Tennessee Connections for Better Birth Outcomes

Completed · Not applicable

Conditions studied: Preterm Birth

In brief

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.

Key facts

Study ID

NCT00502697

Run by

Vanderbilt University

People needed

236

Starts

2006-11-01

Expected to finish

2012-12-01

Last updated by the study team

2017-04-07

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Documented history of previous preterm delivery. Defined as delivery from 20 weeks to 36 weeks 6 days gestation.
• Proven pregnancy
• Reside in Davidson County, Tennessee (TN) or surrounding county in 90 mile driving radius.
• Less than 24 weeks gestation at enrollment
• Will receive prenatal care at a Vnderbilt University Medical Center (VUMC) clinic
• Willing to accept nurse home visits and be randomly assigned to conventional care or care with home visits
• Speaks and understands English
• Between the ages of 18 and 40 years.

You may not qualify if…

• Known fetal anomaly that can not be managed conservatively or fetal demise
• Maternal medical or obstetrical complications including:
• Current or scheduled cervical cerclage
• PROM in current pregnancy prior to enrollment
• Participation in an antenatal study in which the clinical status or intervention may influence gestational age at delivery
• Profound mental dysfunction or under guardianship

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.