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NCT Number: NCT07318467

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

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Amount of blood loss

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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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