Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Intervention: Misoprostol; Folic Acid
Intervention description: At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.; At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.
Intervention MeSH terms: Folic Acid; Misoprostol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Buccal Misoprostol; Uterine Atony; Postpartum Hemorrhage

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.
    

Eligibility 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.