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Completed

NCT Number: NCT01733329

Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

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.

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Key information

Conditions

Postpartum Hemorrhage Dystocia Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage Uterine Inertia

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • Fetal macrosomia (estimated fetal weight ≥ 4 Kilos) diagnosed by clinical measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula).
  • Polyhydramnios (defined as Phelan´s amniotic fluid index > 24 cm)
  • Twin or Multiple pregnancy.
  • Prolonged labour (prolonged active phase > 12 hours) or precipitate labour(cervical dilatation ≥ 10 cm/hour).
  • Magnesium sulphate or any other tocolytic agent therapy for ≥ 8 hours before cesarean section.
  • Intravenous oxytocin therapy for at least 4 hours before cesarean section.
  • Multiparous women (≥ 3 prior abdominal or vaginal deliveries )
  • 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.
  • Known myomatosis, uterine Müllerian malformations or those diagnosed by ultrasound.

Exclusion criteria

  • Misoprostol incorrect administration
  • Severe allergic, bleeding disorders (e.g., haemophilia); severe asthma or any other absolute contraindication to misoprostol use.
  • Any bleeding occurred before delivery (abruptio placentae, placenta praevia) or bleeding due to other causes different than uterine atony.

Treatment and study plan

Misoprostol

Drug

At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.

Other names: Cytotec

Folic Acid

Drug

At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.

Other names: Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage in Women With Risk Factors for Uterine Atony

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Nov 27, 2012
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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