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Completed

NCT Number: NCT03778242

Tranexamic Acid in Pregnant Women Undergoing Cesarean Section.

Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum hemorrhage in pregnant women with hemorrhagic cesarean section

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Key information

Conditions

Cesarean Section Complications Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Aswan University

Aswān, 81528, Egypt

About this study

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. The aim of the study is to To explore the efficacy and safety of temporary uterine packing combined with topical tranexamic acid (TA) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (CD), compared with placebo.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who were admitted for an elective or non-emergency CS during labor and exposed to intraoperative bleeding about 800 ml

Exclusion criteria

  • placenta praevia and placental abruption
  • Women with a medical disorder,
  • placenta accrete,
  • allergy to TA, and
  • intraoperative bleeding thanks to causes aside from uterine atony
  • Patients over 40 or who have
  • pre-existing coagulation disorders,
  • with a severe medical disorder
  • allergy to tranexamic acid
  • refuse to consent

Treatment and study plan

Topical tranexamic acid

Drug

temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid

Other names: Active Comparator

normal saline

Drug

2 placebo ampoules to TA in 100 ml saline by slow infusion

Other names: Placebo comparator

Primary outcomes

  1. number of patients need of additional pharmacological uterotonic

    Time frame: 24 hours post operative

    calculation number of patients need of additional pharmacological uterotonic

Secondary outcomes

  1. estimation of intraoperative blood loss (ml)

    Time frame: during the operation

    measure Intraoperative blood loss in ml by gravimetric methods

  2. amount of postoperative blood loss

    Time frame: 4 hours postoperative

    measure amount of blood loss post operative in ml by gravimetric methods

  3. number of patient with postpartum hemorrhage

    Time frame: 24 hours post operative

    calculation of the number of the patients with blood loss >1000 ml

Sponsors and collaborators

Lead sponsor

Aswan University Hospital

Other

Registry information

Official study title

The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for Reducing Blood Loss During Hemorrhagic Cesarean Delivery: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2018
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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