Tranexamic acid along with AMTSL for Preventing PPH in Vaginal Delivery :TAAPP-V

Effect of Intravenous Tranexamic Acid (TXA) In Addition To Active Management Of Third Stage Of Labour On Postpartum Blood Loss In Vaginal Delivery: A double Blinded , Randomized Controlled Trial - TAAPP-V Trial

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033500

Enrollment

650

Registered

2021-05-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: TXA: Patient in intervention group will receive single dose of 1 g intravenous TXA over 2 minutes of vaginal delivery Control Intervention1: Normal Saline: Patient will receive single

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. Gestational age 34+0 weeks or more 3. Singleton pregnancy 4. Planned vaginal delivery 5. Available venous hemogram value in week before vaginal delivery 6. Signed informed consent to participate in study

Exclusion criteria

Exclusion criteria: 1. History of venous thrombosis: deep vein thrombosis, pulmonary embolism 2. History of arterial thrombosis: myocardial infarction, stroke 3. Any known cardiovascular, renal, or liver disorders 4. Autoimmune disease e.g. secondary APLA 5. Sickle cell disease 6. Severe haemorrhagic disease e.g.; VWD 7. Obstetric complications - multiple pregnancy, placenta previa, abruptio placentae, Abnormal invasive placenta (placenta accrete/ increta/ percreta), Eclampsia or HELLP (haemolysis elevated liver low platelet) syndrome, in utero fetal death 8. Administration of low-molecular weight heparin or antiplatelet agents in the week before delivery 9. History of Epilepsy or seizure 10. Active subarachnoid haemorrhage 11. Colour vision disturbances 12. Known hypersensitivity to tranexamic acid

Design outcomes

Primary

Measure	Time frame
1.To assess the effect of intravenous TXA (1 g) in reducing blood loss during 3rd and 4th stage of labour following vaginal deliveryTimepoint: 1 hour after delivery	—

Secondary

Measure	Time frame
1.To determine incidence of primary PPH,severe PPH and secondary PPH 2.To assess the potential adverse effects of TXA after vaginal delivery. 3.To compare peripartum changes in haemoglobin, haematocrit and platelet count and to compare changes in PT/INR, APTT,LFT and RFT between intervention group and placebo group, within 12-24 hour following delivery. 4.To compare need for additional uterotonics and blood transfusion in two arms. Timepoint: 3 months	—

Measure

Time frame

1.To determine incidence of primary PPH,severe PPH and secondary PPH 2.To assess the potential adverse effects of TXA after vaginal delivery. 3.To compare peripartum changes in haemoglobin, haematocrit and platelet count and to compare changes in PT/INR, APTT,LFT and RFT between intervention group and placebo group, within 12-24 hour following delivery. 4.To compare need for additional uterotonics and blood transfusion in two arms. Timepoint: 3 months

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Countries

India

Contacts

Public ContactDr Garima Yadav

AIIMS Jodhpur

garimapunein@gmail.com

Outcome results

None listed

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