Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery

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

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

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Drug: TA; Drug: placebo to TA; Drug: Misoprostol; Drug: placebo to misoprostol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: hany f sallam, md; Phone Number: 01022336052; Email: hany.farouk@aswu.edu.eg

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Misoprostol with TA; 400 μg of buccal misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout	Drug: TA; 1 gm of tranexamic acid in 100 ml saline iv; Other Names: active comparator; Drug: Misoprostol; 400 μg of buccal misoprostol; Other Names: Active Comparator
Active Comparator: Misoprostol with placebo to TA; 400 μg of buccal misoprostol (two tablets) plus 110 ml saline by iv rout	Drug: placebo to TA; 110 ml saline iv; Other Names: placebo comparator; Drug: Misoprostol; 400 μg of buccal misoprostol; Other Names: Active Comparator
Placebo Comparator: placebo to Misoprostol and TA; placebo to misoprostol plus placebo to tranexamic acid	Drug: TA; 1 gm of tranexamic acid in 100 ml saline iv; Other Names: active comparator; Drug: placebo to misoprostol; placebo tablets to misoprostol buccal; Other Names: Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
estimation of intraoperative blood loss (ml)	measure Intraoperative blood loss in ml by gravimetric methods	during the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patient with postpartum hemorrhage	calculation of the number of the patients with blood loss >1000 ml	24 hours post operative
amount of postoperative blood loss	measure amount of blood loss post operative in ml by gravimetric methods	6 hours post operative

Collaborators and Investigators

• Sponsor: hany farouk

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: cesarean section; tranexamic acid; postpartum hemorrhage; misoprostol
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: aswu /185/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No