INTRAUTERINE DEVICES IN PRIMARY CARE

1. INTRAUTERINE DEVICES IN PRIMARY CARE Huddersfield 2008

2. IUD • 110 million users • UK rate 5% • Long Acting Contraception 8%

3. Background • Camels • 1950’s : plastic devices – effectiveness related to size – FB effect + leucocytes: “unfavourable endometrium” • Lippes loop in use till 1980’s • Copper /silver wire on base +/- arms: “irritant” effect with smaller devices; interference with fertilisation ( sperm motility, ova development)

4. IUD prevents fertilisation not implantation • Reduction in sperm reaching fallopian tube reduced • Sperm motility reduced • Ova development is impeded • Presence of betaHCG is rare • Histological changes not important

5. IUD • Suitable for parous and nulliparous • Advantages (over oral hormonal methods) • Full sexual history vital • Chlamydia testing (under 25yrs : 6-20%) • Fitted after age 40 – can stay in till after menopause • Cost-effective

6. IUD Contraindications • Pregnancy or past ectopic history • Undiagnosed irregular bleeding • Current or suspected pelvic or vaginal infection • HIV or immunosuppressive therapy • Distorted scarred uterine cavities • Small uterus 5.5cm • Bacterial endocarditis • Wilson's disease

7. IUD Relative contraindications • Valvular heart disease • Prothesis • Subfertility • Fibroids or endometriosis • Cervical Stenosis • (Penicillamine use) (Diabetes)

8. Which IUD? • Cervical length and Endometrial length vary • Varies in same cycle • Fundal width can vary • Most devices are 32mm width 36mm length • Cu TSafe 380A Nova T380 Multiload 375

9. Types of IUDs: Copper • Copper T 380 Efficacy 0.3 /100 w. yrs (0.3%) • Copper T 380 replaced by T-Safe 380A • No pregnancies beyond 8yrs reported • Licensed for 8 yrs (effective for >10 years) • Ectopic rate: absolute rate no different to ‘no contraception users’, but relative rate (since overall pg rates with IUDs so low)

10. Types of IUDs: Copper • Nova T200 : 12.3% gross cumulative failure rate @ 5 yrs (ie 1%-2% failures /year), discontinued in Oct. 2001 • Nova T 380: 2% gross cumulative rate @ 5 yrs • Multiload 375: 3% gross cumulative rate @5yrs • Multiload 250 Short : use if fundus <6cm (but less reliable than M375 for Pg prevention)

11. Types of IUDs: Copper • Gynefix: frameless; failure rate = 0 - 0.5% over 3-4 yrs , expulsion rates variable (0.7 – 7.6%); suitable for nullips; expert fitting. • Flexi-T380 (Cu-Safe 300): failure rate and expulsion rate = 0.6%, plastic frame smaller and more flexible, simple technique. Suitable for EC

12. Nulliparous • Nova T • Short Multiload 250 • Flexi T • IUS

13. Counselling prior to IUD Risks and benefits(including): • Efficacy • Bleeding Pattern • Perforation 1 in 1000 • Ectopic Rate • Expulsion 3-15/100 women • PID

14. IUDs and PID • infection is related to the insertion process • no correlation with type of device • direct link with pre-existing STI • mutual monogamy = no PID (China) • risk of PID increases above background rate within first 20 days after insertion only • pre-insertion counselling and assessment of STI risk + swabs for Chlamydia

15. Testing for STI • Women assessed to have a higher risk of STI may also be offered testing for N. gonorrhoea prior to IUD insertion, depending on its local prevalence. • There is no indication to test for other lower genital tract organisms in asymptomatic women attending for IUD insertion. • Ideally women assessed as a higher risk of STI, the results of tests should be available and appropriate treatment provided prior to IUD insertion. • For women assessed as at higher risk of STI, if results are not available and IUD insertion cannot be delayed, the use of prophylactic antibiotics may be considered.

