dark-brown or bluish lesions, nodules or small cysts containing old haemorrhage surrounded by a variable extent of fibrosis. 3. Atypical or „subtle‟ lesions, including red implants (petechial, vesicular, , red flame-like) and serous or clear vesicles. 4. white plaques or scarring and yellow-brown peritoneal discoloration of the peritoneum. 5. Endometriomas containing thick chocolate fluid often adherent to the peritoneum of the ovarian fossa and the surrounding fibrosis may involve the tubes and bowel. Deep infiltrating nodules extend more than 5 mm beneath the peritoneum and may involve the uterosacral ligaments, vagina, bowel, bladder or ureters. The depth of infiltration is related to the type and severity of symptoms. Severe cases of endometriosis should be referred to units with multi-disciplinary context including advanced laparoscopic surgery. Diagnosis 1) History and clinical examination: Endometriosis can cause the following symptoms: Severe dysmenorrhoea Deep dyspareunia Chronic pelvic pain Ovulation pain Cyclical or perimenstrual symptoms, such as bowel or bladder, with or without abnormal bleeding Infertility 69 Chronic fatigue Diagnosis on the basis of symptoms alone is difficult because there is overlap with other conditions such as IBS and PID. So there is often a delay up to 12 yrs between symptom onset and a definitive diagnosis. Deeply infiltrating nodules are most reliably detected when examination is performed during menstruation. Finding pelvic tenderness, fixed retroverted uterus, tender uterosacral ligaments or enlarged ovaries is suggestive of endometriosis. Palpable nodules on the uterosacral ligaments or in the pouch of Douglas or visible lesions seen in the vagina or on the cervix is more certain for diagnosis. 2) Laparoscopy Visual inspection of the pelvis at laparoscopy is the gold standard investigation. Ideal practice is to record the findings on video or DVD. At laparoscopy, deeply infiltrating endometriosis may appear as minimal disease,. 3) Histological examination Visual inspection is usually adequate but histological confirmation of at least one lesion is ideal. Positive histology confirms the diagnosis of endometriosis; negative histology does not exclude it. In cases of ovarian endometrioma > 3 cm in diameter and deeply infiltrating disease, histology should be obtained to to exclude rare instances of malignancy. 4) Imaging TVS has limited value in diagnosing peritoneal endometriosis but it is a useful for ovarian endometrioma. 5) Serum CA125 Serum CA125 levels may be elevated in endometriosis. Compared with laparoscopy, serum CA125 has no value as a diagnostic tool, sensitivity 28-47%. Empirical treatment of pain symptoms without a definitive diagnosis Empirical treatment for pain presumed to be caused by endometriosis without a definitive diagnosis includes: counselling, adequate analgesia, progestogens or COC. Medical treatment of endometriosis-associated pain 1) NSAIDs: no conclusive evidence to show whether NSAIDs(specifically naproxen)are effective for pain 2) Hormonal treatment: Suppression of ovarian function for 6 months reduces endometriosis-associated pain. COC, danazol, gestrinone, Depo-Provera and GnRH are equally effective but adverse effect and cost differ. medical treatment does not always provide complete pain relief and Symptom recurrence is common. Pilot data suggesting that the aromatase inhibitor, letrozole, may be effective although it is associated with significant bone density loss. 3) LNG-IUS: appears to reduce endometriosis-associated pain with symptom control over 3 years. How long should treatment be continued? Duration of therapy should be determined by the choice of drug, response to treatment and adverse effect. The combined oral contraceptive and Depo-Provera can be used long term but the use of danazol and GnRH agonists is usually restricted to 6 months. GnRH associated with loss of up to 6% of bone density in 6 months which not entirely reversible. Conversely, danazol produces an increase in bone mineral density. 71 The use of a GnRH with „add-back‟ therapy(HRT or tibolone)protects against bone mineral density loss. Preoperative assessment What investigations are recommended to assess disease extent? If there is clinical evidence of deeply infiltrating endometriosis Consider performing MRI or ultrasound (transrectal and/or TVS and/or renal), with or without IVP and barium enema, to map the extent of disease. How should suspected severe/deeply infiltrating disease be managed? The management of severe/deeply infiltrating endometriosis is complex. If multiple organs are suspected or diagnosed referral to a centre with a multidisciplinary context, including advanced laparoscopic surgery and laparotomy, is strongly recommended. Surgical treatment of endometriosis-associated pain 1) Ablation of endometriotic lesions reduces endometriosis-associated pain compared with diagnostic laparoscopy. 