Sublingual Misoprostol and Tranexamic Acid in Pregnant Women With Twin Pregnancy Undergoing Cesarean Section

Study Overview
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Brief Summary
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Purpose to evaluate the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) in comparison with placebo on reducing post-partum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean section.

Detailed Description
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Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine contraction following delivery is an important issue. Risk factors of uterine atony include obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis as well as a twin pregnancy. With the increasingly common use of ovulation induction and assisted reproduction techniques, the incidence of multiple gestation pregnancies has progressively increased. Suzuki et al reported that elective cesarean delivery of twin pregnancy at a gestational age of 37 weeks or greater may increase the risk of blood transfusion. Several uterotonic agents are used to prevent PPH because of uterine atony, including oxytocin, an ergot alkaloid, and prostaglandin. However, there are currently no data to evaluate the efficacy of co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on prevention of postpartum hemorrhage in pregnant women with twin pregnancy undergoing an elective cesarean. therefore, this study was designed to evaluate and compare these two new therapeutic options in controlling PPH following CS for twin pregnancy

Official Title
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Effects of Co-administered Sublingual Misoprostol and Intravenous Tranexamic Acid on Prevention of Postpartum Hemorrhage in Pregnant Women With Twin Pregnancy Undergoing Elective Cesarean Section: A Double-Blind Randomized Clinical Trial

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: women with a multiple term pregnancy undergoing elective cesarean section Exclusion Criteria: single gestation 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

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 sublingual misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout | Drug: Misoprostol<br>* 400 μg of sublingual 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 sublingual misoprostol (two tablets) plus 110 ml saline by iv rout | Drug: Misoprostol<br>* 400 μg of sublingual misoprostol<br>* Other names: Active Comparator;Drug: placebo to misoprostol<br>* placebo tablets to misoprostol subligual<br>* Other names: Placebo comparator;|
| Placebo Comparator: placebo to Misoprostol with placebo to TA<br>placebo to misoprostol plus placebo to tranexamic acid | Drug: placebo to misoprostol<br>* placebo tablets to misoprostol subligual<br>* Other names: Placebo comparator;Drug: placebo to TA<br>* 110 ml saline iv<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