16. Preparation for Fitting • Practical training strongly advised from FFP of RCOG1 • Use of assistant recommended • Consider analgesics or local anaesthesia - pre-counselling and during fitting • Insert within 7 days of onset of menstruation1 References : 1. Mirena SPC September 1999

17. Insertion of IUD • Initial examination : PV and speculum • Sterile technique • Sound • Local anaesthetic? (rarely needed) • Judd Allis forceps • Dilators • Correct positioning • Antibiotic cover? (if high risk of infection)

18. Cervical cleansing • Cleansing the ectocervix prior to IUD insertion is not essential.

19. Sterile gloves • A ‘no touch’ technique should be used when sounding the uterine cavity and inserting an IUD. Sterile gloves are not required--- but personally!

20. Measurement of pulse and blood pressure • Pulse rate should be measured and documented post-IUD insertion.

21. Prophylaxis to prevent bacterial endocarditis • When prophylaxis against bacterial endocarditis is required, clinicians should refer to the BNF for the most up to date regimen and ensure the IUD procedure takes places in an appropriate setting.

22. REMEMBER THE WOMAN

23. Analgesia and anaesthesia and Oral Valium • Pain relief prior to, and during, IUD insertion should be discussed with women and administered appropriately. • The use of topical anaesthesia or intracervical block for IUD procedures should be discussed with women and provided if requested.

24. Local Anaesthetic? • Lignocaine Gel 2% – Instillagel/Instillaquill • Intra-Cervical-- warm 1% lignocaine 3mls at 12, 4, 8 o’clock • Para-cervical: 5mls at 3 and 9 o’clock • Oral Valium!

25. Menstrual abnormalities • Women should be informed that menstrual abnormalities (including spotting, light bleeding, heavy or longer menstrual periods) are common in the first 3 – 6 months of IUD use (Grade C).

26. Suspected perforation • If uterine perforation at insertion is suspected,, the procedure should be stopped and vital signs and level of discomfort monitored until stable. Urgent and specific follow up should be arranged to include ultrasound scan and/or plain abdominal x-ray to locate the device if it has been left in situ.

27. ‘Lost threads’ • If no threads are seen and uterine placement if the IUD cannot be confirmed clinically, an ultrasound scan should be arranged to locate the device and alternative contraception recommended. • If an ultrasound scan cannot locate the IUD and there is no definite evidence of expulsion, a plain abdominal x-ray should be arranged to identify an extrauterine device.

28. Removal of an IUD • When switching to a hormonal contraceptive, this should be indicated prior to IUD removal to maintain contraceptive protection. • For women who wish to become pregnant, an IUD can be removed at any time in the menstrual cycle. • An IUD can be removed at any time in the cycle if it is to be replaced immediately with another IUD. However, women should be advised to used condoms or abstain from sexual intercourse for 7 days before the exchange, in case a new IUD cannot be inserted immediately. • An IUD can be replaced by an IUS at any time in the menstrual cycle, but women should be advised to use condoms of abstain from sexual intercourse for 7 days before removal of the IUD and for a further 7 days after insertion of the IUD.

29. Postmenopausal removal • Postmenopausal women should be advised to have their IUD’s removed after 1 year after their LMP if this occurs when they are over the age of 50 years, and 2 years after their last LMP if aged less than 50 years.

30. Intrauterine System (IUS) Mirena – releases 20 mcg levonorgestrel/day Local LNG effect on endometrium Progressive reduction of menstruation Initial irregular bleeding x 3 – 5 months, then marked reduction, with 25% women becoming amenorrhoeic at 5 yrs (now licensed for Rx menorrhagia)

31. Progestogen-related breakthrough bleeding • Changes in the superficial endometrium leading to erratic breakdown • Changes in the endometrial vessels and haemostasis leading to fragile, dilated, leaky vessels • Defective endometrial repair mechanisms

