NCT03774524

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Aswan University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Cesarean Section Complications

Interventions

Type	Name	Description
DRUG	Misoprostol	400 μg of sublingual misoprostol
DRUG	TA	1 gm of tranexamic acid in 100 ml saline iv
DRUG	placebo to misoprostol	placebo tablets to misoprostol subligual
DRUG	placebo to TA	110 ml saline iv

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-12-31
• Completion: 2021-03-01
• First posted: 2018-12-13
• Last updated: 2019-02-15

Locations

1 site across 1 country: Egypt