Intrafetal Digoxin as an Adjuvant for Dilation and Evacuation at 20 to 24 Weeks' Gestation

NCT ID: NCT03136068

Last Updated: 2019-10-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-23

Study Completion Date

2018-05-31

Brief Summary

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This is a research study to measure the effect of digoxin injection on Dilation and Evacuation (D\&E) procedure duration. Digoxin is the most commonly used feticidal agent among family planning subspecialists, and is commonly used for a variety of reasons including provider preference, patient preference, and concerns over legal status of later D\&E procedures. There have been several studies on digoxin administration, adverse effects, and impact on the D\&E procedure, but doctors want to clarify how digoxin effects D\&E procedure time, if at all.

Detailed Description

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Conditions

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Abortion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Digoxin

Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance

Group Type EXPERIMENTAL

Digoxin

Intervention Type DRUG

Trans-abdominal injection

Placebo

Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Trans-abdominal injection

Interventions

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Digoxin

Trans-abdominal injection

Intervention Type DRUG

Placebo

Trans-abdominal injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 20 weeks 0 days-24 weeks 0 days gestation
* English or Spanish speaking
* 18 years or older

Exclusion Criteria

* Under 18
* Contraindications to digoxin
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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FPA Women's Health

UNKNOWN

Sponsor Role collaborator

Society of Family Planning

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Kerns, MD, MS, MPH

Assistant Professor department of Obstetrics, Gynecology and Reproductive Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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FPA Women's Health

Long Beach, California, United States

Site Status

SFGH Women's Options Center

San Francisco, California, United States

Site Status

Lovejoy Surgicenter

Portland, Oregon, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Digoxin RCT

Identifier Type: -

Identifier Source: org_study_id

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