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
1 other identifier
interventional
140
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2026
CompletedFirst Submitted
Initial submission to the registry
July 21, 2026
CompletedFirst Posted
Study publicly available on registry
July 27, 2026
CompletedJuly 27, 2026
July 1, 2026
1.3 years
July 21, 2026
July 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Estimated intraoperative blood loss
Combined blood from suction and soaked materials
at time of surgery
Study Arms (2)
Intrauterine Misoprostol
ACTIVE COMPARATOR400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered intrauterinely after placental delivery during cesarean section. The dose was divided as 200 μg placed at each uterine cornu.
Rectal Misoprostol
ACTIVE COMPARATOR400 μg of misoprostol administered rectally via urinary catheter insertion preoperatively.
Interventions
400 μg of misoprostol administered intrauterinely after placental delivery during cesarean section
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Cairo Governorate, 12111, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed Maged
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 21, 2026
First Posted
July 27, 2026
Study Start
January 13, 2025
Primary Completion
April 25, 2026
Study Completion
June 29, 2026
Last Updated
July 27, 2026
Record last verified: 2026-07