Newer Intra-Uterine Contraceptive Devices. Dr. Mandakini Parihar Director Mandakini IVF Centre, Chembur Associate Hon. Prof. Obs & Gyn K.J.Somaiya Medical.

Newer Intra-Uterine Contraceptive

Devices

Dr. Mandakini PariharDirector

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 UseIndian 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

Henshaw SK. Fam Plann Perspect. 1998;30:24-29.

Unintended Unintended

49%49%

Intended Intended 51%51%

Unintended Unintended births births

(22.5%)(22.5%)

Elective Elective abortions abortions (26.5%) (26.5%)

Unmet Need in IndiaUnmet 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)Unmet need for family planning (NFHS-3)

SpacingSpacing 7.3% 7.3%

Limiting Limiting 7.3% 7.3%

Total Total 14.6% 14.6%

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-upIUD: Work-up

• History: – STD’s, Sexual History, Ectopic

• Examination:– Size / Configuration of Uterus– Cervical Cultures– Pap Smear

• Counseling

IUD: Mechanisms of ActionIUD: 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: OverviewNew Cu-IUD: Overview

• ParaGard (CuT380A)• Very Effective (~ TL)• ReversibleHowever-• Monogamy Essential• Does Not Protect Against STD’s• Can Remain for 10 Years

Cu-IUD: ComplicationsCu-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%

Nova T Levonorgestrelintrauterine system

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

The levonorgestrel intrauterine system

Levonorgestrelintrauterine

system

Detail

Hormone cylinderRate-controllingmembrane

Uterinewall

Section ofsystem

Randomized studies

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

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

≤ 25 5.6 0.3 *26–30 3.0 1.431–35 1.4 0.7≥ 36 0 0.3Total 2.2 0.8 *

Pelvic inflammatory disease5-year cumulative gross

termination rates

Age group Nova T Levonorgestrel(years) IUS

*p < 0.01 Andersson et al., 1994

Body weight over 5 years of use

65

64

63

62

61

kg

0 12 24 36 4860 Months

Copper IUDMirena

Andersson et al., 1993

Return of fertility after removal of thelevonorgestrel intrauterine system

0

20

40

60

80

100

3 6 9 12Months

Cum

ulat

ive

preg

nanc

y ra

te (%

)

Levonorgestrelintrauterine systemCopper IUD

Andersson et al., 1992

LNG – other health benefits

Reduction in• Amount and duration of bleeding• Incidence of ectopic pregnancies• Menstrual crampsNon-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

T shaped LNG

Gynefix Fibrofix

Fibroplant

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.