Newer Intra-Uterine Contraceptive Devices

Dr. Mandakini Parihar Director Mandakini IVF Centre, Chembur Associate Hon. Prof. Obs & Gyn K.J.Somaiya Medical College Member Managing Committee, ISAR Member Governing Council, ICOG

“ Family Planning alone could bring more benefits to more people at less cost than any other single technology now available to the human race.” UNICEF

Contraceptive Use Indian Scenario There has been consistent improvement in the levels of contraceptive use in the country over time. However, these changes have not necessarily brought along corresponding decline in fertility levels for various reasons The data from the NFHS I and II indicate that the contraceptive prevalence rate for India was about 41 per cent during 1992-3 that increased to slightly over 48 per cent by the end of the last century, an increase of 7 per cent points in 6 years which is not significant and is the main reason for our mammoth population growth

Unintended vs. Intended Pregnancies 51% Unintended 49% Unintended births (22.5%) Elective abortions (26.5%) U.S. Pregnancies: Unintended vs. Intended Unintended pregnancy continues to be a major public health issue in the United States. Each year, half of all pregnancies are unintended. Half of unintended pregnancies – or one in four pregnancies overall – end in abortion. The abortion rate in the United States is the highest of all Western developed countries and Japan. It goes without saying that effective, accessible contraception is imperative to the health of a society. No single method, however, is universally suitable for all women and many factors affect a woman’s choice of contraception. Reference: Henshaw SK. Unintended pregnancy in the United States. Fam Plann Perspect. 1998 Jan-Feb;30(1):24-9,46. POSTED: September 25, 2002 REVIEWED: September 25, 2002 Henshaw SK. Fam Plann Perspect. 1998;30:24-29.

Unmet Need in India Millions of women would prefer to avoid becoming pregnant either right away or ever, but are not using any contraception These women have an unmet need Awareness Access Availability Unmet need for family planning (NFHS-3) Spacing 7.3% Limiting 7.3% Total 14.6% Fact sheet Table 5.32 (NRT) Table 5.32 (NRT) or table 5.32 (national report-pg 159) or table 28 (SRT) Unmet need for FP NFHS-2 + Spacing 9% +Limiting 9% Total 18% 6 6

Everything changes continually. What is history but a record of change? Mahatma Gandhi

Evolution of IUCDs 1st generation : Lippes Loop 2nd generation : copper containing 3rd generation : progesterone containing Progestasert Levonorgestrel (Mirena) 4th generation : frameless IUD GyneFix (copper) FibroPlant ( levonorgestrel)

Evolution of Cu-IUCD 2nd generation : copper containing Cu-T 200 Multi-load 250 –375 Nova –T Newer Cu-380A

Currently there are 100 million IUCD users in the world, 80 % of them are in China

IUD: Work-up History: STD’s, Sexual History, Ectopic Examination: Size / Configuration of Uterus Cervical Cultures Pap Smear Counseling

IUD: Mechanisms of Action NOT ABORTIFACIENT!!!!!!!! Prevents Conception local Foreign body reaction Sperm Transport Inhibited Sperm Survival / Capacitation Diminished Prevents Implantation

Cu IUD typically comprise a solid plastic frame loaded with copper wire and/or copper sleeves very effective (pregnancy rates <2%) Once inserted, protects for 3-10 years depending on type of IUD Easy to insert and remove Does not protect from STDs

New Cu-IUD: Overview ParaGard (CuT380A) Very Effective (~ TL) Reversible However- Monogamy Essential Does Not Protect Against STD’s Can Remain for 10 Years

Cu-IUD: Complications PID: Usually secondary to Insertional Contamination – Unproven Role for Prophylactic ABx Menorrhagia Expulsion Perforation (< 0.1%) Failure: IUD Should be Removed ??Ectopic

LNG IUS pure levonorgestrel in the vertical stem @ 20 micrograms per day into the endometrium approved for five years of use menstrual bleeding, overall a reduction by 90%

LNG – Mechanism of action Endometrium suppressed Cervical mucous thickening Sperm motility and function affected Weak foreign body reaction Rare cases inhibits ovulation Johnson et al , Contra: 1991,43;447 Videla-Ribero et a l, Contra:1997,46;217

