Comparing Tranexamic Acid Versus Ecbolics in Preventing Hemorrhage During and After Cesarean Section
Postpartum Hemorrhage, Blood Loss, Postoperative, Cesarean Section Complications
About this trial
This is an interventional prevention trial for Postpartum Hemorrhage
Eligibility Criteria
Inclusion Criteria: 2. Pregnant women candidate for LSCS. 3. Age: 20-40 years old. 4. Full term pregnancies (> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan). 5. Singleton pregnancies. 6. One or more of the following criteria to be considered as high-risk case for PPH (RCOG, 2016): Maternal Anemia (hemoglobin < 10 g%). Known placenta previa. Proven or suspected case of placental abruption. Preeclampsia or gestational hypertension. Polyhydramnios (DVP > 8cm). Macrosomia (> 4 Kg) Previous history of uterine atony or postpartum hemorrhage). Prolonged labour (>12 hours). 7. CS under spinal anesthesia. Exclusion Criteria: 1. Fetal death (IUFD). 2. Fetal anomalies. 3. IUGR (Estimated fetal weight below the 5th centile) 4. Women presenting with an obstetric emergency necessitating immediate surgery (Cord prolapse, severe antepartum hemorrhage, severe fetal distress etc.) 5. More than 2 previous CS procedures. 6. Prolonged procedure (more than 2 hours from skin incision to skin closure). 7. History of prostaglandin, Tranexamic acid or carbetocin allergy. 8. Multifetal pregnancies. 9. Abnormally invasive placenta. 10. Known deep venous thrombosis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Oxytocin Group
Tranexamic acid
Misoprostol
Carbetocin
o In Oxytocin group (n=111), patients will receive 10 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) given as infusion in 500 ml lactated ringer/s solution at a rate of 125ml/hour after delivery of the placenta.
o In Tranexamic group (n=111), patients will be given 1 gm (10 ml) TXA (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision). Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.
o In Misoprostol group (n=111), 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) will be inserted intraoperative inside the uterus after delivery of the placenta Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.
o In carbetocin group (n=111) 100 microgram carbetocin (Pabal, Ferring, Kiel, Germany) will be given as an intravenous bolus dose following the delivery of the placenta. Oxytocin 5 IU will be given slowly intravenous following delivery of the baby.