Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery

Cesarean Section Complications Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Co-administered Buccal Misoprostol and Intravenous Tranexamic Acid, Versus Buccal Misoprostol Alone for the Prevention of Postpartum Hemorrhage Following an Emergent Cesarean Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03777696
• Other study ID #: aswu /185/18
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2019
• Source: Aswan University Hospital
• Contact: hany f sallam, md
• Phone: 01022336052
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
400 µg of buccal misoprostol
• TA
1 gm of tranexamic acid in 100 ml saline iv
• placebo to misoprostol
placebo tablets to misoprostol buccal
• placebo to TA
110 ml saline iv

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
hany farouk

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimation of intraoperative blood loss (ml)	measure Intraoperative blood loss in ml by gravimetric methods	during the operation
Secondary	amount of postoperative blood loss	measure amount of blood loss post operative in ml by gravimetric methods	6 hours post operative
Secondary	number of patient with postpartum hemorrhage	calculation of the number of the patients with blood loss >1000 ml	24 hours post operative