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Trial record 98 of 419 for:    TRANEXAMIC ACID

Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa

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ClinicalTrials.gov Identifier: NCT04055194
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Amal Ramadan, Ain Shams University

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).

Condition or disease Intervention/treatment Phase
Placenta Previa Drug: Tranexamic acid tablets Drug: Placebo oral tablet Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Visually-identical drug and placebo tablets will be assigned to each participant using SNOSE congaing assignment code.
Primary Purpose: Prevention
Official Title: Efficacy of Antenatal Tranexamic Acid in Pregnant Women With Symptomatic Placenta Previa in Decreasing Antepartum Hemorrhage - A Randomized Controlled Trial
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Tranexamic acid group
100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.
Drug: Tranexamic acid tablets
Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.
Other Name: Kapron(R)

Placebo Comparator: Placebo group
100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.
Drug: Placebo oral tablet
Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.




Primary Outcome Measures :
  1. Amount of bleeding during antepartum bleeding attacks [ Time Frame: 9 weeks GA ]
    Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery.


Secondary Outcome Measures :
  1. Number of women requiring antepartum blood transfusion [ Time Frame: 9 weeks GA ]
    Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.

  2. Number of PRBCs units required during antepartum blood transfusion [ Time Frame: 9 weeks GA ]
    Number of PRBCs required during antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.

  3. Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery [ Time Frame: 9 weeks GA ]
    Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery

  4. Gestational age at delivery [ Time Frame: 9 weeks GA ]
    Gestational age in weeks at the time of delivery

  5. Neonatal intensive care unit (NICU) admission [ Time Frame: 9 weeks ]
    Number of neonates requiring NICU admission.



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055194


Contacts
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Contact: Amal Ramadan, MBBCh +201098093525 dr.amalramadan11@gmail.com

Locations
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Egypt
Ain SHams Maternity Hospital Recruiting
Cairo, Abbaseya, Egypt, 002
Contact: Amal Ramadan, MBBCh    201098093525    dr.amalramadan11@gmail.com   
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Amal Ramadan, MBBCh A Ramadan

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Responsible Party: Amal Ramadan, Clinical fellow of Obstetrics & Gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT04055194     History of Changes
Other Study ID Numbers: AntenatalTRX-PP
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Placenta Previa
Obstetric Labor Complications
Pregnancy Complications
Placenta Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants