Transabdominal and Transvaginal Sonography in Medical Abortion
NCT ID: NCT03047551
Last Updated: 2019-09-30
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
634 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-07-31
Study Completion Date
2018-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Abortion Early
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
HEALTH_SERVICES_RESEARCH
Blinding Strategy
NONE
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
Transabdominal sonography
Intervention Type
PROCEDURE
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.
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.
Group Type
ACTIVE_COMPARATOR
Transvaginal sonography
Intervention Type
PROCEDURE
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.
Interventions
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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.
Intervention Type
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.
Intervention Type
PROCEDURE
Other Intervention Names
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TAS
TVS
Eligibility Criteria
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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)
* 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
* Women at an estimated gestational age greater than 70 days from LMP at enrollment
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Columbia University
OTHER
Sponsor Role
lead
Responsible Party
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Carolyn Westhoff
Professor of Obstetrics and Gynecology
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Carolyn Westhoff, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Planned Parenthood of Northern, Central, and Southern New Jersey
Morristown, New Jersey, United States
Site Status
Columbia University Medical Center
New York, New York, United States
Site Status
Countries
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United States
References
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Reference Type
BACKGROUND
Fu A, Weber CE, Gilmore E, Davis AR, Hirsch G, Westhoff CL. A noninferiority randomized controlled trial to compare transabdominal and transvaginal sonography for eligibility assessment prior to medical abortion. Contraception. 2018 Sep;98(3):199-204. doi: 10.1016/j.contraception.2018.05.005. Epub 2018 May 9.
Reference Type
RESULT
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AAAQ8722
Identifier Type: -
Identifier Source: org_study_id
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NA
Transvaginal Pelvic Ultrasound in the ED
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COMPLETED
Ultrasound-guided Manual Vacuum Aspiration (USG-MVA)
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RECRUITING
Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations
NCT02372422
COMPLETED
NA
Ultrasound Guidance for Embryo Transfer
NCT03851536
COMPLETED
NA
Remnants of Conception After Suction Evacuation of Missed Abortion
NCT03813849
UNKNOWN
Transvaginal Ultrasonography Guided Embryo Transfer
NCT03473028
COMPLETED
NA
Study of FemVue(TM) Sono Tubal Evaluation System Method Comparison to HSG
NCT01053052
WITHDRAWN
NA
Intrapartum Translabial Ultrasonography Reliability
NCT04844437
UNKNOWN
Pelvic Examination in Pregnancy
NCT01570413
COMPLETED
NA
Comparison of Uterine Distension in Hysterosonography Among Patients Monitored for Infertility
NCT07170137
RECRUITING
Added Value of Three-dimensional Transvaginal Ultrasound (3D TVUS) and Gel Infusion Sonography (3D GIS) Compared With Magnetic Resonance Imaging (MRI) in the Diagnosis of Patients With Suspicion of a Uterine Septum.
NCT07263984
RECRUITING
NA
Surgical Evacuation of Abortion Under Ultrasonographic Guide
NCT02580175
COMPLETED
NA
The Correlation Between Uterine Endometrial Pattern and Ectopic Pregnancy
NCT02963012
UNKNOWN
Point of Care 3D Ultrasound for Various Applications: A Pilot Study
NCT02831556
COMPLETED
Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour
NCT02814344
TERMINATED
The Role of Ultrasonography in Labor in Predicting the Outcomes of Childbirth
NCT06806904
RECRUITING