Induced Abortion Clinical Trial
Official title:
Mifepristone Versus Misoprostol for Cervical Preparation Prior to Surgical Abortion Between 11 to 15 Weeks
Surgical abortion in the late first trimester and early second trimester is usually
performed with the aid of a cervical preparing agent, which helps to open up the uterine
cervix for the procedure. Routine use of cervical preparants is recommended by several
organizations during this period of pregnancy before surgical abortion, especially in
younger women or those who have not delivered a baby, because their cervices may be more
difficult to dilate without a preparant.
The standard medication used for cervical preparation is misoprostol. Unfortunately,
misoprostol may cause uncomfortable uterine cramping and vaginal bleeding in patients who
use it. Another medication called mifepristone has been shown to dilate the cervix better
than misoprostol in the first trimester, but little information exists about using
mifepristone in the late first trimester and early second trimester.
The investigators plan to perform a prospective, double-blind, randomized trial to evaluate
if mifepristone is a better cervical preparant than misoprostol. A total of 110 participants
who are pregnant women desiring pregnancy termination 11 to 15 weeks gestational age will be
recruited. Half will receive mifepristone and the other half misoprostol. The investigators
will measure the amount of cervical dilation achieved right before a surgical abortion to
determine if mifepristone is significantly different than misoprostol as a cervical
preparant at this stage of pregnancy. The investigators expect that mifepristone will work
better than misoprostol for this purpose.
The investigators hope to generate information about mifepristone so that women and their
health care providers can know more about mifepristone as an option for cervical preparation
before surgical abortion.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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