Sublingual Misoprostol and Tranexamic Acid in Pregnant Women With Twin Pregnancy Undergoing Cesarean Section
- Conditions
- Cesarean Section Complications
- Interventions
- Registration Number
- NCT03774524
- Lead Sponsor
- Aswan University Hospital
- Brief 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 150
- women with a multiple term pregnancy undergoing elective cesarean section
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Misoprostol with placebo to TA placebo to misoprostol 400 μg of sublingual misoprostol (two tablets) plus 110 ml saline by iv rout placebo to Misoprostol with placebo to TA placebo to misoprostol placebo to misoprostol plus placebo to tranexamic acid placebo to Misoprostol with placebo to TA placebo to TA placebo to misoprostol plus placebo to tranexamic acid Misoprostol with TA Misoprostol 400 μg of sublingual misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout Misoprostol with placebo to TA Misoprostol 400 μg of sublingual misoprostol (two tablets) plus 110 ml saline by iv rout Misoprostol with TA TA 400 μg of sublingual misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout
- Primary Outcome Measures
Name Time Method estimation of intraoperative blood loss (ml) during the operation measure Intraoperative blood loss in ml by gravimetric methods
- Secondary Outcome Measures
Name Time Method amount of postoperative blood loss 6 hours post operative measure amount of blood loss post operative in ml by gravimetric methods
number of patient with postpartum hemorrhage 24 hours post operative calculation of the number of the patients with blood loss \>1000 ml
Trial Locations
- Locations (1)
Aswan University
🇪🇬Aswan, Egypt