Tennessee Connections for Better Birth Outcomes
NCT00502697 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236
Last updated 2017-04-07
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
Interventions
- BEHAVIORAL
-
Targeted Nurse Home Visits
Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic care. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
- OTHER
-
Conventional prenatal/postpartum care
Women in this group received conventional prenatal care and postpartum clinic care.
Sponsors & Collaborators
-
Blue Cross Blue Shield
collaborator OTHER -
Nurses for Newborns Foundation
collaborator OTHER -
Vanderbilt University
lead OTHER
Principal Investigators
-
Melanie Lutenbacher, PhD · Vanderbilt University
-
Patricia Temple, MD, MPH · Ohio State University and Vanderbilt University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-11-30
- Primary Completion
- 2012-12-31
- Completion
- 2012-12-31
Countries
- United States
Study Locations
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