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Best time to give tranexamic acid to prevent and reduce the blood loss in cesarean deliveries.

Ideal time for administration of prophylactic tranexamic acid for reducing blood loss and preventing postpartum hemorrhage in cesarean delivery in a tertiary health care centre: A single-centre, double-blind, randomized controlled non-inferiority trial. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/066737
Enrollment
224
Registered
2024-05-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O720- Third-stage hemorrhage

Interventions

Intervention1: Study group receiving Tranexamic acid after cord clamping.: The group will receive Tranexamic acid (1g in 10ml NS over 10min) after cord clamping and 20ml NS iv over 10min at 10min befo

Sponsors

AIIMS, Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Women undergoing elective or emergency LSCS. b) Gestational age = 32weeks.

Exclusion criteria

Exclusion criteria: a) History of previous thrombotic event or preexisting pro-thrombotic disease. b) Any active or chronic cardiovascular disease except for hypertension. c) Any chronic or active kidney disease or insufficiency. d) Chronic or active liver disease. e) Autoimmune disease. f) Sickle cell disease. g) Placenta accreta/increta/percreta. h) Eclampsia, HELLP syndrome i) Received antiplatelet drugs during the week before delivery. j) Known allergy to tranexamic acid. k) Women who develop PPH before cord clamping

Design outcomes

Primary

MeasureTime frame
a) To assess the reduction in blood loss, as determined by calculated estimated blood loss (cEBL), among women undergoing cesarean delivery, by comparing those who receive prophylactic tranexamic acid 10 minutes before skin incision with those who receive it after cord clamping.Timepoint: a) Pre operative hematocrit - within 1 week before surgery. b) post operative hematocrit 6hours after surgery.

Secondary

MeasureTime frame
To find & compare the incidence of PPH defined by a calculated estimated blood loss = 1000ml in both study groups. To compare the calculated estimated blood loss in women with risk factors in both study groups. To compare the number of women requiring blood transfusions within 48hrs of surgery in both study groups. To compare the neonatal outcome in the form of APGAR score at 5min after birth in both study groups.Timepoint: Number of packed red blood cells transfused within 48hours. APGAR score at 5 min.

Countries

India

Contacts

Public ContactPruthwiraj Sethi

AIIMS, Bhubaneswar

shreejasatapathy007@gmail.com8895038178

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026