Rectal Misoprostol for Reducing Blood Loss in Elective Cesarean Section

NCT07188207 | Not Yet Recruiting

• 1 other identifier: MISOCS-2025
• Study Type: interventional
• Target: 282
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Misoprostol; Oxytocin; Cesarean Delivery

Outcome Measures

Primary Outcomes (1)

• 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.

  From skin incision until 24 hours after cesarean delivery

Secondary Outcomes (1)

• Change in Hemoglobin and Hematocrit

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

Study Arms (2)

Control: Oxytocin only

EXPERIMENTAL

Description: Participants receive standard intraoperative uterotonic therapy with oxytocin according to hospital protocol immediately after delivery of the baby and placenta. Standard perioperative care (spinal anesthesia, prophylactic antibiotics, fluid management, monitoring) is provided. Rescue uterotonic measures and transfusion given as clinically indicated.

Drug: Oxytocin

Intervention: Oxytocin + Rectal Misoprostol

EXPERIMENTAL

Participants receive the same oxytocin regimen as Arm 1 plus a single rectal dose of misoprostol (600-1000 µg depending on risk profile) administered immediately after delivery of the baby and placenta. Standard perioperative care is identical to Arm 1. Rescue uterotonic measures and transfusion given as clinically indicated.

Drug: Oxytocin

Interventions

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.

Control: Oxytocin only; Intervention: Oxytocin + Rectal Misoprostol

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 18-45 years.
• Singleton pregnancy at ≥37 weeks of gestation.
• Elective cesarean section planned under spinal anesthesia.
• Hemodynamically stable prior to surgery.
• Provided written informed consent.

You may not qualify if:

• 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).
• Known allergy or contraindication to prostaglandins or oxytocin.
• Intrauterine fetal death or major fetal anomaly.
• Refusal to participate.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Federspiel JJ, Eke AC, Eppes CS. Postpartum hemorrhage protocols and benchmarks: improving care through standardization. Am J Obstet Gynecol MFM. 2023 Feb;5(2S):100740. doi: 10.1016/j.ajogmf.2022.100740. Epub 2022 Sep 2.

  PMID: 36058518 BACKGROUND

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

amira zanaty khalaf, resident

CONTACT

01004231328; amirazanatya@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The study will be conducted in a blinded manner. Neither the participants nor the outcome assessors will know the treatment allocation. Care providers administering the intervention will also be blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Obstetric and Gynecology Department

Model Details: Participants will be randomly assigned into two equal parallel groups: one receiving oxytocin alone (control group), and the other receiving oxytocin plus rectal misoprostol (intervention group).

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share