Buccal Misoprostol During Cesarean Section for Preventing Postpartum Hemorrhage (NCT01733329) | Clinical Trial Compass
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
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Need for Additional Uterotonic Medications
Timeframe: 24 hours
Trial details
NCT IDNCT01733329
SponsorHospital Universitario Dr. Jose E. Gonzalez