Newer Intra-Uterine Contraceptive Devices

1
Newer Intra-Uterine Contraceptive Devices
2
Dr. Mandakini PariharDirector Mandakini IVF
Centre, Chembur
Associate Hon. Prof. Obs Gyn K.J.Somaiya
Medical CollegeMember Managing Committee,
ISARMember Governing Council, ICOG
3
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
4
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

5
Unintended vs. Intended Pregnancies
Unintended 49
Intended 51
Unintended births (22.5)
Elective abortions (26.5)
Henshaw SK. Fam Plann Perspect. 19983024-29.
6
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

7

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

8
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)

9
Evolution of Cu-IUCD

• 2nd generation copper containing
• Cu-T 200
• Multi-load 250 375
• Nova T
• Newer Cu-380A

10

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

11
IUD Work-up

• History
• STDs, Sexual History, Ectopic
• Examination
• Size / Configuration of Uterus
• Cervical Cultures
• Pap Smear
• Counseling

12
IUD Mechanisms of Action

• NOT ABORTIFACIENT!!!!!!!!
• Prevents Conception
• local Foreign body reaction
• Sperm Transport Inhibited
• Sperm Survival / Capacitation Diminished
• Prevents Implantation

13
Cu IUD

• typically comprise a solid plastic frame loaded
  with copper wire and/or copper sleeves
• very effective
• (pregnancy rates lt2)
• Once inserted, protects for 3-10 years depending
  on type of IUD
• Easy to insert and remove
• Does not protect from STDs

14
New Cu-IUD Overview

• ParaGard (CuT380A)
• Very Effective ( TL)
• Reversible
• However-
• Monogamy Essential
• Does Not Protect Against STDs
• Can Remain for 10 Years

15
Cu-IUD Complications

• PID Usually secondary to Insertional
  Contamination
• Unproven Role for Prophylactic ABx
• Menorrhagia
• Expulsion
• Perforation (lt 0.1)
• Failure IUD Should be Removed
• ??Ectopic

16
LNG IUS

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

17
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 1991,43447
Videla-Ribero et a l, Contra1997,46217
18
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
19
Apprehension caused by amenorrhea can be
minimized by appropriate counsellingUser
satisfaction strongly correlates with counselling

• Backman et al. Br J Obstet Gynaecol
• 2000107335-339

20
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

21
LNG IUS

• Main reasons for premature removal were
• Bleeding problems 5.4
• Amenorrhea 1
• Pain 2.5
• Acne 1

22
Benefits of local action of LNG

• No significant change in
• Blood pressure
• Serum lipids
• Coagulation factors
• Carbohydrate metabolism
• Liver function

23
(No Transcript)
24
(No Transcript)
25
Pelvic inflammatory disease5-year cumulative
gross termination rates
Age group
Nova T Levonorgestrel (years)

IUS
25 5.6 0.3 2630 3.0 1.4 3135 1.4 0.7
36 0 0.3 Total 2.2 0.8
p lt 0.01
Andersson et al., 1994
26
Body weight over 5 years of use
Copper IUD Mirena

• 65
• 64
• 63
• 62
• 61

kg
0 12 24 36 48 60
Months
Andersson et al., 1993
27
(No Transcript)
28
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

29
Other newer IUCDs

30

• 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

31
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 Jun7(2)65-70

32
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.

33
Gynefix Insertion
34
Newer IUCDs To Come
Fibroplant
Gynefix Fibrofix

• T shaped LNG

35
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
• Jun6(2)93-101

36
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 Dec5(4)295-304

37

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

38
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.