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Misoprostol in the Treatment of Postpartum Hemorrhage

NCT00116480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2009-03-19

No results posted yet for this study

Summary

Postpartum haemorrhage (PPH) remains a leading cause of maternal mortality, despite treatment with conventional methods. Uncontrolled reports and three small randomised controlled trials have suggested that misoprostol may have an additive effect to routine treatment, and there is a serious danger that this method will be used widely without research to document the effectiveness or risks of this method. In this randomised controlled trial (RCT), we propose to test whether 600 μg of sublingually administered misoprostol in women requiring additional uterotonics after delivery, and after routine syntocinon to all women during or after delivery, has additional effects above the additional conventional uterotonics in reducing PPH. Women with measured blood loss greater than or equal to 500 mls in 4 Karachi hospitals who give consent will be given locally routine treatment for PPH. In addition, they will be enrolled by drawing the next of a series of randomised treatment packs containing misoprostol or placebo. The primary outcome measure will be blood loss greater than or equal to 500 mls after enrolment.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Misoprostol

600 mcg of sublingual misoprostol

Sponsors & Collaborators

  • Aga Khan University

    collaborator OTHER

  • Aga Khan Health Services

    collaborator OTHER

  • The Aga Khan Foundation

    collaborator OTHER

  • Family Care International

    collaborator OTHER

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Nadeem F Zuberi, MD · Aga Khan University Hospital, Karachi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • Pakistan

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 NCT00116480 on ClinicalTrials.gov