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.

INJECTION TRANEXAMIC ACID FOR PREVENTING POSTPARTUM HEMORRHAGE AFTER VAGINAL DELIVERY: ONE YEAR HOSPITAL BASED RANDOMIZED,PLACEBO-CONTROLLED TRIAL.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/01/017077

Enrollment

200

Registered

2019-01-14

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O721- Other immediate postpartum hemorrhage

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: 1)Term pregnancy 2)Planned vaginal delivery 3)Singleton pregnancy

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

India

Contacts

Public ContactDr Kamal P Patil

KLE Universitys J N Medical college ,Belgaum

kamalpatil1967@yahoo.co.in9845565454

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026