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Previous Volume 348:2379-2385 June 12, 2003 Number 24 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Greene, M. F. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article PubMed Citation

ABSTRACT

Background Women who have had a spontaneous preterm delivery are at greatly increased risk for preterm delivery in subsequent pregnancies. The results of several small trials have suggested that 17 alpha-hydroxyprogesterone caproate (17P) may reduce the risk of preterm delivery.

Methods We conducted a double-blind, placebo-controlled trial involving pregnant women with a documented history of spontaneous preterm delivery. Women were enrolled at 19 clinical centers at 16 to 20 weeks of gestation and randomly assigned by a central data center, in a 2:1 ratio, to receive either weekly injections of 250 mg of 17P or weekly injections of an inert oil placebo; injections were continued until delivery or to 36 weeks of gestation. The primary outcome was preterm delivery before 37 weeks of gestation. Analysis was performed according to the intention-to-treat principle.

Results Base-line characteristics of the 310 women in the progesterone group and the 153 women in the placebo group were similar. Treatment with 17P significantly reduced the risk of delivery at less than 37 weeks of gestation (incidence, 36.3 percent in the progesterone group vs. 54.9 percent in the placebo group; relative risk, 0.66 [95 percent confidence interval, 0.54 to 0.81]), delivery at less than 35 weeks of gestation (incidence, 20.6 percent vs. 30.7 percent; relative risk, 0.67 [95 percent confidence interval, 0.48 to 0.93]), and delivery at less than 32 weeks of gestation (11.4 percent vs. 19.6 percent; relative risk, 0.58 [95 percent confidence interval, 0.37 to 0.91]). Infants of women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen.

Conclusions Weekly injections of 17P resulted in a substantial reduction in the rate of recurrent preterm delivery among women who were at particularly high risk for preterm delivery and reduced the likelihood of several complications in their infants.

Source Information

From Wake Forest University, Winston-Salem, N.C. (P.J.M.); the National Institute of Child Health and Human Development, Bethesda, Md. (M.K., C.Y.S.); the Biostatistics Center, George Washington University, Rockville, Md. (E.T.); Wayne State University, Detroit (M.P.D.); the University of Tennessee, Memphis (B.S.); the University of Chicago, Chicago (A.H.M.); the University of Alabama, Birmingham (J.C.H.); the University of Cincinnati, Cincinnati, and Columbia University, New York (M.M.); the University of Utah, Salt Lake City (M.W.V.); the University of Texas Southwestern Medical Center, Dallas (K.J.L.); the University of Pittsburgh, Pittsburgh (S.N.C.); Ohio State University, Columbus (J.D.I.); Thomas Jefferson University, Philadelphia (R.J.W.); the University of Texas, San Antonio (D.C.); the University of Miami, Miami (M.J.O.); Brown University, Providence, R.I. (M.C.); Case Western Reserve University, Cleveland (B.M.); the University of Texas, Houston (S.M.R.); the University of North Carolina, Chapel Hill (J.M.T.); and Northwestern University, Chicago (A.M.P.).

Address reprint requests to Dr. Meis at the Department of Obstetrics and Gynecology, Wake Forest University, Medical Center Blvd., Winston-Salem, NC 27157, or at pmeis{at}wfubmc.edu.

Full Text of this Article

Related Letters:

Prevention of Recurrent Preterm Delivery by 17 Alpha-Hydroxyprogesterone Caproate
Brancazio L. R., Murtha A. P., Heine R. P., Meis P. J., Spong C. Y.
Extract | Full Text | PDF  
N Engl J Med 2003; 349:1087-1088, Sep 11, 2003. Correspondence

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