Comparing Intramyometrial Tranexamic Acid and Oxytocin for Blood Loss in Cesarean Section

Launched by CAIRO UNIVERSITY · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two medications, tranexamic acid and oxytocin, to see which one is more effective at reducing blood loss during and after a cesarean section (C-section). Postpartum hemorrhage, or excessive bleeding after childbirth, is a serious complication that can lead to severe health issues for mothers. The trial aims to find out if using tranexamic acid, a medicine that helps with blood clotting, is better than oxytocin, which is commonly used to help the uterus contract after delivery.

Women who are between 20 and 40 years old, are planning to have an elective C-section, and meet certain health criteria may be eligible to participate in this trial. Participants can expect to receive either tranexamic acid or oxytocin during their surgery and will be monitored for any bleeding issues. It’s important to note that women with certain health conditions, like high blood pressure or diabetes, may not be able to join the study. This research aims to enhance the safety of C-sections and reduce the risk of complications related to excessive bleeding.

Gender

FEMALE

Eligibility criteria

• 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)