Prophylactic Tranexamic Acid in Low-Risk Repeat Cesarean Delivery: A Randomized Controlled Trial

January 29, 2026 updated by: Sabahattin Anıl Arı, Ege University

Effect of Prophylactic Tranexamic Acid Administered After Fetal Delivery on Perioperative Blood Loss and Neonatal Outcomes in Low-Risk Repeat Cesarean Delivery: A Randomized Controlled Trial

Postpartum hemorrhage remains a leading cause of maternal morbidity following cesarean delivery. Tranexamic acid (TXA) has been shown to reduce blood loss when used for the treatment of postpartum hemorrhage; however, its routine prophylactic use during cesarean delivery, particularly in low-risk women, remains controversial. Large randomized trials have demonstrated limited benefit on major maternal outcomes, and data regarding clinically meaningful blood loss reduction and neonatal safety are still inconclusive.

This randomized controlled trial aims to evaluate the effect of prophylactic tranexamic acid administered after fetal delivery on perioperative blood loss in women undergoing low-risk repeat cesarean delivery. Secondary objectives include the assessment of neonatal outcomes to further evaluate the safety of routine TXA administration in this population.

The results of this study are expected to provide evidence to inform clinical decision-making regarding the routine use of tranexamic acid in low-risk repeat cesarean deliveries, balancing potential maternal benefits against neonatal safety considerations.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Postpartum hemorrhage remains one of the leading causes of maternal morbidity worldwide, and cesarean delivery is associated with a higher risk of perioperative blood loss compared with vaginal birth. Tranexamic acid (TXA), a synthetic antifibrinolytic agent, is well established for the treatment of postpartum hemorrhage. However, the role of routine prophylactic TXA administration during cesarean delivery remains controversial, particularly in women without established risk factors for excessive bleeding.

Recent large randomized trials have demonstrated that prophylactic TXA administered after fetal delivery may reduce measured blood loss but does not significantly improve major maternal outcomes such as the need for blood transfusion or maternal mortality in unselected cesarean populations. Furthermore, data regarding the clinical relevance of modest reductions in blood loss and the potential impact on neonatal outcomes remain limited.

This randomized controlled trial is designed to evaluate the effect of prophylactic tranexamic acid administered after fetal delivery on perioperative blood loss in women undergoing low-risk repeat cesarean delivery. The study focuses on women undergoing their second or third cesarean section without additional risk factors for postpartum hemorrhage, representing a clinically common yet understudied population.

Participants will be randomized in a 1:1 ratio to receive either intravenous tranexamic acid (1 g) administered immediately after fetal delivery or standard care without tranexamic acid. All participants will receive standardized surgical technique and uterotonic management according to institutional protocols. Perioperative blood loss will be measured using standardized methods. A difference of 200 mL in perioperative blood loss is considered clinically meaningful for the purposes of this study.

In addition to maternal outcomes, neonatal outcomes will be prospectively assessed to evaluate the safety of routine prophylactic TXA administration when given after fetal delivery. Neonatal assessments will include immediate postnatal adaptation, need for resuscitation, admission to the neonatal intensive care unit, and selected laboratory and clinical outcomes during the early neonatal period.

By focusing on a homogeneous low-risk repeat cesarean population and incorporating both maternal and neonatal outcomes, this study aims to clarify whether routine prophylactic tranexamic acid use provides clinically meaningful benefit without compromising neonatal safety. The findings are expected to inform evidence-based decision-making regarding the routine use of tranexamic acid in low-risk repeat cesarean delivery.

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Menemen
      • Izmir, Menemen, Turkey (Türkiye), 35665
        • Izmir Bakircay University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Women aged 18 to 45 years Singleton pregnancy Gestational age ≥37+0 weeks Scheduled second or third cesarean delivery Classified as low risk for postpartum hemorrhage Ability to provide written informed consent Planned cesarean delivery under regional or general anesthesia

Exclusion Criteria:

Primary cesarean delivery More than three previous cesarean deliveries Placenta previa, placenta accreta spectrum, or suspected abnormal placentation Multiple pregnancy Known coagulation disorders or use of anticoagulant therapy History of thromboembolic disease Severe anemia (hemoglobin <10 g/dL) Hypertensive disorders of pregnancy (including preeclampsia or eclampsia) Intrauterine fetal demise Emergency cesarean delivery Known hypersensitivity to tranexamic acid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranexamic Acid Group
Participants randomized to this arm will receive a single dose of tranexamic acid (1 g) administered intravenously immediately after fetal delivery during cesarean section, in addition to standard surgical and uterotonic management.
Drug: Tranexamic Acid
Tranexamic acid 1 g will be administered intravenously as a single dose immediately after fetal delivery during cesarean section, in addition to standard surgical and uterotonic management.
No Intervention: Control Group
Participants randomized to this arm will receive standard surgical and uterotonic management during cesarean section without the administration of tranexamic acid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative blood loss (mL)
Time Frame: From skin incision until completion of surgery
Perioperative blood loss will be quantified using standardized measurement methods during cesarean delivery. A difference of 200 mL in perioperative blood loss between groups is considered clinically meaningful.
From skin incision until completion of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ege University

Investigators

  • Principal Investigator: Sabahattin Anıl A ARI, Associate Professor, Izmir Bakircay University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2517

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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