Same-day Dilapan-S With Adjunctive Misoprostol — DAM  

Pregnancy Trimester, Second Clinical Trial

Official title: Dilapan-S With Adjunctive Misoprostol for Same-day Second Trimester Dilation and Evacuation: A Randomized Trial

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy Trimester, Second

• NCT number: NCT01818414
• Study type: Interventional
• Source: University of Pittsburgh
• Status: Terminated
• Phase: N/A
• Start date: October 2013
• Completion date: April 2014