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

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: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage， Cesarean Section
• Intervention / Treatment: Drug: Misoprostol Tabets; Drug: Misoprostol Tabets

Detailed Description

Intrauterine Misoprostol Group (n=70) Participants received 400 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 Group (n=70) Participants received 400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered rectally via urinary catheter insertion preoperatively Standard Care All participants received standard active management of the third stage of labor including: Intravenous bolus of 5 IU oxytocin after fetal delivery 20 IU oxytocin diluted in 500 mL lactated Ringer's solution infused at 125 mL/hour Surgical Protocol All cesarean deliveries were performed under spinal anesthesia using a standardized surgical technique

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 12111
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intrauterine Misoprostol; 400 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.	Drug: Misoprostol Tabets; 400 μg of misoprostol administered intrauterinely after placental delivery during cesarean section; Drug: Misoprostol Tabets; 400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered rectally via urinary catheter insertion preoperatively
Active Comparator: Rectal Misoprostol; 400 μg of misoprostol administered rectally via urinary catheter insertion preoperatively.	Drug: Misoprostol Tabets; 400 μg of misoprostol administered intrauterinely after placental delivery during cesarean section; Drug: Misoprostol Tabets; 400 μg of misoprostol (Cytotec, Pfizer, G.D. Searle LLC) administered rectally via urinary catheter insertion preoperatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated intraoperative blood loss	Combined blood from suction and soaked materials	at time of surgery

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Ahmed Maged, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2025
• Primary Completion (Actual): April 25, 2026
• Study Completion (Actual): June 29, 2026

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No