Preterm BirthNCT03833284
Transvaginal Ultrasound: Preterm Birth Prevention in Appalachia
A study testing Participant Barriers to TVU Screening and Provider Barriers to TVU Screening in people with Preterm Birth, run by Niraj Chavan at 1 site in United States.
Trial summary
Preterm Birth is the number one cause of infant morbidity and mortality worldwide and represents an important health disparity in the United States, particularly across the state of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal ultrasound (TVU). Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Participant Barriers to TVU Screening and Provider Barriers to TVU Screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2019to 29 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female Sex
- Prior history of preterm birth (for initial set of interviews), no preterm birth history required for intervention feedback
- Current pregnant status
- Certified as obstetric/gynecologic provider
Who cannot join
- Male Sex
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of a Transvaginal Ultrasound Surveillance Program in Women With a History of Previous Preterm Birth: Disseminating Evidenced Based Practices for Reducing Preterm Birth in Appalachian Kentucky
Preterm Birth is the number one cause of infant morbidity and mortality worldwide and represents an important health disparity in the United States, particularly across the state of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal ultrasound (TVU). This study will attempt to identify and rectify provider and patient related barriers to TVU screening implementation.
Read the detailed description
Preterm birth is the number one cause of infant morbidity and mortality worldwide and represents an important health disparity in the United States, and especially across the state of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal ultrasound (TVU) measurement of cervical length. However, several unique provider and patient related barriers for implementation of this screening limit the widespread uptake of this evidence based practice in Appalachian KY. The investigators propose to adopt a dissemination and implementation science approach using the Consolidated Framework for Implementation Research (CFIR) as the guiding framework for identification of key areas of knowledge deficits as well as attitudes, practices and perceived barriers among prenatal care providers and patients in eastern KY towards TVU cervical length screening using a mixed - methods design. This will be utilized to develop a multifaceted implementation strategy best suited for addressing and overcoming barriers identified by the target population in eastern KY. The investigators anticipate that such an implementation strategy will likely include an educational component targeting obstetric care providers and patients in addition to hands-on TVU cervical length evaluation as well as telemedicine support and surveillance. Three community based sites (Hazard, Morehead and Ashland, KY) will be recruited for implementation of this multi-component pilot program focused on community engagement and outreach targeting obstetric providers and their patients. At the end of the pilot implementation phase, acceptability of the study intervention and feasibility of implementation will be evaluated along with a preliminary assessment of effectiveness of implementation.
- Conditions
- Preterm Birth
- Being tested
- Participant Barriers to TVU Screening, Provider Barriers to TVU Screening
- Keywords
- Transvaginal Ultrasound, Telemedicine
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participant Barriers to TVU ScreeningBehavioural
Workshops tailored toward patients to increase knowledge about TVU screening guidelines and benefits.
Provider Barriers to TVU ScreeningBehavioural
Workshops tailored toward providers to increase knowledge about TVU screening guidelines and benefits.
| Study group | Role | What they receive |
|---|---|---|
| Participant Barriers to TVU Screening | Experimental | Patients with a history of pre-term birth will be identified through a review of their medical history. Patients will then be asked to complete a survey assessing their knowledge of transvaginal ultrasound screening. Patients will then be asked to attend in-person or online workshops designed to increase patient knowledge of TVU screening guidelines and benefits. Finally, patients will complete exit surveys to determine whether their attitudes and beliefs towards screening have changed over time. Receives: Behavioral: Participant Barriers to TVU Screening |
| Provider Barriers to TVU Screening | Experimental | Obstetric and Gynecologic Providers will be identified based on prior working relationships with the University of Kentucky outreach programs. Chosen providers will be asked to complete a survey assessing their attitudes towards TVU screening. Following completion, providers will be asked to attend either in-person or online workshops designed to increase provider knowledge of TVU screening guidelines and benefits. Finally, providers will complete exit surveys to determine whether their attitudes and beliefs toward screening have changed over time. Receives: Behavioral: Provider Barriers to TVU Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in attitudes towards TVU screening among patients and practitioners
The primary purpose of this study is to evaluate the change in attitudes towards TVU screening among patients and practitioners. This will be accomplished by conducting a qualitative interview with each participant at baseline and again at one year (after completing the CLEAR program workshop).
Measured: At baseline and at one year.
Potential for future TVU screening implementation based on changes in attitudes towards TVU screening among providers and participants.
The primary purpose of this study is to evaluate the change in attitudes towards TVU screening among patients and practitioners. This will be accomplished by conducting a qualitative interview with each participant at baseline and again at one year (after completing the CLEAR program workshop). Analysis of these interviews will aid in determining feasibility of implementing a future TVU screening component in Obstetric and Gynecologic care.
Measured: At baseline and at one year.
Secondary outcomes (5)
Rate of preterm birth at <34 weeks gestation
Subjects (patients) included in this study will be followed to determine rate of preterm birth at various time points.
Measured: Through study completion, average of 1 year from study initiation
Rate of preterm birth at <37 weeks gestation
Subjects (patients) included in this study will be followed to determine rate of preterm birth at various time points.
Measured: Through study completion, average of 1 year from study initiation
Number of TVU scans identifying a short cervix (≤ 25 mm) in any pregnant women at each study site
Records of TVU scans identifying a short cervix among the study population will be analyzed to determine the rate of short cervix issues among the population. The percentage will aid in determining the need for future TVU screening in similar populations.
Measured: Through study completion, average of 1 year from study initiation.
Rate of inpatient hospitalization for preterm labor management prior to delivery
Subjects (patients) included in this study will be followed to determine whether they are subjects to hospitalization prior to birthing due to complications associated with preterm labor.
Measured: Through study completion, average of 1 year from study initiation.
