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

NCT ID: NCT07002749

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post Partum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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A

tranexamic acid

Group Type ACTIVE_COMPARATOR

Tranexamic Acid (TXA)

Intervention Type DRUG

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

B

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

one group will get placebo

Interventions

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Tranexamic Acid (TXA)

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

Intervention Type DRUG

Placebo

one group will get placebo

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Women with medical disorder or complex pregnancy.

* Women with history of PPH.
* Women with bleeding disorder.
* Abnormal placentation (MAP, placenta previa)
* Multiple pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Patel Hospital, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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NIMRA ABID CHAUHAN

RESIDENT OBGYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Patel Hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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NIMRA ABID

Role: CONTACT

+92 3342430703

Facility Contacts

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patel hospital erc commitee

Role: primary

+92 2138658894

Related Links

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Other Identifiers

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PH/IRB/2025/002

Identifier Type: -

Identifier Source: org_study_id

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