Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery

NCT ID: NCT03777696

Last Updated: 2019-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-01-31

Brief 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

Detailed 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.

Conditions

Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Misoprostol with TA

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

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

400 μg of buccal misoprostol

TA

Intervention Type: DRUG

1 gm of tranexamic acid in 100 ml saline iv

Misoprostol with placebo to TA

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

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

400 μg of buccal misoprostol

placebo to TA

Intervention Type: DRUG

110 ml saline iv

placebo to Misoprostol and TA

placebo to misoprostol plus placebo to tranexamic acid

Group Type: PLACEBO_COMPARATOR

TA

Intervention Type: DRUG

1 gm of tranexamic acid in 100 ml saline iv

placebo to misoprostol

Intervention Type: DRUG

placebo tablets to misoprostol buccal

Interventions

Misoprostol

400 μg of buccal misoprostol

Intervention Type: DRUG

TA

1 gm of tranexamic acid in 100 ml saline iv

Intervention Type: DRUG

placebo to misoprostol

placebo tablets to misoprostol buccal

Intervention Type: DRUG

placebo to TA

110 ml saline iv

Intervention Type: DRUG

Other Intervention Names

Active Comparator; active comparator; Placebo comparator; placebo comparator

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

hany farouk

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

hany f sallam, md

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

Aswan University

Aswān, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

hany f sallam, md

Role: CONTACT

hany.farouk@aswu.edu.eg

01022336052

Facility Contacts

hany f sallam, md

Role: primary

nahla.elsayed@aswu.ed.eg

01092440504 ext. 002

Nahla w Shady, md

Role: backup

nahla.elsayed@aswu.edu.eg

1019240504 ext. 002

Other Identifiers

aswu /185/18

Identifier Type: -

Identifier Source: org_study_id