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An update on Contraception to the Hillingdon Independent GP Group 18 August 2004. Dr Bela Reed Family Planning & Reproductive Health Service for Harrow/Hillingdon. The main contraceptive methods in the UK. Male condom Female condom Diaphragm, caps, spermicides Natural methods
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An update on Contraceptiontothe Hillingdon Independent GP Group18 August 2004 Dr Bela Reed Family Planning & Reproductive Health Service for Harrow/Hillingdon
The main contraceptive methods in the UK • Male condom • Female condom • Diaphragm, caps, spermicides • Natural methods • Combined Pills • Transdermal Patch • Vaginal ring • Progestogen only pills • Contraceptive injection(s) • Sub-dermal implant • Hormonal Emergency Contraception • Levonelle-2 (Levonelle) • Intra-uterine devices • Intrauterine systems (Mirena) • Intrauterine implant (GyneFix) • Male and Female sterilisation
Balancing clinical risks and benefits 4 categories of risk(WHO): 1.No restriction for use 2.Advantages outweigh risks 3. Risks outweigh advantages 4. Unacceptable health risk
Barrier methods and spermicides Nonoxynol-9 • No evidence that condoms lubricated with N-9 are more effective in preventing a pregnancy than … silicone. Such condoms should no longer be promoted • N-9 offers no protection against STI • N-9 increases the risk of HIV infection when used by women at high risk • It is better to use a N-9 lubricated condom than no condom at all WHO 2001
Lactational Amenorrhoea Method (LAM) The risk of pregnancy is 1% providing … • Fully or almost fully breastfeeding • Amenorrhoeic • Baby < 6 months
COC and Arterial Diseaseie Myocardial infarction, Ischaemic stroke (incl TIA),Haemorrhagic stroke • Age (>35) is a risk factor • Of the women who had MI <45 years, 88% had one or more risk factors • No difference on risk of MI between 2nd and 3rd generation COCs • Young women who wish to preserve their health should be advised to stop smoking above all else
COC and Cardiovascular disease • Avoid COC if 2 or more risks apply or if >35 years + 1 risk factor • Discontinue COC if smoker age >35 years • Discontinue COC at age 50 years
COC and Migraine Risk of ischaemic stroke 20-25 years – increased 5x COC contraindicated when • Migraine with with aura/focal neurological symptoms • Migraine lasting >72 hours • Migraine treated with ergot derivatives • Common migraine but other risk factors for stroke
COC and Migraine Use COC with caution when • Migraine or headaches worsening • First onset of migraine after starting COC • A history of focal migraine but no recent attacks
COC and VTE • High profile court case in 2002 • Risk of VTE is 25 per 100,000 women per year (cf to 15 with 2nd generation COCs) • Risk higher in first year of use
COC and VTE Good practice for prescribing 3rd gen COC • Screen for risk markers for VTE • Arrange a thrombophilia screen if first degree relatives had VTE age <45 • Ensure informed consent – that patient aware of this increased risk of VTE
COC and VTE Risk markers for VTE: • Family history of VTE age <45 years • BMI > 30 kg/m2 • Severe varicose veins • Trauma, major surgery, abdominal or leg surgery, leg in plaster • Acquired thrombophilia – chronic disease -anti-phospholipids and lupus factor • ?long distance travel • Congenital or valvular heart disease
COC and smoking • Smoking in women<35 years, on COC, increases the risk of CVD from 3.56 to 42.7 per million user years • Smokingin women>35 years,on COC, increases the risk of CVD from 40.4 to484.6 per million user years Dunn et al BJFP 1997:23:88-91 • The pill taker who smoked was more likely to suffer a heart attack and more likely to die from it RCGP studies 1983
