March of Dimes and Johnson and Johnson Fund 3-Year Demonstration Project in Kentucky:
Healthy Babies Are Worth the Wait ... A Prematurity Demonstration Partnership among Kentucky, March of Dimes, and Johnson & Johnson
Map showing proposed sites. Letters of Agreement are pending at this time.
Demonstration Project to Prevent Preterm Birth
Despite decades of research and many programs designed to reduce preterm labor and premature birth, the nation’s preterm birth rate continues to rise, having reached an all time high of 12.5% in 2004. The goals of the March of Dimes National Prematurity Campaign are to increase awareness about this major problem and to reduce its occurrence. The 30% increase in preterm birth rates over the past two decades, primarily due to increases in the rates of late preterm birth (34-36 weeks), reflects the underlying myriad of complex factors associated with being born too soon, as well as opportunities to reverse this trend. Based on current medical knowledge and three years of experience from the Prematurity Campaign, the time is right for the implementation and evaluation of an innovative preterm birth prevention program consisting of evidence-based clinical interventions in a targeted geographic region with a high, rapidly rising incidence of preterm birth and prevalence of modifiable risk factors.
A demonstration project will be specifically designed to prevent “preventable” preterm birth in subgroups of the population where interventions have a high likelihood of success in a reasonable period of time. The primary goal of this project is to demonstrate a 15% reduction in spontaneous singleton preterm births in a specific community. The crux of the intervention will be a collaboration with local and state-level clinical and public health partners, as well as enhancing synergy among families and services in the community. The 3.5 year multi-faceted preterm birth prevention program will utilize a study design with a geographically defined intervention area and a comparable observational area within the same state, including 6-month planning phase, a 2.5-year intervention phase and a final 6-month follow-up/evaluation.
A Program Team will be comprised of national, regional, and local March of Dimes staff, key staff from the Johnson & Johnson Pediatric Institute, specific experts who will be serving as advisors and/or consultants to the project, local leadership in obstetrics, nursing and public health, and an Advisory Committee to provide independent oversight. The P.I. is Dr. Nancy Green and the Program Director is Dr. Karla Damus. The intervention and comparison areas will be determined in the planning phase, and must meet criteria that are conducive to demonstrating a substantial reduction in singleton spontaneous preterm birth rates during the 3 year study. Interventions will primarily target perinatal providers and childbearing-aged women in the intervention area.
The program content and design is based on combining information from several sources:
- epidemiological analyses of preterm birth trends
- evidence-based interventions to prevent preterm birth
- provider clinical practice
- public preferences related to the changing culture of child-bearing
A key element of project planning is the site selection, with two key aspects:
- Risk factors for preterm birth that are potentially reversible or preventable. Many of these factors impact preterm birth at the later stages, i.e. later preterm birth (34-36 weeks gestation). The main measure of reversible factors are high preterm birth rates, especially late preterm births, that have risen steeply over the past decade. Such factors include smoking cessation, compliance with prenatal care, appropriate weight gain during pregnancy, avoiding unnecessary medical interventions (Cesarean sections and inductions) prior to term. Other conditions and risk factors are also associated with a greater chance of earlier delivery but many are not amenable to change, particularly when the women is currently pregnant, such as multiple gestations.
- An obstetric health community with sufficient interest to embrace a medical care - public health collaboration, good organizational structure of hospital policies and staffing, public health services, and sufficient delivery volume to generate the numbers to power the project over a three-year period. At least 6,000 births each in the intervention and comparison sites will be assessed.
Interventions will consist of :
- Preventing unnecessary obstetric interventions prior to term
- Promoting patient safety and decreasing risk exposure
- Smoking cessation
- Infection prevention and management
- Promoting centering of pregnancy and treatment with 17-hydroxy progesterone for prevention of recurrent preterm birth
- Promoting culturally competent care and enhancing health literacy
- Screening and referral for domestic violence
- Promoting pre- and inter-conception care
APPROXIMATE TIMELINE (subject to changes)
June - July 2006: Site selection - MOD Chapter consultation, site visits.
July - December 2006: Planning Phase - Convening the study team and consultants to finalize all aspects of the program and related study materials, begin local training, creation of an evaluation plan.
January 2007 - June 2009: Implementation Phase - Interventions will primarily target perinatal providers and child bearing-aged women in the intervention area. There will be no interventions from the study team in the comparison area, although relevant perinatal health activities will be documented and comparable perinatal outcome data will be obtained from vital records and hospital discharge databases.
July - December 2009: Follow-Up/Evaluation Phase - Clinical practice surveys in the intervention and comparison areas, execution of planned analyses, report writing, manuscript preparation and beginning the dissemination of study findings through project members, March of Dimes and JJPI, Prematurity Campaign structure of collaborating organizations.(Text coutesy Dr. Nancy Green, National March of Dimes)
The KPA website will keep you updated on this project’s status.
