Transvaginal Ultrasound: Preterm Birth Prevention in Appalachia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-03

Study Completion Date

2021-10-29

Brief Summary

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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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Detailed Description

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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

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Preterm Birth

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Participant Barriers to TVU Screening

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.

Group Type EXPERIMENTAL

Participant Barriers to TVU Screening

Intervention Type BEHAVIORAL

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

Provider Barriers to TVU Screening

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.

Group Type EXPERIMENTAL

Provider Barriers to TVU Screening

Intervention Type BEHAVIORAL

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

Interventions

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Participant Barriers to TVU Screening

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

Intervention Type BEHAVIORAL

Provider Barriers to TVU Screening

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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