Tennessee Connections for Better Birth Outcomes

NCT ID: NCT00502697

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2012-12-31

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?

Conditions

Preterm Birth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Targeted Nurse Home Visits

Intervention Type: BEHAVIORAL

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.

Conventional prenatal/postpartum care

Intervention Type: OTHER

Women in this group received conventional prenatal care and postpartum clinic care.

Conventional prenatal/postpartum care

Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.

Group Type: OTHER

Conventional prenatal/postpartum care

Intervention Type: OTHER

Women in this group received conventional prenatal care and postpartum clinic care.

Interventions

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.

Intervention Type: BEHAVIORAL

Conventional prenatal/postpartum care

Women in this group received conventional prenatal care and postpartum clinic care.

Intervention Type: OTHER

Other Intervention Names

standard medical prenatal and postpartum 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Blue Cross Blue Shield

OTHER

Sponsor Role: collaborator

Nurses for Newborns Foundation

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Melanie Lutenbacher

Associate Professor of Nursing and Medicine (General Pediatrics)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melanie Lutenbacher, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Patricia Temple, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ohio State University and Vanderbilt University

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23922160 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23484671 (View on PubMed)

Other Identifiers

070684

Identifier Type: -

Identifier Source: org_study_id