NCT03047551

Brief Summary

The investigator will perform a multicenter, randomized controlled trial in practices that routinely use transvaginal sonography (TVS) to compare how often clinicians order additional testing prior to medical abortion after the use of either TVS or transabdominal ultrasound (TAS) in medical abortion eligibility assessment. Women will be randomized to receive either TVS or TAS prior to medical abortion. We anticipate enrolling 800 patients receiving care from about 30 providers over 6-8 months. The primary study outcome will be the proportion of women that requires additional evaluation after sonography, prior to determination of medical abortion eligibility. The second primary outcome will be patient satisfaction, determined by a patient satisfaction questionnaire utilizing a visual analog scale.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
634

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 30, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

1.9 years

First QC Date

October 24, 2016

Results QC Date

April 16, 2019

Last Update Submit

September 27, 2019

Conditions

Abortion Early

Keywords

Abortion, inducedUltrasonographyHealth Services accessibilityPragmatic Clinical TrialRandomized controlled trial as topic

Outcome Measures

Primary Outcomes (2)

  • Percentage of Subjects in Each Ultrasound Group With Additional Testing

    Evaluate how often a provider orders additional testing prior to medical abortion, but after either 1) patient history and TAS or 2) patient history and TVS.

    1 day

  • Visual Analog Scale (VAS) Score for Patient Acceptability for Either Modality of Ultrasound

    To measure patient satisfaction after ultrasound examination, each participant will complete an acceptability questionnaire regarding the type of ultrasound she received (TVS or TAS) using a visual analog scale (VAS). The score is on a scale range of 0-100, with 0 being "unacceptable" and 100 being "acceptable." Thus, higher scores are better.

    1 day

Study Arms (2)

Transabdominal Sonography

ACTIVE COMPARATOR

Subjects will receive transabdominal sonography using a standard ultrasound device to determine medical abortion eligibility. A transabdominal ultrasound is used to look at the pelvic organs. Gel is placed on your abdomen. Then a small, handheld unit called a transducer is gently moved around to view the pelvic organs. The transducer sound waves make a picture on the TV screen.

Procedure: Transabdominal sonography

Transvaginal Sonography

ACTIVE COMPARATOR

Subjects will receive transvaginal sonography using a standard ultrasound device to determine medical abortion eligibility. Transvaginal ultrasound is an examination of the female pelvis and urogenital tract (kidneys and bladder). It differs from an abdominal ultrasound as it looks at the pelvic organs from inside the vagina.

Procedure: Transvaginal sonography

Interventions

Transabdominal sonographyPROCEDURE

Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.

Also known as: TAS
Transabdominal Sonography
Transvaginal sonographyPROCEDURE

Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.

Also known as: TVS
Transvaginal Sonography

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • English- or Spanish- speaking women seeking medical abortion
  • years or older
  • Women at an estimated gestational age up to 70 days from last menstrual period (LMP)

You may not qualify if:

  • Women under 18 years old
  • Women at an estimated gestational age greater than 70 days from LMP at enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Planned Parenthood of Northern, Central, and Southern New Jersey

Morristown, New Jersey, 07960, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (56)

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    PMID: 29752922RESULT

Results Point of Contact

Title
Carolyn Westhoff, MD
Organization
Columbia University
clw3@cumc.columbia.edu
212-305-4805

Study Officials

  • Carolyn Westhoff, MD MSc

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

October 24, 2016

First Posted

February 9, 2017

Study Start

July 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

September 30, 2019

Results First Posted

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)