CHILDREN BY CHOICE ASSOCIATION INCORPORATED

Mifepristone

Mifepristone (also known as RU-486) is a medication that blocks the action of the hormone progesterone. Progesterone is needed to sustain a pregnancy. Mifepristone has been used, in combination with other medications called prostaglandins, for medical abortion since 1988 in France and China, and since the early 1990's in the United Kingdom and Sweden. It has been more recently licensed in nine other European countries and Israel. In September 2001, Mifepristone was approved for distribution in New Zealand. Millions of women worldwide have safely used mifepristone regimens to end their pregnancies.

How mifepristone works to end pregnancy

Mifepristone blocks the action of progesterone, which is needed to sustain a pregnancy. This results in:

• Changes in the uterine lining and detachment of the pregnancy,
• Softening and opening of the cervix,
• Increased uterine sensitivity to prostaglandin.

Mifepristone is used in combination with another medication, a prostaglandin analogue called misoprostol. Misoprostol causes the uterus to contract, and helps the pregnancy tissue to pass.

How effective is the combination of mifepristone and misoprostol in terminating an early pregnancy?

Approximately 95% of women will have a complete abortion when using mifepristone/misoprostol up to 49 days after the start of the last menstrual period. The remaining women will need a suction abortion either because of ongoing or excessive bleeding, an incomplete abortion (tissue remains in the uterus but there is no growing embryo), or an ongoing pregnancy (a viable growing pregnancy, which occurs in less than 1% of cases).

Treatment regimen with mifepristone/misoprostol

Clinical studies have shown that several variations in mifepristone/misoprostol treatment regimens are safe and effective. Generally, however, once a woman has decided to have a medical abortion, there are three steps in the process of a medical abortion:

Step One (at the doctor's office or clinic)

• A medical history is taken and a clinical exam and lab tests are performed.
• Counselling is completed and informed consent is obtained.
• If eligible for medical abortion, the woman swallows the mifepristone pill(s).

Step Two (at the office/clinic or at home depending on the treatment regimen)

• This step takes place about two days after step 1.
• Unless abortion has occurred and has been confirmed by the clinician, the woman uses misoprostol. Misoprostol tablets may be swallowed or inserted into the vagina, depending on the treatment regimen.

Step Three (at the office or clinic)

• This step takes place approximately 11-17 days after step 2.
• The clinician evaluates the woman to confirm a complete abortion. It is essential for women to return to the office/clinic to confirm that the abortion is complete.
• If there is an ongoing pregnancy, a suction abortion should be performed.
• If there is an incomplete abortion, the clinician will discuss possible treatment options with the woman. These may include waiting and re-evaluating for complete abortion in a number of days or performing a suction abortion.

Possible side effects of a mifepristone abortion

Side effects, such as pain, cramping and vaginal bleeding, result from the abortion process itself, and are therefore expected with a medical abortion. Other side effects of the medications themselves may include nausea, vomiting, diarrhea, chills, or fever. Complications are rare, but may include excessive vaginal bleeding requiring transfusion (occurs in approximately 1 in 500 cases), incomplete abortion or ongoing pregnancy which requires a suction abortion (see above).

What women can expect from a mifepristone abortion

• Medical abortion with mifepristone/misoprostol requires at least two visits to a doctor's office or clinic.
• Approximately 95% of women using mifepristone/misoprostol up to 49 days since the last menstrual period will have a complete medical abortion.
• Approximately two-thirds of women will have a complete medical abortion within 4 hours of using the misoprostol.
• Approximately 90% of women will have a complete medical abortion within 24 hours of using the misoprostol.
• Complete abortion generally occurs more quickly when misoprostol is used vaginally rather than orally.
• On average, women may expect to have bleeding and/or spotting for 9-16 days.
• Women may pass clots, ranging in size.
• Some women may see grayish pregnancy tissue.
• If the medications fail to end the pregnancy, a suction abortion should be performed. For this reason, a woman who chooses medical abortion must be willing to have a suction abortion if needed.