Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Blue Cross Blue Shield | OTHER |
| Nurses for Newborns Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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?
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Conventional prenatal/postpartum care | Other | Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Gestational Age | Infant gestational age was determined by the weeks and days gestation documented in the maternal delivery record. | Time of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Length of Stay at Delivery | Number of maternal hospital days associated with delivery | Hospital discharge point following delivery |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Known fetal anomaly that can not be managed conservatively or fetal demise
Maternal medical or obstetrical complications including:
Participation in an antenatal study in which the clinical status or intervention may influence gestational age at delivery
Profound mental dysfunction or under guardianship
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Melanie Lutenbacher, PhD | Vanderbilt University | Principal Investigator |
| Patricia Temple, MD, MPH | Ohio State University and Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23922160 | Background | 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. | |
| 23484671 | Result |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention 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 (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
We analyzed data for participants who remained in the study for at least four weeks following enrollment. The final sample totaled 211 women: 109 intervention and 102 controls.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infant Gestational Age | Infant gestational age was determined by the weeks and days gestation documented in the maternal delivery record. | ITT analysis used with all participants that birth information could be obtained. | Posted | Median | Inter-Quartile Range | weeks | Time of delivery |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention 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 (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melanie Lutenbacher, PhD, MSN, FAAN | Vanderbilt University | 615-343-3314 | melanie.lutenbacher@vanderbilt.edu |
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
| ID | Term |
|---|---|
| D011181 | Postnatal Care |
| ID | Term |
|---|---|
| D018743 | Perinatal Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D008427 | Maternal Health Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Conventional prenatal/postpartum care | Other | Women in this group received conventional prenatal care 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. |
| found not to meet eligibility criteria |
|
| did not meet assignment criteria |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Marital Status | Number | participants |
|
| Type of insurance | Number | participants |
|
| Level of education in years | Mean | Standard Deviation | years |
|
| Gestational age at enrollment in weeks | Mean | Standard Deviation | weeks |
|
| OG001 | 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. |
|
|
|
| Secondary | Maternal Length of Stay at Delivery | Number of maternal hospital days associated with delivery | 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. | Posted | Median | Full Range | days | Hospital discharge point following delivery |
|
|
|
| 0 |
| 122 |
| 0 |
| 122 |
| EG001 | 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. | 0 | 114 | 0 | 114 |
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| D003153 |
| Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |