Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery

hany farouk

Status: Unknown

Conditions: Cesarean Section Complications

Treatments: Drug: TA; Drug: Misoprostol; Drug: placebo to TA; Drug: placebo to misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03777696

aswu /185/18

Details and patient eligibility

About

Purpose to evaluate the effects of buccal misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women undergoing emergent cesarean section

Full description

The American Congress of Obstetricians and Gynecologists (ACOG) defines postpartum hemorrhage (PPH) as the loss of more than 1,000 mL after cesarean delivery. 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 the investigator reach unless prioritize the prevention and treatment of PPH in low-resource countries. Consequently, the administration of uterotonic drugs during cesarean section (CS) has become essential to diminish the risk of PPH and improve maternal safety. 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 CS has not been investigated as much.T he 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. Anti-fibrinolytic agents, such as tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other hand, it has been suggested that TA administration reduces blood loss and the incidence of PPH in females after vaginal or elective CS. The investigators designed this study to evaluate and compare these two new therapeutic options in controlling PPH following emergent CS.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age >18 years, singleton pregnancy, term gestation and decision made for a cesarean section in labor

Exclusion criteria

• multiple gestations
• placenta praevia and placental abruption
• undergoing cesarean section with general anesthesia
• women undergoing cesarean section at less than 37 weeks of gestation--with a severe medical disorder
• allergy to tranexamic acid or misoprostol
• refuse to consent
• elective cesarean section

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 3 patient groups, including a placebo group

Misoprostol with TA

Active Comparator group

Description:

400 μg of buccal misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout

Treatment:

Drug: Misoprostol

Drug: TA

Misoprostol with placebo to TA

Active Comparator group

Description:

400 μg of buccal misoprostol (two tablets) plus 110 ml saline by iv rout

Treatment:

Drug: placebo to TA

Drug: Misoprostol

placebo to Misoprostol and TA

Placebo Comparator group

Description:

placebo to misoprostol plus placebo to tranexamic acid

Treatment:

Drug: placebo to misoprostol

Drug: TA