Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

Hospital Universitario Dr. Jose E. Gonzalez

Status and phase: Completed; Phase 4

Conditions: Postpartum Hemorrhage

Treatments: Drug: Misoprostol; Drug: Folic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01733329

GI07-011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 123 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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123 participants in 2 patient groups, including a placebo group

Misoprostol

Experimental group

Description:

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.

Treatment:

Drug: Misoprostol

Folic Acid

Placebo Comparator group

Description:

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.

Treatment:

Drug: Folic Acid