Tranexamic Acid in Patients for Caesarian Delivery.

NCT ID: NCT05759156

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 572 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2024-02-10

Brief Summary

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.

Conditions

Postpartum Hemorrhage; Cesarean Section Complications; Obstetric Anesthesia Problems

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Tranexamic Acid

Group Type: ACTIVE_COMPARATOR

Tranexamic acid injection

Intervention Type: DRUG

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.

Normal Saline

Group Type: PLACEBO_COMPARATOR

Tranexamic acid injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Atif Shafqat

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

DowUHS

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

2891

Identifier Type: -

Identifier Source: org_study_id