Same-day Dilapan-S With Adjunctive Misoprostol

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pittsburgh
• Treatments: Folic Acid; Misoprostol; Vitamin B Complex; Vitamins

Criteria

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