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

NCT ID: NCT04651166

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-07-27

Brief Summary

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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.

Detailed Description

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Conditions

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Abortion Dilation and Evacuation Hemorrhage Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

100mL saline or lactated ringer without tranexamic acid added given intravenously over 10 minutes at start of procedure

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100mL saline or lactated ringers

Active Comparator

1g tranexamic acid mixed in 100mL saline or lactated ringer given intravenously over 10 minutes at start of procedure

Group Type ACTIVE_COMPARATOR

Tranexamic acid

Intervention Type DRUG

1g tranexamic acid mixed in 100mL saline or lactated ringer

Interventions

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Tranexamic acid

1g tranexamic acid mixed in 100mL saline or lactated ringer

Intervention Type DRUG

Placebo

100mL saline or lactated ringers

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Society of Family Planning

OTHER

Sponsor Role collaborator

University of Hawaii

OTHER

Sponsor Role lead

Responsible Party

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Marit Pearlman Shapiro

Complex Family Planning Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marit Pearlman Shapiro

Role: PRINCIPAL_INVESTIGATOR

University of Hawaii

Locations

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Queens Medical Center

Honolulu, Hawaii, United States

Site Status

Countries

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United States

Other Identifiers

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RA-2020-050

Identifier Type: -

Identifier Source: org_study_id

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