Same-day Dilapan-S With Adjunctive Misoprostol
Stopped early · Not applicable
Conditions studied: Therapeutic Abortion
In brief
Cervical preparation before second trimester dilation and evacuation (D\&E) reduces risks and complications. Osmotic cervical dilators as well as prostaglandin analogues have been studied for cervical preparation. However, the optimal method for cervical preparation, especially for D\&E procedures that occur on the same day as cervical preparation, is not known. This study will investigate misoprostol versus placebo as an adjunct to Dilapan-S for cervical preparation for same-day D\&E between 16+0 and 20+6 weeks gestation. HYPOTHESIS: Administration of 400 µg buccal misoprostol compared to placebo at least 3 hours prior to D\&E as an adjunct to cervical preparation with Dilapan-S will decrease operative time for same-day D\&E performed between 16+0 and 20+6 weeks.
Key facts
- Study ID
- NCT01818414
- Run by
- University of Pittsburgh
- People needed
- 29
- Starts
- 2013-10-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2017-02-28
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Age greater than or equal to 18 years (no upper age limit)
- Gestational age between 16+0 and 20+6 weeks gestation on day of D\&E with confirmation of gestational age by ultrasound
- Desires D\&E for termination of pregnancy or for fetal demise
- Able to provide written informed consent
- Able to comply with study procedures
- English-speaking
You may not qualify if…
- Known allergy or contraindication to misoprostol
- Pregnancy with a multiple gestation
- Known bleeding disorder or current anticoagulation therapy (within one month of procedure)
- Active bleeding or hemodynamically unstable at enrollment
- Signs of chorioamnionitis or clinical infection at enrollment
- Signs of spontaneous labor or cervical insufficiency at enrollment
Where it is running
- Planned Parenthood of Western Pennsylvania — Pittsburgh, Pennsylvania, United States
- Univeristy of Pittsburgh, Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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