Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Tennessee Connections for Better Birth Outcomes (BBO)

This study has been completed.
Sponsor:
Collaborators:
Blue Cross Blue Shield
Nurses for Newborns Foundation
Information provided by (Responsible Party):
Melanie Lutenbacher, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00502697
First received: July 16, 2007
Last updated: March 7, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Preterm Birth
Behavioral: Targeted Nurse Home Visits
Other: Conventional prenatal/postpartum care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Tennessee Connections for Better Birth Outcomes

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Infant Gestational Age [ Time Frame: Time of delivery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Hospital discharge point following delivery ] [ Designated as safety issue: No ]
    Number of maternal hospital days associated with delivery


Enrollment: 236
Study Start Date: November 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 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.
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.
Other Name: standard medical prenatal and postpartum care
Conventional prenatal/postpartum care
Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Other: Conventional prenatal/postpartum care
Women in this group received conventional prenatal care and postpartum clinic care.
Other Name: standard medical prenatal and postpartum care

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?

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00502697

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Blue Cross Blue Shield
Nurses for Newborns Foundation
Investigators
Principal Investigator: Melanie Lutenbacher, PhD Vanderbilt University
Principal Investigator: Patricia Temple, MD, MPH Ohio State University and Vanderbilt University
  More Information

Publications:
Responsible Party: Melanie Lutenbacher, Associate Professor of Nursing and Medicine (General Pediatrics), Vanderbilt University
ClinicalTrials.gov Identifier: NCT00502697     History of Changes
Other Study ID Numbers: 070684 
Study First Received: July 16, 2007
Results First Received: April 13, 2015
Last Updated: March 7, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Vanderbilt University:
preterm
prematurity
home visitation
system of care

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on December 09, 2016