Rates of clinical therapy
Defined as prescribing vaginal progesterone or performing cervical cerclage
Measured: Through study completion, average of 1 year from study initiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start3 Jun 2019
- Primary completion29 Oct 2021
- Study completion29 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niraj Chavan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Niraj Chavan, University of Kentucky
- Investigators
- Niraj Chavan, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833284
- Sponsor's protocol ID
- 45131
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2019
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Transvaginal Ultrasound Surveillance Program in Women With a History of Previous Preterm Birth: Disseminating Evidenced Based Practices for Reducing Preterm Birth in Appalachian Kentucky
- ClinicalTrials.gov ID
- NCT03833284
- Acronym / sponsor ID
- 45131
- Conditions
- Preterm Birth
- Keywords
- Transvaginal Ultrasound, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Niraj ChavanUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 29 Oct 2021 (actual)
- Study completion
- 29 Oct 2021 (actual)
- First posted
- 6 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preterm Birth is the number one cause of infant morbidity and mortality worldwide and represents an important health disparity in the United States, particularly across the state of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal ultrasound (TVU). This study will attempt to identify and rectify provider and patient related barriers to TVU screening implementation.
Detailed description
Preterm birth is the number one cause of infant morbidity and mortality worldwide and represents an important health disparity in the United States, and especially across the state of Kentucky. The best biomarker for the prediction of preterm birth is transvaginal ultrasound (TVU) measurement of cervical length. However, several unique provider and patient related barriers for implementation of this screening limit the widespread uptake of this evidence based practice in Appalachian KY. The investigators propose to adopt a dissemination and implementation science approach using the Consolidated Framework for Implementation Research (CFIR) as the guiding framework for identification of key areas of knowledge deficits as well as attitudes, practices and perceived barriers among prenatal care providers and patients in eastern KY towards TVU cervical length screening using a mixed - methods design. This will be utilized to develop a multifaceted implementation strategy best suited for addressing and overcoming barriers identified by the target population in eastern KY. The investigators anticipate that such an implementation strategy will likely include an educational component targeting obstetric care providers and patients in addition to hands-on TVU cervical length evaluation as well as telemedicine support and surveillance. Three community based sites (Hazard, Morehead and Ashland, KY) will be recruited for implementation of this multi-component pilot program focused on community engagement and outreach targeting obstetric providers and their patients. At the end of the pilot implementation phase, acceptability of the study intervention and feasibility of implementation will be evaluated along with a preliminary assessment of effectiveness of implementation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant Barriers to TVU Screening | Experimental | Behavioral: Participant Barriers to TVU ScreeningPatients with a history of pre-term birth will be identified through a review of their medical history. Patients will then be asked to complete a survey assessing their knowledge of transvaginal ultrasound screening. Patients will then be asked to attend in-person or online workshops designed to increase patient knowledge of TVU screening guidelines and benefits. Finally, patients will complete exit surveys to determine whether their attitudes and beliefs towards screening have changed over time. |
| Provider Barriers to TVU Screening | Experimental | Behavioral: Provider Barriers to TVU ScreeningObstetric and Gynecologic Providers will be identified based on prior working relationships with the University of Kentucky outreach programs. Chosen providers will be asked to complete a survey assessing their attitudes towards TVU screening. Following completion, providers will be asked to attend either in-person or online workshops designed to increase provider knowledge of TVU screening guidelines and benefits. Finally, providers will complete exit surveys to determine whether their attitudes and beliefs toward screening have changed over time. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female Sex
- Prior history of preterm birth (for initial set of interviews), no preterm birth history required for intervention feedback
- Current pregnant status
- Certified as obstetric/gynecologic provider
Key exclusion criteria (1 listed)
- Male Sex
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 |
|---|---|---|
| Participant Barriers to TVU ScreeningWorkshops tailored toward patients to increase knowledge about TVU screening guidelines and benefits. | Behavioural | Participant Barriers to TVU Screening |
| Provider Barriers to TVU ScreeningWorkshops tailored toward providers to increase knowledge about TVU screening guidelines and benefits. | Behavioural | Provider Barriers to TVU Screening |
Primary outcome
Change in attitudes towards TVU screening among patients and practitioners
Time frame: At baseline and at one year.
The primary purpose of this study is to evaluate the change in attitudes towards TVU screening among patients and practitioners. This will be accomplished by conducting a qualitative interview with each participant at baseline and again at one year (after completing the CLEAR program workshop).
Potential for future TVU screening implementation based on changes in attitudes towards TVU screening among providers and participants.
Time frame: At baseline and at one year.
The primary purpose of this study is to evaluate the change in attitudes towards TVU screening among patients and practitioners. This will be accomplished by conducting a qualitative interview with each participant at baseline and again at one year (after completing the CLEAR program workshop). Analysis of these interviews will aid in determining feasibility of implementing a future TVU screening component in Obstetric and Gynecologic care.
5 secondary outcomes
Rate of preterm birth at <34 weeks gestation
Time frame: Through study completion, average of 1 year from study initiation
Rate of preterm birth at <37 weeks gestation
Time frame: Through study completion, average of 1 year from study initiation
Number of TVU scans identifying a short cervix (≤ 25 mm) in any pregnant women at each study site
Time frame: Through study completion, average of 1 year from study initiation.
Rate of inpatient hospitalization for preterm labor management prior to delivery
Time frame: Through study completion, average of 1 year from study initiation.
Rates of clinical therapy
Time frame: Through study completion, average of 1 year from study initiation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- 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.
Niraj Chavan principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Participant Barriers to TVU Screening and Provider Barriers to TVU Screening in people with Preterm Birth, run by Niraj Chavan at 1 site 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 4 inclusion and 1 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 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in attitudes towards TVU screening among patients and practitioners (time frame: At baseline and at one year.). 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?
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 5 Jan 2022.