An incorrect word appeared in an SMFM Clinical Guideline (Society for Maternal-Fetal Medicine Publications Committee, Berghella V. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol 2012;206:376-86) published in the May 2012 issue of the Journal.
On page 380, the first sentence of the second paragraph under the heading “What is the evidence and recommendation for use of progestogens for prevention of PTB in singleton gestations with prior PTB, and unknown or normal CL? (Levels I, II, and III),” subheading “17P,” in which an NICHD MFMU Network trial involving 17-α-hydroxyprogesterone caproate, published in the New England Journal of Medicine in 2003, is described, should have read:
In 463 women with singleton gestation and prior SPTB at 20-36 6/7 weeks of a singleton gestation, 17P 250 mg IM weekly started at 16-20 6/7 weeks was associated with reduction in the incidence of PTB <35 (RR, 0.66; 95% CI, 0.54–0.81), PTB <37 and <32 weeks, and supplemental oxygen and intraventricular hemorrhage (IVH) compared to placebo.6
In the May 2012 Clinical Guideline, “17P 250 mg IM weekly” was preceded by the word “compounded.” As a Letter to the Editors and author's reply explain (Meis PJ. The source of 17P used in NICHD trial. Am J Obstet Gynecol 2012;207:e11 and Berghella V. Reply. Am J Obstet Gynecol 2012;207:e12), this was incorrect. The 17P used in the NICHD MFMU Network trial was manufactured by a research pharmacy using FDA's Good Manufacturing Practices.
Published online: October 15, 2012
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