2) Laparoscopic uterine nerve ablation by itself does not reduce endometriosis-associated pain. 3) Radical surgery removing the entire lesions in severe and deeply infiltrating disease reduces pain. If a hysterectomy is performed, all visible endometriotic tissue should be removed at the same time. Bilateral salpingo-oophorectomy may result in improved pain and a reduced chance of future surgery. 4) There is insufficient evidence to justify the use of preoperative or postoperative hormonal treatment. 5) The ideal HRT regimen after bilateral oophorectomy is unclear and should be discussed on an individual basis. HRT has small risk of recurrent disease. Adding progestogen is unnecessary but may protect against the unopposed action of oestrogen on any residual disease. Treatment of endometriosis-associated infertility 1) Suppression of ovarian function to improve fertility in minimal–mild endometriosis is not effective and There is no evidence of its effectiveness for moderate-severe disease. 2) Ablation of endometriotic lesions plus adhesiolysis to improve fertility in minimal–mild endometriosis is effective and the role of surgery in improving pregnancy rates for moderate-severe disease is uncertain. 3) Laparoscopic cystectomy for ovarian endometriomas is better than drainage and coagulation. Subsequent spontaneous pregnancy rates in women who were previously subfertile are also improved. 4) Postoperative hormonal treatment has no beneficial effect on pregnancy rates after surgery. 5) Tubal flushing with oil-soluble media improve pregnancy rates in endometriosis- associated infertility. Assisted reproduction in endometriosis 1) IUI plus gonadotrophins improves fertility in minimal to mild endometriosis. 2) IVF is appropriate, if tubal function is compromised, male factor infertility, and/or other treatments failed. 3) Laparoscopic ovarian cystectomy before IVF is recommended for endometriomas ≥ 4 cm in diameter. to confirm the diagnosis histologically; reduce the risk of infection; improve access to follicles, and improve ovarian response and prevent endometriosis progression. 71 4) GnRH agonist for 3–6 months before IVF in endometriosis increases the rate of clinical pregnancy. Coping with disease complementary therapies The role of complementary therapies in relieving endometriosis-associated pain is unclear. There is evidence from two systematic reviews suggesting that high frequency TENS, acupuncture, vitamin B1 vitamin E and magnesium may help to relieve dysmenorrhoea. What is the role for patient support groups Patient self-help groups can provide invaluable counselling, support and advice. 72 PREVENTING ENTRY LAPAROSCOPIC INJURIES Purpose and scope serious complications occur in about 1/ 500 cases. Laparoscopic injuries frequently occur during the blind insertion of needles, trocars and cannulae. Background One of the difficulties of bowel damage with laparoscopic surgery is that it may not be immediately recognized and present some time later or after discharge from hospital. Incidence of complications The rate of major complications is 1.4/1000 procedures: intestinal injuries 0.6/1000, urological injuries 0.3/1000 and vascular injuries 0.1/1000. Assessment, counselling and consent Women must be informed of the risks and potential complications associated with laparoscopy. The risks of the entry technique used: injury to the bowel, urinary tract major blood vessels, Frequent risks include wound bruising shoulder-tip pain wound gaping wound infection later complications associated with the entry ports: hernia formation. Women at increased risks are: obese or significantly underweight previous midline abdominal incisions, peritonitis or inflammatory bowel disease. Safe surgical techniques and training Surgeons undertaking laparoscopic surgery : should have appropriate training, supervision and experience. should be familiar with the equipment, instrumentation and energy sources they intend to use. should ensure that nursing staff and surgical assistants are appropriately trained for their roles. Laparoscopic entry techniques The effective way to reduce entry complications is to optimize insertion of the primary trocar and cannula. Gynaecologists favour the closed or Veress needle entry technique. The RCS of England recommends the open (Hasson) approach in all circumstances. 