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Tennessee Connections for Better Birth Outcomes (BBO)

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Nurse Home Visits
Conventional prenatal/postpartum care
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring preterm, prematurity, home visitation, system of care

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Arm Type

Experimental

Other

Arm Label

Targeted Nurse Home Visits

Conventional prenatal/postpartum care

Arm Description

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.

Outcomes

Primary Outcome Measures

Infant Gestational Age
Infant gestational age was determined by the weeks and days gestation documented in the maternal delivery record.

Secondary Outcome Measures

Maternal Length of Stay at Delivery
Number of maternal hospital days associated with delivery

Full Information

First Posted
July 16, 2007
Last Updated
April 5, 2017
Sponsor
Vanderbilt University
Collaborators
Blue Cross Blue Shield, Nurses for Newborns Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00502697
Brief Title
Tennessee Connections for Better Birth Outcomes
Acronym
BBO
Official Title
Tennessee Connections for Better Birth Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
Blue Cross Blue Shield, Nurses for Newborns Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
Preterm births (PTBs) are the leading cause of death in infants under the age of one. Tennessee (TN) is one of the lowest ranking states in the US for rates of PTBs (46th) and infant mortality (48th). Costs for neonatal care increase exponentially with decreasing gestational age, and there are lifelong consequences for families and communities. Despite medications and improved diagnostic tools, a 27% increase in PTBs has occurred in the past 20 years. With a history of one PTB, the probability of another PTB is approximately 30%. The risk of having another PTB rises to almost 70% if the woman has a history of more than one PTB. Relationships between a variety of factors (e.g., African American race, smoking, short interval between pregnancies, socio-environmental stressors) likely contribute to TN's high rate of PTBs. Several interventions have been identified to reduce PTBs and improve maternal and infant health indicators but with varying success; administering intramuscular injections of progesterone between 16 and 36 weeks gestation, providing some prenatal care in the home of women with a high risk pregnancy, increasing the interval between pregnancies, and reducing social factors that negatively impact health, such as smoking, substance abuse and stress. The overall purpose of this study was to determine if a combined medical and biobehavioral intervention would prevent PTBs and reduce healthcare costs in a sample of women who have had a prior PTB. The medical intervention was conventional prenatal and postpartum clinic care. The biobehavioral intervention included certified nurse midwife home visitors who engaged women in an integrated System of Care (SOC) during their prenatal care. Care continued during the first 18 months of the infant's life by maternal-child nurse visitors. Home visits were in addition to regularly scheduled conventional prenatal and postpartum clinic care. Main study questions were: Is there a difference in: 1) the length of gestational age of infants of high-risk pregnant women who receive the medical intervention and high-risk pregnant women who receive the SOC? 2) in health care costs between women who receive the medical intervention and the SOC? 3) intervals between the current pregnancy and a subsequent pregnancy across groups? and 4) in length of gestational age of current infant with gestational age of index prior preterm birth?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
Keywords
preterm, prematurity, home visitation, system of care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Targeted Nurse Home Visits
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional prenatal/postpartum care
Arm Type
Other
Arm Description
Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Intervention Type
Behavioral
Intervention Name(s)
Targeted Nurse Home Visits
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional prenatal/postpartum care
Other Intervention Name(s)
standard medical prenatal and postpartum care
Intervention Description
Women in this group received conventional prenatal care and postpartum clinic care.
Primary Outcome Measure Information:
Title
Infant Gestational Age
Description
Infant gestational age was determined by the weeks and days gestation documented in the maternal delivery record.
Time Frame
Time of delivery
Secondary Outcome Measure Information:
Title
Maternal Length of Stay at Delivery
Description
Number of maternal hospital days associated with delivery
Time Frame
Hospital discharge point following delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Lutenbacher, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia Temple, MD, MPH
Organizational Affiliation
Ohio State University and Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23922160
Citation
Lutenbacher M, Gabbe PT, Karp SM, Dietrich MS, Narrigan D, Carpenter L, Walsh W. Does additional prenatal care in the home improve birth outcomes for women with a prior preterm delivery? A randomized clinical trial. Matern Child Health J. 2014 Jul;18(5):1142-54. doi: 10.1007/s10995-013-1344-4.
Results Reference
background
PubMed Identifier
23484671
Citation
Karp SM, Howe-Heyman A, Dietrich MS, Lutenbacher M. Breastfeeding initiation in the context of a home intervention to promote better birth outcomes. Breastfeed Med. 2013 Aug;8(4):381-7. doi: 10.1089/bfm.2012.0151. Epub 2013 Mar 13.
Results Reference
result

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Tennessee Connections for Better Birth Outcomes

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