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Prevention of Postpartum Haemorrhage With Sublingual Misoprostol or Oxytocin

NCT01373359 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 652

Last updated 2011-06-14

No results posted yet for this study

Summary

Sublingual misoprostol produces rapid peak concentration and is more effective than oral misoprostol for prevention of excessive postpartum bleeding. The study hypothesis was to test whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage have 30 ml less average blood loss than women receiving oxytocin, the standard of care for prevention of postpartum hemorrhage. We conducted a Double blind randomized controlled trial of .652 consenting, eligible pregnant women admitted to the labor room of the teaching hospital at J N Medical College, Belgaum, India. Women participating in the study were assigned by computer generated randomization to receive the study medications and placebos within one minute after clamping and cutting the umbilical cord. We also looked at the drugs effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the percent of women experiencing more than a 10% decline in haemoglobin, and reported drug side effects.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Misoprostol

400 µg sublingual misoprostol

DRUG

Oxytocin

10 IU IM

Sponsors & Collaborators

  • Cipla Ltd.

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • Jawaharlal Nehru Medical College

    lead OTHER

Principal Investigators

  • M B Bellad, M.D. · Jawaharlal Nehru Medical College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • India

Study Locations

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Drugs
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 NCT01373359 on ClinicalTrials.gov