1) Veress needle (closed) laparoscopic entry technique the primary incision for laparoscopy should be vertical from the base of the umbilicus. Care should be taken not to enter the peritoneal cavity. The Veress needle should be sharp, with a good and tested spring action. A disposable needle is recommended. The operating table should be horizontal at the start of the procedure. The abdomen is palpated to check for any masses and for the position of the aorta before insertion. 73 The lower abdominal wall should be stabilised to allow right angles insertion of the Veress needle. Two audible clicks are usually heard as the fascia and the peritoneum are penetrated. Excessive lateral movement of the needle should be avoided, as this may convert a small needlepoint injury into a more complex tear. An intra-abdominal pressure of 20–25 mmHg should be used before inserting the primary trocar. Pressure should be reduced to 12–15 mmHg once the insertion of the trocars is complete. This gives adequate distension for operation and allows the anaesthetist to ventilate the patient effectively. Where should the primary trocar be inserted ? The primary trocar should be inserted in a controlled manner at 90 degrees in the base of the umbilicus. Once the laparoscope has been introduced it should be rotated 360degrees to check for any adherent bowel, haemorrhage, damage or retroperitoneal haematoma. If there is concern that the bowel may be adherent to umbilicus, the primary trocar site should be visualised from a secondary port site. After completion, use the laparoscope to check that there are no injury by visual control during removal. 2) Hasson (open) entry technique Confirm the peritoneum is opened by visualising bowel or omentum before inserting the blunt tipped cannula. After the initial skin incision. Fascial edges are incised and held by a lateral stay suture on either side. The peritoneum is opened, The fascial sutures are then pulled into the suture holders on the cannula to produce an airtight seal. Gas is insufflated directly through the cannula to produce the pneumoperitoneum. The blunt trocar is withdrawn only after the abdomen is partially distended. At the end, the fascial defect should be closed using the stay sutures to minimize herniation. Alternative entry techniques 1) Direct trocar insertion Direct trocar insertion is an acceptable alternative method. This technique overcome difficulty associated with grasping distended abdominal wall by gas. with experienced hands it is the most rapid method of entry and can be safely used with selected cases. 2) Alternative entry devices Several ingenious devices introduced to minimize the risk during primary trocar insertion. These include visual access systems, radially expanding trocars and 2nd generation Endotip systems. 3) Alternative sites for primary trocar or Veress needle insertion Palmer‟s point is the preferred alternative site, except in previous surgery in this area or splenomegaly. It is 3 cm below the left costal margin in the mid-clavicular line. Adhesion at umbilicus is 50% after midline laparotomy and 23% after low transverse incision. 2–5 mm endoscope is used through Palmer‟s point to inspect the undersurface of umbilicus. 74 If this is free of adhesions, trocar and cannulae can be inserted under direct laparoscopic vision. If there are adhesions, it can be dissected via secondary ports in the lower left abdomen or an alternative entry site can be selected visually. Other sites have been tried but, are to be avoided(Suprapubic insertion of the Veress needle, Instillation of gas through the uterine fundus with the Veress needle, entry through the posterior fornix). Secondary ports How should secondary ports be inserted? Should be inserted under direct vision perpendicular to skin, with 20–25 mmHg pneumoperitoneum. Inferior epigastric vessels should be visualized laparoscopically to enter away from the vessels. The deep epigastric arteries and the venae comitantes running beside them can be visualised just lateral to the lateral umbilical ligaments (the obliterated hypogastric arteries) Once the tip of the trocar has pierced the peritoneum it should be angled towards the anterior pelvis under careful visual control until the sharp tip has been removed. Secondary ports must be removed under direct vision. Any non-midline port over 7 mm and any midline port greater than 10 mm requires formal sheath closure to avoid the occurrence of port site hernia. The woman who is obese Hasson technique or entry at Palmer‟s point are recommended for the primary entry. If Veress needle is used, care must taken to ensure that the incision is made at the base of the umbilicus. The woman who is very thin Hasson technique or entry at Palmer‟s point are recommended for the primary entry. Women at highest risk of vascular injury are: the young, thin, nulliparous women with well developed abdominal musculature. The aorta may lie less than 2.5 cm below the skin in these women. 75 MANAGEMENT OF PREMENSTRUAL SYNDROME Introduction 5% of women experience severe premenstrual symptoms including: 1) Psychological symptoms: mood swings, depression, anxiety, irritability, loss of confidence, feeling out of control, 2) physical symptoms: headaches, bloating , mastalgia. 3) behavioural symptoms: reduced visuospatial, cognitive ability, increase in accidents Definition of PMS distressing physical, behavioural and psychological symptoms, in the absence of organic or psychiatric disease, regularly recurs during the luteal phase of cycle and disappears or regresses by the end of menstruation‟. Aetiology and prevalence unknown but cyclical ovarian activity and the effect of estradiol and progesterone on the neurotransmitters serotonin and gamma-aminobutyric acid (GABA) appear to be key factors. Absence of PMS before puberty, in pregnancy and after the menopause supports this theory. The prevalence of severe PMS is between 3% to 30%. PMS more prevalent in women who are obese, perform less exercise and are of lower academic achievement. PMS lower prevalent in women using hormonal contraception. Diagnosis of PMS symptoms should be recorded prospectively, over two cycles using a symptom diary. Management of severe PMS 1) general advice about: exercise, diet and stress reduction before starting treatment. 76 2) women with marked underlying psychopathology should be referred to a psychiatrist. 3) symptom diaries (DRSP) should be used to assess the effect of treatment. 4) Referral to a gynaecologist should be considered when : Simple measures have been explored and failed. when the severity of the PMS justifies gynaecological intervention. 5) Complementary therapies 6) cognitive behavioural therapy 7) SSRIs and selective serotonin and noradrenaline reuptake inhibitors (SNRIs) 1) Complementary therapies Complementary medicines may be of benefit, but clinicians need to consider that: data from clinical studies are insufficient clinician has legal responsibility for the patient‟s wellbeing when refering to complementary therapists Interactions with conventional medicines should be considered. Example for Complementary therapies: Lifestyle changes (reduction in alcohol, caffeine and refined carbohydrates Reflexology Vitamin B6 Magnesium Nutritional supplements Calcium/vitamin Pollen extract Evening primrose oil Light therapy (bright light therapy has the possibility of retinopathy). 2) Managing severe PMS with cognitive behavioural therapy(CBT) Cognitive behavioral therapy should be provided routinely through a clinical psychology service for severe PMS. Ten sessions of CBT is associated with better maintenance of treatment compared with fluoxetine. No additional benefit of combining the treatments. 3) Management of PMS with SSRIs and SNRIs Physical and psychological symptoms of PMS improve with SSRIs. SSRIs are effective in treatment of depression and anxiety and their benefits outweigh their risks. risks include: nausea, insomnia, reduction in libido and few suicides in young people being treated for depression 77 Should be considered one of the first line treatment in severe PMS. Should only prescribed by health professionals (gynaecologists, psychiatrists or GPs) who have expertise. Either luteal phase or continuous dosing with SSRIs can be recommended for PMS. SSRI therapy should be withdrawn gradually to avoid withdrawal symptoms, if given on a continuous basis. withdrawal symptoms: GIT disturbances, Headache Anxiety Dizziness Paraesthesia Sleep disturbances Fatigue Influenza like symptoms, Efficacy and adverse effects of SSRIs can be optimised by the use of luteal-phase regimens with the newer agents. The use of newer SSRIs, such as citalopram, may produce resolution where other SSRIs have failed. 