Trial | NCT04201951  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    196
Postpartum hemorrhage and its complications are very well known causes for maternal mortality .Uterine atony is the most common cause for postpartum hemorrhage
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
Study Started
Feb 01
2020
Primary Completion
Oct 10
2020
Study Completion
Oct 10
2020
Last Update
Dec 24
2020

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 names: TRENAXA 500 mg, MACLEODS PHARMACEUTICALS LTD.India

Other Glucose water 5%

Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus

  • Other names: Glucose B.Braun 50 mg/mL

Tranexamic group Active Comparator

Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water

Placebo group Placebo Comparator

Group B will receive 30ML 5% glucose water

Criteria 

Inclusion Criteria:

Age ≥ 18 year.
Planed vaginal delivery
Grand multiparity
Twin pregnancy
Polyhydramnios
Previous history of PPH
Macrosomic baby
Prolonged labour
HELLP syndrome
Using of low-molecular weight heparin and Asprin during pregnancy.
Vaginal birth after Cesarean section

Exclusion Criteria:

Intrauterine death.
History of thromboembolic disease
Current or previous history of heart disease ,renal and liver disorders
History of seizure or epilepsy
Placenta previa
Placental abruptio
No Results Posted