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COMPLETED NA

Tennessee Connections for Better Birth Outcomes

NCT00502697 · View on ClinicalTrials.gov ↗

Study Summary

Women with a history of a prior preterm birth (PTB) have a high probability of a recurrent preterm birth. Some risk factors and health behaviors that contribute to PTB may be amenable to intervention. Home visitation is a promising method to deliver evidence based interventions. We evaluated a system of care designed to reduce preterm births and hospital length of stay in a sample of pregnant women with a history of a PTB. All participants (N = 211) received standard prenatal care. Intervention participants (N = 109) also received home visits by certified nurse-midwives guided by protocols for specific risk factors (e.g., depressive symptoms, abuse, smoking). Data was collected via multiple methods and sources including intervention fidelity assessments. Average age was 27.6 years. Racial breakdown mirrored local demographics. Most women had a partner, a high school education, and Medicaid. Enhanced prenatal care by nurse-midwife home visits may limit some risk factors and shorten intrapartum length of stay for women with a prior PTB. This study contributes to knowledge about evidence-based home visit interventions directed at risk factors associated with PTB.

Conditions Studied

Interventions

  • BEHAVIORAL Targeted Nurse Home Visits
  • OTHER Conventional prenatal/postpartum care

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center — Nashville

Trial Details

FieldValue
Enrollment Target 236 participants
Start Date 2006-11
Est. Completion 2012-12
Phase NA

Sponsor

Vanderbilt University

194 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00502697

The ClinicalTrials.gov registry entry for NCT00502697 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 236 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 194 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Preterm Birth appearing as the primary indexed condition, and to 2 interventions — of which Targeted Nurse Home Visits is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00502697 reports 1 study location spanning 1 distinct geographic area — top geographies include Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00502697 about?

NCT00502697 is a clinical study titled "Tennessee Connections for Better Birth Outcomes". Women with a history of a prior preterm birth (PTB) have a high probability of a recurrent preterm birth. Some risk factors and health behaviors that contribute to PTB may be amenable to intervention. Home visitation is a promising method to deliver evidence based interventions. We evaluated a syste...

What is the current status of trial NCT00502697?

This trial is currently completed. It is a NA study. The enrollment target is 236 participants. The study started on 2006-11. Estimated completion is 2012-12.

What conditions does trial NCT00502697 study?

This clinical trial studies the following conditions: Preterm Birth. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00502697?

The interventions under investigation include: Targeted Nurse Home Visits (BEHAVIORAL), Conventional prenatal/postpartum care (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00502697?

This trial is sponsored by Vanderbilt University, which has 194 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00502697 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial