ROLE OF PROPHYLACTIC TRANEXAMIC ACID IN PREVENTION OF POST-PARTUM HEMORRHAGE IN ELLSCS

NCT07002749 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: PH/IRB/2025/002
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

IN THIS STUDY WOMEN UNDER GOING ELLSCS WOULD BE DIVIDED INTO TWO GROUPS , ONE GROUP WOULD BE GIVEN TRANEXAMIC ACID WHILE THE OTHER WOULD BE GETTING PLACEBO PROPHYLACTICALLY TO SEE THE EFFECT OF TRANEXAMIC ACID IN PREVENTING PPH. THIS IS A RANDOMIZED CONTROLLED TRIAL. THE SAMPLING TECHNIQUE WOULD BE NON-PROBABILITY TECHNIQUE RANDOMIZATION WOULD BE DONE VIA BALLOTING METHOD.

Conditions

Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• prophylactic tranexamic acid in prevention of post-partum haemorrhage in ELLSCS

  In this study, the role of tranexamic acid is being observed in preventing PPH in women undergoing ELLSCS by dividing women into two groups and giving one group placebo while the other would receive tranexamic acid. Two boxes, A and B, each containing 52 vials of the same size and color; one would contain the drug, i.e: TXA 1000 mg in 10 ml , while the other would contain a placebo in 10 ml vial, provided by a company; these would be revealed at the end of the study. A jar containing 104 chits, 52 of which would have the letter A written on them and the other 52 would have the letter B, would be kept in GYNAE OT. Prior to ELLSCS, a chit would be selected from the jar, and the patient would be given the drug according to the chit. It's a triple-blinded study; the patient, doctor, surgeon, and data analyst all will be blinded.

  6 months from the time of approval from CPSP till the completion of data collection

Study Arms (2)

A

ACTIVE COMPARATOR

tranexamic acid

Drug: Tranexamic Acid (TXA)

B

PLACEBO COMPARATOR

Device: Placebo

Interventions

Tranexamic Acid (TXA) DRUG

I would like to see the effect of prophylactic tranexamic acid in women undergoing ELLSCS in preventing PPH in my setup.

A

Placebo DEVICE

one group will get placebo

B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women with singleton pregnancy and low risk for PPH admitted for ELLSCS

You may not qualify if:

• Women with medical disorder or complex pregnancy.
• Women with history of PPH.
• Women with bleeding disorder.
• Abnormal placentation (MAP, placenta previa)
• Multiple pregnancy.

Sponsors & Collaborators

• Patel Hospital, Pakistan: lead

Study Sites (1)

Patel Hospital

Karachi, Sindh, Pakistan

Location

Related Links

• Related Info

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

Central Study Contacts

NIMRA ABID

CONTACT

+92 3342430703; nimrachauhan12@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RESIDENT OBGYN

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 4, 2025
• Study Start: June 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)