1. Emergency Contraception (evidence based) Dr. Ashraf Fouda Ob./Gyn. Consultant Damietta General Hospital

2. Sources Cochrane library 2007 Family Planning, A GLOBAL HANDBOOK FOR PROVIDERS (WHO 2007) The Royal Australian and New Zealand College of Obstet. and Gynaec. (RANZCOG), July 2007 Faculty of Family Planning and Reproductive Health Care, April 2006 Uptodate on line, August 2006 Uptodate on line, August 2006 American Family of Pediatrics (AAP), October 2005 American Family of Pediatrics (AAP), October 2005 ACOG; Dec. 2005 ACOG; Dec. 2005 SOGC August 2003

3. Emergency contraception (EC) is any method of contraception which is used after intercourse and before the potential time of implantation Emergency contraception (EC) is any method of contraception which is used after intercourse and before the potential time of implantation What is emergency contraception?

4. From fertilization to implantation about 6 days

5. What is emergency contraception? (EC) provides women with a safe means of preventing pregnancy following unprotected sexual intercourse (UPSI) or potential contraceptive failure. Alternative terms such as ‘postcoital contraception’ or ‘the morning-after pill’ are often confusing and ‘emergency contraception’ is the preferred term.

6. In the USA, EC could potentially prevent up to 1.7 million unintended pregnancies and 800,000 abortions each year

7. U.S.A. Pregnancies: Unintended vs. Intended Henshaw SK. Fam Plann Perspect. 1998;30:24-29. Unintended Intended Unintended births Elective abortions 49%: 22.5% 26.5% 51% 3 million unintended pregnancies a year in the U.S.A.

8. Unintended Pregnancy Pregnancy that is unwanted or mistimed at conception Pregnancy that is unwanted or mistimed at conception Approximately half of all unintended pregnancies end in abortion Approximately half of all unintended pregnancies end in abortion Greater risks for mother Greater risks for mother depression, physical abuse, risk of not achieving educational, financial, career goals, relationship challenges depression, physical abuse, risk of not achieving educational, financial, career goals, relationship challenges Greater risks for child Greater risks for child low birthweight, infant mortality, neglect low birthweight, infant mortality, neglect Source: Institute of Medicine, 1995.

9. 53% of the women with unplanned pregnancies were using contraception 53% of the women with unplanned pregnancies were using contraception 48% of women aged 15-44 have had an unplanned pregnancy 48% of women aged 15-44 have had an unplanned pregnancy 60% of women aged 35-39 have had an unplanned pregnancy 60% of women aged 35-39 have had an unplanned pregnancy DID YOU KNOW -

10. HISTORY of EC - "First immediately after ejaculation let the two come apart and let the woman arise roughly, squeeze and blow her nose seven times and call out in a loud voice. "First immediately after ejaculation let the two come apart and let the woman arise roughly, squeeze and blow her nose seven times and call out in a loud voice. She should jump violently backwards seven to nine times." She should jump violently backwards seven to nine times." Abu Bakr Muhammad al-Razi (865 AD-925 AD)

11. EC is Not a New Idea …. “ Traditional ” methods for post coital contraception have been used for decades “ Traditional ” methods for post coital contraception have been used for decades High doses of vitamin C, aspirin or chloroquine High doses of vitamin C, aspirin or chloroquine Douches of coca cola, baking soda, urine Douches of coca cola, baking soda, urine Family Planning Perspectives.1996;22:52-66

12. History The first published study on the subject appearing in 1967. The first published study on the subject appearing in 1967. The first widely used methods were five-day treatments with high-dose estrogens, using diethylstilbestrol (DES) in the USA and ethinyl estradiol in the Netherlands. The first widely used methods were five-day treatments with high-dose estrogens, using diethylstilbestrol (DES) in the USA and ethinyl estradiol in the Netherlands.

