Clinical trial NCT03833284: 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
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Birth
Keywords: Transvaginal Ultrasound
Telemedicine
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in attitudes towards TVU screening among patients and practitioners
timeFrame: At baseline and at one year.
measure: Potential for future TVU screening implementation based on changes in attitudes towards TVU screening among providers and participants.
timeFrame: At baseline and at one year.
Secondary outcomes:
measure: Rate of preterm birth at <34 weeks gestation
timeFrame: Through study completion, average of 1 year from study initiation
measure: Rate of preterm birth at <37 weeks gestation
timeFrame: Through study completion, average of 1 year from study initiation
measure: Number of TVU scans identifying a short cervix (≤ 25 mm) in any pregnant women at each study site
timeFrame: Through study completion, average of 1 year from study initiation.
measure: Rate of inpatient hospitalization for preterm labor management prior to delivery
timeFrame: Through study completion, average of 1 year from study initiation.
measure: Rates of clinical therapy
timeFrame: Through study completion, average of 1 year from study initiation.
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Niraj Chavan
role: PRINCIPAL_INVESTIGATOR
References: