Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section (NCT06010368) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section
Egypt150 participantsStarted 2024-10-01
Plain-language 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 (3). However, the cesarean section has many serious complications, including the primary postpartum hemorrhage (PPH) (4). During labor, the average blood loss is about 300 to 400 ml. Bleeding postpartum is known as losing over five hundred milliliter of blood following a vaginal birth and losing over one thousand milliliter after the cesarean section (5). The prime cause of maternal death rate is postpartum bleeding, predominately in poor countries, and the estimated mortality number due to postpartum bleeding is one hundred thousand per year (6). Therefore, it is essential to reduce bleeding during and after CS to diminish maternal mortality and morbidity (7). The most successful technique for decreasing PPH is the active third stage labor management, requiring prophylactic uterotonic drugs like oxytocin, ergometrine malate, prostaglandins (E1, E2, and F2α), and combinations of them, or hemostatic agent as tranexamic acid (Kapron) and Etamsylate (Dicynon) (8, 9).
Who can participate
Age range20 Years – 40 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 hemogl…