Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01733329
First received: November 16, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Postpartum Hemorrhage
Drug: Misoprostol
Drug: Folic Acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

Primary Outcome Measures:
  • Need for Additional Uterotonic Medications [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Uterine Atony [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: February 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Misoprostol
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 Names:
  • Folic acid
  • Placebo

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01733329

Locations
Mexico
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, Mexico, 64460
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
  More Information

Publications:
Responsible Party: Flavio Hernández Castro, Principal Investigator, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01733329     History of Changes
Other Study ID Numbers: GI07-011
Study First Received: November 16, 2012
Results First Received: December 14, 2013
Last Updated: February 12, 2014
Health Authority: Mexico: Ethics Committee

Keywords provided by Hospital Universitario Dr. Jose E. Gonzalez:
Buccal Misoprostol
Uterine Atony
Postpartum Hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Uterine Inertia
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Dystocia
Folic Acid
Vitamin B Complex
Hematinics
Misoprostol
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Reproductive Control Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on April 17, 2014