COC and obesity • Weight gain on COC due to • water retention • Increase in appetite • Metabolic disturbance • BMI >30 associated with increase in risk of venous thrombo-embolism and cardio-vascular disease Avoid COC if other risk markers present • BMI >39 COC contraindicated
COC and Breast cancer • Age is most significant risk factor Breast cancer is rare in women < 40 whether on COCs or not background risk increases with age – significant after age 35. The excess risk with users of COC gradually disappear after 10 years • Duration of use is less important • The possible increase in risk of breast cancer should be discussed with the user and weighed against the benefits From the meta-analysis of the collaborative group on hormonal contraceptives in breast cancer. Lancet 1996 • Good practice – discuss breast cancer risks routinely at age 35
The risk of familial breast cancer • Most women with breast cancer have no positive family history • Increased risk with a family history • 2 first degree relatives, 13.3% • 1 first degree relative 5.5% • Risk grater the younger the affected relative If women with positive family history do develop breast cancer - unlikely to get it at a younger age - does not affect tumour spread nor mortality
COC and Cervical cancer • “a causal link between the pill and cervical cancer was likely…increasing risk of cervical cancer and increasing duration of use of OCs”. • Risk disappears when pill stopped. • taking OCs for up to 5 years – no increase in risk use OC 5-10 years or more – 3 fold increase use OC >10 years – 4 fold increase of cervical cancer” The Lancet. March 2002 • “Evidence not sufficiently robust … based on small number of cases DH March 2002 CEM/CMO/2002/5 Further information on www.doh.gov.uk or www.cancerscreening.nhs.uk
Reminder! • Ca Cx is an STI – HPV • Risk is higher in smokers • No need to stop COC because of an abnormal smear • Be scrupulous about cervical cancerscreening if used OC >5 years • Pills are safe and highly effective in preventing pregnancy
What is new/news? • COCs containing cyproterone acetate (Dianette) have 3.9 times increased relative risk of VTE than on an LNG pill (Microgynon) (Vasilaakis-Scaramozza C, Jick H. Lancet 2001; 358: 1427-1429) • Dianette is not licensed as a contraceptive. It is to be used for acne or hirsutism and discontinued 3-4 months after condition has resolved (CSM/MCA Oct 2002)
Is COC effective for acne? • COC usually improves acne. • Third generation COCs and oestrogen dominant COCs are particularly helpful • POP and progestogen dominant pills should be avoided • Dianette is useful but remains a second choice for long term treatment • ? Yasmin
New COC“Yasmin”30mcg ethinyl oestradiol + 3mg drospirenone drospirenone – • “a progestogen resembling natural progesterone” • Anti-mineralocorticoid - prevents sodium retention • Mean weight below baseline value (2 year data) • BP both systolic and diastolic less compared to Marvelon • Improvement in PMT and PMDD symptoms • Anti-androgenic • Improvement in skin – acne and sebum formation less • No data on effect on PCO or hirsutism
The contraceptive transdermal patch – Evra® • Contains ethinyl oestradiol and norelgestromin • Constant levels of hormones • Each patch for 7 days effective up to 9 days • Applied to clean dry skin on buttocks, front/back (not breasts), abdomen, upper arm • Similar to COC in efficacy, side effects etc
