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Tranexamic Acid as an Intervention in Placenta Previa

Primary Purpose

Interventional Drug in Placenta Previa

Status
Recruiting
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 treatment trial for Interventional Drug in Placenta Previa focused on measuring Placenta previa, Tranexamic acid, intervention, Double blind

Eligibility Criteria

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

Inclusion Criteria: Pregnant at 24 weeks gestation and more Vaginal bleeding due to placenta previa Stable hemodynamically Accept to participate in the trial Exclusion Criteria: Hypersensitivity to tranexamic acid Acquired defective color vision History of venous thromboembolism Pre-existing medical conditions (diabetes mellitus, hypertension, renal disease) Smokers Refused to participate in the trial

Sites / Locations

  • Ariana kh. JawadRecruiting
  • Kurdistan Board for Medical specialityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid group

Glucose water group

Arm Description

This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml glucose water 5% intravenously twice daily in the acute stage of bleeding for 48 hours. This will be followed by 500 mg tranexamic acid tablets (Trenaxa; Macleods Pharmaceuticals Pvt. Ltd.) three times daily for five days. Participants will be followed up for recurrence of bleeding during pregnancy. The course of treatment will be repeated again if bleeding recurred. The hospital data safety and monitoring board ensured the continued safety of the Participants.

Participants will receive 30 mL of 5% glucose water slowly intravenously immediately during the attack of the bleeding, twice daily for 48 hours. Accompanied with the usual expectant management care.

Outcomes

Primary Outcome Measures

To stope or decrease vaginal bleeding
Receiving Tranexamic acid decreases or stops vaginal bleeding in women with placenta previa
Prolong pregnancy to 36 weeks
Decreased vaginal bleeding may prolong pregnancy
Favorable perinatal outcome
Delivery of active newborn at or more than 36 weeks gestation

Secondary Outcome Measures

Full Information

First Posted
January 8, 2023
Last Updated
January 19, 2023
Sponsor
Hawler Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05688111
Brief Title
Tranexamic Acid as an Intervention in Placenta Previa
Official Title
Tranexamic Acid in Pregnant Women With Placentae Previa: A Double-blind, Multicenter Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
November 2, 2023 (Anticipated)
Study Completion Date
December 2, 2023 (Anticipated)

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
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women
Detailed Description
Antepartum hemorrhage (APH) due to placenta previa is an important cause of worldwide perinatal mortality and maternal morbidity in pregnant women. No medication is of specific benefit to a patient with placenta previa. Tocolysis may be cautiously considered in some circumstances in order to administer antenatal corticosteroids. A review article concluded that there is no improvement in perinatal outcome with prolonged tocolytics, and tocolysis beyond 48 hours is not clinically indicated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interventional Drug in Placenta Previa
Keywords
Placenta previa, Tranexamic acid, intervention, Double blind

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization for both groups to the 2 groups will be done using Randomization Allocation Software program and whom will add the numbers on each syringe will be a pharmacist not involve in the study and will have the cods belong to the type of the intervention with him until the end of the research . Random Allocation Software(https://random-allocation-software.software.informer.com/2.0/)
Masking
ParticipantCare ProviderInvestigator
Masking Description
Two similar size syringes will be prepared and labeled as A (experimental group) containing 1 g/10mL Tranexamic acid diluted with 20mL of 5% glucose water, and syringe B (placebo group) containing 30 mL of 5% glucose water. The 2 groups of syringes will be labeled with different numbers not known by the investigator or the patient
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid group
Arm Type
Active Comparator
Arm Description
This interventional arm will receive tranexamic acid 1 g(10ml) (2 ampules each of 500 mg, 5ML) of tranexamic acid in 20 ml glucose water 5% intravenously twice daily in the acute stage of bleeding for 48 hours. This will be followed by 500 mg tranexamic acid tablets (Trenaxa; Macleods Pharmaceuticals Pvt. Ltd.) three times daily for five days. Participants will be followed up for recurrence of bleeding during pregnancy. The course of treatment will be repeated again if bleeding recurred. The hospital data safety and monitoring board ensured the continued safety of the Participants.
Arm Title
Glucose water group
Arm Type
Placebo Comparator
Arm Description
Participants will receive 30 mL of 5% glucose water slowly intravenously immediately during the attack of the bleeding, twice daily for 48 hours. Accompanied with the usual expectant management care.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid injection
Other Intervention Name(s)
Trenaxa; Macleods Pharmaceuticals Pvt.Ltd., Mumbai, India
Intervention Description
Active group will receive 1gm Tranexamic acid 12 hourly for 48 hours
Intervention Type
Other
Intervention Name(s)
Glucose water 5%
Other Intervention Name(s)
Glucose B.Braun
Intervention Description
Placebo group 30ml will be received 12 hourly for 48 hours
Primary Outcome Measure Information:
Title
To stope or decrease vaginal bleeding
Description
Receiving Tranexamic acid decreases or stops vaginal bleeding in women with placenta previa
Time Frame
Up to time of delivery
Title
Prolong pregnancy to 36 weeks
Description
Decreased vaginal bleeding may prolong pregnancy
Time Frame
Up to delivery of the fetus
Title
Favorable perinatal outcome
Description
Delivery of active newborn at or more than 36 weeks gestation
Time Frame
7 days post partum

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: Pregnant at 24 weeks gestation and more Vaginal bleeding due to placenta previa Stable hemodynamically Accept to participate in the trial Exclusion Criteria: Hypersensitivity to tranexamic acid Acquired defective color vision History of venous thromboembolism Pre-existing medical conditions (diabetes mellitus, hypertension, renal disease) Smokers Refused to participate in the trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SHAHLA ALALAF, prof.
Phone
07504480711
Ext
00964
Email
shahla_alaf@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abu bakir Majeed, PhD
Phone
07504494656
Ext
00964
Email
abubakir.majeed@hmu.edu.krd
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SHAHLA K ALALAF, prof.
Organizational Affiliation
Hawler Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ariana Jawad, professor
Organizational Affiliation
Kurdistan Higher Counsel of Medical Specialties
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
khalida Amin, Ass. Prof
Organizational Affiliation
karkuk Medical college
Official's Role
Study Chair
Facility Information:
Facility Name
Ariana kh. Jawad
City
Erbil
State/Province
Kurdistan Region
ZIP/Postal Code
44001
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SHAHLA k. ALALAF
Phone
07504480711
Facility Name
Kurdistan Board for Medical speciality
City
Erbil
State/Province
Kurdistan Region
ZIP/Postal Code
44001
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
Phone
07504480711

12. IPD Sharing Statement

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Tranexamic Acid as an Intervention in Placenta Previa

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