Rectal Misoprostol for Reducing Blood Loss in Elective Cesarean Section

ConditionPostpartum Hemorrhage

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women aged 18-45 years.

Singleton pregnancy at ≥37 weeks of gestation.

Elective cesarean section planned under spinal anesthesia.

Hemodynamically stable prior to surgery.

Disqualifiers

Multiple pregnancy.

Antepartum hemorrhage (e.g., placenta previa, abruption).

Coagulopathy, thrombocytopenia, or anticoagulant therapy.

Severe medical comorbidities (e.g., uncontrolled hypertension, cardiac disease, hepatic or renal impairment).

Trial design

Design model

Parallel

Treatments tested in this trial

Oxytocin
Drug
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.

Treatment groups

282 Participants

are divided into 2 treatment groups

Group A: Control: Oxytocin onlyExperimental treatment 1 intervention

Group B: Intervention: Oxytocin + Rectal MisoprostolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Intraoperative and postoperative blood loss

Total blood loss will be measured intraoperatively by suction canister volume (minus irrigation fluid) and gravimetric method (weighing surgical pads/swabs), and postoperatively by weighing perineal pads up to 24 hours.

Time frame

From skin incision until 24 hours after cesarean delivery

Secondary outcomes

Change in Hemoglobin and Hematocrit

Difference between pre- and postoperative hemoglobin/hematocrit values to estimate blood loss.

Time frame

Preoperative (within 24 hours before surgery) and 24 hours postoperative

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: