Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery

hany farouk300 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

300

Conditions

Cesarean Section Complications

Interventions

MisoprostolDRUG

400 μg of buccal misoprostol

TADRUG

1 gm of tranexamic acid in 100 ml saline iv

placebo to misoprostolDRUG

placebo tablets to misoprostol buccal

placebo to TA

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Aswan University

Aswān, Egypt

RECRUITING

Outcomes

Primary Outcomes

estimation of intraoperative blood loss (ml)

measure Intraoperative blood loss in ml by gravimetric methods

Time frame: during the operation

Secondary Outcomes

amount of postoperative blood loss

measure amount of blood loss post operative in ml by gravimetric methods

Time frame: 6 hours post operative

number of patient with postpartum hemorrhage

calculation of the number of the patients with blood loss \>1000 ml

Time frame: 24 hours post operative

Central Contacts

hany f sallam, md

CONTACT

01022336052 hany.farouk@aswu.edu.eg

Data from ClinicalTrials.gov

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