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ORIGINAL ARTICLES |
-Hydroxyprogesterone Caproate Compared With PlaceboFrom the Departments of Obstetrics and Gynecology, 1Center for Womens Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama; 2Wayne State University, Detroit, Michigan; 3University of Utah, Salt Lake City, Utah; 4University of Texas Southwestern Medical Center, Dallas, Texas; 5Drexel University, Philadelphia, Pennsylvania; 6University of Pittsburgh, Pittsburgh, Pennsylvania; 7Wake Forest University, Winston-Salem, North Carolina; 8Columbia University, New York, New York; 9Ohio State University, Columbus, Ohio; 10University of North Carolina, Chapel Hill, North Carolina; 11Case Western Reserve University, Cleveland, Ohio; 12Brown University, Providence, Rhode Island; 13University of Texas at Houston, Houston, Texas; 14Northwestern University, Chicago, Illinois; 15the George Washington University Biostatistics Center, Washington, DC; 16National Institute of Child Health and Human Development (NICHD), Bethesda, Maryland; and 17the University of Texas Medical Branch, Galveston, Texas.
ABSTRACT
OBJECTIVE: To assess whether there are evident adverse effects of 17
-hydroxyprogesterone caproate after in utero exposure.
METHODS: This study evaluated surviving children of mothers who participated in a multicenter placebo-controlled trial of weekly intramuscular 17
-hydroxyprogesterone caproate, with a 2:1 allocation to 17
-hydroxyprogesterone caproate and placebo, respectively. The guardian was interviewed about the childs general health. Children underwent a physical examination and developmental screen with the Ages and Stages Questionnaire. Gender-specific roles were assessed with the Preschool Activities Inventory.
RESULTS: Of 348 eligible surviving children, 278 (80%) were available for evaluation (194 in the 17
-hydroxyprogesterone caproate group and 84 in the placebo group). The mean age at follow-up was 48 months. No significant differences were seen in health status or physical examination, including genital anomalies, between 17
-hydroxyprogesterone caproate and placebo children. Scores for gender-specific roles (Preschool Activities Inventory) were within the normal range and similar between 17
-hydroxyprogesterone caproate and placebo groups.
CONCLUSION: 17
-hydroxyprogesterone caproate seems to be safe for the fetus when administered in the second and third trimesters.
LEVEL OF EVIDENCE: II
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J. M. Dodd, V. J. Flenady, R. Cincotta, and C. A. Crowther Progesterone for the Prevention of Preterm Birth: A Systematic Review Obstet. Gynecol., July 1, 2008; 112(1): 127 - 134. [Abstract] [Full Text] [PDF] |
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J. M. O'Brien, M. Chandiramani, R. Tribe, A. Shennan, K. H. Nicolaides, E. Celik, E. B. Fonseca, D. J. Rouse, E. A. Thom, C. Y. Spong, et al. Progesterone and Preterm Birth N. Engl. J. Med., November 29, 2007; 357(22): 2306 - 2307. [Full Text] [PDF] |
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