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The incidence of premature delivery continues to increase in the United States and now exceeds 12% of all pregnancies. High levels of progesterone, which is normally produced by the placenta, help to maintain pregnancy. A drop in progesterone levels is one of the steps that stimulate the onset of labor. An extensive federally sponsored double-blind study was conducted at 19 academic medical centers that comprise the Maternal-Fetal Medicine Units Network under the National Institutes of Health to evaluate the potential for 17-Alpha Hydroxyprogesterone Caproate (17P) to decrease the risk of pre-term birth. Participants included 459 pregnant women (16 to 20 weeks gestation) who had a history of spontaneously giving birth before 37 weeks gestation, and were therefore at risk of experiencing another pre-term birth. Of these, 306 were randomly assigned to receive weekly injections of 250 mg of 17P, while 153 received placebo injections. The injections continued until 36 weeks of gestation. Progesterone had a substantial benefit. In the placebo group, 54.9% of the women gave birth before 37 weeks, compared with 36.3% of those who received the progesterone derivative, translating to a risk reduction of 34%. The difference was even more striking for births occurring before 32 weeks: 19.6% in the placebo group and 11.4% in the 17P group, for a risk reduction of 42%. "This is the first real success we've had in dealing with the biggest problem in obstetrics, which is preterm birth," said Dr. Paul Meis, professor of obstetrics and gynecology at Wake Forest University. In fact, the treatment was considered so effective that the study was halted early because it would have been unethical to continue to administer a placebo to some of the high-risk women in the study group.

Another study sought to identify the effect of early cessation of 17P on the incidence of spontaneous recurrent preterm delivery (PTD). Retrospective analysis of data from women who were enrolled for outpatient 17P administration between January 2004 and May 2006 included women with previous PTD and current singleton pregnancy who were beginning weekly 17P injections (250 mg intramuscularly) at 16-20.9 weeks. Results suggested that the early cessation of 17P is associated with an increased risk of preterm delivery across all preterm gestational ages. Data supported continuation of 17P until 36 completed weeks of gestation, as standardized in the Meis et al. protocol, because the early discontinuation of treatment was found to be a significant factor for recurrent preterm delivery, with its associated increased neonatal morbidity and mortality rates.

Undelivered patients after preterm labor undergo progressive shortening of the cervix, which is attenuated by 17P treatment. This effect is associated with a reduction in the rate of PTD. The precise mechanism by which progesterone prevents preterm birth is unknown although it is has been shown to decrease inflammation and blocks the effect of oxytocin on the myometrium.

Studies to date have demonstrated that 17P is not associated with congenital anomalies or other neonatal developmental problems. Northen etal. of the Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, investigated the health outcomes of 194 children who were exposed as fetuses to 17P in the second and third trimesters. The results were compared with those for 84 unexposed children. The mean age at follow-up was 48 months. The guardian was interviewed about the child's general health, and children underwent a physical examination and developmental screen with the Ages and Stages Questionnaire. Gender-specific roles were assessed with the Preschool Activities Inventory. No significant differences were seen in health status or physical examination, including genital anomalies, between 17P and placebo children. Scores for gender-specific roles (Preschool Activities Inventory) were within the normal range and similar between 17P and placebo groups. The investigators concluded 17P seems to be safe for the fetus when administered in the second and third trimesters.

The American College of Obstetricians and Gynecologists has strongly endorsed the 17P regimen, and conducted a number of studies demonstrating its cost-effectiveness. The health consequences of prematurity can include cerebral palsy, neurodevelopmental disability and chronic illnesses, such as lung disease. The March of Dimes estimates that the average cost is about $2,800 to provide medical care to infants who are carried to term, compared to $41,600 for a preterm baby. More importantly, prolonging pregnancy can decrease morbidity in the NICU, and significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage and the need for supplemental oxygen.

North Carolina has become one of the first states to implement a state-wide 17P-injection program aimed at preventing preterm births among low-income women. The “17P Project” provides qualifying pregnant women with free weekly intramuscular injections of 250 mg of 17P ideally starting at 16 weeks gestation and continuing to 36 weeks and 6 days. See http://www.mombaby.org for more information.

An important feature of recent studies and the 17P Project is that enrollment has been 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 once preterm contractions have occurred.

N Engl J Med 2003;348:2379-85
Obstet Gynecol 2005 May;105(5 Pt 1):1128-35
Am J Obstet Gynecol 2007;196:224.e1-224.e4.
Am J Obstet Gynecol 2007;196:453.e1-453.e4.
Obstet Gynecol. 2007 Oct;110(4):865-72

You can fax your patient’s prescription for 17P to
Anderson Compounding Pharmacy--Women’s Health Clinical Services — fax# 423.764.4130 Thank you!

In order to expedite the filling of prescriptions for your patients, please be sure to provide us with the following patient information:

  • Name
  • Address
  • Phone #
  • Date-of-birth
  • Prescription Insurance Coverage information – fax both sides of insurance card, if applicable.

**WE ELECTRONICALLY BILL ALL MAJOR INSURANCES.** The patient will be responsible for paying her copay (if applicable).

Our goal is to help you help your patients. If we can be of service to you, or if you would like more information, please call us at 1.800.263.8890 or 423.764.4136 (option #3).


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