Abortion EarlyTASvTVSNCT03047551
Transabdominal and Transvaginal Sonography in Medical Abortion
A study testing Transabdominal sonography and Transvaginal sonography in people with Abortion Early, run by Columbia University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion Early
- What is being tested?
- Transabdominal sonography and Transvaginal sonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 634 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Women under 18 years old
- Women at an estimated gestational age greater than 70 days from LMP at enrollment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood of Northern, Central, and Southern New Jersey
Morristown, New Jersey, 07960
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: 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.
Read the 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.
- Conditions
- Abortion Early
- Being tested
- Transabdominal sonography, Transvaginal sonography
- Keywords
- Abortion, induced, Ultrasonography, Health Services accessibility, Pragmatic Clinical Trial, Randomized controlled trial as topic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transabdominal sonographyProcedure or surgery
Also called TAS
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 sonographyProcedure or surgery
Also called TVS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Transvaginal sonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startJul 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Abortion EarlyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 634 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Westhoff, Columbia University
- Investigators
- Carolyn Westhoff, MD MSc, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047551
- Sponsor's protocol ID
- AAAQ8722
- Acronym
- TASvTVS
- Status last verified
- Sep 2019
- First submitted
- 24 Oct 2016
- Last updated
- 30 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pazol K, Creanga AA, Burley KD, Jamieson DJ. Abortion surveillance - United States, 2011. MMWR Surveill Summ. 2014 Nov 28;63(11):1-41.
PubMed 25426741Pazol K, Creanga AA, Zane SB. Trends in use of medical abortion in the United States: reanalysis of surveillance data from the Centers for Disease Control and Prevention, 2001-2008. Contraception. 2012 Dec;86(6):746-51. doi: 10.1016/j.contraception.2012.05.023. Epub 2012 Jul 6.
PubMed 22770796Jordan B, Shields WC. Happy anniversary mifepristone: a decade of promise and challenges. Contraception. 2010 Sep;82(3):219-20. doi: 10.1016/j.contraception.2010.05.017. No abstract available.
PubMed 20705148Finer LB, Wei J. Effect of mifepristone on abortion access in the United States. Obstet Gynecol. 2009 Sep;114(3):623-630. doi: 10.1097/AOG.0b013e3181b2a74d.
PubMed 19701044Raymond EG, Grossman D, Wiebe E, Winikoff B. Reaching women where they are: eliminating the initial in-person medical abortion visit. Contraception. 2015 Sep;92(3):190-3. doi: 10.1016/j.contraception.2015.06.020. Epub 2015 Jun 29.
PubMed 26134280Chong E, Frye LJ, Castle J, Dean G, Kuehl L, Winikoff B. A prospective, non-randomized study of home use of mifepristone for medical abortion in the U.S. Contraception. 2015 Sep;92(3):215-9. doi: 10.1016/j.contraception.2015.06.026. Epub 2015 Jul 2.
PubMed 26142620Gold M, Chong E. If we can do it for misoprostol, why not for mifepristone? The case for taking mifepristone out of the office in medical abortion. Contraception. 2015 Sep;92(3):194-6. doi: 10.1016/j.contraception.2015.06.011. Epub 2015 Jun 18.
PubMed 26093187Grossman D, Goldstone P. Mifepristone by prescription: a dream in the United States but reality in Australia. Contraception. 2015 Sep;92(3):186-9. doi: 10.1016/j.contraception.2015.06.014. Epub 2015 Jun 19.
PubMed 26096369Harper C, Ellertson C, Winikoff B. Could American women use mifepristone-misoprostol pills safely with less medical supervision? Contraception. 2002 Feb;65(2):133-42. doi: 10.1016/s0010-7824(01)00300-6.
PubMed 11927116Foster AM, Jackson CB, LaRoche KJ, Simmonds K, Taylor D. From qualified physician to licensed health care professional: the time has come to change mifepristone's label. Contraception. 2015 Sep;92(3):200-2. doi: 10.1016/j.contraception.2015.06.022. Epub 2015 Jun 30. No abstract available.
PubMed 26134281Kopp Kallner H, Gomperts R, Salomonsson E, Johansson M, Marions L, Gemzell-Danielsson K. The efficacy, safety and acceptability of medical termination of pregnancy provided by standard care by doctors or by nurse-midwives: a randomised controlled equivalence trial. BJOG. 2015 Mar;122(4):510-7. doi: 10.1111/1471-0528.12982. Epub 2014 Jul 18.
PubMed 25040643Warriner IK, Wang D, Huong NT, Thapa K, Tamang A, Shah I, Baird DT, Meirik O. Can midlevel health-care providers administer early medical abortion as safely and effectively as doctors? A randomised controlled equivalence trial in Nepal. Lancet. 2011 Apr 2;377(9772):1155-61. doi: 10.1016/S0140-6736(10)62229-5.
PubMed 21458058Bennett IM, Baylson M, Kalkstein K, Gillespie G, Bellamy SL, Fleischman J. Early abortion in family medicine: clinical outcomes. Ann Fam Med. 2009 Nov-Dec;7(6):527-33. doi: 10.1370/afm.1051.
PubMed 19901312Prine LW, Lesnewski R. Medication abortion and family physicians' scope of practice. J Am Board Fam Pract. 2005 Jul-Aug;18(4):304-6. doi: 10.3122/jabfm.18.4.304. No abstract available.
