Prophylactic Regimen of Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative for Primary Prevention of Postpartum Hemorrhage in Intrapartum Cesarean Section Versus Intravenous Carbetocin Alone

December 20, 2025 updated by: Abdalla Mousa, Cairo University
While Carbetocin is effective in reducing PPH, the combination of oxytocin, Tranexamic acid, and Ergot derivatives may offer additional benefits in high-risk populations. We hypothesize that the combination regimen will reduce PPH incidence and severity compared to Carbetocin alone and may be more cost effective

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women undergoing C-Sections.
  • Women between the ages of 18 and 45 years.
  • Singleton pregnancy.
  • Gestational age is equal to or more than 36 weeks.
  • No known coagulopathy or bleeding disorders.
  • No known hypersensitivity or allergy to drugs used in the study.
  • Normal obstetric ultrasonography with no fetal abnormalities.

Exclusion Criteria:

  • Hemodynamically unstable or immobile patients.
  • Multifetal pregnancy.
  • Patients who are receiving prophylactic or therapeutic anticoagulation.
  • Known comorbidities and contraindications to the use of Ergot derivatives or Carbetocin such as hypertension or cardiovascular disorders.
  • Placenta previa and/or Placenta accreta spectrum.
  • History of thromboembolism.
  • Preeclampsia or eclampsia.
  • Any additional measurements needed to control or stop excessive bleeding intraoperatively such as uterine artery ligation or use of sterile gelatin absorbable foam.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A

Group A will receive a combination regimen of intravenous Oxytocin (5-10IU), Tranexamic acid (intravenous bolus 1 gram), and intramuscular ergot derivative (methylergometrine maleate 0.2 mg/ ml).

The participants will receive intravenous Oxytocin immediately after delivery of the fetus, intravenous Tranexamic acid during the procedure and intramuscular Ergot derivative after delivery of the placenta
Drug: Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative

Group A will receive a combination regimen of intravenous Oxytocin (5-10IU), Tranexamic acid (intravenous bolus 1 gram), and intramuscular ergot derivative (methylergometrine maleate 0.2 mg/ ml).

The participants will receive intravenous Oxytocin immediately after delivery of the fetus, intravenous Tranexamic acid during the procedure and intramuscular Ergot derivative after delivery of the placenta
Active Comparator: Group B
Group B will receive intravenous Carbetocin (100 mcg) only. The participants will receive intravenous Carbetocin only immediately after delivery of the fetus.
Drug: Intravenous Carbetocin alone
Group B will receive intravenous Carbetocin (100 mcg) only. The participants will receive intravenous Carbetocin only immediately after delivery of the fetus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of blood loss
Time Frame: during and up to 24 hours after cesarean section
during and up to 24 hours after cesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

December 20, 2025

First Submitted That Met QC Criteria

December 20, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

December 20, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-306-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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