Status:
NOT_YET_RECRUITING
Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section
Lead Sponsor:
Cairo University
Conditions:
Cesarean Section Complications
Tranexamic Acid
Eligibility:
FEMALE
20-40 years
Phase:
PHASE3
Brief Summary
Cesarean section is the most prevalent operation among women globally, 10-15% (1, 2). Recent research has shown Egypt to be the third-largest country globally, with an estimated 52% cesarean sections ...
Detailed Description
Study design: This study is a double-blinded prospective randomized comparative Clinical trial to compare and evaluate the effectiveness of intra-myometrial oxytocin injection and intra-myometrial tra...
Eligibility Criteria
Inclusion
- nclusion Criteria:
- Women booked for a primary elective cesarean section, not in active labor
- Aged between 20-40 years.
- BMI 18.5-29.9 kg/ m2 pre-pregnancy weight
- Term pregnancies (Early term: between 37 weeks, 0 days and 38 weeks, 6 days. Full term: between 39 weeks, 0 days and 40 weeks, 6 days. Late term: between 41 weeks, 0 days and 41 weeks, 6 days).
- Singleton pregnancies.
- Indication of elective cesarean section (Malpresentation, Malposition, Cephalopelvic disproportion, active herpes)
- Fetal macrosomia (Macrosomia is defined as birth-weight over 4,000 g irrespective of gestational age)
- Certain congenital fetal malformation and skeletal disorders (Several congenital anomalies are controversial indications for cesarean delivery; these include fetal neural tube defects (to avoid sac rupture), particularly defects that are larger than 5-6 cm in diameter as anterior cystic hygroma vascular sacrococcygeal teratoma, giant omphalocele and hydrocephalus with an enlarged biparietal diameter, and some skeletal dysplasia such as type III osteogenesis imperfecta. (Hamrick et al., 2008)
- Exclusion Criteria:
- Placenta previa.
- Maternal hypertension and Preeclampsia.
- Diabetes mellitus.
- Severe medical disorder (renal or hepatic).
- Multiple Fibroid uterus.
- Multiple pregnancies.
- Polyhydramnios.
- Previous uterine surgery as myomectomy.
- Contraindication to spinal anesthesia.
- Blood coagulopathy and bleeding disorder.
- Marked maternal anemia (Preoperative hemoglobin \<9 gm/dl).
- Contraindications to TXA or oxytocin therapy (e.g. allergy)
Exclusion
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06010368
Start Date
October 1 2024
End Date
January 1 2026
Last Update
September 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Suez Canal University
Ismailia, Egypt, 8366004