1. Emergency contraception in Hungary Professor George Bartfai
Dept of Ob/Gyn,
Univ of Szeged, Hungary

2. Content Definition History Indication Mechanism of action Methods
Effectiveness, Timing
Contraindications
Follow-up
Awareness, access to EC, OTC
Recommendations

3. In the US about 50% of the pregnancies are unwanted and half of them occur due to method or patient failure (Henshaw, 1998).

4. The number of deliveries and abortions in Hungary

5. Definition
Emergency contraception refers to a particular type of contraception that is used as an emergency procedure to prevent pregnancy following unprotected, possibly fertile, intercourse.
Van Look, Br. Med.Bull. 1993

6. History
Postcoital hormonal contraception with high-dose diethylstilboestrol or ethinyl estradiol for rape victims in 1960s van Wagenen, Morris, Haspels
Combined regimen (E2 & P) early 1970s
(Yuzpe)
IUD as an EC has been applied first in 1976
(Lippes)
LNG only 1980s
RU-486, mifepristone 1990s

7. Indications for emergency contraception
1. Unprotected intercourse
No method-especially first-time intercourse
Coitus interruptus/failed coitus interruptus
Ejaculation on external genitalia
Miscalculation of the rhythm method (fertility awareness method/periodic abstinence)
Spermicide use alone in woman at high risk of pregnancy

8. Indications for emergency contraception (cont)
2. Potential barrier method failures
Condom rupture, dislodgement or misuse
Diaphragm or cap inserted incorrectly, dislodged during intercourse, found to be torn or removed too early
3. Potential pill failures
Missed pills
4. Potential IUD failures
Complete or partial expulsion of an IUD
Midcycle IUD removal considered absolutely necessary

9. Indications for emergency contraception (cont)
5. Sexual assault
Is an important indication for EC. Providers must be aware of STI. Police involvement-forensic tests.
Woman may require long-term emotional support.
6. Recent use of suspected teratogens
Drugs, e.g. cytotoxics
Live vaccines such as yellow fever

10. Mechanism of action
Prevention of ovulation,
fertilization or implantation depending on the time of administration relative to the appropriate part of the
menstrual cycle.

11. Mechanism of action
In humans the contraceptive effects of both LNG and mifepristone, when used for EC, involve either blockade or delay of ovulation (prevention or delay of the LH surge) rather than to inhibition of implantation.
Gemzell-Danielsson, 2004

12. Action on endometrium
Disappearance of microvilli, flattering of the cylindric epithelium and its cobblestone like appearance:
on rabbits (Ugocsai et al 1984),
in humans (Nikas et al 1995).

13. Recently, treatment with either 10 mg mifepristone or 1,5 mg of LNG has emerged as the most effective hormonal method for emergency contraception with very low side-effects.
Gemzell-Danielsson, 2004

14. METHODS OF EMERGENCY CONTRACEPTION
Ethinyl estradiol with LNG (Yuzpe regimen)
LNG alone
IUD
Mifepristone (antiprogesterone)
GnRH antagonists

15. Yuzpe method 2 tablets: EE (0.05mg) + LNG (0.25mg)
Administration within 72 hours
1st dosage followed by the 2nd 12 hours later

16. Licenced products in Hungary
Rigesoft (2x1): 0,75 mg LNG
Escapelle (1x1): 1.50 mg LNG
Fertilan is not registered anymore

17. Sales of Rigesoft in Hungary

19. Effectiveness of Postinor®
cycle
coitus
pregnancy
Pearl index effectiveness 0,83+/-0,44
coitus/pregnancy ,9%
Gy. Seregély, 1986

20. Efficacy of EC methods Method No. of Reduction pregnancies %
No treatment
Yuzpe regimen
LNG only
Mifepristone
IUD
If women have unprotected intercourse once in the middle of the cycle Am.Family Phys.2004

21. Efficacy of EC Method No. of No. of unprotected unwonted
intercourse pregnancy
No contraception
LNG
No contraception 7 million
prevented pregnant
LNG (10% used)
LNG (50% used) 3.5 mill

22. Effectiveness
The chance of pregnancy after single unprotected intercourse is 8% (Trussel J. 1982)
The likelihood of pegnancy is decreased by 75% using EC.

