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

Sponsor
University of Hawaii (Other)
Overall Status
Recruiting
CT.gov ID
NCT04651166
Collaborator
Society of Family Planning (Other)
50
Enrollment
1
Location
2
Arms
10.5
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Tranexamic acid
  • Drug: Placebo
 N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 15, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. Intervention to control blood loss [At time of procedure]

    Rate at which providers perform interventions to control blood loss during D&E procedures

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Queens Medical Center Honolulu Hawaii United States 96814

Sponsors and Collaborators

  • University of Hawaii
  • Society of Family Planning

Investigators

  • Principal Investigator: Marit Pearlman Shapiro, University of Hawaii

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Dec 3, 2020
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Hemorrhage
Dilatation, Pathologic
Tranexamic Acid

Study Results

No Results Posted as of May 26, 2022