13. In the early 1970s, the Yuzpe regimen was developed (Combined preparation containing both ethinyl estradiol & levonorgestrel (1974)); In the early 1970s, the Yuzpe regimen was developed (Combined preparation containing both ethinyl estradiol & levonorgestrel (1974)); Progestin-only postcoital contraception was investigated (1975); and Progestin-only postcoital contraception was investigated (1975); and Copper IUD was first studied for use as emergency contraception (1975). Copper IUD was first studied for use as emergency contraception (1975). Danazol was tested in the early 1980s, but was found to be ineffective. Danazol was tested in the early 1980s, but was found to be ineffective. Danazol History

14. The Yuzpe regimen became the standard course of treatment for postcoital contraception in many countries in the 1980s. The Yuzpe regimen became the standard course of treatment for postcoital contraception in many countries in the 1980s. Regular combined oral contraceptive pills (which were less expensive and more widely available) were more commonly used for the Yuzpe regimen even in countries where dedicated products (e.g.Preven) were available. Regular combined oral contraceptive pills (which were less expensive and more widely available) were more commonly used for the Yuzpe regimen even in countries where dedicated products (e.g.Preven) were available. History

15. After the WHO conducted a large trial comparing Yuzpe and levonorgestrel in 1998, combined estrogen-progestin products were gradually withdrawn from some markets (Preven in the United States discontinued at May 2004) in favor of progestin-only EC. After the WHO conducted a large trial comparing Yuzpe and levonorgestrel in 1998, combined estrogen-progestin products were gradually withdrawn from some markets (Preven in the United States discontinued at May 2004) in favor of progestin-only EC.United StatesUnited States In 2002, China became the first country in which mifepristone (antiprogesterone drug, not a hormone) was registered for use as EC. In 2002, China became the first country in which mifepristone (antiprogesterone drug, not a hormone) was registered for use as EC. History

16. As these methods work prior to implantation, they are not abortifacients. As these methods work prior to implantation, they are not abortifacients. Emergency contraception is a backup method for occasional use, and should not be used as a regular method of birth control. Emergency contraception is a backup method for occasional use, and should not be used as a regular method of birth control. IMPORTANT NOTES

17. OPTIONS There are 2 methods of emergency contraception: There are 2 methods of emergency contraception: 1. Hormonal methods, which involve the use of emergency contraceptive pills (ECPs), and 2. The post-coital insertion of a copper intrauterine device (IUD).

18. Two hormonal preparations are: Two hormonal preparations are: 1. One contains only the progestin levonorgestrel, while the other is a 2. Combined preparation containing both ethinyl estradiol and levonorgestrel. OPTIONS

19. Preven No longer available in USA since May 2004 Preven (USA), PC4 (UK) ethinyl estradiol and levonorgestrel Yuzpe method) Dedicated products : Combined ethinyl estradiol and levonorgestrel ( Yuzpe method)

20. Dedicated products : Progestin-only (Levonorgestrel) Plan B, Levonelle, Postinor, Contraplan II

21. The levonorgestrel-only method, (The regimen consists of 2 doses of 750 µg levonorgestrel taken orally 12 hours apart). The levonorgestrel-only method, (The regimen consists of 2 doses of 750 µg levonorgestrel taken orally 12 hours apart). OPTIONS

22. Yuzpe method consists of the oral administration of 2 doses of 100 µg ethinyl estradiol (EE) and 500 µg levonorgestrel 12 hours apart. Yuzpe method consists of the oral administration of 2 doses of 100 µg ethinyl estradiol (EE) and 500 µg levonorgestrel 12 hours apart. Ovral tablets (each containing 50 µg ethinyl estradiol and 250 µg levonorgestrel) are most commonly used to provide these doses. Ovral tablets (each containing 50 µg ethinyl estradiol and 250 µg levonorgestrel) are most commonly used to provide these doses. OPTIONS

23. ECPs Can Be Used when: A woman was raped A woman was raped No contraception used No contraception used Condom slipped, leaked, or broke Condom slipped, leaked, or broke Diaphragm or cervical cap inserted incorrectly, removed too soon, or torn Diaphragm or cervical cap inserted incorrectly, removed too soon, or torn Two consecutive birth control pills were missed Two consecutive birth control pills were missed An IUD was partially or totally expelled An IUD was partially or totally expelled A three-month contraceptive injection was missed by more than two weeks A three-month contraceptive injection was missed by more than two weeks A one-month contraceptive injection was missed by more than three days A one-month contraceptive injection was missed by more than three days

24. Pregnancy Prevention NIH, FDA, and ACOG all define pregnancy as beginning with implantation. NIH, FDA, and ACOG all define pregnancy as beginning with implantation. It takes about 6 days for a fertilized egg to begin to implant It takes about 6 days for a fertilized egg to begin to implant Intervention within 72 hours cannot result in abortion Intervention within 72 hours cannot result in abortion ECPs are not effective if a woman is already pregnant ECPs are not effective if a woman is already pregnant Source: Code of Federal Regulations, 1998; Hughes, 1972.

