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Completed

NCT Number: NCT03833284

Transvaginal Ultrasound: Preterm Birth Prevention in Appalachia

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Participant Barriers to TVU Screening

Behavioral

Workshops tailored toward patients to increase knowledge about TVU screening guidelines and benefits.

Provider Barriers to TVU Screening

Behavioral

Workshops tailored toward providers to increase knowledge about TVU screening guidelines and benefits.

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. Rate of preterm birth at <34 weeks gestation

    Time frame: Through study completion, average of 1 year from study initiation

    Subjects (patients) included in this study will be followed to determine rate of preterm birth at various time points.

  2. Rate of preterm birth at <37 weeks gestation

    Time frame: Through study completion, average of 1 year from study initiation

    Subjects (patients) included in this study will be followed to determine rate of preterm birth at various time points.

  3. 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.

    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.

  4. Rate of inpatient hospitalization for preterm labor management prior to delivery

    Time frame: Through study completion, average of 1 year from study initiation.

    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.

  5. Rates of clinical therapy

    Time frame: Through study completion, average of 1 year from study initiation.

    Defined as prescribing vaginal progesterone or performing cervical cerclage

Sponsors and collaborators

Lead sponsor

Niraj Chavan

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 6, 2019
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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