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

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.

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Drug: Misoprostol; Drug: TA; Drug: placebo to misoprostol; Drug: placebo to TA

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

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Recruiting
    • Aswan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Misoprostol with TA; 400 μg of sublingual misoprostol (two tablets) plus 1 gm tranexamic acid in 100 ml saline by iv rout	Drug: Misoprostol; 400 μg of sublingual misoprostol; Other Names: Active Comparator; Drug: TA; 1 gm of tranexamic acid in 100 ml saline iv; Other Names: Active Comparator
Active Comparator: Misoprostol with placebo to TA; 400 μg of sublingual misoprostol (two tablets) plus 110 ml saline by iv rout	Drug: Misoprostol; 400 μg of sublingual misoprostol; Other Names: Active Comparator; Drug: placebo to misoprostol; placebo tablets to misoprostol subligual; Other Names: Placebo comparator
Placebo Comparator: placebo to Misoprostol with placebo to TA; placebo to misoprostol plus placebo to tranexamic acid	Drug: placebo to misoprostol; placebo tablets to misoprostol subligual; Other Names: Placebo comparator; Drug: placebo to TA; 110 ml saline iv; Other Names: placebo comparator

What is the study measuring?

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
number of patient with postpartum hemorrhage	calculation of the number of the patients with blood loss >1000 ml	24 hours post operative
amount of postoperative blood loss	measure amount of blood loss post operative in ml by gravimetric methods	6 hours post operative

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: December 12, 2018
• First Submitted That Met QC Criteria: December 12, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: cesarean section; tranexamic acid; postpartum hemorrhage; misoprostol
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: aswu / 183/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No