Follow-up of Children Exposed in Utero to 17 Hydroxyprogesterone Caproate Compared With Placebo
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 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 -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 assessed with the Preschool Activities Inventory.
Conclusion
17-hydroxyprogesterone caproate seems to be safe for the fetus when administered in the second and third trimesters.
From the Departments of Obstetrics and Gynecology, 1Center for Women's 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.
Allison T. Northen, RN, BSN1, Gwendolyn S. Norman, RN, BSN, MPH2, Kristine Anderson, RN, BSN3, Lisa Moseley, RN4, Michelle DiVito, RN, MSN5, Margaret Cotroneo, RN, CCRC6, Melissa Swain, RN7, Sabine Bousleiman, RNC, MSN8, Francee Johnson, RN, BSN9, Karen Dorman, RN, MS10, Cynthia Milluzzi, RN, BSN11, Jo-Ann Tillinghast, RN, MSN12, Marcia Kerr, RN, CCRC13, Gail Mallett, BSN, CCRC14, Elizabeth Thom, PhD15, Susan Pagliaro16, Garland D. Anderson, MD17 for the National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network*