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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201951
• Other study ID #: HawlerMU3
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: October 10, 2020

Study information

• Verified date: December 2020
• Source: Hawler Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: October 10, 2020
• Est. primary completion date: October 10, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Iraq	Kurdistan Board for Medical speciality	Erbil	Kurdistan Region
Iraq	Maternity Teaching Hospital	Erbil	Kurdistan Region

Sponsors (1)

Lead Sponsor	Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From the time of injection and up to 2 hours after delivery
Secondary	Number of participant with Post Partum Hemorrhage	Vaginal blood loss of more than 500 mL	up to 2 hours after delivery
Secondary	Number of participant with severe postpartum hemorrhage	Vaginal blood loss =1000mL	up to 2 hours after delivery
Secondary	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	up to 2 hours after delivery
Secondary	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	up to 30 minutes