Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol
Completed · Not applicable
Conditions studied: Second Trimester Abortions
In brief
This randomized controlled trial will use a 2 by 2 factorial design to assess methods of cervical preparation prior to Dilation and Evacuations (D\&Es) at 14 0/7 to 19 6/7 weeks gestational age. In total, 160 woman will be randomized to misoprostol alone or Dilapan with misoprostol and separately randomized to buccal or vaginal administration of 400-mcg misoprostol. A total of 80 women will receive 400-mcg misoprostol only (40 vaginal and 40 buccal). Another 80 women will have Dilapan inserted and then use misoprostol (40 vaginal and 40 buccal). Four to six hours later, the Dilation and Evacuation (D\&E) procedure will be performed.
Key facts
- Study ID
- NCT02363556
- Run by
- Medstar Health Research Institute
- People needed
- 160
- Starts
- 2015-01-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2017-08-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Healthy pregnant women
- 18 years of age or older
- Eligible for non-urgent Dilation and Evacuations at 14 0/7 - 19 6/7 weeks gestation confirmed by sonogram.
You may not qualify if…
- Women who do not speak English.
- Fetal demise
- Intolerance, allergy or contraindication to misoprostol or Dilapan.
Where it is running
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Planned Parenthood Metropolitan Washington — Silver Spring, Maryland, United States
Full record on ClinicalTrials.gov
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