Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

NCT01733329 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2018-10-11

Study results available
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Summary

Objective: to demonstrate that buccal misoprostol administration during cesarean delivery in women with risk factors for uterine atony decreases the need for additional uterotonic medications, uterine atony and postpartum hemorrhage.

Design: randomized, double-blinded, placebo-controlled trial.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Misoprostol

At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.

DRUG

Folic Acid

At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.

Sponsors & Collaborators

  • Hospital Universitario Dr. Jose E. Gonzalez

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Mexico

Study Locations

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Entities

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 NCT01733329 on ClinicalTrials.gov