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: January 22, 2013
Last verified: January 2013

July 16, 2007
January 22, 2013
November 2006
December 2012   (final data collection date for primary outcome measure)
  • Length of gestation [ Time Frame: Time of delivery ] [ Designated as safety issue: No ]
  • Increase in length of gestational age from gestational age of index preterm birth [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Delay of Subsequent Pregnancy (> 9 months postpartum) [ Time Frame: 9 months postpartum ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: No ]
Length of gestation [ Time Frame: Time of delivery ]
Complete list of historical versions of study NCT00502697 on ClinicalTrials.gov Archive Site
Level of depressive symptoms [ Time Frame: prenatal through 2 months postpartum ] [ Designated as safety issue: No ]
Inter pregnancy interval between delivery and subsequent pregnancy [ Time Frame: 18 months postpartum ]
Not Provided
Not Provided
 
Tennessee Connections for Better Birth Outcomes
Tennessee Connections for Better Birth Outcomes

Preterm births (PTBs) are the leading cause of death in infants under the age of one, the second leading cause of infants dying in the first 30 days of life and a major contributor to the low US ranking (27th) in infant mortality among all industrialized nations. 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 other factors and PTBs noted in prior studies likely contribute to TN's high rate of PTBs. These include short cervical length, African American race, low pre-pregnancy weight, smoking, substance abuse, lack of or delayed prenatal care, short interval between pregnancies, socio-environmental stressors (e.g., poverty, violence), infections, multiple gestations, and chronic diseases. 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:

  • 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?
  • in health care costs between women who receive the medical intervention and the SOC?
  • intervals between the current pregnancy and a subsequent pregnancy across groups?
  • in length of gestational age of current infant with gestational age of index prior preterm birth?
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Preterm Birth
  • Recurrent Preterm Birth
  • 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 and postpartum clinic care
    Women in this group received conventional prenatal care and postpartum clinic care.
  • Experimental: 1
    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.
    Interventions:
    • Behavioral: Targeted Nurse Home Visits
    • Other: Conventional prenatal and postpartum clinic care
  • 2
    Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
    Intervention: Other: Conventional prenatal and postpartum clinic care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
232
December 2012
December 2012   (final data collection date for primary outcome measure)

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, TN or surrounding county in 90 mile driving radius.
  • Less than 24 weeks gestation at enrollment
  • Will receive prenatal care at a 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
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00502697
070684
No
Melanie Lutenbacher, Vanderbilt University
Vanderbilt University
  • Blue Cross Blue Shield
  • Nurses for Newborns Foundation
Principal Investigator: Melanie Lutenbacher, PhD Vanderbilt University
Principal Investigator: Patricia Temple, MD, MPH Ohio State University and Vanderbilt University
Vanderbilt University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP