Transvaginal Ultrasound: Preterm Birth Prevention in Appalachia

NCT03833284 | Completed

• 1 other identifier: 45131
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

Transvaginal Ultrasound; Telemedicine

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  At baseline and at one year.

Secondary Outcomes (5)

• Rate of preterm birth at <34 weeks gestation

  Through study completion, average of 1 year from study initiation

• Rate of preterm birth at <37 weeks gestation

  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

  Through study completion, average of 1 year from study initiation.

• Rate of inpatient hospitalization for preterm labor management prior to delivery

  Through study completion, average of 1 year from study initiation.

• Rates of clinical therapy

  Through study completion, average of 1 year from study initiation.

Study Arms (2)

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.

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.

Behavioral: Provider Barriers to TVU Screening

Interventions

Participant Barriers to TVU Screening BEHAVIORAL

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

Participant Barriers to TVU Screening

Provider Barriers to TVU Screening BEHAVIORAL

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

Provider Barriers to TVU Screening

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Male Sex
• Certified as obstetric/gynecologic provider

Sponsors & Collaborators

• Niraj Chavan: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Niraj Chavan

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor in Maternal Fetal Medicine

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: February 6, 2019
• Study Start: June 3, 2019
• Primary Completion: October 29, 2021
• Study Completion: October 29, 2021
• Last Updated: January 5, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)