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

NCT04201951 | Completed DMC

• 1 other identifier: HawlerMU3
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 2

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of participant with Post Partum Hemorrhage

  up to 2 hours after delivery

• Number of participant with severe postpartum hemorrhage

  up to 2 hours after delivery

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

  up to 2 hours after delivery

• the mean length of third stage of labor in both groups

  up to 30 minutes

Study Arms (2)

Tranexamic group

ACTIVE COMPARATOR

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

Drug: Tranexamic acid injection; Other: Glucose water 5%

Placebo group

PLACEBO COMPARATOR

Group B will receive 30ML 5% glucose water

Drug: Tranexamic acid injection; Other: Glucose water 5%

Interventions

Tranexamic acid injection DRUG

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

Also known as: TRENAXA 500 mg, MACLEODS PHARMACEUTICALS LTD.India

Placebo group; Tranexamic group

Glucose water 5% OTHER

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

Also known as: Glucose B.Braun 50 mg/mL

Placebo group; Tranexamic group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (2)

Kurdistan Board for Medical speciality

Erbil, Kurdistan Region, 44001, Iraq

Location

Maternity Teaching Hospital

Erbil, Kurdistan Region, 44001, Iraq

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Shahla K. Alalaf, professor

  Hawler Medical University

  PRINCIPAL INVESTIGATOR

• Sazgar A. Rashid, FIBOG

  Ministery of Health

  STUDY CHAIR

• Chro S. Hassan, MBChB

  Kurdistan Board for Medical Speciality

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: All providers and delivered women will be blinded for the content of the bags which will be applied for women randomly
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two infusion bags will be prepared and labeled as bag A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and bag B (placebo group) containing 30 mL of 5% glucose water. Providers and patients will be blinded to the contents of the bags until the end of the study. TA or placebo will be administered intravenously immediately after the delivery of the fetus.

Study Record Dates

• First Submitted: December 14, 2019
• First Posted: December 17, 2019
• Study Start: February 1, 2020
• Primary Completion: October 10, 2020
• Study Completion: October 10, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

IR (2)