Tennessee Connections for Better Birth Outcomes (BBO)
Preterm Birth

About this trial
This is an interventional prevention trial for Preterm Birth focused on measuring preterm, prematurity, home visitation, system of care
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Targeted Nurse Home Visits
Conventional prenatal/postpartum care
Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. 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.
Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.