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
NCT ID: NCT07318467
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2026-01-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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
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
Group B
Group B will receive intravenous Carbetocin (100 mcg) only. The participants will receive intravenous Carbetocin only immediately after delivery of the fetus.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Cairo University
OTHER
Responsible Party
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Abdalla Mousa
Lecturer of Obstetrics and Gynecology
Other Identifiers
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MS-306-2025
Identifier Type: -
Identifier Source: org_study_id
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