Post Partum Hemorrhage
Conditions
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
Interventions
DRUGIntravenous 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
DRUGIntravenous Carbetocin alone
Group B will receive intravenous Carbetocin (100 mcg) only. The participants will receive intravenous Carbetocin only immediately after delivery of the fetus.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of blood loss | during and up to 24 hours after cesarean section |
Outcome results
None listed