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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorPatel Hospital, Pakistan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Women with history of PPH.

Women with bleeding disorder.

Abnormal placentation (MAP, placenta previa)

Multiple pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Placebo

    Device

    one group will get placebo

Treatment groups

104 Participants
are divided into 2 treatment groups
Group A: AActive comparator 1 intervention
Group B: BPlacebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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