CompletedPhase 4

Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage

Mexico123 participantsStarted 2008-02

Plain-language 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.

Who can participate

SexFEMALE

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Inclusion criteria

✓. 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.

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.

What they're measuring

Need for Additional Uterotonic Medications

Timeframe: 24 hours

Trial details

NCT IDNCT01733329

SponsorHospital Universitario Dr. Jose E. Gonzalez

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

Results submitted2013-12-14

View on ClinicalTrials.gov More Postpartum Hemorrhage trials