Clinical Trial: Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony
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 Summary: 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.
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Current Primary Outcome: Need for Additional Uterotonic Medications [ Time Frame: 24 hours ]
Original Primary Outcome: Need for Additional Uterotonic Medications [ Time Frame: 24 hours ]
Current Secondary Outcome:
- Uterine Atony [ Time Frame: 24 hours ]Uterine atony is defined as failure of the uterus to contract adequately following delivery. Recognition of a soft, "boggy" uterus in the setting of excessive postpartum bleeding can alert the attendant to atony and should trigger a series of interventions aimed at achieving tonic sustained uterine contraction.
- Postpartum Hemorrhage [ Time Frame: 24 HOURS ]
Defined as:
Estimated blood loss ≥1000 mL after cesarean delivery. A substantial fall in the haematocrit e.g. 10% The requirement for a blood transfusion
- Blood Loss [ Time Frame: 24 hours ]
Original Secondary Outcome:
- uterine atony [ Time Frame: 24 HOURS ]
- postpartum hemorrhage [ Time Frame: 24 hours ]Defined as Estimated blood loss ≥1000 mL after cesarean delivery. A substantial fall in the haematocrit e.g. 10% The requirement for a blood transfusion
- Blood Loss [ Time Frame: 24 hours ]
Information By: Hospital Universitario Dr. Jose E. Gonzalez
Dates:
Date Received: November 16, 2012
Date Started: February 2008
Date Completion:
Last Updated: February 12, 2014
Last Verified: February 2014