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Uterotonic Prophylaxis Trial

NCT02408965 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2019-09-06

Study results available
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Summary

Excessive bleeding after dilation and evacuation (D\&E) requiring interventions is common, occurring in approximately 30% of cases at one large abortion-providing clinic. Uterotonic prophylaxis at the time of D\&E, particularly with methylergonovine maleate (MM), is a common practice among D\&E providers despite nearly no evidence for its efficacy. Finding ways to decrease excessive bleeding after D\&E has the potential both to improve patient safety and to reduce costs of provider-initiated interventions. The investigators propose a randomized, controlled trial to investigate the efficacy of MM prophylaxis versus placebo in decreasing excessive bleeding measured by a composite outcome among women undergoing D\&E at 20 to 24 weeks.

Conditions

Interventions

DRUG

Methergine

0.2 mg of methylergonovine maleate

OTHER

placebo

saline placebo to maintain blinding

Sponsors & Collaborators

Principal Investigators

  • Jennifer Kerns, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT02408965 on ClinicalTrials.gov