23. Efficacy of EC and time of treatment
Percentage of expected pregnancies prevented
100 95 83 79 66 61 47 50
0 - 12
Delay between intercourse and time of treatment with EC

24. Emergency Contraception

25. Percentage of expected pregnancies prevented in relation to the delay between intercourse and time of treatment with EC
Time of treatment
Levonorgestrel %
Yuzpe
Within 24 hours 95 77
24-48 hours 85 36
48-72 hours 58 31
WHO 1998.

26. EC is less effective than consistent use of any other reliable methods

27. 06-30-30-30-456 EC outpatient clinics in Hungary 5 3 2 4 1 6+1 2 5
Telephone-number of EC out-patient clinics in Hungary 5 3 2 4 1
6+1 2 5

28. Outpatient clinics supported by the Industry: 58
Age
No of patients
< 20 yrs
> 20 yrs
 /year
 /month
No previous contraception (40.43%)

29. Youth friendly health service

30. Progestin-only regimen containing levonorgestrel was found to be more effective than the Yuzpe regimen and caused significantly less nausea and vomiting.

31. WHO trials (1)
Randomized double blind multicenter trial of LNG (0.75 mg) vs Yzpe (0.1 mg EE mg LNG) two doses 12 h apart within 72 h concluded:
LNG regimen is
more effective better tolerated
WHO, Lancet 1998

32. WHO trials (2)
Randomized double blind multicenter trial compared 3 single doses of Mifepristone up to 120 h.
WHO, Lancet 1999

33. Conclusions:
LNG is more effective than Yuzpe regimen with less side effects
Single dose of Mifepristone (10 mg) is effective but some delay expected in the onset of menses

34. Aim of the present research activity
simplify the treatment modality ( single dose )
extended the administration up to 120 h since intercourse
to compare:
the compliance: the effectiveness the acceptability
WHO 2001

35. Safety No protection against HIV and STD!
No change in clotting factors (A. Webb 1993)
No effect on lactation
There is no increase in fetal malformation using E/P or P regimens (MB. Bracken 1990)
No protection against HIV and STD!

36. Contraindication:
pregnancy

37. Contraindications to emergency contraception
Royal College obst. Gyna

38. Onset of menses after Mifepristone
Early onset (>5 days) 9,6 In time ,9 Late onset (>5,13±7) 20,0
WHO 1997

39. continued risk of pregnancy
Delay of ovulation = late return of menses
continued risk of pregnancy
recommend the use of contraception if abstaining is not possible
later relieved from anxiety about unwanted pregnancy

40. Follow-up Proper contraceptive counselling emphasised.
In case of regular menses follow-up is not important.

41. Limits to Access to EC 72 hour time limit Prescribed by a doctor
Often required at a weekend
Embarrassment
Fear about confidentiality
Inertia

42. Emergency Contraception OTC
Dangerous
Encourages promiscuity
Discourages safe sex
Improper use /abuse/ misuse
Recurrent use
Abandon more reliable methods

43. Flow chart (1) Yes Patient requests emergency contraception
Pregnancy test, vaginal examination ultrasound and manage accordingly
Could she be pregnant already?
Yes No
Enquire re last menstrual period, cycle length and exposure day of cycle. Assess risk
IUD an option as long as within 5 days of earliest ovulation
Did intercourse take place within the previous 72 h? No
Counsel, screen for infection and fit copper IUD
Yes
Kubba, A. 2001

44. Flow chart (2)
Is there a history of thromboembolism or current migraine with past history of migraine with focal aura
Yes No
Emergency combined pills or LNG suitable
Yes
1. Check blood presure
2. Give verbal information and
patient information leaflet
3. Prescribe pills and consider antiemetic use
4. Arrange ongoing contraception
5. Arrange follow-up
6. Complete records
Recommend IUD or progestogen only method
Kubba, A. 2001

45. No women can call herself free who does not controll her body
Margaret Sanger 1920

46. Thank you for your attention