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Completed

NCT Number: NCT07728084

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Cairo Governorate, 12111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol Tabets

Drug

400 μg of misoprostol administered intrauterinely after placental delivery during cesarean section

Primary outcomes

  1. Estimated intraoperative blood loss

    Time frame: at time of surgery

    Combined blood from suction and soaked materials

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.