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

Phase 3

Completed

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

• Registration Number: CTRI/2021/05/033500
• Lead Sponsor: AIIMS Jodhpur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-13
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 641

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1.To determine incidence of primary PPH,severe PPH and secondary PPH <br/ ><br>2.To assess the potential adverse effects of TXA after vaginal delivery. <br/ ><br>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. <br/ ><br>4.To compare need for additional uterotonics and blood transfusion in two arms. <br/ ><br>Timepoint: 3 months