Transvaginal Ultrasound: Preterm Birth Prevention in Appalachia

Preterm Birth Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03833284
• Other study ID #: 45131
• Status: Completed
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: October 29, 2021

Study information

• Verified date: January 2022
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 29, 2021
• Est. primary completion date: October 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

Behavioral:
• Participant Barriers to TVU Screening
Workshops tailored toward patients to increase knowledge about TVU screening guidelines and benefits.
• Provider Barriers to TVU Screening
Workshops tailored toward providers to increase knowledge about TVU screening guidelines and benefits.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Niraj Chavan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.	Through study completion, average of 1 year from study initiation
Secondary	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.	Through study completion, average of 1 year from study initiation
Secondary	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.	Through study completion, average of 1 year from study initiation.
Secondary	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.	Through study completion, average of 1 year from study initiation.
Secondary	Rates of clinical therapy	Defined as prescribing vaginal progesterone or performing cervical cerclage	Through study completion, average of 1 year from study initiation.