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Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

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ClinicalTrials.gov Identifier: NCT01733329
Recruitment Status : Completed
First Posted : November 27, 2012
Results First Posted : March 31, 2014
Last Update Posted : March 31, 2014
Sponsor:
Information provided by (Responsible Party):
Flavio Hernández Castro, Hospital Universitario Dr. Jose E. Gonzalez

Study Description
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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.


Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Misoprostol Drug: Folic Acid Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

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Arms and Interventions
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Arm Intervention/treatment
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 Name: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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


  3. Blood Loss [ Time Frame: 24 hours ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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
First Posted: November 27, 2012    Key Record Dates
Results First Posted: March 31, 2014
Last Update Posted: March 31, 2014
Last Verified: February 2014

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

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