Sublingual Misoprostol With or Without Intravenous Tranexamic Acid During Hemorrhagic Cesarean Section

Role of Sublingual Misoprostol With or Without Intravenous Tranexamic Acid for Reducing Post-partum Hemorrhage During and After Hemorrhagic Cesarean Section: A Double-Blind Randomized Clinical Trial

Purpose to evaluates the effects of sublingual misoprostol with or without intravenous tranexamic acid (TA) on reducing post-partum hemorrhage during and after hemorrhagic cesarean section.

Study Overview

• Status: Unknown
• Conditions: Cesarean Section Complications
• Intervention / Treatment: Drug: Misoprostol; Drug: Tranexamic Acid; Drug: placebo to tranexamic acid

Detailed Description

Different uterotonic agents administration, mainly oxytocin, has been routinely used to reduce the frequency of cesarean section (CS) -related hemorrhage; however, some studies reported that oxytocin use in the setting of CS may result in maternal adverse effects, including hypotension and tachycardia., Therefore, investigating other therapeutic agents with lower adverse effects and higher efficacy is needed. Recently, a number of studies reported a correlation between fibrinogen decrease and cesarean-related hemorrhage. Furthermore, extensive tissue injury increases fibrinolysis by shifting the hemostatic equilibrium and contributing to bleeding. Therefore, anti-fibrinolytic agents, such as tranexamic acid (TA), reduce the risk of death in bleeding trauma patients. On the other hand, it has been suggested that TA administration reduces blood loss and the incidence of postpartum hemorrhage (PPH) in females after vaginal or elective CS verse effects and higher efficacy is needed. Moreover, misoprostol is a prostaglandin E1 analog which has been introduced as a uterotonic agent for preventing PPH following CS. A recent study reported that oral or sublingual misoprostol is more effective than the placebo in reducing severe PPH, following CS

• 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 who undergone elective cesarean section (C.S) and exposed to intraoperative bleeding about 500 ml diagnosed by visual analog estimation due to atonic uterus
• age between 18 and 45 years, gestational age of 37-40 weeks, singleton pregnancy, CS with inferior segment incision, and spinal anesthesia.

Exclusion Criteria:

• having an underlying disease (heart, liver, kidney, pulmonary, etc.),
• eclampsia and severe preeclampsia
• allergy to TA (such as known allergy or thromboembolic event during pregnancy) and misoprostol
• coagulation disorders
• refuse or unable to consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Misoprostol with TA; two tablets sublingual misoprostol plus IgM tranexamic acid in 100 ml saline by slow iv	Drug: Misoprostol; two tablets misoprostol 400 μg sublingual; Other Names: Active Comparator; Drug: Tranexamic Acid; two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline; Other Names: active comparator
Active Comparator: Misoprostol with placebo to TA; two tablets sublingual misoprostol plus placebo to tranexamic acid ( 110 ml saline) by slow iv	Drug: Misoprostol; two tablets misoprostol 400 μg sublingual; Other Names: Active Comparator; Drug: placebo to tranexamic acid; placebo to tranexamic acid (110 ml saline); Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients develop postpartum hemorrhage	calculation of number of patients develop postpartum hemorrhage	6 hours post operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative blood loss (ml)	calculation of the amount of blood loss in ml by gravimetric methods	during the operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative blood loss (ml)	calculation of the amount of blood loss in ml by gravimetric methods	6 hours post operative
number of patients need blood transfusion	calculation of number of patients need blood transfusion	24 hours postoperative

Collaborators and Investigators

• Sponsor: Aswan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 18, 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; misoprostol
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Gastrointestinal Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Tranexamic Acid; Misoprostol
• Other Study ID Numbers: aswu/184/18

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