NCT04201951

Tranexamic Acid for the Prevention of Blood Loss in High Risk Delivered Women

Tranexamic Acid for the Prevention of Blood Loss After Vaginal Delivery in a High Risk Pregnancy: A Double Blind Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Hawler Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage

Detailed description

Postpartum hemorrhage and its complications are very well known causes for maternal mortality and morbidity especially in developing countries. World Health Organization Recommendations for Active Management of the Third Stage of Labor (AMTSL), on 2012 included the use of uterotonics for the prevention of postpartum hemorrhage (PPH) during the third stage of labor for all births. Tranexamic acid (TA) is antifibrinolytic agent used to decrease blood loss in surgery and health conditions associated with increased bleeding. A Cochrane Systematic Review from the best available evidence to determine whether TA is effective and safe for preventing PPH in comparison to placebo or no treatment the review concluded that TA (in addition to uterotonic medications) decreases blood loss postpartum and prevents PPH and blood transfusions following vaginal birth and abdominal delivery in women at low risk of PPH based on studies of mixed quality. There was insufficient evidence to draw conclusions about serious side effects and the effects of TA on venous thromboembolic events and mortality beside its use in high-risk women was not investigated on

Conditions

• Postpartum Hemorrhage
• High Risk Pregnancy
• Tranexamic Acid
• Third-Stage Postpartum Hemorrhage, With Delivery

Interventions

Type	Name	Description
DRUG	Tranexamic acid injection	Participant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus
OTHER	Glucose water 5%	Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus

Timeline

• Start date: 2020-02-01
• Primary completion: 2020-10-10
• Completion: 2020-10-10
• First posted: 2019-12-17
• Last updated: 2020-12-24

Locations

2 sites across 1 country: Iraq