Tranexamic Acid Versus Misoprostol in Reducing Blood Loss in Cesarean Section in Primigravida

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of the work is to compare the efficacy of preoperative IV tranexamic acid and rectal misoprostol in reducing blood loss in the elective cesarean section.

Research question:

In women undergoing elective cesarean section, is preoperative administration of IV tranexamic acid better than rectal misoprostol in reducing blood loss?

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Misoprostol; Tranexamic Acid

Criteria

Inclusion Criteria:

• Women booked for a primary elective cesarean section, not in active labor

• Aged between 18-40 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 prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol) or TXA