NCT07390799

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

January 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 29, 2026

Last Update Submit

January 29, 2026

Conditions

Cesarean Delivery

Keywords

Tranexamic AcidRepeat Cesarean SectionPerioperative Blood Loss

Outcome Measures

Primary Outcomes (1)

  • Perioperative blood loss (mL)

    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

Study Arms (2)

Tranexamic Acid Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants randomized to this arm will receive standard surgical and uterotonic management during cesarean section without the administration of tranexamic acid.

Interventions

Tranexamic AcidDRUG

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.

Tranexamic Acid Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Bakircay University

Izmir, Menemen, 35665, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Sabahattin Anıl A ARI, Associate Professor

    Izmir Bakircay University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabahattin A Arı, Associate Professor

CONTACT

+905547139994s.anil.ari.md@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 29, 2026

First Posted

February 5, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

February 5, 2026

Record last verified: 2026-01

Locations

TU(1)