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A study to assess the role of Tranexamic acid in reducing blood loss in Cesarean Sections in women at high risk for Postpartum Hemorrhage

To assess the role of Tranexamic acid in reducing the blood loss in women at high risk for Postpartum Hemorrhage undergoing Cesarean Section - A Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/03/031690
Enrollment
200
Registered
2021-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: O721- Other immediate postpartum hemorrhage

Interventions

Intervention1: Tranexamic acid: After randomisation, Treatment group (Group A) will receive Inj Tranexamic acid 1g (10ml) slow iv, over 2 minutes at least 10 minutes prior to skin incision in cesarean

Sponsors

Jawaharlal Nehru Medical College KLE University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women at gestational age of 34 weeks or more, who are to undergo elective or emergency caesarean delivery, with at least one risk factor including Obesity, Chronic Hypertension, Gestational hypertension, Pre-eclampsia, Eclampsia, Anemia, Use of Oxytocin augmentation >4hrs, Multiparity (Parity >4), Multiple pregnancy, Abnormally implanted placenta, Placenta previa, Abruption, Uterine Leiomyomas, Polyhydramnios, Fetal macrosomia, Previous LSCS, History of postpartum hemorrhage in previous pregnancy, Chorioamnionitis and Cholestasis of pregnancy

Exclusion criteria

Exclusion criteria: Patients with Impaired colour vision, Known cardiovascular, renal or liver disorders, Current or past history of DVT, Anticoagulant therapy, Coagulation defects, HELLP syndrome and Sensitivity to Tranexamic acid.

Design outcomes

Primary

MeasureTime frame
Reduction in estimated blood loss in cesarean sections by formula using difference between pre and post op hematocrit and estimated blood volume. Difference in pre and post op hemoglobinTimepoint: 1 year—

Secondary

MeasureTime frame
Need for blood and blood product transfusion intra-op or post-operatively Need for additional uterotonics/surgical procedure during cesarean section Need for additional Tranexamic acid to control bleeding Maternal and fetal complications related to Tranexamic acidTimepoint: 1 year—

Countries

India

Contacts

Public ContactBethany Grace Neumann

Jawaharlal Nehru Medical College

metm67@gmail.com9164693333

Outcome results

None listed

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