Status:
COMPLETED
Tranexamic Acid Versus Sublingual Misoprostol in Reducing Blood Loss During Elective CS in High Risk Cases
Lead Sponsor:
Cairo University
Conditions:
Post Partum Hemorrhage
Eligibility:
FEMALE
20-40 years
Phase:
PHASE2
Brief Summary
The Efficacy and safety of Preoperative Intravenous Tranexamic acid versus Sublingual misoprostol in reducing blood loss during and after Elective Cesarean section among high risk pregnant cases.
Detailed Description
The study will include (345) pregnant women attending for elective cesarean delivery in the Kasr Elaini hospital (faculty of medicine - Cairo university). All the patients will be subjected to inform...
Eligibility Criteria
Inclusion
- Pregnant women candidate for LSCS.
- Age: 20-40 years old.
- Full term pregnancies (\> 37 weeks confirmed by the 1st day of the LMP or 1st trimesteric ultrasound scan).
- Singleton or twin pregnancies.
- Maternal Anemia (hemoglobin \< 9.9 g%)
- Maternal medical disorders (e.g. cardiac, renal, and hepatic diseases, Thromboembolic disorders or coagulopathies).
- High risk case for obstetric hemorrhage (e.g. peripartum hemorrhage, accidental hemorrhage, placenta previa, previous history of uterine atony or postpartum hemorrhage).
- CS under spinal anesthesia.
Exclusion
- Fetal death (IUFD).
- Fetal anomalies or IUGR (estimated fetal weight below the 5th centile)
- Women attending for emergency CS.
- More than 2 previous CS procedures.
- Prolonged procedure (more than 2 hours from skin incision to skin closure).
- History of prostaglandin or Tranexamic acid allergy.
Key Trial Info
Start Date :
January 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
345 Patients enrolled
Trial Details
Trial ID
NCT04117243
Start Date
January 20 2020
End Date
December 31 2020
Last Update
July 28 2025
Active Locations (1)
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1
Faculty of Medicine
Cairo, Egypt