NCT01733329

Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 123 (actual)
• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

Patients and methods: 120 pregnant women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-02-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-11-27
• Last updated: 2018-10-11
• Results posted: 2014-03-31

Locations

1 site across 1 country: Mexico