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Same-day Dilapan-S With Adjunctive Misoprostol

NCT01818414 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2017-02-28

Study results available
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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.

Conditions

  • Therapeutic Abortion

Interventions

DRUG

Misoprostol

400 mcg of buccal misoprostol, 3 hours prior to planned D\&E

DRUG

Folic Acid

4 mg of buccal folic acid, 3 hours prior to planned D\&E

Sponsors & Collaborators

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Principal Investigator, MD MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-03-31
Completion
2014-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01818414 on ClinicalTrials.gov