Phase 4
N=123
Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage
Postpartum Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT01733329 ↗Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Need for Additional Uterotonic Medications — 10; 40 percentage of participants — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Misoprostol (Drug); Folic Acid (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Need for Additional Uterotonic Medications |
10; 40 | <0.01 sig |
| SECONDARY Uterine Atony |
8.3; 25 | 0.026 sig |
| SECONDARY Postpartum Hemorrhage |
6.6; 20 | 0.058 |
| SECONDARY Blood Loss |
470; 653.33 | 0.007 sig |
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:
- 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.
Data sourced from ClinicalTrials.gov (NCT01733329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.