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 ]

The surgeon requested additional uterotonic agents on the basis of the clinical findings during surgery (e.g. uterine atony or blood loss of at least 1000 mL) Additional oxytocin was considered additional oxytocic intervention for purposes of data analysis.


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