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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- 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
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
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
Abdalla Mousa
Lecturer of Obstetrics and Gynecology
Cairo University