Tranexamic Acid in Patients for Caesarian Delivery. (TXA; CD)

Prophylactic Tranexamic Acid (TXA) Administration in Patients Undergoing Caesarean Delivery (CD).

This is a prospective, double-blinded, randomized placebo-controlled trial. The study will be approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. After receiving the trial information from the obstetricians during prenatal visits or from the anaesthetists during the systematic anaesthesia visit, or both the prospective women will be invited to participate in the trial. The intervention consists of administration of 1gm of tranexemic acid (TXA) or 10-mls of placebo (normal saline) intravenously, according to the randomization groups slowly over 30-60 sec, within 3 mins of the delivery of baby, after the routine prophylactic uterotonic administration and cord clamping. Administration of the prophylactic uterotonic agent (and TXA or placebo) may be followed by a two-hour oxytocin infusion, in accordance with the hospital policy. All women will be followed up at 48 hours after caeserian delivery. A venous blood sample will be obtained on day-two (D2) after delivery for outcome assessment. Adverse events will be assessed until hospital discharge and by telephone interview at 8 weeks after delivery.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Postpartum Hemorrhage; Obstetric Anesthesia Problems
• Intervention / Treatment: Drug: Tranexamic acid injection

• Study Type: Interventional
• Enrollment (Actual): 572
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sind
    • Karachi, Sind, Pakistan
      • DowUHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

The inclusion criteria will include:

1. Informed consent of the participant
2. All women who are 18 years old or above
3. Gestational age equal or above 34 weeks
4. Women undergoing emergency or elective CD
5. Complete blood count (CBC) within seven days before the CD

Exclusion Criteria:

The exclusion criteria will include:

1. Women with thromboembolic or bleeding incidents in the past
2. Hypersensitivity to TXA
3. History of epilepsy or seizure
4. Women with abnormal placenta including accreta, increta or percreta
5. Any active cardiovascular, renal, or liver disorders
6. Autoimmune disorders
7. Sickle cell disease
8. Placenta Previa
9. Abruptio Placentae
10. Eclampsia or HELLP syndrome
11. Women who might undergo intraoperative complications.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Normal Saline	Drug: Tranexamic acid injection; The intervention consists of administration of 1gm of Tranexamic acid (TXA) intravenously or 10-mls of placebo (normal saline) intravenously, slowly over 30-60 sec, within 3 mins of the delivery of baby.
Active Comparator: Tranexamic Acid	Drug: Tranexamic acid injection; The intervention consists of administration of 1gm of Tranexamic acid (TXA) intravenously or 10-mls of placebo (normal saline) intravenously, slowly over 30-60 sec, within 3 mins of the delivery of baby.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of postpartum haemorrhage (PPH)	up to 2 days
Obstetrics quality of recovery (ObsQoR) score	at 2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Measurement of postpartum blood loss	at 2 days
Operative time	up to 3 hours
Length of hospital stay	up to 4 days
Frequency of emergency surgery for postpartum haemorrhage	up to 12 hours
Rate of ICU transfer	up to 1 day
Rate of Maternal death	up to 3 months
Adverse events related to tranexamic acid	up to 3 months

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Actual): February 5, 2024
• Study Completion (Actual): February 10, 2024

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 1, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: tranexamic acid; postpartum haemorrhage; caesarian delivery; obstetrics quality of recovery
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Puerperal Disorders; Uterine Hemorrhage; Postpartum Hemorrhage; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Antifibrinolytic Agents; Fibrin Modulating Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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