Effectiveness and safety of using intravenous injection tranexamic acid before vaginal/caesarean delivery in order to avoid excessive blood loss after delivery.

Efficacy and safety of IV Tranexamic acid in the prevention of postpartum haemorrhage:A Randomized controlled study - Nil

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/05/067790

Enrollment

480

Registered

2024-05-21

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: Receiving IV Tranexamic acid (1 gm ): Women undergoing vaginal delivery – Women will receive IV(route) tranexamic acid (frequency-only once) slowly during 30-60 sec during crowning of

Eligibility

Inclusion criteria

Inclusion criteria: 1.All women undergoing vaginal delivery/LSCS at QMH,KGMU. 2.Patient who have given written informed consent will be taken

Exclusion criteria

Exclusion criteria: 1.Patient not giving written informed consent 2.Antenatal diagnosis of placenta accreta spectrum (PAS), 3.Genital tract trauma 4.Known background of thrombophilia or coagulopathy 5.Women with renal, cardiac or liver disease. 6.Known hypersensitivity with tranexamic acid. 7.Women with increased risk of arterial or venous thrombosis 8.Women with epilepsy or seizures

Design outcomes

Primary

Measure	Time frame
Calculated EBL(cEBL)-Estimated blood vol×(predelivery or preop haematocrit- Post delivery or postop haematocrit)/predelivery or preop haematocrit. Estimated blood vol in ml -bodyweight in kg×85. For participants who received transfusion before postnatal blood sample taken,the corrected postop hb will be post-transfusion hb 48 hrs postop- (1 × unit of RBC transfused), and postop haematocrit as post-transfusion haematocrit 48 hrs postop - (3 × units of RBC transfused). Timepoint: 48 hours	—

Measure

Time frame

Calculated EBL(cEBL)-Estimated blood vol×(predelivery or preop haematocrit- Post delivery or postop haematocrit)/predelivery or preop haematocrit. Estimated blood vol in ml -bodyweight in kg×85. For participants who received transfusion before postnatal blood sample taken,the corrected postop hb will be post-transfusion hb 48 hrs postop- (1 × unit of RBC transfused), and postop haematocrit as post-transfusion haematocrit 48 hrs postop - (3 × units of RBC transfused). Timepoint: 48 hours

—

Secondary

Measure	Time frame
1.Need for additional medical interventions (additional uterotonics, additional TXA 2.Need for additional surgical & mechanical interventions for haemostasis 3.Need of blood and blood products 4.Difference between hemoglobin before and after 24 hours of delivery. 5.Adverse events like nausea, vomiting, photopsia (sensation of seeing lights, sparks, or flashes of color) or thromboembolic event Timepoint: Immediate post partum till next 48 hours	—

Measure

Time frame

1.Need for additional medical interventions (additional uterotonics, additional TXA 2.Need for additional surgical & mechanical interventions for haemostasis 3.Need of blood and blood products 4.Difference between hemoglobin before and after 24 hours of delivery. 5.Adverse events like nausea, vomiting, photopsia (sensation of seeing lights, sparks, or flashes of color) or thromboembolic event Timepoint: Immediate post partum till next 48 hours

—

Countries

India

Contacts

Public ContactAradhya Garg

King George Medical University,Lucknow,Uttar Pradesh

mehrotra.seema@gmail.com9918924300

Outcome results

None listed

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