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

Not Applicable

Completed

• Conditions: High Risk Pregnancy; Third-Stage Postpartum Hemorrhage, With Delivery; Postpartum Hemorrhage; Tranexamic Acid
• Interventions: Drug: Tranexamic acid injection; Other: Glucose water 5%

• Registration Number: NCT04201951
• Lead Sponsor: Hawler Medical University

Brief 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

Study Timeline

• Study First Submitted: 2019-12-14
• Study First Submitted QC: 2019-12-14
• Study First Posted: 2019-12-17
• Study Start: 2020-02-01
• Primary Completion: 2020-10-10
• Study Completion: 2020-10-10
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-23
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic group	Tranexamic acid injection	Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water
Tranexamic group	Glucose water 5%	Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water
Placebo group	Glucose water 5%	Group B will receive 30ML 5% glucose water
Placebo group	Tranexamic acid injection	Group B will receive 30ML 5% glucose water

Primary Outcome Measures

Name	Time	Method
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)	From the time of injection and up to 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)

Secondary Outcome Measures

Name	Time	Method
Number of participant with Post Partum Hemorrhage	up to 2 hours after delivery	Vaginal blood loss of more than 500 mL
Number of participant with severe postpartum hemorrhage	up to 2 hours after delivery	Vaginal blood loss ≥1000mL
Number of participant who will need additional uterotonic drugs to control blood loss	up to 2 hours after delivery	Methyl Ergometrine 0.2 mL, 20 IU oxytocin , and/or 800 misoprostol rectally
the mean length of third stage of labor in both groups	up to 30 minutes	time from injection of the intervention and placebo group till the delivery of placenta

Trial Locations

Locations (2)

Kurdistan Board for Medical speciality; 🇮🇶 Erbil, Kurdistan Region, Iraq

Maternity Teaching Hospital; 🇮🇶 Erbil, Kurdistan Region, Iraq