Vanderbilt Study Integrates Evidence to Improve Preterm Rates
Tennessee Connections for Better Birth Outcomes recently received an installment of $637,000 from the BlueCross BlueShield of Tennessee Health Foundation as part of a four-year research program launched by Vanderbilt University Schools of Nursing and Medicine to improve the gestational age of newborns carried by women at increased risk for preterm birth.
One of the largest funding grants ever awarded by the foundation, the $2.48 million project follows high-risk pregnant women from early pregnancy through 18 months postpartum. While there are no income limitations on participation, women must have experienced a prior preterm birth to be included in the study.
Better Birth Outcomes (BBO) Principal Investigator Melanie Lutenbacher, PhD, MSN, is extremely grateful for the foundation's support. The associate professor at Vanderbilt School of Nursing said the grant enables hands-on intervention to improve the state's "abominable" preterm birth rates.
"We are really interested in helping Tennessee deal with the issue of preterm births and infant mortality," noted Lutenbacher, who also has an appointment in general pediatrics at Vanderbilt School of Medicine. "The goal of this whole project is to come up with a replicable model for service delivery," she added of the translational research.
As a starting point, evidence garnered from previous studies was collected by Lutenbacher and co-principal investigator Patricia Temple, MD, MPH – who has since left Nashville to accept an appointment at Ohio State University but continues to be involved in BBO. This information included research from an NIH trial focused on 17P Progesterone injections to delay preterm birth; Lutenbacher's own research on the impact of biobehavioral issues such as stress, depressive symptoms and domestic violence in high-risk women; and the benefits of home visitation as evidenced through research led by Dorothy Brooten, who sits on the BBO advisory panel and is internationally known for her study of transitional care for high-risk patients.
"We developed a system of care that could address the known factors related to premature birth. We wanted to test this home visit model with all the information we had available," Lutenbacher explained. She added that the study's interventionists are not prescribing or providing the progesterone injections but are working closely with participants' physicians to help educate women about all their medical options.
"Our interventionists are working very hard to facilitate women's ability to adhere to recommended medical prescriptions and practices," she continued.
Participants are randomized either into the control group (standard obstetrical care) or the treatment group (standard care plus home visits). The trial employs two sets of interventionists … certified nurse midwifes make the home visits during the prenatal period followed by 18 months of visits from Nurses for Newborns, the nonprofit organization with which Vanderbilt has contracted.
Lutenbacher explained the protocol calls for everyone in the treatment group to receive at least one home visit in between normal prenatal clinical visits. However, she added, many participants receive more depending upon the number of risk factors present such as gestational diabetes or high blood pressure. The interventionists specifically address biobehavioral and medical factors known to increase the risk of early labor.
There are two main outcomes the team hopes to achieve for the mothers, Lutenbacher said. "We are working to help them have a baby that is greater than 37 weeks gestation … or at least get their gestational age higher than previous preterm births and as close to 37 (weeks) as possible."
The second goal, she continued, is to follow these women to try to address health concerns and delay another pregnancy.
At 48 hours postpartum, a hand-off occurs in a joint meeting with the new mother, certified nurse midwife and maternal child nurse from Nurses for Newborns. Lutenbacher said the joint meeting establishes continuity in terms of following up on chronic conditions and provides an opportunity to share care plans. In the postpartum phase, interconception care is the focus. The nurses provide information and assistance with issues ranging from continued smoking cessation to breastfeeding to contraception.
"Rapid, repeat pregnancies also lend themselves to increased risk," she pointed out. Lutenbacher noted the research clearly shows one preterm birth increases the risk of a second child being born early by 30-50 percent. "If they've had two, it can be as high as 70 percent."
Interested in Learning More?
While a recruitment mechanism is in place for women utilizing Vanderbilt Obstetric or Midwifery Clinics, BBO investigators are interested in expanding the project to other sites. Baseline inclusion requires a woman has experienced a prior preterm birth and be enrolled in the study by 24 weeks gestation. Participants cover the spectrum in terms of income and education levels, race and ethnicity. The randomized trial has a capacity to enroll 300 high-risk women during the course of the four-year grant. By mid-January 2009, 127 expectant mothers had been enrolled.
Providers interested in learning more about the intervention and inclusion criteria for patients should call (615) 322-4659.As of press time, Lutenbacher said there had been around 86 deliveries, which were fairly evenly split between the control and treatment groups.
"While we don't have data of statistical significance yet, the trend is really promising and positive about the impact of the intervention to prevent prematurity," she said.
Given the state's history, she continued, finding effective, replicable models is critical … not only for the physical health of the mother and child but also for the fiscal health of the state.
"It would just be a 'win/win' for everybody – for the women, for the healthcare industry, for society. It would just have such a positive ripple effect, but it requires coordination and collaboration within and across systems."