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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03774524
• Other study ID #: aswu / 183/18
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: February 2019
• Source: Aswan University Hospital
• Contact: hany f sallam, md
• Phone: 01022336052
• Email: hany.farouk[@]aswu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol
400 µg of sublingual misoprostol
• TA
1 gm of tranexamic acid in 100 ml saline iv
• placebo to misoprostol
placebo tablets to misoprostol subligual
• placebo to TA
110 ml saline iv

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimation of intraoperative blood loss (ml)	measure Intraoperative blood loss in ml by gravimetric methods	during the operation
Secondary	amount of postoperative blood loss	measure amount of blood loss post operative in ml by gravimetric methods	6 hours post operative
Secondary	number of patient with postpartum hemorrhage	calculation of the number of the patients with blood loss >1000 ml	24 hours post operative