Tranexamic Acid in Patients for Caesarian Delivery.

NCT05759156 | Completed

• 1 other identifier: 2891
• Study Type: interventional
• Target: 572
• Locations: 1 country
• Sites: 1

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

Keywords

caesarian delivery; postpartum haemorrhage; obstetrics quality of recovery; tranexamic acid

Outcome Measures

Primary Outcomes (2)

• Occurrence of postpartum haemorrhage (PPH)

  up to 2 days

• Obstetrics quality of recovery (ObsQoR) score

  at 2 days

Secondary Outcomes (7)

• 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

Study Arms (2)

Tranexamic Acid

ACTIVE COMPARATOR

Drug: Tranexamic acid injection

Normal Saline

PLACEBO COMPARATOR

Drug: Tranexamic acid injection

Interventions

Tranexamic acid injection 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; Tranexamic Acid

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Women with thromboembolic or bleeding incidents in the past
• Hypersensitivity to TXA
• History of epilepsy or seizure
• Women with abnormal placenta including accreta, increta or percreta
• Any active cardiovascular, renal, or liver disorders
• Autoimmune disorders
• Sickle cell disease
• Placenta Previa
• Abruptio Placentae
• Eclampsia or HELLP syndrome
• Women who might undergo intraoperative complications.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

DowUHS

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 8, 2023
• Study Start: March 20, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 10, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)