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

N/ACompletedNCT04201951

Hawler Medical University196 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

196

Conditions

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

Interventions

Tranexamic acid injectionDRUG

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

Glucose water 5%OTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (2)

Kurdistan Board for Medical speciality

Erbil, Kurdistan Region, Iraq

Maternity Teaching Hospital

Erbil, Kurdistan Region, Iraq

Outcomes

Primary Outcomes

The amount of vaginal blood loss in the third and fourth stages (the fourth begins with delivery of the placenta and ends 2 hours after delivery)

The volume of blood loss vaginally will be measured by weighing a specially prepared pad applied beneath the delivered women buttocks before the delivery of the fetus. An electronic scale will be used to weigh the pads before and after 2 hours of the delivery. The quantity of blood (ml) will be = (weight of used materials - weight of materials prior to use)

Time frame: From the time of injection and up to 2 hours after delivery

Secondary Outcomes

Number of participant with Post Partum Hemorrhage

Vaginal blood loss of more than 500 mL

Time frame: up to 2 hours after delivery

Number of participant with severe postpartum hemorrhage

Vaginal blood loss ≥1000mL

Time frame: up to 2 hours after delivery

Number of participant who will need additional uterotonic drugs to control blood loss

Methyl Ergometrine 0.2 mL, 20 IU oxytocin , and/or 800 misoprostol rectally

Time frame: up to 2 hours after delivery

the mean length of third stage of labor in both groups

time from injection of the intervention and placebo group till the delivery of placenta

Time frame: up to 30 minutes

Data from ClinicalTrials.gov

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