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Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa

Primary Purpose

Placenta Previa

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Tranexamic acid tablets
Placebo oral tablet
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Previa

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Gestational age 28 weeks of gestation.
  • Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using transvaginal ultrasound scan.
  • Haemodynamically stable pregnant women.
  • Maternal age:20-40years old.
  • Pregnant women with placenta previa, and had previous bleeding attacks or admitted with antepartum haemorrhage.

Exclusion Criteria:

  • Multiple pregnancy.
  • Women with bleeding tendency due to any medical disorder (ITP, thrombocytopenia, coagulopathies),or on anticoagulants .
  • Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.
  • Women have hypersensitivity or any contraindication to use of tranexamic acid.
  • Pregnant women with placenta previa with doppler showing morbidly adherent placenta.

Sites / Locations

  • Ain SHams Maternity HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tranexamic acid group

Placebo group

Arm Description

100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.

100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.

Outcomes

Primary Outcome Measures

Amount of bleeding during antepartum bleeding attacks
Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery.

Secondary Outcome Measures

Number of women requiring antepartum blood transfusion
Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.
Number of PRBCs units required during antepartum blood transfusion
Number of PRBCs required during antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.
Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery
Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery
Gestational age at delivery
Gestational age in weeks at the time of delivery
Neonatal intensive care unit (NICU) admission
Number of neonates requiring NICU admission.

Full Information

First Posted
August 10, 2019
Last Updated
August 10, 2019
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT04055194
Brief Title
Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa
Official Title
Efficacy of Antenatal Tranexamic Acid in Pregnant Women With Symptomatic Placenta Previa in Decreasing Antepartum Hemorrhage - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Anticipated)
Study Completion Date
August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
200 pregnant women with symptomatic placenta previa with previous bleeding attacks attending Ain Shams University maternity hospital will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Placenta Previa

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Pregnant women with symptomatic placenta previa with previous bleeding attacks will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo till delivery. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Visually-identical drug and placebo tablets will be assigned to each participant using SNOSE congaing assignment code.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid group
Arm Type
Active Comparator
Arm Description
100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.
Intervention Type
Drug
Intervention Name(s)
Tranexamic acid tablets
Other Intervention Name(s)
Kapron(R)
Intervention Description
Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.
Primary Outcome Measure Information:
Title
Amount of bleeding during antepartum bleeding attacks
Description
Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery.
Time Frame
9 weeks GA
Secondary Outcome Measure Information:
Title
Number of women requiring antepartum blood transfusion
Description
Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.
Time Frame
9 weeks GA
Title
Number of PRBCs units required during antepartum blood transfusion
Description
Number of PRBCs required during antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.
Time Frame
9 weeks GA
Title
Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery
Description
Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery
Time Frame
9 weeks GA
Title
Gestational age at delivery
Description
Gestational age in weeks at the time of delivery
Time Frame
9 weeks GA
Title
Neonatal intensive care unit (NICU) admission
Description
Number of neonates requiring NICU admission.
Time Frame
9 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age 28 weeks of gestation. Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using transvaginal ultrasound scan. Haemodynamically stable pregnant women. Maternal age:20-40years old. Pregnant women with placenta previa, and had previous bleeding attacks or admitted with antepartum haemorrhage. Exclusion Criteria: Multiple pregnancy. Women with bleeding tendency due to any medical disorder (ITP, thrombocytopenia, coagulopathies),or on anticoagulants . Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery. Women have hypersensitivity or any contraindication to use of tranexamic acid. Pregnant women with placenta previa with doppler showing morbidly adherent placenta.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amal Ramadan, MBBCh
Phone
+201098093525
Email
dr.amalramadan11@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Ramadan, MBBCh
Organizational Affiliation
A Ramadan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain SHams Maternity Hospital
City
Cairo
State/Province
Abbaseya
ZIP/Postal Code
002
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amal Ramadan, MBBCh
Phone
201098093525
Email
dr.amalramadan11@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa

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