CompletedNot Applicable

A Comparative Study Between Rectal and Intrauterine Misoprostol Administration in the Reduction of Blood Loss During and After Elective Cesarean Delivery in Low Risk Women

Egypt140 participantsStarted 2025-01-13

Plain-language summary

One hundred forty low risk pregnant women scheduled for elective cesarean delivery were randomized (1:1) into two groups: the intrauterine group (n=70) received 400 μg misoprostol (200 μg at each uterine cornu) after placental delivery, while the rectal group (n=70) received 400 μg misoprostol rectally via urinary catheter insertion preoperatively.

Who can participate

Age range

20 Years – 40 Years

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: * Low risk women with singleton living fetus scheduled for elective cesarean delivery * American Society of Anesthesiologists (ASA) physical status I or II * Age: 20-40 years * Parity: 0-3 * Gestational age: 37-40 completed weeks * Body mass index (BMI): 18-30 kg/m² * Planned spinal anesthesia * Provision of informed consent Exclusion Criteria: * High risk pregnancies (anemia, renal disease, cardiac disease, hepatic disease, coagulopathies) * Increased risk for obstetric hemorrhage (placenta previa, placenta accreta spectrum, polyhydramnios, history of PPH, uterine rupture, uterine fibroids) * Allergy to prostaglandins or prostaglandin contraindications (e.g., asthma) * Complicated cesarean sections (bladder/ureteric injury, intestinal injury, massive intraoperative bleeding) * Known fetal or structural anomalies * Refusal to participate

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

Estimated intraoperative blood loss

Timeframe: at time of surgery

Trial details

NCT IDNCT07728084

SponsorCairo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-25

View on ClinicalTrials.gov More Postpartum Hemorrhage， Cesarean Section trials