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American Journal of Obstetrics and Gynecology

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Relationship between 17-alpha hydroxyprogesterone caproate concentration and spontaneous preterm birth - 25/01/14

Doi : 10.1016/j.ajog.2013.10.008 
Steve N. Caritis, MD a, Raman Venkataramanan, PhD a, Elizabeth Thom, PhD c, Margaret Harper, MD d, Mark A. Klebanoff, MD n, Yoram Sorokin, MD e, John M. Thorp, MD d, Michael W. Varner, MD f, Ronald J. Wapner, MD g, Jay D. Iams, MD h, Marshall W. Carpenter, MD j, William A. Grobman, MD, MBA k, Brian M. Mercer, MD i, Anthony Sciscione, DO b, Dwight J. Rouse, MD l, Susan Ramin, MD m
for the

Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network and Obstetric-Fetal Pharmacology Research Units Network

a Department of Obstetrics and Gynecology and Reproductive Sciences and Pharmaceutical Sciences, University of Pittsburgh Schools of Medicine and Pharmacy, Pittsburgh, PA 
b Drexel University College of Medicine, Philadelphia, PA 
c The George Washington University Biostatistics Center, Washington, DC 
d Department of Obstetrics and Gynecology, Wake Forest University Health Sciences, Winston-Salem, and University of North Carolina at Chapel Hill, Chapel Hill, NC 
e Department of Obstetrics and Gynecology, Wayne State University, Detroit, MI 
f Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City, UT 
g Department of Obstetrics and Gynecology, College of Physicians and Surgeons, Columbia University, New York, NY 
h Department of Obstetrics and Gynecology, The Ohio State University, Columbus, OH 
i Department of Obstetrics and Gynecology, Case Western Reserve University–MetroHealth Medical Center, Cleveland, OH 
j Department of Obstetrics and Gynecology, Women and Infants Hospital, Alpert Medical School, Brown University, Providence, RI 
k Department of Obstetrics and Gynecology, Feinberg School of Medicine, Northwestern University, Chicago, IL 
l Department of Obstetrics and Gynecology, University of Alabama at Birmingham School of Medicine, Birmingham, AL 
m Department of Obstetrics and Gynecology, University of Texas Health Science Center at Houston, Houston, TX 
n Maternal-Fetal Medicine Units, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD 

Abstract

Objective

17-alpha hydroxyprogesterone caproate 250 mg weekly reduces recurrent spontaneous preterm birth in women with a prior spontaneous preterm birth by 33%. The dose is not based on pharmacologic considerations. A therapeutic concentration has not been determined hampering any attempt to optimize treatment. This study evaluated the relationship between 17-alpha hydroxyprogesterone caproate plasma concentrations and the rate of spontaneous preterm birth in women with singleton gestation.

Study Design

A single blood sample was obtained between 25 and 28 weeks' gestation from 315 women with a spontaneous preterm birth who participated in a placebo-controlled, prospective, randomized clinical trial evaluating the benefit of omega-3 supplementation in reducing preterm birth. All women in the parent study received 17-alpha hydroxyprogesterone caproate and 434 received omega-3 supplementation and 418 received a placebo. Plasma from 315 consenting women was analyzed for 17-alpha hydroxyprogesterone caproate concentration.

Results

There were no differences between placebo and omega-3 supplemented groups in demographic variables, outcomes or in mean 17-alpha hydroxyprogesterone caproate concentration. Plasma concentrations of 17-alpha hydroxyprogesterone caproate ranged from 3.7-56 ng/mL. Women with plasma concentrations of 17-alpha hydroxyprogesterone caproate in the lowest quartile had a significantly higher risk of spontaneous preterm birth (P = .03) and delivered at significantly earlier gestational ages (P = .002) than did women in the second to fourth quartiles. The lowest preterm birth rates were seen when median 17-alpha hydroxyprogesterone caproate concentrations exceeded 6.4 ng/mL.

Conclusion

Low plasma 17-alpha hydroxyprogesterone caproate concentration is associated with an increased risk of spontaneous preterm birth. This finding validates efficacy of this treatment but suggests that additional studies are needed to determine the optimal dosage.

Il testo completo di questo articolo è disponibile in PDF.

Key words : dose response, pharmacodynamics, 17-hydroxyprogesterone caproate concentration-response


Mappa


 Additional members of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network are listed in the Acknowledgments.
 The project described was supported by grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (HD047905, HD27860, HD27917, HD40560, HD34208, HD40485, HD21410, HD27915, HD40500, HD40512, HD40544, MO1-RR-000080, HD34136, HD27869, HD40545, HD36801) and does not necessarily represent the official views of the NICHD or NIH.
 The authors report no conflict of interest.
 Reprints not available from authors.
 Cite this article as: Caritis SN, Venkataramanan R, Thom E, et al. Relationship between 17-alpha hydroxyprogesterone caproate concentration and spontaneous preterm birth. Am J Obstet Gynecol 2014;210:128.e1-6.


© 2014  Mosby, Inc. Tutti i diritti riservati.
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Vol 210 - N° 2

P. 128.e1-128.e6 - febbraio 2014 Ritorno al numero
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