25. MECHANISM OF ACTION Hormonal forms of emergency contraception, prevent pregnancy by having several effects: 1. 1. Ovulation is inhibited or delayed. 2. 2. Fertilization is impaired by altering tubal transport of sperm or ova. 3. 3. Endometrial changes that prevent a fertilized egg from implantation. 4. 4. Cervical mucus is thickened.

26. Mode of action "The effect of treatment depends on when in the female's cycle it is used." Corpus luteum … disrupted formation … interfe-rence with its function Cervical mucus … alteration in it sperm entrapped or impaired function Before ovulation … disrupt normal follicular development & maturation interference in ovulation, with deficient/ impaired luteal function & delay in LH surge Fertilization … direct inhibition Sperm … interferes with its migration & function in the genital tract

27. Mechanism of Action prevents pregnancy Emergency contraception prevents pregnancy & does not interrupt established pregnancy

28. The Yuzpe and levonorgestrel-only methods have been shown in randomized trials to reduce the risk of pregnancy by approximately 75 and 85% respectively. The Yuzpe and levonorgestrel-only methods have been shown in randomized trials to reduce the risk of pregnancy by approximately 75 and 85% respectively. This does not mean that 25% of women using the Yuzpe method will become pregnant. This does not mean that 25% of women using the Yuzpe method will become pregnant. OPTIONSEFFECTIVENESS

30. Although they have generally been used only up to 72 hours after intercourse, both hormonal methods of EC are effective when taken between 72 and 120 hours after unprotected intercourse. Although they have generally been used only up to 72 hours after intercourse, both hormonal methods of EC are effective when taken between 72 and 120 hours after unprotected intercourse. The effectiveness when used after 72 hours seems to be slightly lower. The effectiveness when used after 72 hours seems to be slightly lower. EFFECTIVENESS

33. Early Use of Levonogestrel Increases Efficacy WHO Trial: LNG Regimen Source: WHO 1998

34. How effective is emergency contraception and how can efficacy be optimized? Women should be given information regarding the failure rates of oral and intrauterine EC to allow them to make informed choices and to increase compliance and efficacy (Grade A).

36. Women can be advised that LNG EC can be used more than once in a cycle if clinically indicated (Good Practice Point). How effective is emergency contraception and how can efficacy be optimized?

37. An IUD (or advice on how to obtain one) should be offered to all women attending for EC even if presenting within 72 hours of UPSI (Good Practice Point). How effective is emergency contraception and how can efficacy be optimized?

38. IUDs containing at least 380 mm2 of copper have the lowest failure rates and should be the first-line choice, particularly if the woman intends to continue the IUD as long-term contraception (Grade A). How effective is emergency contraception and how can efficacy be optimized?

39.  A meta-analysis has demonstrated that the effectiveness of post-coital IUDs approaches 100%, significantly higher than the effectiveness of hormonal EC.   A copper IUD can be inserted up to 5 days after the first episode of UPSI. EFFECTIVENESS

40. Limitations of ECPs ECPs are not a good long-term method of contraception ECPs are not a good long-term method of contraception Should be used as a bridge to a regular form of birth control Should be used as a bridge to a regular form of birth control ECPs do not protect against STDs ECPs do not protect against STDs

41. Are there any contraindications to emergency contraception? The WHO Medical Eligibility Criteria for Contraceptive Use advises that there are no medical contraindications to the use of hormonal EC (Grade C).

42. CONTRAINDICATIONS The only absolute contraindication to the use of emergency hormonal contraception is known pregnancy. The only absolute contraindication to the use of emergency hormonal contraception is known pregnancy.

43. Are ECPs Safe? ECPs are safe and easy to use ECPs are safe and easy to use The amount of active ingredient (hormone) is small The amount of active ingredient (hormone) is small Short-term use Short-term use Repeated use is safe Repeated use is safe Source: WHO, 1996.

44. What if a Woman Is Already Pregnant? ECPs cannot dislodge an established pregnancy ECPs cannot dislodge an established pregnancy They do not cause abortion They do not cause abortion ECPs do not affect fetal development ( not teratogenic ). ECPs do not affect fetal development ( not teratogenic ). Source: Lancet, 1998.

45. No, because : No, because :  ANY other BCM is more effective than ECPs!  ECPs are more expensive than most other BCMs!  ECPs contain a higher dose of hormones than ongoing BCPs  Nausea & cycle irregularity might hinder routine use. Will women stop using other forms of contraception if EC becomes too easily available?

