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RecruitingNCT06604325Updated Oct 24, 2024

Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery.

An interventional study of Tranexamic acid injection and Placebo in Post Partum Hemorrhage, sponsored by Aligarh Muslim University. Recruiting at 1 site in India. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-10-24.

Sponsored by Aligarh Muslim University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 7 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 2 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Postpartum hemorrhage continues to be the leading cause of maternal morbidity and mortality. Globally, it is responsible for 25% of all pregnancy-related deaths. PPH is unpredictable and may occur in the absence of risk factors. Tranexamic acid is an antifibrinolytic proven to reduce blood loss and transfusion requirements for various surgeries. This study aims to explore the effectiveness of tranexamic acid as an adjunct to other uterotonics before the Caesarian Section.

02

Conditions studied

  • Post Partum Hemorrhage

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03

In context

Postpartum Hemorrhage

469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.

This study's planned enrollment of 300 is above the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.

Browse Postpartum Hemorrhage studies →

Lead sponsor

Aligarh Muslim University is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The women undergoing cesarean delivery (both elective and emergency) during the study period.
  2. Willing to participate in the study after understanding the concept.

Exclusion criteria

Exclusion Criteria:

  1. Critically ill patient.
  2. Not willing to give consent to participate in the study
  3. Cases diagnosed with a ruptured uterus or undergoing caesarian hysterectomy during operation.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    Group A

    All women recruited to Group A will receive tranexamic acid 1 gram in 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.

    Drug: Tranexamic acid injection

  • Placebo comparator
    Group B

    All women recruited to Group A will receive 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision, as placebo.

    Drug: Placebo

Interventions

  • DrugTranexamic acid injection

    All women recruited to Group A will receive tranexamic acid 1 gram in 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.

  • DrugPlacebo

    All women recruited to Group B will receive 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.

06

What researchers measure

Primary outcomes

  1. Perioperative blood loss

    The primary aim of the trial is to investigate the effect of tranexamic acid on peri and post- operative blood loss during caesarean section

    Time frame: Amount of blood loss from starting from surgical incision till 24 hours post caesarean section.

07

Study locations

1 of 1 sites recruiting
  • ASJSATDS Medical College
    Fatehpur, Uttar Pradesh 212601, India
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Mar 2025, 5 months after the start.

Of 112 non-industry interventional studies with no phase under Postpartum Hemorrhage, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's planned 5 months is below that.

Counting every sponsor, half of 119 studies reached it within 16 months; a quarter within 7 and three quarters within 26.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 17, 2024
First posted
Sep 19, 2024
StartActual
Oct 1, 2024
Primary completionEst.
Mar 30, 2025
CompletionEst.
Mar 30, 2025
Last update
Oct 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06604325
Lead sponsor
Aligarh Muslim University
Responsible party
MUAZZAM HASAN (Associate Professor, Aligarh Muslim University) — Principal investigator
First posted
Sep 19, 2024
Start date
Oct 1, 2024
Primary completion
Mar 30, 2025 (estimated)
Completion
Mar 30, 2025 (estimated)
Last update
Oct 24, 2024

Study contacts

MUAZZAM HASAN, MD
Contact
MUAZZAMSH@GMAIL.COM
9808447427
MUAZZAM HASAN, MD
principal investigator · AMU

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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