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Transvaginal Ultrasound: Preterm Birth Prevention in Appalachia

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Participant Barriers to TVU Screening
Provider Barriers to TVU Screening
Sponsored by
Niraj Chavan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Transvaginal Ultrasound, Telemedicine

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant

  • Female Sex
  • Prior history of preterm birth (for initial set of interviews), no preterm birth history required for intervention feedback
  • Current pregnant status

Exclusion Criteria: Participant

  • Male Sex

Inclusion Criteria: Provider

  • Certified as obstetric/gynecologic provider

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Participant Barriers to TVU Screening

Provider Barriers to TVU Screening

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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.
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.
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.
Rates of clinical therapy
Defined as prescribing vaginal progesterone or performing cervical cerclage

Full Information

First Posted
January 3, 2019
Last Updated
January 4, 2022
Sponsor
Niraj Chavan
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1. Study Identification

Unique Protocol Identification Number
NCT03833284
Brief Title
Transvaginal Ultrasound: Preterm Birth Prevention in Appalachia
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 3, 2019 (Actual)
Primary Completion Date
October 29, 2021 (Actual)
Study Completion Date
October 29, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Niraj Chavan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
Transvaginal Ultrasound, Telemedicine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Participant Barriers to TVU Screening
Arm Type
Experimental
Arm Description
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.
Arm Title
Provider Barriers to TVU Screening
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Participant Barriers to TVU Screening
Intervention Description
Workshops tailored toward patients to increase knowledge about TVU screening guidelines and benefits.
Intervention Type
Behavioral
Intervention Name(s)
Provider Barriers to TVU Screening
Intervention Description
Workshops tailored toward providers to increase knowledge about TVU screening guidelines and benefits.
Primary Outcome Measure Information:
Title
Change in attitudes towards TVU screening among patients and practitioners
Description
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).
Time Frame
At baseline and at one year.
Title
Potential for future TVU screening implementation based on changes in attitudes towards TVU screening among providers and participants.
Description
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.
Time Frame
At baseline and at one year.
Secondary Outcome Measure Information:
Title
Rate of preterm birth at <34 weeks gestation
Description
Subjects (patients) included in this study will be followed to determine rate of preterm birth at various time points.
Time Frame
Through study completion, average of 1 year from study initiation
Title
Rate of preterm birth at <37 weeks gestation
Description
Subjects (patients) included in this study will be followed to determine rate of preterm birth at various time points.
Time Frame
Through study completion, average of 1 year from study initiation
Title
Number of TVU scans identifying a short cervix (≤ 25 mm) in any pregnant women at each study site
Description
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.
Time Frame
Through study completion, average of 1 year from study initiation.
Title
Rate of inpatient hospitalization for preterm labor management prior to delivery
Description
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.
Time Frame
Through study completion, average of 1 year from study initiation.
Title
Rates of clinical therapy
Description
Defined as prescribing vaginal progesterone or performing cervical cerclage
Time Frame
Through study completion, average of 1 year from study initiation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant Female Sex Prior history of preterm birth (for initial set of interviews), no preterm birth history required for intervention feedback Current pregnant status Exclusion Criteria: Participant Male Sex Inclusion Criteria: Provider Certified as obstetric/gynecologic provider
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niraj Chavan
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transvaginal Ultrasound: Preterm Birth Prevention in Appalachia

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