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Clinical Trials/NCT07318467
NCT07318467Not yet recruitingNot Applicable

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

Cairo University0 sites80 target enrollmentStarted: January 1, 2026Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
80
Primary Endpoint
Amount of blood loss

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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

Intervention: Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative (Drug)

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.

Intervention: Intravenous Carbetocin alone (Drug)

Outcomes

Primary Outcomes

Amount of blood loss

Time Frame: during and up to 24 hours after cesarean section

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdalla Mousa

Lecturer of Obstetrics and Gynecology

Cairo University

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