PubMed 15994476Prine L, Shannon C, Gillespie G, Crowden WA, Fortin J, Howe M, Dzuba I. Medical abortion: outcomes in a family medicine setting. J Am Board Fam Med. 2010 Jul-Aug;23(4):509-13. doi: 10.3122/jabfm.2010.04.090229.
PubMed 20616293
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Transabdominal Sonography Comparable to Transvaginal Sonography for Eligibility Assessment Prior to Medical Abortion? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03047551
- Acronym / sponsor ID
- TASvTVS / AAAQ8722
- Conditions
- Abortion Early
- Keywords
- Abortion, induced, Ultrasonography, Health Services accessibility, Pragmatic Clinical Trial, Randomized controlled trial as topic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 634 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 9 Feb 2017 (estimated)
- Results
- Posted 30 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transabdominal Sonography | Active comparator | Procedure: Transabdominal sonographySubjects 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. |
| Transvaginal Sonography | Active comparator | Procedure: Transvaginal sonographySubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Women under 18 years old
- Women at an estimated gestational age greater than 70 days from LMP at enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transabdominal sonographyAlso: TASUltrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare. | Procedure or surgery | Transabdominal Sonography |
| Transvaginal sonographyAlso: TVSUltrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare. | Procedure or surgery | Transvaginal Sonography |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25426741Pazol K, Creanga AA, Burley KD, Jamieson DJ. Abortion surveillance - United States, 2011. MMWR Surveill Summ. 2014 Nov 28;63(11):1-41.
- Background: PubMed 22770796Pazol K, Creanga AA, Zane SB. Trends in use of medical abortion in the United States: reanalysis of surveillance data from the Centers for Disease Control and Prevention, 2001-2008. Contraception. 2012 Dec;86(6):746-51. doi: 10.1016/j.contraception.2012.05.023. Epub 2012 Jul 6.
- Background: PubMed 20705148Jordan B, Shields WC. Happy anniversary mifepristone: a decade of promise and challenges. Contraception. 2010 Sep;82(3):219-20. doi: 10.1016/j.contraception.2010.05.017. No abstract available.
- Background: PubMed 19701044Finer LB, Wei J. Effect of mifepristone on abortion access in the United States. Obstet Gynecol. 2009 Sep;114(3):623-630. doi: 10.1097/AOG.0b013e3181b2a74d.
- Background: PubMed 26134280Raymond EG, Grossman D, Wiebe E, Winikoff B. Reaching women where they are: eliminating the initial in-person medical abortion visit. Contraception. 2015 Sep;92(3):190-3. doi: 10.1016/j.contraception.2015.06.020. Epub 2015 Jun 29.
- Background: PubMed 26142620Chong E, Frye LJ, Castle J, Dean G, Kuehl L, Winikoff B. A prospective, non-randomized study of home use of mifepristone for medical abortion in the U.S. Contraception. 2015 Sep;92(3):215-9. doi: 10.1016/j.contraception.2015.06.026. Epub 2015 Jul 2.
- Background: PubMed 26093187Gold M, Chong E. If we can do it for misoprostol, why not for mifepristone? The case for taking mifepristone out of the office in medical abortion. Contraception. 2015 Sep;92(3):194-6. doi: 10.1016/j.contraception.2015.06.011. Epub 2015 Jun 18.
- Background: PubMed 26096369Grossman D, Goldstone P. Mifepristone by prescription: a dream in the United States but reality in Australia. Contraception. 2015 Sep;92(3):186-9. doi: 10.1016/j.contraception.2015.06.014. Epub 2015 Jun 19.
- Background: PubMed 11927116Harper C, Ellertson C, Winikoff B. Could American women use mifepristone-misoprostol pills safely with less medical supervision? Contraception. 2002 Feb;65(2):133-42. doi: 10.1016/s0010-7824(01)00300-6.
- Background: PubMed 26134281Foster AM, Jackson CB, LaRoche KJ, Simmonds K, Taylor D. From qualified physician to licensed health care professional: the time has come to change mifepristone's label. Contraception. 2015 Sep;92(3):200-2. doi: 10.1016/j.contraception.2015.06.022. Epub 2015 Jun 30. No abstract available.
- Background: PubMed 25040643Kopp Kallner H, Gomperts R, Salomonsson E, Johansson M, Marions L, Gemzell-Danielsson K. The efficacy, safety and acceptability of medical termination of pregnancy provided by standard care by doctors or by nurse-midwives: a randomised controlled equivalence trial. BJOG. 2015 Mar;122(4):510-7. doi: 10.1111/1471-0528.12982. Epub 2014 Jul 18.
- Background: PubMed 21458058Warriner IK, Wang D, Huong NT, Thapa K, Tamang A, Shah I, Baird DT, Meirik O. Can midlevel health-care providers administer early medical abortion as safely and effectively as doctors? A randomised controlled equivalence trial in Nepal. Lancet. 2011 Apr 2;377(9772):1155-61. doi: 10.1016/S0140-6736(10)62229-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Westhoff, MD MSc principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transabdominal sonography and Transvaginal sonography in people with Abortion Early, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects in Each Ultrasound Group With Additional Testing (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047551, which also lists 56 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.