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

Patel Hospital, Pakistan

Status and phase: Not yet enrolling; Phase 1

Conditions: Post Partum Hemorrhage

Treatments: Device: Placebo; Drug: Tranexamic Acid (TXA)

Study type: Interventional

Funder types: Other

Identifiers

NCT07002749

PH/IRB/2025/002

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

tranexamic acid

Treatment:

Drug: Tranexamic Acid (TXA)

B

Placebo Comparator group

Treatment:

Device: Placebo