Transvaginal Ultrasound: Preterm Birth Prevention in Appalachia

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03833284
Study type	Interventional
Source	University of Kentucky
Contact
Status	Completed
Phase	N/A
Start date	June 3, 2019
Completion date	October 29, 2021

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05934318` - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)	N/A
Completed	`NCT05502510` - Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
Not yet recruiting	`NCT03418311` - Cervical Pessary Treatment for Prevention of s PTB in Twin Pregnancies on Children`s Long-Term Outcome	N/A
Not yet recruiting	`NCT03418012` - Prevention of sPTB With Early Cervical Pessary Treatment in Women at High Risk for PTB	N/A
Completed	`NCT02993744` - Maternal Inflammatory Parameters Within Routine Treatment With Betamethasone	N/A
Active, not recruiting	`NCT02673216` - Infection and Adverse Pregnancy Outcome
Completed	`NCT01683565` - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood	Phase 4
Completed	`NCT01412931` - Protein and Ultrasound Indicators of Preterm Birth	N/A
Completed	`NCT01460576` - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt	N/A
Completed	`NCT02606058` - The Australian Placental Transfusion Study (APTS): Should Very Pre Term Babies Receive a Placental Blood Transfusion at Birth Via Deferring Cord Clamping Versus Standard Cord Clamping Procedures?	N/A
Terminated	`NCT03715530` - Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women	N/A
Completed	`NCT00422526` - Progesterone for Prevention of Preterm Birth in Women With Short Cervix: Randomized Controlled Trial	Phase 3
Enrolling by invitation	`NCT04251260` - Effectiveness of Positioning in Preterm Neonates	N/A
Completed	`NCT03668860` - India Dexamethasone and Betamethasone	Phase 1
Recruiting	`NCT03638037` - Correlation Between Maternal Vitamin D Level And Preterm Birth
Completed	`NCT02225353` - Efficacy Study of a Cervical Pessary Containing Progesterone for the Prevention of Preterm Delivery	Phase 2
Recruiting	`NCT03992534` - The FLIP-1 Study: Vaginal Lactobacillus Supplementation in Women at High Risk of Preterm Birth	Phase 1
Completed	`NCT03144141` - Association Between EHG and Risk of Preterm Delivery in Women Hospitalized for Threatened Premature Delivery	N/A
Completed	`NCT05210985` - Examination of the Relationship Between Home Affordances With Development
Completed	`NCT04021654` - What is the Future of Vulnerable New-borns

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.