An interventional study of Targeted Nurse Home Visits and Conventional prenatal/postpartum care in Preterm Birth, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-07.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Prevention
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?
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's enrollment of 236 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
Maternal medical or obstetrical complications including:
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
Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.
Other: Conventional prenatal/postpartum care
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.
Women in this group received conventional prenatal care and postpartum clinic care.
Also known as: standard medical prenatal and postpartum care
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
Maternal Length of Stay at Delivery
Number of maternal hospital days associated with delivery
Time frame: Hospital discharge point following delivery
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.
| Milestone | Intervention Group | Control Group |
|---|---|---|
| Started | 122 | 114 |
| Completed | 109 | 102 |
| Not completed | 13 | 12 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Withdrew: Disenrolled due to pregnancy loss | 3 | 5 |
| Withdrew: Found not to meet eligibility criteria | 3 | 4 |
| Withdrew: Did not meet assignment criteria | 4 | 2 |
Infant gestational age was determined by the weeks and days gestation documented in the maternal delivery record.
| weeks | Intervention Group | Control Group |
|---|---|---|
| Infant Gestational Age | 38.14 (36.57 to 39.29) | 38.14 (36.29 to 39.14) |
Number of maternal hospital days associated with delivery
| days | Intervention Group | Control Group |
|---|---|---|
| Maternal Length of Stay at Delivery | 2 (1 to 12) | 3 (0 to 40) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | — | 0/122 (0%) | 0/122 (0%) |
| Control Group | — | 0/114 (0%) | 0/114 (0%) |
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.
| Age, Categorical(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 109 | 102 | 211 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 27.4 ± 5.5 | 27.8 ± 5.2 | 27.6 ± 5.3 |
| Sex: Female, Male(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Female | 109 | 102 | 211 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 41 | 34 | 75 |
| White | 67 | 67 | 134 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| United States | 109 | 102 | 211 |
| Marital Status(participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Married or Partnered | 78 | 75 | 153 |
| Divorced or Separated | 4 | 8 | 12 |
| Never Married | 27 | 19 | 46 |
| Type of insurance(participants) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Medicaid | 64 | 62 | 126 |
| Private/Champus | 44 | 36 | 80 |
| None/self pay | 0 | 3 | 3 |
| Unknown or not reported | 1 | 1 | 2 |
| Level of education in years(years) | Treatment Group | Control Group | Total |
|---|---|---|---|
| Mean | 13.2 ± 2.5 | 13.4 ± 2.6 | 13.3 ± 2.6 |
1 further baseline measures are reported on the registry.
Plan to share: Undecided
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