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Effect of Preoperative Buccal Misoprostol on Blood Loss in Second-trimester Dilation and Evacuation Abortion

NCT01436266 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2017-05-30

Study results available
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Summary

Misoprostol is a medication used extensively in obstetrics and gynecology for its ability to aid in softening the cervix as well as decreasing blood loss after abortion or vaginal delivery. Opinions vary as to its usefulness in aiding in cervical dilation, and in decreasing blood loss. The investigators propose to conduct a randomized, placebo-controlled trial to evaluate whether misoprostol given buccally 2 hours prior to second trimester surgical abortion decreases blood loss from the procedure. The investigators will also assess whether misoprostol improves cervical dilation, changes the length of the procedure, changes the need for additional mechanical dilation, changes the subjective ease of the procedure, and changes a woman's pain.

Conditions

  • Abortion
  • Blood Loss

Interventions

DRUG

Misoprostol

400 mcg buccally 2 hours prior to procedure

OTHER

Folic acid

2mg buccally 2 hours prior to procedure

Sponsors & Collaborators

  • Boston University

    lead OTHER

Principal Investigators

  • Sarita Sonalkar, MD · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-08-31
Completion
2012-08-31
FDA Drug
Yes

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 NCT01436266 on ClinicalTrials.gov