4) Management of PMS with cycle-modifying hormonal agents 1. The combined oral contraceptive pill New contraceptive pill (Yasmin) contains an anti-mineralocorticoid and anti-androgenic progestogen may be effective treatment for PMS and should be considered as one of the first-line pharmaceutical interventions. data suggest that the contraceptive pill should be given continuously rather than cyclically. Percutaneous estradiol, implant(100- microgram implant) or patch(200 micrograms), combined with cyclical progestogen, is effective for the management of physical and psychological symptoms of severe PMS. Alternative barrier or intrauterine methods of contraception should be used when estradiol (patches and implant) are used for PMS. The lowest possible dose of progestogen is recommended to minimise adverse effects. Women should be informed that low systemic levels of levonorgestrel released by (LNG- IUS) can initially produce PMS-type adverse effects. There are insufficient data on the long-term effects of estradiol on endometrial or breast carcinoma. 2. Danazol although treatment with low-dose danazol (200 mg twice daily) is effective, it has irreversible virilising effects. Women treated with danazol for PMS should be advised to use contraception during treatment. 5) Gonadotrophin-releasing analogues GnRH analogue therapy results in profound ovarian suppression and elimination of PMS. Lack of efficacy suggests a questionable diagnosis rather than a limitation of therapy. GnRH analogue therapy should be recommended as second- or even third-line treatment therapy should not be used as a first-line treatment, except for women with the most severe PMS add-back therapy with continuous combined HRT or tibolone is recommended, as it reduces menopausal symptoms without reappearance of PMS-like progestogenic effects low-dose therapy is not recommended and showed no benefit. Treatment should only be continued for 6 months when used alone. 78 Treatment should be stopped if bone density declines significantly in scans performed 1 year apart. General advice about how exercise, diet and smoking affect bone mineral density should be given. 6) Progesterone and progestogens There is insufficient evidence to recommend the routine use of progesterone or progestogens for PMS. 7) Surgical approach (hysterectomy and bilateral salpingo-oophorectomy) Hysterectomy and bilateral salpingo-oophorectomy has been shown to be of benefit with severe PMS. Surgery should not be done without preoperative GnRH analogues test of cure. Such therapy should be reserved for extremely severe PMS sufferers in whom other treatment has failed. How vital is the role of continuing hormone therapy? HRT should be considered in women undergoing surgical oophorectomy before the age of 50 years. Without adequate hormone therapy, PMS symptoms are replaced by those of the menopause. Consideration should also be given to replacing testosterone, as the ovaries are a major production source (50%) and deficiency could result in distressing low libido. Summary The aetiology and management of premenstrual syndrome continues to be poorly understood and in many cases inadequately managed. It is important that appropriate multidisciplinary services are provided in an appropriate setting throughout the country. 79 LONG-TERM CONSEQUENCES OF PCOS Introduction PCOS is a common disorder, complicated by: chronic anovulatory infertility and hyperandrogenism.With the clinical manifestation of oligomenorrhoea, hirsutism and acne. obesity and a higher prevalence of impaired glucose tolerance, type 2 diabetes and sleep apnoea than is observed in the general population. cardiometabolic syndrome: hypertension, dyslipidaemia, visceral obesity, Insulin resistance and hyperinsulinaemia. Prevalence of PCOS Prior to the new Rotterdam diagnostic criteria. Prevalence is 6–7% of the population. The prevalence of PCOS may differ according to ethnic background; in women of South Asian origin, PCOS presents at a younger age, have more severe symptoms and a higher prevalence. Diagnosis How is PCOS diagnosed? Diagnosis of PCOS can only be made when other aetiologies have been excluded (thyroid dysfunction, congenital adrenal hyperplasia, hyperprolactinaemia, androgen- secreting tumours and Cushing syndrome). Rotterdam diagnostic criteria has suggested a broader definition for PCOS, with two of the three following criteria : polycystic ovaries (either 12 or more peripheral follicles each one of(2-9mm)or increased ovarian volume > 10 cm3) oligo- or anovulation(cycle42days) Clinical and/or biochemical signs of hyperandrogenism; alopecia, hirsutism and acne. A raised LH/FSH ratio is no longer a diagnostic criterion for PCOS. Baseline screening tests: Thyroid function tests, serum prolactin and free androgen index (total testosterone x 100 / SHBG to give a calculated free testosterone level) If clinical evidence of hyperandrogenism and total testosterone > 5nmol/l →do 17- hydroxyprogesterone role out androgen-secreting tumors AMH; a special protein release