Status:
COMPLETED
Comparing Tranexamic Acid Versus Ecbolics in Preventing Hemorrhage During and After Cesarean Section
Lead Sponsor:
Cairo University
Conditions:
Postpartum Hemorrhage
Blood Loss, Postoperative
Eligibility:
FEMALE
20-40 years
Phase:
NA
Brief Summary
The study will include 444 pregnant patients undergoing cesarean section in Kasr Al Aini. Following a proper medical history taking, examination will be done, investigations including laboratory test...
Detailed Description
The study will include (444) pregnant women attending for cesarean delivery in Kasr El Aini hospital (faculty of medicine - Cairo university). The following will be done to all participants: * Infor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2024
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT06060327
Start Date
October 15 2023
End Date
June 15 2024
Last Update
July 23 2024
Active Locations (2)
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1
kasr elainy hospital (Faculty of Medicine - Cairo University)
Cairo, Egypt, 115431
2
Faculty of medicine - Cairo university
Cairo, Egypt