Same-day Dilapan-S With Adjunctive Misoprostol
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | October 2013 |
| End Date: | July 2014 |
| Contact: | Christy M Boraas, MD, MPH |
| Email: | boraascm@upmc.edu |
| Phone: | 412-641-3464 |
Dilapan-S With Adjunctive Misoprostol for Same-day Second Trimester Dilation and Evacuation: A Randomized, Double-Blind, Placebo-Controlled Trial
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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