A study to assess the role of Tranexamic acid in reducing blood loss in Cesarean Sections in women at high risk for Postpartum Hemorrhage

Not yet recruiting

Conditions: Other immediate postpartum hemorrhage,

Registration Number: CTRI/2021/03/031690

Lead Sponsor: Jawaharlal Nehru Medical College KLE University

Brief Summary: This study is being conducted to assess the role of prophylactic Tranexamic acid in reducing blood loss in elective and emergency cesarean sections in women at high risk for postpartum hemorrhage. Hemorrhage is a leading cause of maternal morbidly and mortality. Tranexamic acid is an anti-fibrinolytic agent that helps to reduce bleeding. It is safe in pregnancy (FDA category B). Several studies have been conducted regarding the use of Tranexamic acid to prevent postpartum hemorrhage in cesarean sections with conclusive results showing statistically significant decrease in the blood loss and incidence of post partum hemorrhage. However very little research has been done to study the effectiveness among women with high risk pregnancies. This study aims to bridge that gap.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Female

Target Recruitment: 200

Inclusion Criteria

Pregnant women at gestational age of 34 weeks or more, who are to undergo elective or emergency caesarean delivery, with at least one risk factor including Obesity, Chronic Hypertension, Gestational hypertension, Pre-eclampsia, Eclampsia, Anemia, Use of Oxytocin augmentation >4hrs, Multiparity (Parity >4), Multiple pregnancy, Abnormally implanted placenta, Placenta previa, Abruption, Uterine Leiomyomas, Polyhydramnios, Fetal macrosomia, Previous LSCS, History of postpartum hemorrhage in previous pregnancy, Chorioamnionitis and Cholestasis of pregnancy.

Exclusion Criteria

Patients with Impaired colour vision, Known cardiovascular, renal or liver disorders, Current or past history of DVT, Anticoagulant therapy, Coagulation defects, HELLP syndrome and Sensitivity to Tranexamic acid.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in pre and post op hemoglobin	1 year
Reduction in estimated blood loss in cesarean sections by formula using difference between pre and post op hematocrit and estimated blood volume.	1 year

Secondary Outcome Measures

Name	Time	Method
Need for blood and blood product transfusion intra-op or post-operatively	Need for additional uterotonics/surgical procedure during cesarean section

Trial Locations

Locations (1): KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi
🇮🇳
Belgaum, KARNATAKA, India
KLES Dr. Prabhakar Kore Hospital and Medical Research Centre, Belagavi
🇮🇳Belgaum, KARNATAKA, India
Dr Bethany Grace Neumann
Principal investigator
7829567851
beth.grace10@gmail.com