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Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol

NCT02363556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2017-08-30

No results posted yet for this study

Summary

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.

Conditions

  • Second Trimester Abortions

Interventions

PROCEDURE

Misoprostol administered vaginally

PROCEDURE

Misoprostol administered buccally

PROCEDURE

Misoprostol administered vaginally with Dilapan

PROCEDURE

Misoprostol administered buccally with Dilapan

Sponsors & Collaborators

Principal Investigators

  • Dr. Matthew Reeves, MD MPH · MedStar Washington Hospital Center & Planned Parenthood of Metropolitan Washington

  • Dr. Jamilah Shakir, MD MPH · Medstar Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-07-31
Completion
2017-06-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02363556 on ClinicalTrials.gov