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Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01733329
First Posted: November 27, 2012
Last Update Posted: March 31, 2014
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.
Information provided by (Responsible Party):
Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez
November 16, 2012
November 27, 2012
December 14, 2013
March 31, 2014
March 31, 2014
February 2008
December 2013   (Final data collection date for primary outcome measure)
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.
Need for Additional Uterotonic Medications [ Time Frame: 24 hours ]
Complete list of historical versions of study NCT01733329 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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

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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Postpartum Hemorrhage
  • Drug: Misoprostol
    At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.
    Other Name: Cytotec
  • Drug: Folic Acid
    At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.
    Other Name: Placebo
  • Experimental: Misoprostol
    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.
    Intervention: Drug: Misoprostol
  • 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.
    Intervention: Drug: Folic Acid

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
123
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women who underwent delivery either by elective or emergent cesarean section at 24 week gestation or later with preoperative levels of hemoglobin and hematocrit determined up to 72 hours prior to delivery. The patients must have at least one of the risk factors for uterine atony listed below:

    1. Fetal macrosomia (estimated fetal weight ≥ 4 Kilos) diagnosed by clinical measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula).
    2. Polyhydramnios (defined as Phelan´s amniotic fluid index > 24 cm)
    3. Twin or Multiple pregnancy.
    4. Prolonged labour (prolonged active phase > 12 hours) or precipitate labour(cervical dilatation ≥ 10 cm/hour).
    5. Magnesium sulphate or any other tocolytic agent therapy for ≥ 8 hours before cesarean section.
    6. Intravenous oxytocin therapy for at least 4 hours before cesarean section.
    7. Multiparous women (≥ 3 prior abdominal or vaginal deliveries )
    8. Clinical chorioamnionitis was defined as maternal temperature of ≥ 38°C in addition to more than one of the following criteria: fetal tachycardia (> 160 beats per minute), maternal tachycardia (>100 beats per minute, maternal leukocytosis (15,000 cells/mm3), uterine tenderness or foul smelling amniotic fluid.
    9. Known myomatosis, uterine Müllerian malformations or those diagnosed by ultrasound.

Exclusion Criteria:

  1. Misoprostol incorrect administration
  2. Severe allergic, bleeding disorders (e.g., haemophilia); severe asthma or any other absolute contraindication to misoprostol use.
  3. Any bleeding occurred before delivery (abruptio placentae, placenta praevia) or bleeding due to other causes different than uterine atony.
Sexes Eligible for Study: Female
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT01733329
GI07-011
Yes
Not Provided
Not Provided
Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez
Hospital Universitario Dr. Jose E. Gonzalez
Not Provided
Not Provided
Hospital Universitario Dr. Jose E. Gonzalez
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP