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

NCT07318467 | Not Yet Recruiting

• 1 other identifier: MS-306-2025
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Amount of blood loss

  during and up to 24 hours after cesarean section

Study Arms (2)

Group A

EXPERIMENTAL

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 B

ACTIVE COMPARATOR

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

Interventions

Intravenous Carbetocin alone DRUG

Group B will receive intravenous Carbetocin (100 mcg) only. The participants will receive intravenous Carbetocin only immediately after delivery of the fetus.

Group B

Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative DRUG

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

Group A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Postpartum Hemorrhage

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 6, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12