Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: Tranexamic Acid (TXA): TXA injection will be prepared by diluting 1 gram (10ml) TXA in 100ml of NS. TXA will be administered as intravenous infusion (over 15 minutes), at least 20 minut
Sponsors
AIIMS Raipur
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with singleton pregnancy (parity not more than 3) 2. Age � 18 and 3. � 37 weeks and 4. Alive fetus. 5. Hb � 9 g % in recent 3rd trimester report. 6. Subjects receiving spinal anaesthesia for Cesarean Section
Exclusion criteria
Exclusion criteria: 1. History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombosis 2. Subjects with medical disorders like chronic hypertension, renal disease, heart disease, liver disease complicating pregnancy 3. Known case of coagulation disorders 4. Pregnancy related complication like severe preeclampsia, multiple pregnancy, polyhydramnios, and macrosomia, with abnormal placentation, previous two or more caesarean sections 5. Intrauterine death 6. Woman on anticoagulant therapy during the week before delivery 7. Sickle cell disease 8. History of seizures 9. Allergy to TXA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ The intraoperative and postoperative volume of blood loss in the study group (those who received preoperative Tranexamic Acid) and placebo group (those who did not receive Tranexamic Acid)Timepoint: ââ?¬Â¢ The intraoperative blood loss from time of placenta delivery to vaginal toileting. Postoperative blood loss is from end of vaginal toileting to 3 hours postpartum | — |
Secondary
| Measure | Time frame |
|---|---|
| ââ?¬Â¢ Mean change in hemoglobin between before surgery and 48 hours post surgery in both the groups. ââ?¬Â¢ Proportion of women requiring supplementary uterotonic agent other other than routine use of inj. oxytocin 10 mg intramuscular injection immediately after delivery of the baby. Timepoint: Intraoperative period will be considered from skin incision to completion of vaginal toileting. Postoperative period will be considered from from completion of vaginal toileting to first 3 hours. | — |
Countries
India
Contacts
Public ContactNutan Sinha
All India Institute of Medical Sciences, Raipur
Outcome results
None listed