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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Kurdistan Region
    • Erbil, Kurdistan Region, Iraq, 44001
      • Kurdistan Board for Medical speciality
    • Erbil, Kurdistan Region, Iraq, 44001
      • Maternity Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic group; Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water	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
Placebo Comparator: Placebo group; Group B will receive 30ML 5% glucose water	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participant with Post Partum Hemorrhage	Vaginal blood loss of more than 500 mL	up to 2 hours after delivery
Number of participant with severe postpartum hemorrhage	Vaginal blood loss ≥1000mL	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	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	up to 30 minutes

Collaborators and Investigators

• Sponsor: Hawler Medical University
• Investigators: Study Chair: Sazgar A. Rashid, FIBOG, Ministery of Health; Study Chair: Chro S. Hassan, MBChB, Kurdistan Board for Medical speciality

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): October 10, 2020
• Study Completion (Actual): October 10, 2020

Study Registration Dates

• First Submitted: December 14, 2019
• First Submitted That Met QC Criteria: December 14, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: HawlerMU3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No