The contraceptive transdermal patch – Evra® ADVANTAGES • Better compliance = less failures • ? teenagers • Women who are unable to swallow pills • Gastrointestinal problems • ??? Less VTE (as in HRT studies) DISADVANTAGES • Local reaction • Patch gets unstuck • ?effectiveness if weight over 90kg • Cost (£23.23 for 3 months) compared to Microgynon 30 at £2.82, Cilest at £6.42
Progestogen only pills • Use in womenover 70 Kg (11 stone)? Possible increase in failure especially in younger women More effective in older women (>40 effective as COC), breastfeeding women and meticulous pill takers. Use of double dose?? Unlicensed use but consider in women who bleed “regularly” or with nuisance bleeding • Use in women with PCO? Functional ovarian cysts common (50%) Risk/benefit assessment required in individual cases. • Increased risk of ectopic pregnancy • Emergency Contraception indicated if pill taking late by >3 hours and UPSI has taken place from time of missed pill to 48 hours of restartingPOP
Cerazette - Each tablet contains 75 mcg desogestrel (metabolised to etonogestrel) Inhibits ovulation Efficacy: Pearl index for Cerazette was 0.14 compared to 1.17 for LNG 30 microgram Low androgenic activity Some ovarian follicular activity present Bleeding pattern – early treatment phase (first month) variable bleeding pattern late phase (9-12 months) – bleeding less frequent Less dysmenorrhoea Acne not worse No weight change Effective taken up to 12 hours late What is new? “Insufficient evidence that it is more effective than other POPs. Irregular vaginal bleeding similar. ..No compelling reason to use Cerazette instead of a standard POP” DTB Sep 2003
Long term DMPAuse and effect on bone mass- Review by Olav Meirik IPPF Medical Bulletin 5 Oct 2000 • women in the ‘middle years’ of reproductive life - effects small and transient. Changes negligible with rapid return to normal Use DMPAwith caution in • adolescents (<20) - process of building up bone mass • perimenopausal years(>45) - about to lose bone mass rapidly • women with risk factors for osteoporosis
Risk factors for osteoporosis • genetic - causasians and asians • Amenorrhoea – athletes, anorexia • diet - low in calcium or vitamin D • physical inactivity • smoking • excessive alcohol intake • excess of hormones eg steroids, thyroid, parathyroid • lack of oestrogen • BMI <18
IMPLANON A biodegradable single flexible rod 4cm long x 2mm diameter Contains 68mg ETONOGESTREL, an active metabolite of desogestrel Licensed for 3 years – what aboutwomen weighing >70 Kg
Implanon Release of etonogestrel 60-70ug/day in first 5-6 weeks 35-45ug/day end of year 1 30-40ug/day end of year 2 25-30ug/day end of year 3
Benefits reliable long term contraception Improvement in menorrhagia and dysmenorrhoea Beneficial effect on acne in 59% No adverse effects on bone mass No significant effect on lipids, haemostasis or liver function Adverse side effects Bleeding pattern altered: Amenorrhoea 20% Infrequent B-S 26% Frequent B-S 6% Prolonged BS 12% Weight gain of >10% in 21% - no change from reference group Hormonal ‘nuisance’ effects eg breast pain, headache, libido decrease, dizziness, nausea Other (<2.5%) alopecia,depression,change in libido Implanon
How effective is Levonelle-2? • Overall effectiveness is 85% ie prevents 7 out of 8 pregnancies • Taken within 24hours, it prevents 95% of pregnancies • Taken 25-48 hours after UPSI, it is 85% • Taken 49-72 hours, it is 58%
Pregnancy previous adverse reactions severe liver disease active pophyria Current breast cancer Certain medical conditions Special precautions Enzyme inducing medications Pharmacy Under 16 Gastro-intestinal disease What are the contraindications?
