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

NCT04651166 | Completed Phase 2 FDA Drug

• 1 other identifier: RA-2020-050
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Abortion; Dilation and Evacuation; Hemorrhage; Blood Loss

Outcome Measures

Primary Outcomes (1)

• Intervention to control blood loss

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

  At time of procedure

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

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

Interventions

Tranexamic acid DRUG

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

Active Comparator

Placebo DRUG

100mL saline or lactated ringers

Placebo

Eligibility Criteria

• Age: 14 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of thromboembolic events (i.e. deep vein thrombosis, stroke, pulmonary embolism)

Sponsors & Collaborators

• University of Hawaii: lead
• Society of Family Planning: collaborator

Study Sites (1)

Queens Medical Center

Honolulu, Hawaii, 96814, United States

Location

MeSH Terms

Conditions

Dilatation, Pathologic; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Marit Pearlman Shapiro

  University of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Complex Family Planning Fellow

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: February 15, 2022
• Primary Completion: July 27, 2023
• Study Completion: July 27, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)