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.
- Conditions
- Other immediate postpartum hemorrhage,
- Registration Number
- CTRI/2019/01/017077
- Lead Sponsor
- Dr Kshama A Hinchigeri
- Brief Summary
This is an interventional , randomized, placebo controlled trial to asses the effect of injection tranexamic acid in preventing postpartum hemorrhage after a vaginal delivery, conducted at a tertiary care centre. This study will enroll term pregnant women who are planned for vaginal delivery .Women who have even one of the exclusion criteria will not be enrolled into this study..Randomization will be done by computer based randomisation. Soon after the delivery of the baby, injection tranexamic acid or placebo which is normal saline will be given by intravenous route. The primary outcome will be assessed by the amount of blood loss in the calibrated collector bag which will be placed under the waist of the woman soon after delivery of baby. The secondary outcome will be assessed by the mean change in hemoglobin and packed cell volume.Adverse effects of the drug which include immediate and long term adverse effects will also be studied.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 200
1)Term pregnancy 2)Planned vaginal delivery 3)Singleton pregnancy.
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 . Blood loss- End of 30 minutes | End of 2 hours | Time of removal of bag Mean total blood loss is total blood in the calibrated collector bag at the time of bag removal. Blood loss- End of 30 minutes | End of 2 hours | Time of removal of bag
- Secondary Outcome Measures
Name Time Method Laboratory parameters Hemoglobin 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. Hemodynamic parameters Patients will be followed up until the day of discharge to know incidence of Postpartum blood transfusion
Trial Locations
- Locations (1)
KLEs Dr Prabhakar Kore Charitable Hospital
🇮🇳Belgaum, KARNATAKA, India
KLEs Dr Prabhakar Kore Charitable Hospital🇮🇳Belgaum, KARNATAKA, IndiaDr Kshama A HinchigeriPrincipal investigator9071978689kshamah92@gmail.com