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Mifepristone versus laminaria for cervical preparation prior to surgical abortion at 14-16 weeks

Lynn Borgatta, Boston Medical Center, 2009
See also executive summary.

Project abstract

This project is a randomized controlled trial of two methods of cervical preparation before second trimester surgical abortion at between 14 and 16 weeks. During this period of pregnancy, cervical preparation is usual, but not uniform, and there are two methods of cervical preparation commonly used. One is the insertion of osmotic dilators, usually performed the day before abortion, which provides primarily mechanical dilation. The other is the use of buccal or vaginal misoprostol placed one or several hours prior to abortion.

Both methods have their advocates, and both methods have some disadvantages. Using mifepristone the day prior to abortion would avoid some disadvantages of osmotic dilators, including the discomfort of osmotic dilators and the need for a separate insertion procedure. Mifepristone, although necessitating use the day before the abortion, would avoid the wait on the day of the abortion associated with misoprostol.

In this study we would compare mifepristone use to osmotic dilator use, as both are administered the day beforehand. Osmotic dilators are the method currently used. Outcomes would include the time for the abortion procedure, patient assessment of discomfort after mifepristone or dilators, discomfort during and after the abortion procedure, acceptability to patients, and acceptability to staff. A non-inferiority design will be used to show that mifepristone is not worse than osmotic dilators. A two-way comparison was chosen for simplicity and a relatively small sample size.


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