Conditions: Postpartum Hemorrhage
Keywords: Buccal Misoprostol Uterine Atony Postpartum Hemorrhage
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 123
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to 400 mcg misoprostol (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony. arm 2: women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to 10 mg Folic acid (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.

Interventions: intervention 1: Misoprostol intervention 2: Folic Acid
Intervention descriptions: intervention 1: At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist. intervention 2: At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.

Protocol document: