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.

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2019
INTERVENTION: Intervention1: ‐‐‐‐: ‐‐‐‐ Intervention2: Injection tranexamic acid: Dose is 1 gram. Frequency is single dose. Administered by intravenous route. Total duration of therapy‐the drug will be given within 2 minutes from time of delivery of baby and will be administered as a single dose slowly over a minute. Control Intervention1: normal saline as placebo: ‐‐‐ Control Intervention2: Normal saline: 10 ml of normal saline as placebo will be given by intravenous route. Control Intervention3: Placebo‐Normal saline: Dose is 10 ml of normal saline. Frequency is single dose. Administered by intravenous route.Total duration of therapy ‐ the drug will be given within 2 minutes from time of delivery of baby and will be administered as a single dose slowly over a minute. CONDITION: Other immediate postpartum hemorrhage PRIMARY OUTCOME: Amount of blood loss at the end of 30 minutes and at the end of 2 hours . ; 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 ; End of 2 hours ; Time of removal of bag SECONDARY OUTCOME: 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 ; 15 minutes ; 30 minutes ; 45 minutes ; 1 hour ; 2 hour ; follow up for major adverse effects till 3 months post delivery Laboratory parameters ; Hemoglobin ; Packed Cell Volume(PCV) ; The mean change in peripartum hemoglobin and PCV will be calculated ; Timepoint: Postnatal day 2 Patients will be followed up until the day of discharge to know incidence of ; Postpartum blood transfusion ; Arterial embolization ; Emergency hysterectomy ; Timepoint: Date of discharge INCLUSION CRITERIA: 1)Term pregnancy 2)Planned vaginal delivery 3)Singleton pregnancy
Epistemonikos ID: 28966b026dd67f2603fd1af0cdab8c7720be9762
First added on: Aug 24, 2024