A clinical trial to study the effect of a drug,injection tranexamic acid in reducing the amount of blood loss after a normal delivery, in comparison with an inactive medicine like normal saline.

Phase 3

• Conditions: Health Condition 1: O721- Other immediate postpartum hemorrhage

• Registration Number: CTRI/2019/01/017077
• Lead Sponsor: Dr Kshama A Hinchigeri

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)Term pregnancy

2)Planned vaginal delivery

3)Singleton pregnancy

Exclusion Criteria

1)History of thrombosis

venous-deep vein thrombosis and/or pulmonary embolism

arterial -angina pectoris, myocardial infarction, stroke

2)History of epilepsy or seizure

3)Any known cardiovascular, renal, or liver disorders

4)Autoimmune disease

5)Sickle cell disease

6)Severe hemorrhagic disease

7)Placental Abnormalilty-

8)Placenta previa

9)Invasive placenta (placenta accreta/ increta/

percreta)

10)Abruptio placentae

11)Eclampsia, and HELLP syndrome

12)Intra utero fetal death

13)Administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery

14)Caeserean sections

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Amount of blood loss at the end of 30 minutes and at the end of 2 hours . <br/ ><br>Mean total blood loss is total blood in the calibrated collector bag at the time of bag removal.Timepoint: Blood loss- End of 30 minutes <br/ ><br>End of 2 hours <br/ ><br>Time of removal of bag

Secondary Outcome Measures

Name	Time	Method
Adverse effects of the drug will be noted by monitoring hemodynamic parameters and by follow up visits upto 3 months in the post natal period.Timepoint: Hemodynamic parameters <br/ ><br>15 minutes <br/ ><br>30 minutes <br/ ><br>45 minutes <br/ ><br>1 hour <br/ ><br>2 hour <br/ ><br>follow up for major adverse effects till 3 months post delivery;Laboratory parameters <br/ ><br>Hemoglobin <br/ ><br>Packed Cell Volume(PCV) <br/ ><br> The mean change in peripartum hemoglobin and PCV will be calculated <br/ ><br>Timepoint: Postnatal day 2;Patients will be followed up until the day of discharge to know incidence of <br/ ><br>Postpartum blood transfusion <br/ ><br>Arterial embolization <br/ ><br>Emergency hysterectomy <br/ ><br>Timepoint: Date of discharge