Buccal Misoprostol and Intravenous Tranexamic Acid During Emergent Cesarean Delivery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cesarean Section Complications

Intervention / Treatment
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* Drug: Misoprostol
* Drug: TA
* Drug: placebo to misoprostol
* Drug: placebo to TA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Double-Blind Randomized Clinical Trial
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |
| --- | --- | --- |
| amount of postoperative blood loss | measure amount of blood loss post operative in ml by gravimetric methods | 6 hours post operative | 
| number of patient with postpartum hemorrhage | calculation of the number of the patients with blood loss >1000 ml | 24 hours post operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cesarean section, tranexamic acid, postpartum hemorrhage, misoprostol