Comparative Study Between Preoperative and Postoperative Rectal Misoprostol (NCT06049160) | Clinical Trial Compass
CompletedNot Applicable
Comparative Study Between Preoperative and Postoperative Rectal Misoprostol
Egypt128 participantsStarted 2023-08-31
Plain-language summary
Cesarean delivery (CD) is the most common major surgical procedure undergone by women around the world. Over the past two decades, there has been a witnessed increase in rates of caesarean deliveries, which continues to rise, achieving 30% in resource-rich countries and exceeding 60% in resource-limited countries. According to a Lancet report 2014, Egypt is one of the countries with the highest rates of caesarean delivery, in which the rate had reached 55.5%. The rate is almost double to three times the ideal rate of 10%-15%
Who can participate
Age range
18 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
. Gestational age ( 37 to 41 weeks).
. Singleton healthy fetus.
. Scheduled for elective lower segment caesarean delivery under spinal anaesthesia.
. Body mass index of (25-30 Kg/m2).
. Normal coagulation profile.
. Normal amniotic fluid volume assessed by amniotic fluid index.
Exclusion criteria
. Maternal comorbidity: Hypertension; diabetes; heart, kidney, or liver disorders.
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
Intraoperative blood loss (defined as blood loss ≥500 cc)
Timeframe: First 2 hours from the starting of the operation
2
Intraoperative blood loss (defined as blood loss ≥500 cc)
Timeframe: First 2 hours from the starting of the operation
. Contraindication to use of misoprostol like known allergy to misoprostol or asthmatic patients.
. Women who had undergone any previous uterine surgery such as myomectomy because it is considered upper uterine segment operation with more destruction in myometrium but caesarean section is a lower segment uterine operation with minimal destruction in myometrium.
. Women at higher risk of intraoperative blood loss or PPH, such as those with hemoglobin levels less than 9 g/dl, history of PPH, or uterine fibroids.
. Antepartum hemorrhage ( placenta previa and placental abruption).
. Women who will undergo caesarean section because of failure of induction of labor.