Pre-Operative Effects of Mifepristone on Dilation and Evacuation Services



Status:Completed
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:July 2013
End Date:April 2016

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Protocol Title: Reducing Complications and Patient Barriers in Second Trimester Abortion: Pre-Operative Effects of Mifepristone (POEM) on Dilatation and Evacuation Services

This research study investigates the use of a drug, mifepristone, given before second
trimester abortion. Mifepristone is a medication that is approved for medical abortion
during the first trimester. It also has been used prior to abortion in the early seconds
trimester (14-16 weeks gestation) and for medication abortion in the second trimester (also
called induction abortion). This medication has effects on the uterus that may help dilate,
or open, the cervix. Abortion requires opening of the cervix to safely remove the pregnancy.
Cervical dilation, or opening, is essential to both ease of completion of procedure and
reducing complications that can occur. These complications include laceration, or tearing,
of the cervix and perforation of the uterus (a hole made unintentionally in the muscle wall
of the uterus) and are not expected to be increased in the study. Dilation of the cervix is
usually achieved by placing thin rods (cervical dilators) through the cervix. These rods
then absorb the moisture of the vagina and slowly expand, opening the cervix. The standard
method of dilation is performed at the clinic and involves the placement of cervical
dilators the day before the procedure. This procedure can be uncomfortable. A prior study
showed that mifepristone reduces the number of osmotic dilators that need to be placed prior
to the procedure after 19 weeks gestation. We aim to investigate mifepristone as a potential
adjunct to cervical dilation or used alone, without dilators, as method of cervical
preparation with the hopes of reducing barriers imposed by painful procedures and time in
clinic and away from work/home that the current approach involving dilators requires.


Inclusion Criteria:

- >18 years old

- Viable, Singleton pregnancy

- Voluntarily seeking abortion between 19 and 24 wks gestation

- Able to give informed consent and comply with study protocol

- Fluent in English or Spanish

Exclusion Criteria:

- Allergy to misoprostol or mifepristone
We found this trial at
2
sites
San Jose, California 95128
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San Jose, CA
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Stanford, CA
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