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Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation

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ClinicalTrials.gov Identifier: NCT04651166
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : May 26, 2022
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Marit Pearlman Shapiro, University of Hawaii

Study Description
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Brief Summary:
Prophylactic tranexamic acid has shown been shown to reduce maternal mortality from postpartum hemorrhage with no adverse effects, but has not been studied to reduce bleeding complications with dilation and evacuation (D&E). We propose a randomized, double-blinded, placebo-controlled pilot study to determine whether routine use of intravenous (IV) tranexamic acid will decrease the need for interventions to control bleeding at the time of D&E at 16 to 24 weeks gestation.

Condition or disease Intervention/treatment Phase
Abortion Dilation and Evacuation Hemorrhage Blood Loss Drug: Tranexamic acid Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation
Actual Study Start Date : February 15, 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
100mL saline or lactated ringer without tranexamic acid added given intravenously over 10 minutes at start of procedure
 Drug: Placebo
100mL saline or lactated ringers
Active Comparator: Active Comparator
1g tranexamic acid mixed in 100mL saline or lactated ringer given intravenously over 10 minutes at start of procedure
 Drug: Tranexamic acid
1g tranexamic acid mixed in 100mL saline or lactated ringer


Outcome Measures
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Primary Outcome Measures :
  1. Intervention to control blood loss [ Time Frame: At time of procedure ]
    Rate at which providers perform interventions to control blood loss during D&E procedures


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Requesting pregnancy termination
  • Intrauterine pregnancy at 16 to 24 weeks gestation
  • Participants must be willing and capable of giving informed consent and able to understand and sign written consents in English.

Exclusion Criteria:

  • History of thromboembolic events (i.e. deep vein thrombosis, stroke, pulmonary embolism)
Contacts and Locations
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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): NCT04651166


Contacts
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Contact: Marit Pearlman Shapiro 8082036508 maritps@hawaii.edu

Locations
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United States, Hawaii
Queens Medical Center Recruiting
Honolulu, Hawaii, United States, 96814
Contact: Marit Pearlman Shapiro, MD         
Sponsors and Collaborators
University of Hawaii
Society of Family Planning
Investigators
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Principal Investigator: Marit Pearlman Shapiro University of Hawaii
More Information
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Responsible Party: Marit Pearlman Shapiro, Complex Family Planning Fellow, University of Hawaii
ClinicalTrials.gov Identifier: NCT04651166    
Other Study ID Numbers: RA-2020-050
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
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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Hemorrhage
Dilatation, Pathologic
Pathologic Processes
Pathological Conditions, Anatomical
Tranexamic Acid
 Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants