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

ConditionPost Partum Hemorrhage

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorCairo University

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Group AExperimental treatment 1 intervention

Group B: Group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

Amount of blood loss

Time frame

during and up to 24 hours after cesarean section

Locations

This trial has no locations.

Sponsors and contacts

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Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: