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Tennessee Connections for Better Birth Outcomes

Tennessee Connections for Better Birth Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00502697
Acronym
BBO
Enrollment
236
Registered
2007-07-18
Start date
2006-11-30
Completion date
2012-12-31
Last updated
2017-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

Keywords

preterm, prematurity, home visitation, system of care

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?

Interventions

OTHERConventional prenatal/postpartum care

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

BEHAVIORALTargeted 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.

Sponsors

Blue Cross Blue Shield
CollaboratorOTHER
Nurses for Newborns Foundation
CollaboratorOTHER
Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Infant Gestational AgeTime of deliveryInfant gestational age was determined by the weeks and days gestation documented in the maternal delivery record.

Secondary

MeasureTime frameDescription
Maternal Length of Stay at DeliveryHospital discharge point following deliveryNumber of maternal hospital days associated with delivery

Countries

United States

Participant flow

Recruitment details

The sample consisted of pregnant women receiving prenatal care with a (physician or nurse-midwife) at a large regional medical center in the Southeastern U.S. from April, 2007 through January, 2010.

Participants by arm

ArmCount
Treatment Group
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 (18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
109
Control Group
Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care. Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care.
102
Total211

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studydid not meet assignment criteria42
Overall Studydisenrolled due to pregnancy loss35
Overall Studyfound not to meet eligibility criteria34
Overall StudyWithdrawal by Subject31

Baseline characteristics

CharacteristicControl GroupTotalTreatment Group
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
102 Participants211 Participants109 Participants
Age, Continuous27.8 years
STANDARD_DEVIATION 5.2
27.6 years
STANDARD_DEVIATION 5.3
27.4 years
STANDARD_DEVIATION 5.5
Gestational age at enrollment in weeks15.29 weeks
STANDARD_DEVIATION 4.57
15.43 weeks
STANDARD_DEVIATION 4.57
15.43 weeks
STANDARD_DEVIATION 4.57
Level of education in years13.4 years
STANDARD_DEVIATION 2.6
13.3 years
STANDARD_DEVIATION 2.6
13.2 years
STANDARD_DEVIATION 2.5
Marital Status
Divorced or Separated
8 participants12 participants4 participants
Marital Status
Married or Partnered
75 participants153 participants78 participants
Marital Status
Never Married
19 participants46 participants27 participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
34 Participants75 Participants41 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants
Race (NIH/OMB)
White
67 Participants134 Participants67 Participants
Region of Enrollment
United States
102 participants211 participants109 participants
Sex: Female, Male
Female
102 Participants211 Participants109 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Type of insurance
Medicaid
62 participants126 participants64 participants
Type of insurance
None/self pay
3 participants3 participants0 participants
Type of insurance
Private/Champus
36 participants80 participants44 participants
Type of insurance
Unknown or not reported
1 participants2 participants1 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1220 / 114
serious
Total, serious adverse events
0 / 1220 / 114

Outcome results

Primary

Infant Gestational Age

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

Time frame: Time of delivery

Population: ITT analysis used with all participants that birth information could be obtained.

ArmMeasureValue (MEDIAN)
Intervention GroupInfant Gestational Age38.14 weeks
Control GroupInfant Gestational Age38.14 weeks
Comparison: The original proposed sample size for this study was 300. This sample size was based on previous evidence that indicated that a reduction of 15% in the rate of preterm birth would be detectable with groups of 150. Because of concerns with systemic changes in the study's health care delivery environment, an interim analysis was conducted after 200 women had delivered. As a result of that analysis a decision was made to stop recruitment.p-value: 0.64Wilcoxon (Mann-Whitney)
Secondary

Maternal Length of Stay at Delivery

Number of maternal hospital days associated with delivery

Time frame: Hospital discharge point following delivery

Population: Of the 211 participants, data on length of stay at delivery were available for 194 women. The most common reason for the lack of this information was that the birth did not take place at the study's medical center.

ArmMeasureValue (MEDIAN)
Intervention GroupMaternal Length of Stay at Delivery2 days
Control GroupMaternal Length of Stay at Delivery3 days

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026