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Randomized Controlled Trial
. 2007 Oct;110(4):865-72.
doi: 10.1097/01.AOG.0000281348.51499.bc.

Follow-up of children exposed in utero to 17 alpha-hydroxyprogesterone caproate compared with placebo

Allison T Northen  1 , Gwendolyn S Norman, Kristine Anderson, Lisa Moseley, Michelle Divito, Margaret Cotroneo, Melissa Swain, Sabine Bousleiman, Francee Johnson, Karen Dorman, Cynthia Milluzzi, Jo-Ann Tillinghast, Marcia Kerr, Gail Mallett, Elizabeth Thom, Susan Pagliaro, Garland D Anderson; National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network
Affiliations
Randomized Controlled Trial

Follow-up of children exposed in utero to 17 alpha-hydroxyprogesterone caproate compared with placebo

Allison T Northen et al. Obstet Gynecol. 2007 Oct.

Abstract

Objective: To assess whether there are evident adverse effects of 17 alpha-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 alpha-hydroxyprogesterone caproate, with a 2:1 allocation to 17 alpha-hydroxyprogesterone caproate and placebo, respectively. The guardian was interviewed about the child's 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 alpha-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 alpha-hydroxyprogesterone caproate and placebo children. Scores for gender-specific roles (Preschool Activities Inventory) were within the normal range and similar between 17 alpha-hydroxyprogesterone caproate and placebo groups.

Conclusion: 17 alpha-hydroxyprogesterone caproate seems to be safe for the fetus when administered in the second and third trimesters.

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