Clinical trial NCT03777696: Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Keywords: cesarean section
tranexamic acid
postpartum hemorrhage
misoprostol
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Double-Blind Randomized Clinical Trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: estimation of intraoperative blood loss (ml)
timeFrame: during the operation
Secondary outcomes:
measure: amount of postoperative blood loss
timeFrame: 6 hours post operative
measure: number of patient with postpartum hemorrhage
timeFrame: 24 hours post operative
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References: