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

Primary Purpose

Postpartum Hemorrhage, High Risk Pregnancy, Tranexamic Acid

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Tranexamic acid injection
Glucose water 5%
Sponsored by
Hawler Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kurdistan Board for Medical speciality
  • Maternity Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic group

Placebo group

Arm Description

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

Group B will receive 30ML 5% glucose water

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of participant with Post Partum Hemorrhage
Vaginal blood loss of more than 500 mL
Number of participant with severe postpartum hemorrhage
Vaginal blood loss ≥1000mL
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
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

Full Information

First Posted
December 14, 2019
Last Updated
December 23, 2020
Sponsor
Hawler Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04201951
Brief Title
Tranexamic Acid for the Prevention of Blood Loss in High Risk Delivered Women
Official Title
Tranexamic Acid for the Prevention of Blood Loss After Vaginal Delivery in a High Risk Pregnancy: A Double Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
October 10, 2020 (Actual)
Study Completion Date
October 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hawler Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage, High Risk Pregnancy, Tranexamic Acid, Third-Stage Postpartum Hemorrhage, With Delivery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
All providers and delivered women will be blinded for the content of the bags which will be applied for women randomly
Allocation
Randomized
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic group
Arm Type
Active Comparator
Arm Description
Group A will receive 1gm Tranexamic acide diluted in 20 ML 5% glucose water
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Group B will receive 30ML 5% glucose water
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Other Intervention Name(s)
TRENAXA 500 mg, MACLEODS PHARMACEUTICALS LTD.India
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Glucose water 5%
Other Intervention Name(s)
Glucose B.Braun 50 mg/mL
Intervention Description
Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus
Primary Outcome Measure Information:
Title
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)
Description
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 Outcome Measure Information:
Title
Number of participant with Post Partum Hemorrhage
Description
Vaginal blood loss of more than 500 mL
Time Frame
up to 2 hours after delivery
Title
Number of participant with severe postpartum hemorrhage
Description
Vaginal blood loss ≥1000mL
Time Frame
up to 2 hours after delivery
Title
Number of participant who will need additional uterotonic drugs to control blood loss
Description
Methyl Ergometrine 0.2 mL, 20 IU oxytocin , and/or 800 misoprostol rectally
Time Frame
up to 2 hours after delivery
Title
the mean length of third stage of labor in both groups
Description
time from injection of the intervention and placebo group till the delivery of placenta
Time Frame
up to 30 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahla K. Alalaf, professor
Organizational Affiliation
Hawler Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sazgar A. Rashid, FIBOG
Organizational Affiliation
Ministery of Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Chro S. Hassan, MBChB
Organizational Affiliation
Kurdistan Board for Medical Speciality
Official's Role
Study Chair
Facility Information:
Facility Name
Kurdistan Board for Medical speciality
City
Erbil
State/Province
Kurdistan Region
ZIP/Postal Code
44001
Country
Iraq
Facility Name
Maternity Teaching Hospital
City
Erbil
State/Province
Kurdistan Region
ZIP/Postal Code
44001
Country
Iraq

12. IPD Sharing Statement

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

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