32. Estrogen effect Release of leukocyte attractants (chemokines, selectins) Leukocyte infiltration Release of TNF- and IL-1 TGF- Stromal cells epithelium progestins progestins endothelium CD34 androgens Endothelin Apoptosis TGF- Apoptosis proMMP-3 Stromelysin (MMP-3) MMP-1 Angiogenic factors (VEGF, aFGF, bFGF, cytokin., angiog., TGF-) Matrilysin (MMP-7) TIMPs EBAF EBAF Tryptase (u)PA Perivascular SM-actin progestins Vascular fragility Epithelial fragility PAI-1 Uterine contraction/ movement plasminogen plasmin stimulatory BLEEDING Tissue factor inhibitory TGF- (inactive) TGF- (active)

33. Ideas for management of bleeding disturbances • Additional oestrogens • Additional progestogens • Tranexamic acid • Vitamin E • NSAID’s • Doxycline

34. The new Mirena Inserter

35. Benefits of the Inserter • Consistent position of rounded arm ends when loaded • One-handed technique, leaves hand free to hold forceps • Comfortable for left- or right-handed use • Curved insertion tube of firmer plastic, assists fitting and less ‘kinking’

36. Insertion Technique • Open package carefully • Ensure the slider is furthest away from fitter • Check IUS arms lie in a horizontal plane prior to loading Practical tip To make sure arms are horizontal, align on a flat, sterile surface whilst maintaining moderate pressure

37. Important to note when handling with the new inserter • Hold the slider firmly with your forefinger or thumb when pulling on the system into the tube • Tube bends easily after 4th mark (cm scale) if forced too much

38. Knobs at the end of arms close and form a rounded end with a small gap in between the knobs

39. Insertion Technique • Pull on threads to place IUS in insertion tube • Fix threads in cleft at the end of shaft • Set upper edge of flange at the uterine sound measure Practical tip The measurement obtained from sounding the uterus should correspond to the distance from the end of the loaded inserter to the edge of the flange nearest to the cervix

40. Insertion Technique • Mirena is now ready to be inserted • Hold the slider firmly with the forefinger/ thumb in furthermost position • Move inserter gently into uterus until flange is about 1.5 - 2 cm from cervix. Gives sufficient space for arms to open

41. New Insertion Technique • Holding inserter steady, release arms by pulling slider back to the mark • Push inserter gently inwards until flange touches cervix • Mirena should now be in fundal position Practical tip To ensure IUS is in fundal position, continue to advance insertion tube until resistance is met at fundus. The flange may be pushed along the tube by the cervix. Since the arms are unfolded and in absence of strong force, there should be no added risk of perforation

42. New Insertion Technique • Release the IUS by pulling the slider back down all the way • Remove the inserter from the uterus • Cut the threads to leave about 2cm visible outside the cervix Practical tip When removing inserter, make sure thethreads run freely through the tube and do not draw the system from its fundal position

43. The IUS: Mirena • Failure rate very low: only 0.3% over 5 yrs • Ectopic rate very low : 0.02% • 5 years (as effective as CuT380 at 7 years) • Not for EC • STI protection relative, not for sex workers • Good for women with heavy periods • Expulsion rate as other framed devices

44. IUD for Emergency Contraception • up to 5 days after unprotected sex • up to 5 days after possible ovulation, ie up to day 19 of 28 day cycle – legal limit re implantation; no failures with this protocol • If high risk infection, swabs + antibiotic cover : Doxycycline 100 bd x 7days, or Azithromycin 1 gram stat

45. In summary • T Safe 380A = “gold standard” for protection against pg; Gynefix a close 2nd • Mirena = best if heavy periods • Nova T380, Flexi-T380 or remaining stocks of Nova T200 = EC or short-term use in young women • All the Cu IUDs (except Multiload 250) for parous women with normal periods • Gynefix good for nullips or where insertion problems with framed IUDs

46. Questions • Vaso-vagal attack • Post insertion period pains • Actinomycosis • Lost threads • Removal when?