Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01733329|
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : March 31, 2014
Last Update Posted : October 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Hemorrhage||Drug: Misoprostol Drug: Folic Acid||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
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.
At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.
Other Name: Cytotec
Placebo Comparator: Folic Acid
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.
Drug: Folic Acid
At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.
Other Name: Placebo
- 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.
- 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 ]
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01733329
|Hospital Universitario Dr. José Eleuterio González|
|Monterrey, Nuevo León, Mexico, 64460|