46. The drug mifepristone may be used either as an ECP or as an abortifacient, depending on whether it is used before or after implantation. The drug mifepristone may be used either as an ECP or as an abortifacient, depending on whether it is used before or after implantation. In the USA, it is most commonly used in 200 mg doses as an abortifacient, but in China it is commonly used as emergency contraception in 10-mg dose, since 2002. In the USA, it is most commonly used in 200 mg doses as an abortifacient, but in China it is commonly used as emergency contraception in 10-mg dose, since 2002.China The contraceptive effects of the 10-mg dose are due to its effects on ovulationThe contraceptive effects of the 10-mg dose are due to its effects on ovulation Mifepristone, however, is not approved for emergency contraceptive use in the USA.Mifepristone, however, is not approved for emergency contraceptive use in the USA. Mifepristone

47. Higher doses of mifepristone “abortion pill” (RU486), can disrupt implantation and, unlike levonorgestrel, mifepristone is effective in terminating established pregnancies. Higher doses of mifepristone “abortion pill” (RU486), can disrupt implantation and, unlike levonorgestrel, mifepristone is effective in terminating established pregnancies. According to the International Federation of Gynecology and Obstetrics, “EC is not an abortifacient because it has its effect prior to the earliest time of implantation.” According to the International Federation of Gynecology and Obstetrics, “EC is not an abortifacient because it has its effect prior to the earliest time of implantation.” Mifepristone

48. What clinical examinations and investigations are required before providing emergency contraception? A sexual history should be taken from all women attending for EC to assess risk of STIs (Grade C). Prior to emergency IUD insertion, women at higher risk of STIs (age <25 years, change in sexual partner, or more than one partner in the last year) should be offered testing for Chlamydia trachomatis (as a minimum). (Grade C).

49. Possible Side Effects Common side effects: Nausea Vomiting (CEC 2004; FHI 2002; WHO 1998) Menstrual disturbance Fatigue Dizziness Headache Breast tenderness Compared with the combination method, the frequency of nausea and vomiting, dizziness, and fatigue with the progestin-only method is significantly less.

50. Side effects Vomiting following LNG administration is unusual, occurring in only 1% of women. Nausea is reported more frequently (14%). If a woman vomits within 2 hours of taking LNG EC she should take a further dose as soon as possible. Anti-emetics are not routinely recommended. An IUD should be considered for a woman experiencing persistent vomiting with oral EC.

51. Disturbances to the cycle In the WHO trial, 16% of women experienced bleeding (unrelated to expected menstruation) in the 7 days following treatment. Around 50% of women menstruated a few days earlier or a few days later than their expected time. Clinicians and women should be on the side of caution, and undertake pregnancy testing if there is any doubt that menstruation has followed EC use.

52. What aftercare and follow-up is required? Women should be given information and counselling on use of their future contraceptive method of choice (Good Practice Point). LNG EC does not provide contraceptive cover for the remainder of the cycle and effective contraception or abstinence must be advised (Grade B).

53. Women should be advised to have a pregnancy test if their expected menstruation is more than 7 days late, or lighter than usual (Grade B). What aftercare and follow-up is required?

54. OFFER ANOTHER METHOD! Given that EC is less effective than ANY other ongoing contraception, offer another method while you ’ re counseling your patient Given that EC is less effective than ANY other ongoing contraception, offer another method while you ’ re counseling your patient

55. What Methods Could Be Started After the Use of ECP? Condom OCPs Injection IUD Implanon MethodsWhen could be started Immediately after ECP use Next day after the 2nd dose of ECP or 1-7 days of next menses 1-7 days of starting of next period (CEC 2004; FHI 2002; WHO 1998) Natural Method 1-7 days of starting of next period

56. OFFER ANOTHER METHOD! Condoms and other barrier methods can be provided immediately Condoms and other barrier methods can be provided immediately Oral contraceptives may be initiated immediately following ECP treatment or after the next menses Oral contraceptives may be initiated immediately following ECP treatment or after the next menses If waiting until the next menses, impress upon the woman that she should have no unprotected intercourse while waiting! If waiting until the next menses, impress upon the woman that she should have no unprotected intercourse while waiting!

57. Should emergency contraception be supplied in advance of need? Advance provision of LNG can be offered to women to increase early use when required (Grade A).

