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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative, Intravenous Carbetocin alone.
- Who it may be relevant to
- Registry conditions: Post Partum Hemorrhage. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative
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 Carbetocin alone
Group B will receive intravenous Carbetocin (100 mcg) only. The participants will receive intravenous Carbetocin only immediately after delivery of the fetus.
Primary outcome measures
- Amount of blood loss [Time frame: during and up to 24 hours after cesarean section]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07318467 · MS-306-2025