Tennessee Connections for Better Birth Outcomes

NCT00502697 | Completed Results

• 1 other identifier: 070684
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Keywords

preterm; prematurity; home visitation; system of care

Outcome Measures

Primary Outcomes (1)

• Infant Gestational Age

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

  Time of delivery

Secondary Outcomes (1)

• Maternal Length of Stay at Delivery

  Hospital discharge point following delivery

Study Arms (2)

Targeted Nurse Home Visits

EXPERIMENTAL

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; Other: Conventional prenatal/postpartum care

Conventional prenatal/postpartum care

OTHER

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

Other: Conventional prenatal/postpartum care

Interventions

Targeted Nurse Home Visits 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.

Targeted Nurse Home Visits

Conventional prenatal/postpartum care OTHER

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

Also known as: standard medical prenatal and postpartum care

Conventional prenatal/postpartum care; Targeted Nurse Home Visits

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• Blue Cross Blue Shield: collaborator
• Nurses for Newborns Foundation: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• 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.

  PMID: 23922160 BACKGROUND

• 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.

  PMID: 23484671 RESULT

MeSH Terms

Conditions

Premature Birth

Interventions

Postnatal Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Perinatal Care; Patient Care; Therapeutics; Maternal Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Melanie Lutenbacher, PhD, MSN, FAAN
• Organization: Vanderbilt University

melanie.lutenbacher@vanderbilt.edu

615-343-3314

Study Officials

• Melanie Lutenbacher, PhD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Patricia Temple, MD, MPH

  Ohio State University and Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Nursing and Medicine (General Pediatrics)

Study Record Dates

• First Submitted: July 16, 2007
• First Posted: July 18, 2007
• Study Start: November 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 7, 2017
• Results First Posted: March 16, 2016

Record last verified: 2017-04

Locations

US (1)