At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 123 enrolled
Drug / intervention
Misoprostol +1 moredrug
Likely dose
Misoprostol 400 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony
In Brief
A Phase 4 clinical trial evaluating Misoprostol and Folic Acid for Postpartum Hemorrhage. Completed, enrolled 123 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostpartum Hemorrhage
CountriesMexico
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedNov 2012
Primary CompletionDec 2013
TodayJul 2026
First PostedNov 27, 2012
Enrollment StartFeb 1, 2008
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 13.6 years ago
Interventions
Misoprostoldrug
At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.
Folic Aciddrug
At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.