Randomized studies Luukkainen et al., 1986 5 281 Nova-T 0.1 Years Comparison Pearl index Reference of use n method LNG-IUS Luukkainen et al., 1986 5 281 Nova-T 0.1 Sivin et al., 1991 7 1124 Cu T 380 0.2 Faundes et al., 1993 7 581 Cu T 380 0 Andersson et al., 1994 5 1821 Nova-T 0.1 Indian Council, 1989 3 475 Cu IUDs 0 Wang et al., 1992 3 100 Norplant 0.3

Backman et al. Br J Obstet Gynaecol Apprehension caused by amenorrhea can be minimized by appropriate counselling User satisfaction strongly correlates with counselling Backman et al. Br J Obstet Gynaecol 2000;107:335-339

LNG counseling – bleeding patterns 1-4 months irregular bleeding 2-6 months amount and duration of bleeding 20% will have amenorrhoea at the end of one year Overall significant reduction in the bleeding

LNG IUS Main reasons for premature removal were Bleeding problems 5.4 % Amenorrhea 1% Pain 2.5% Acne 1%

Benefits of local action of LNG No significant change in: Blood pressure Serum lipids Coagulation factors Carbohydrate metabolism Liver function

Pelvic inflammatory disease 5-year cumulative gross termination rates Age group Nova T Levonorgestrel (years) IUS ≤ 25 5.6 0.3 * 26–30 3.0 1.4 31–35 1.4 0.7 ≥ 36 0 0.3 Total 2.2 0.8 * *p < 0.01 Andersson et al., 1994

Body weight over 5 years of use 65 64 63 62 61 Copper IUD Mirena kg 0 12 24 36 48 60 Months Andersson et al., 1993

LNG – other health benefits Reduction in Amount and duration of bleeding Incidence of ectopic pregnancies Menstrual cramps Non-contraceptive benefits Treatment of DUB and menorrhagia In HRT for endometrial protection

Other newer IUCDs

The design characteristics of the frameless IUD (fixed, frameless and flexible) are responsible for the low expulsion, high effectiveness and high continuation rates. Insertion is easy and safe in the hands of trained providers and appears to be as reliable and effective as when inserted at interval

GyneFix   The expulsion rate of 8.4% and removal rate for bleeding and/or pain of 9.0% at 12 months within acceptable ranges for framed intrauterine devices does not affect future fertility in nulliparous and parous women Masters T, et al Eur J Contracept Reprod Health Care 2002 Jun;7(2):65-70

Gynefix The frameless intrauterine device (IUD) dispenses with the frame in the classical IUD and holds the device in the uterus by anchoring one end of a nylon thread in the fundal myometrium, to which copper sleeves are attached There are insufficient data to show that problems of early expulsions have been overcome with the new introducer used in GyneFix. Apart from that, the frameless device performs similarly to TCu380A, and appears to have a lower pregnancy rate in later years, although the absolute difference is small.

Gynefix Insertion

Newer IUCD’s To Come Fibroplant Gynefix Fibrofix T shaped LNG

FibroPlant the FibroPlant levonorgestrel intrauterine system (IUS), releasing 14 microg of levonorgestrel/day. Strong endometrial suppression is the principal mechanism explaining both the effect on menstrual blood loss and the contraceptive performance of the IUS Eur J Contracept Reprod Health Care 2001 Jun;6(2):93-101

Conclusion Intrauterine contraception is the most cost-effective reversible method of contraception increasingly attractive due to the development of new technologies that not only enhance the performance of the intrauterine device (i.e. efficacy is now close to 100%), but also reduce the rate of expulsion and the number of removals for medical reasons Eur J Contracept Reprod Health Care 2000 Dec;5(4):295-304

Technology made large populations possible and large populations make technology indispensable Joseph Wood Krutch

Thanks to all contributors. Dr Adarsh Bhargava. Dr Ashwini Bhalerao. Dr Alka Kriplani. Dr. Kalpana Apte. Dr Mala Arora. Dr.Meenakshi Bharath. Dr. Mandakini Parihar. Dr.Nozer Sheriar. Dr.Parikshit Tank. Dr. Roza Olyai. Dr.Sasikala Kola. Dr.Sujata Mishra.