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Rectal Misoprostol for Reducing Blood Loss in Elective Cesarean Section

NCT07188207 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2025-09-23

No results posted yet for this study

Summary

This randomized controlled trial aims to evaluate the efficacy of adding preoperative rectal misoprostol to standard oxytocin for reducing intraoperative and postoperative blood loss in women undergoing elective cesarean section. Misoprostol is a prostaglandin E1 analogue that is inexpensive, heat-stable, and effective as a uterotonic agent. The study will compare outcomes between two groups: women receiving oxytocin alone and women receiving oxytocin plus rectal misoprostol. The primary outcome is the reduction of blood loss during and after surgery. Secondary outcomes include changes in hemoglobin levels, need for additional uterotonics, maternal safety, and overall recovery.

Conditions

  • Postpartum Hemorrhage

Interventions

DRUG

Oxytocin

Intravenous oxytocin administered per hospital protocol immediately after delivery of the baby and placenta (example regimen: 10 IU slow IV bolus followed by infusion e.g., 20 IU in 500-1000 mL isotonic crystalloid run over 2-4 hours; actual dosing adjusted per anesthesiologist/obstetrician and hospital policy). Document exact time, dose, and infusion rate in each case. Single rectal dose of misoprostol 600-1000 µg (select dose based on patient risk profile; e.g., 600 µg for routine prophylaxis, 800-1000 µg for high-risk cases) inserted into the rectum immediately after delivery of the baby and placenta. No dilution required.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-10-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07188207 on ClinicalTrials.gov