Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-04 @ 4:40 AM
Study NCT ID:
NCT03047551
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2016-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transabdominal and Transvaginal Sonography in Medical Abortion
Sponsor:
Columbia University
Organization:
Study Overview
Official Title:
Is Transabdominal Sonography Comparable to Transvaginal Sonography for Eligibility Assessment Prior to Medical Abortion? A Randomized Controlled Trial.
Status:
COMPLETED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TASvTVS
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.
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: