Tranexamic Acid Plus Buccal Misoprostol on Blood Loss During and After Cesarean Delivery

• Status: Completed
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

Postpartum hemorrhage (PPH) is potentially life-threatening and is a significant contributor to maternal mortality and morbidity especially in developing countries.

The risk of PPH is much higher for women undergoing cesarean delivery (CD). In the majority of cases, uterine atony is responsible for the occurrence of excessive bleeding during or following childbirth.

The Millennium Development Goal of reducing the maternal mortality ratio by 75 % by 2015 will remain beyond our reach unless we prioritize the prevention and treatment of PPH in low-resource countries.

Consequently, the administration of uterotonic drugs during cesarean section (CS) and in the third stage of labor for vaginal delivery has become essential to diminish the risk of PPH and improve maternal safety.

Oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period.

Misoprostol is a prostaglandin E1 analog proven in several randomized controlled trials to be effective in preventing PPH because of its strong uterotonic effects. In addition, misoprostol is inexpensive, stable at room temperature, and easy to administer.

Misoprostol has been broadly studied in the prevention and treatment of PPH after vaginal delivery; however, its use in conjunction with CD has not been investigated as much.

The buccal route is recognized as having the greatest benefit due to its rapid uptake, long-acting effect, and greatest bioavailability compared with other routes of misoprostol administration.

Tranexamic acid(TA) is a synthetic analog of the amino acid lysine,10 as an antifibrinolytic agent it has roughly eight times the antifibrinolytic activity of an older analog; ε-aminocaproic acid.

The aim of this study was to compare the effectiveness of combined buccal misoprostol and intravenous TA with intravenous oxytocin for the prevention of PPH in patients with risk factors during cesarean section.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aswan University Hospital
• Treatments: Misoprostol; Oxytocin; Tranexamic Acid

Criteria

Inclusion Criteria:

• patients scheduled for an elective cesarean section with risk factors for atonic PPH

Exclusion Criteria:

• Patients with a cardiac, hepatic, renal or thromboembolic disease

• patients had an allergy to tranexamic acid

• suspected coagulopathy

• history of coronary artery disease or hypertension

• patient refuses to participate