Progesterone Reduces Risk of Pre-Term Delivery

Our local newspaper reports today (August 1, 2003) that; (2005 Update)

Giving pregnant women the hormone progesterone can reduce their risk of premature delivery by one third, offering the first clear-cut way to head off this increasingly common and dangerous problem, a study found

Low birth weight and serious, sometimes deadly complications also occurred less often in babies whose mothers got the weekly injections, according to the study in a recent New England Journal of Medicine.

The progesterone proved so effective that the study was halted early because it would have been unethical to keep giving some women a placebo.

This is a nice report about a study that was presented in some very prestigious medical journals.  The study above used 17 Alpha-Hydroxyprogesterone Caproate.  The results were very positive and I applaud the effort.  I do question why they decided to use an injection of a form of progesterone when pure progesterone is available - AND it can be administered without the need of a needle.  Doctors who treat high risk pregnancies and those who work in the fertility field have known for years that progesterone protects the baby and helps maintain the pregnancy (PRO GEST erone  --  means FOR Gestation).  Here are the details;

Prevention of Recurrent Preterm Delivery by 17 Alpha-Hydroxyprogesterone Caproate

Paul J. Meis, M.D., Mark Klebanoff, M.D., Elizabeth Thom, Ph.D., Mitchell P. Dombrowski, M.D., Baha Sibai, M.D., Atef H. Moawad, M.D., Catherine Y. Spong, M.D., John C. Hauth, M.D., Menachem Miodovnik, M.D., Michael W. Varner, M.D., Kenneth J. Leveno, M.D., Steve N. Caritis, M.D., Jay D. Iams, M.D., Ronald J. Wapner, M.D., Deborah Conway, M.D., Mary J. O'Sullivan, M.D., Marshall Carpenter, M.D., Brian Mercer, M.D., Susan M. Ramin, M.D., John M. Thorp, M.D., Alan M. Peaceman, M.D., for the National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network

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@wfubmc.edu.

Meis, P.J. . . . and A.M. Peaceman. 2003. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. New England Journal of Medicine 348(June 12):2379-2385. Abstract available at http://content.nejm.org/cgi/content/abstract/348/24/2379.

da Fonseca, E.B., et al. 2003. 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. American Journal of Obstetrics and Gynecology 188(February):419-424. Abstract available at http://dx.doi.org/10.1067/mob.2003.41.

 Greene, M.F. 2003. Progesterone and preterm delivery—déjà vu all over again. New England Journal of Medicine 348(June 12):2453-2455. Extract available at http://content.nejm.org/cgi/content/extract/348/24/2453. 

Johnson, J.W.C., et al. 1975. Efficacy of 17-hydroxyprogesterone caproate in the prevention of premature labor. New England Journal of Medicine 293(Oct. 2):675-680. Abstract available at http://content.nejm.org/cgi/content/abstract/293/14/675.

 Yemini, M., et al. 1985. Prevention of premature labor by 17 alpha-hydroxyprogesterone caproate. American Journal of Obstetrics and Gynecology 151:574-577.

Sources:

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