Our state continues to lead the nation in our commitment to reducing recurring preterm birth through the use of 17P. Preterm birth is the leading cause of infant death and disability in North Carolina.One of the strongest clinical risk factors for preterm birth is a prior preterm birth. 17P may reduce a woman's chances of having a subsequent preterm birth by 33%. Therefore, the NC 17P Project works to make the treatment available to all eligible women in theur state. Many partners, including physicians, NC Division of Medical Assistance, the NC Divison of Public Health, Community Care of North Carolina, pharmacists and legislators, are committed to doing everything possible to use this treatment option to its fullest potential.
One important program is the statewide quality improvement initiative focused on 17P led by the Community Care of North Carolina Pregnancy Medical Home program. This initiative includes screening pregnant women for eligiblity for 17P, counseling women about 17P treatment, and providing intensive support to women who accept treatment. The use of intramuscular progesterone (17P) for patients with a history of spontaneous preterm birth is a core performance expectation of all practices participating in the Pregnancy Medical Home program.
Women who have Medicaid for Pregnant Women may be eligible for case management services through the Pregnancy Medical Home / High Risk OB Case Management program. Some health departments also offer Skilled Home Nurse visits for this population of patients. Contact your local health department or local Community Care of North Carolina Network for more information. For more information about this program click here.
Please refer to the sections on Billing, Ordering, and MakenaR for the most current information. Thank you.
It Takes a Team
The implementation of a statewide 17P program requires the commitment of the full clinic team. Clinicians need to develop a comprehensive screening program to identify all women who could benefit from treatment. They then need to provide the patient with clear counseling about 17P and make sure they understand the importance of completing the full treatment. Patients often need support in receiving their weekly injections - transportation, shared care between clinics (high risk vs. local), convenient appointment times, and encouragement. Case managers play an essential role in this care. Office managers also play an important role in working with providers to procur the medication and accurately bill for reimbursement. Payors also have a role to play in making the medication affordable and easily accessible. While it takes effort to establish a 17P program, the positive impact this can have on mothers and babies is worth it all.
North Carolina's Leadership
A story about the North Carolina 17P Project is posted on the Association for State and Territorial Health Officials Healthy Babies' Webpage! To read the story, click here.
The 17P Project has developed a 13-minute video about reducing the risk of recurring preterm birth. The video features comments from mothers who have taken 17P as well as detailed information from physicians about the use of this medication. To view this video online, please click here. Click here to access a 3-minute video clip that describes the 17P Project. Having problems? Give us a call at 919-843-7864.
Reducing the Risk of Recurring Preterm Birth with 17P
In June 2006 the North Carolina General Assembly appropriated nonrecurring funds to reduce preterm birth by improving access to and appropriate use of 17 alpha hydroxyprogesterone caproate (17P). The appropriation was used to expand education about 17P for physicians and consumers and to increase access to the medication by making it available to low-income women free of charge. The 17P Project was born out of the concern of many about the increasing numbers of babies being born too soon in our state. The North Carolina General Assembly has continued to support this important initiative. This decision shows their dedication to improving birth outcomes in our state. Many thanks are due to the NC Child Fatality Task Force for their leadership in securing support for this project since.
A key goal of this initiative is to ensure that all women in North Carolina who meet the clinical eligibility criteria for 17P will have access to this intervention to reduce their risk of a recurring preterm birth. Project partners include: the NC Division of Public Health, the NC Division of Medical Assistance, Community Care of North Carolina and the UNC Center for Maternal and Infant Health.
Premature delivery continues to increase in the United States and now exceeds 13% of all pregnancies.1 It is the leading cause of infant mortality in North Carolina, as well as the single leading cause of cerebral palsy. In North Carolina each year over 13,200 babies are born too soon. Medicaid costs for hospital intensive care for these babies totals over $120 million annually.
Health care providers do not have many tools to use once preterm labor has begun. Tocolytic therapy (terbutaline, ritodrine, indomethacin, magnesium sulfate) has proven to have only minimal impact on preventing preterm delivery. At best, delivery can be delayed for 48 hours allowing for the administration of antenatal steroids to enhance fetal lung maturity. Even the prolonged use of oral tocolytics has not proven effective in averting premature delivery.
Without the ability to stop preterm labor, health care providers continue to look to ways to prevent preterm labor in the first place. Two studies point to prevention as a more optimal approach than treatment once the problem of premature contractions have begun. In 2003, Meis et al.2 reported that the weekly injection of 250 mg of a naturally occurring progesterone (17-hydroxyprogesterone) could result in a 33% reduction in the rate of preterm delivery prior to 35 weeks’ gestation and a 42% reduction prior to 32 weeks’ gestation. This study was the first to demonstrate a decrease in morbidity in the NICU – significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and the need for supplemental oxygen. In a second randomized study from Brazil, a daily 100 mg progesterone vaginal suppository decreased the incidence of preterm delivery from 28.5% (placebo group) to 13.8%. Delivery prior to 34 weeks’ gestation was reduced from 18.5% to 2.7%.3
The exact mechanism by which progesterone prevents preterm birth is unknown although it has been shown to decrease inflammation and to block the effect of oxytocin on the myometrium, keeping the uterus from contracting. Studies to date have demonstrated that hydroxyprogesterone is not associated with congenital anomalies or other neonatal developmental problems.
An important feature of both reported studies is that enrollment was limited to singleton gestations in patients with a previous history of spontaneous preterm delivery. Studies to date have indicated that progesterone is not effective in preventing premature delivery in pregnancies at low risk for prematurity, multiple gestations, or in patients for whom preterm contractions have occurred.
Current candidates for progesterone should meet the following criteria: singleton pregnancy and previous spontaneous preterm delivery (<37 weeks gestation) of a single baby. A preferred use of progesterone is weekly intramuscular injections of 250 mg of 17-hydroxyprogesterone ideally starting at 16 weeks gestation and continuing to 36 weeks and 6 days.
Vaginal progesterone is recommended as a management option to reduce the risk of preterm birth in asymptomatic women with a singlton gestation without a prior preterm birth with an incidentally identified very short certical length less than or equal to 20 mm before or at 24 weeks of gestation.4
Meis PJ. 17 hydroxyprogesterone for the prevention of preterm delivery. Obstet Gynecol 2005;105:1128-35.
Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad Ah, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Eng J Med 2003;348:2379-85.
da Fonseca EB, Bittar RE, Carvalho MH, Zugaub M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: A randomized placebo-controlled double-blind study. Am J Obstet Gynecol 2003;188:419-24.
American College of Obstetricians and Gynecologists (ACOG). (2008, reaffirmed 2012). ACOG practice bulletin number 130: Prediction and prevention of preterm birth. Obstetrics and Gynecology, 120(4):964-973.