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 University (CU)

Status: Not yet enrolling

Conditions: Post Partum Hemorrhage

Treatments: Drug: Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative; Drug: Intravenous Carbetocin alone

Study type: Interventional

Funder types: Other

Identifiers

NCT07318467

MS-306-2025

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative

Group B

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous Carbetocin alone