Transabdominal and Transvaginal Sonography in Medical Abortion (TASvTVS)

September 27, 2019 updated by: Carolyn Westhoff, Columbia University

Is Transabdominal Sonography Comparable to Transvaginal Sonography for Eligibility Assessment Prior to Medical Abortion? A Randomized Controlled Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Ultrasound use in the assessment of medical abortion eligibility varies by practice site. The National Abortion Federation (NAF), the Society of Family Planning (SFP), and the World Health Organization (WHO) guidelines do not recommend routine use of sonography; however, many institutions and practices still require this as part of clinic protocol. Many clinicians routinely perform transvaginal sonography (TVS), a more invasive assessment than transabdominal ultrasound (TAS); reliance on TVS, specifically, can be cost-prohibitive due to high-level disinfection (HLD) requirements. Thus, routine US use can greatly decrease access to abortion services.

Medical abortion accounts for an increasing proportion of abortions performed in the United States; as of 2012, 20.8% of all abortions were medical abortions. Routine use of ultrasonography and particularly TVS may be a holdover secondary to its use in early clinical trials of medical abortion efficacy - its use has remained a part of many providers' clinical practice despite evidence that it is not always necessary.

This study, specifically, would be of value for the many clinicians who currently use TVS for all medical abortion patients and could support using TAS rather than TVS in a majority of these patients. The results could also provide guidance on how often practice settings without TVS and HLD would be able to provide medical abortion, and for which patients. Such settings could include primary care or rural clinics, any low volume clinics, or those where the costs and time associated with the HLD required for use of TVS prohibit or limit the provision of medical abortion. In addition, even high-volume specialty family planning clinics would benefit from a reduction in use of TVS. In the US, many providers have sonography available and use it routinely. However, even in the US, many clinics may seek to offer medical abortion without sonography, and other researchers are studying this type of approach. This proposed study will evaluate a more intermediate change in practice, primarily geared towards the large number of providers who routinely provide transvaginal ultrasound. For those providers, moving from TVS to TAS could be both cost effective and acceptable to patients.

In detail, the study will enroll patients presenting for medical abortion at multiple clinical sites. These women will undergo routine intake per usual clinical protocol, then randomized to receive either TVS or TAS. Afterwards, routine clinical care will be provided by the clinician, which can include medical abortion provision or further testing to determine eligibility. Women will complete an acceptability survey at the conclusion of the visit.

For providers, prior to participation, providers will complete a questionnaire regarding professional characteristics. Investigators will provide a training session for all providers at each site to review TAS (i.e., techniques and standardized reporting) assuming some providers have less experience with this when compared to TVS in early pregnancy. This training session will help minimize differences in TVS and TAS related to provider experience or variability in current practice. In addition, prior to participant enrollment, each clinic site will enroll 5 pilot patients, during which providers will perform only TAS to accustom providers and clinic staff to study protocols. Each clinician will perform TAS on at least 2 but no more than 5 pilot patients.

Study Type

Interventional

Enrollment (Actual)

634

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Planned Parenthood of Northern, Central, and Southern New Jersey
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Transabdominal Sonography

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
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.
Other Names:
  • TAS
Active Comparator: Transvaginal Sonography

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
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.
Other Names:
  • TVS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects in Each Ultrasound Group With Additional Testing
Time Frame: 1 day
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
Time Frame: 1 day
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Carolyn Westhoff, MD MSc, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

October 24, 2016

First Submitted That Met QC Criteria

February 6, 2017

First Posted (Estimate)

February 9, 2017

Study Record Updates

Last Update Posted (Actual)

September 30, 2019

Last Update Submitted That Met QC Criteria

September 27, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAAQ8722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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