Levonelle-2Does it affect menstruation? • Temporary disturbance of menstrual pattern • menstrual pattern after treatment: at expected time (57%), a week early (15%) or a week late (15%) • Any bleeding outside this range should be checked
Levonelle-2 Whats new? *Change in license – 2 tablets to be taken together asap within 12 hours and no later than 72 hours after UPSI *Other - FFPRHC Guidance on Emergency Contraception April 2003 – unlicensed use • Increase dosage in women taking enzyme inducing drugs – double the first dose • Interval between tablets can be up to 16 hours • Repeat use in same cycle is safe • Offer L-2 if within 72 hours of UPSI even if referred for emergency IUD fitted • May be effective up to 5 days after UPSI – small study, IUD better
Levonelle-2 Advice from the Chief Medical Officer (2002) 12 cases of ectopic pregnancies have been reported to the CSM out of a total of 201 unintended pregnancies The Committee on Safety of Medicines (CSM) advises • Women should be encouraged to seek treatment as soon as possible and advised that treatment failure may occur • Women who do not experience a normal period after using Levonelle-2 should be followed up to exclude pregnancy • The possibility of an ectopic pregnancy should be considered especially if history of previous ectopic, tubal surgery or PID NB. High index of suspicion for ectopic pregnancy
Other advice … • Importance of follow up after 3-4 weeks • contraception - interim - longer term (starter pack COC) • Risk assessment for STI
Indications UPSI >72 hours but <120 hours UPSI before day 19 of a 28 day cycle Multiple episodes UPSI Choice as ongoing contraception LEI drugs, L-2 contraindicated Advice Offer L-2 if <72 hours since UPSI even if IUD to be fitted Remove IUD with onset of next menses Emergency Contraception -IUD
INTRA UTERINE CONTRACEPTION Types of devices: Cu IUD T safe Cu 380A Multiload 375 Nova T 380 Flexi-T 300 Other Multiload Cu 250 Gynefix (IUI) multiload Cu 250 shortMirena
Intra-uterine Contraception Gyne T 380S UK gold standard for long term use in younger women • Low intra and extra uterine pregnancy rates - Tcu-380A - failure rate 2.2 after 12 years • Licensed for 8 years use – effective to 10 years • Discontinued after June 2001
T-Safe CU 380A • ‘The replacement for Gyne T 380’ • Stem Cu surface area 200sq mm + copper sleeves = total Cu surface area of 380sq mm • problems with inserting the device into introducer • Cost 165 euros
Intra-uterine Contraception Multiload • 375 mm2 surface area of Cu • Useful post-partum and for repeated expulsion • Low failure rate (2.9) • High rate of removal for pain and bleeding • Also 250 versions short and standard
Intra-uterine Contraception Nova T 380 • Increased surface area of Cu of 380mm2 with silver core • Effective for 5 years • Cost £13.50
Intra-uterine Contraception GyneFix IUI - (Belgium 1985) “frameless and flexible”= less pain and bleeding Non-biodegradable suture thread 6 Cu tubes (5mmx2.2mm) surface area 330mm2 Special inserting device to anchor knot into fundal myometrium Suitable for nullips Expulsion after ToP less than other IUDs Cost +/- £30
Intra-uterine Contraception Flexi-T 300 Size: 2cm wide x 3cmlong Inserter device 3mm Surface area of Cu 300mm2 Push in technique Unplanned pregnancy at end of year three: 2.5 (Pearl index 1.0) Cost £7.35
SUMMARY Devices with surface area >300mm2 Cu are more effective and reduce ectopic pregnancy rates Gyne T 380 is effective for 10 years Flexi-T 300 for emergency use only After age 40, any IUD may be left in situ till the menopause CHOICES T-Safe Cu 380A Nova T 380 Multiload 375 SPECIAL INDICATIONS GyneFix IUI Mirena IUS Flexi T 300 Intra-uterine Contraception
Intra-uterine Contraception Reminder • Infection • Missed pregnancy • Ectopic pregnancy!! • Expulsion • perforation
Intra-uterine ContraceptionLocal Clinical GuidelinesSexual history RISK MARKERS for Chlamydia • Age <25 years • New sexual partner in the last 3 months • 2 or more partners in the last 12 months • History of Chlamydia/BV/PID or NSU in partner • Symptoms and/or signs of cervicitis/PID
At high risk Refer for sexual health screen prior to IUD In an emergency, i. Take an endocervical swab ii. prophylactic treatmentAzithromycin or Doxycycline iii. Sexual health screen (7-10 days after insertion) iv.advise barrier/spermicide At low risk Routine endocervical swab for Chlamydia screening Procedure Pre-test written information Inform patient of the result Treatment and STI screen Contact tracing Intra-uterine ContraceptionLocal Clinical Guidelines Chlamydia Screening (contd)
What next? NEW CHALLENGES The Male implant