58. Why give women ECPs before they need them? 1. 1. Women who have ECPs on hand took them sooner after having unprotected sex. 2. 2. Taken sooner, the ECPs are more likely to be effective. 3. 3. Women given ECPs were more likely to use ECPs than women who had to go to a provider to get ECPs. 4. 4. Women continued to use other contraceptive methods as they did before obtaining ECPs in advance.

59. How long do ECPs protect a woman from pregnancy? Women who take ECPs should understand that they could become pregnant the next time they have sex unless they begin to use another method of contraception at once. Because ECPs delay ovulation in some women, she may be most fertile soon after taking ECPs. If she wants ongoing protection from pregnancy, she must start using another contraceptive method at once.

60. Is it safe to take 40 or 50 progestin- only pills as ECPs? Yes., Progestin-only pills contain very small amounts of hormone. Thus, it is necessary to take many pills in order to receive the total ECP dose needed. In contrast, the ECP dosage with combined (estrogen +progestin) oral contraceptives is generally only 2 to 5 pills in each of 2 doses 12 hours apart.

61. Yes. This is because ECP treatment is very brief. Are women who cannot use combined oral contraceptives or progestin-only pills as an ongoing method still safely use ECPs?

62. If ECPs failed to prevent pregnancy, does a woman have a greater chance of that pregnancy being an ectopic pregnancy? No. To date, no evidence suggests that ECPs increase the risk of ectopic pregnancy. Worldwide studies of progestin-only ECPs, including a FDA review, have not found higher rates of ectopic pregnancy after ECPs failed than are found among pregnancies generally.

63. Recommendations Women who have had unprotected intercourse and wish to prevent pregnancy can be offered use of hormonal emergency contraception up to 5 days after intercourse, Women who have had unprotected intercourse and wish to prevent pregnancy can be offered use of hormonal emergency contraception up to 5 days after intercourse, (Grade A) or (Grade A) or Insertion of a copper IUD up to 5 days after intercourse, to reduce the risk of pregnancy. Insertion of a copper IUD up to 5 days after intercourse, to reduce the risk of pregnancy. (Grade A) (Grade A)

64. The levonorgestrel emergency contraception regimen is more effective and causes fewer side effects than the Yuzpe (ethinyl estradiol–levonorgestrel) regimen. (Grade A) Recommendations

65. One double dose of levonorgestrel emergency contraception (1.5 mg) is as effective as the regular 2-dose levonorgestrel regimen (0.75 mg each dose), with no difference in side effects. Recommendations (Grade A)

66. Advance provision of hormonal emergency contraception increases the use of emergency contraception without decreasing the use of regular contraception. (Grade A) Recommendations

67. A pelvic examination is not a prerequisite to providing emergency contraception. Recommendations (Grade B)

68. RECOMMENDATIONS Because the efficacy of hormonal emergency contraception may be higher if used sooner, it should be started as soon as possible after an act of unprotected intercourse. (Grade A)

69. Hormonal emergency contraception should be available without a prescription in: 1. Pharmacies, 2. Family planning clinics, 3. Emergency rooms, and 4. School health programs. (Grade B) RECOMMENDATIONS

70. Users of emergency contraception should be evaluated for pregnancy if menses have not begun within 21 days following treatment. Users of emergency contraception should be evaluated for pregnancy if menses have not begun within 21 days following treatment. RECOMMENDATIONS (Grade A)

71. Women and men of reproductive age should be counselled about emergency contraception. Women and men of reproductive age should be counselled about emergency contraception. (Grade B) RECOMMENDATIONS

72. levonorgestrel ECPs Safe, all women can use ECPs, even those who are advised not to use OCP as a regular method. Safe, all women can use ECPs, even those who are advised not to use OCP as a regular method. Is a backup method for occasional use, and should not be used as a regular method of birth control Is a backup method for occasional use, and should not be used as a regular method of birth control They do not cause abortion They do not cause abortion Do not affect fetal development ( not teratogenic ). Do not affect fetal development ( not teratogenic ).

73. Easy to use & Repeated use is safe. Easy to use & Repeated use is safe. Does not affect future fertility. Does not affect future fertility. Breastfeeding mothers also can use ECP. Breastfeeding mothers also can use ECP. The contraindication for the use of ECP is pregnancy or suspected pregnancy. This is PRIMARILY because they will not be effective. The contraindication for the use of ECP is pregnancy or suspected pregnancy. This is PRIMARILY because they will not be effective. levonorgestrel ECPs