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

Aswan University Hospital

Status: Unknown

Conditions: Cesarean Section Complications

Treatments: Drug: placebo to TA; Drug: Misoprostol; Drug: placebo to misoprostol; Drug: TA

Study type: Interventional

Funder types: Other

Identifiers

NCT03774524

aswu / 183/18

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

150 participants in 3 patient groups, including a placebo group

Misoprostol with TA

Active Comparator group

Description:

400 μg of sublingual misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout

Treatment:

Drug: TA

Drug: Misoprostol

Misoprostol with placebo to TA

Active Comparator group

Description:

400 μg of sublingual misoprostol (two tablets) plus 110 ml saline by iv rout

Treatment:

Drug: placebo to misoprostol

Drug: Misoprostol

placebo to Misoprostol with placebo to TA

Placebo Comparator group

Description:

placebo to misoprostol plus placebo to tranexamic acid

Treatment:

Drug: placebo to misoprostol

Drug: placebo to TA