title: Follow-up of children exposed in utero to 17 alpha-hydroxyprogesterone caproate compared with placebo.
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.
  
  
  CONCLUSIONS
  17 alpha-hydroxyprogesterone caproate seems to be safe for the fetus when administered in the second and third trimesters.
authors: Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama 35294-0024, USA. anorthen@uab.edu
authors: Allison T
authors: AT
authors: Northen
authors: Gwendolyn S
authors: GS
authors: Norman
authors: Kristine
authors: K
authors: Anderson
authors: Lisa
authors: L
authors: Moseley
authors: Michelle
authors: M
authors: Divito
authors: Margaret
authors: M
authors: Cotroneo
authors: Melissa
authors: M
authors: Swain
authors: Sabine
authors: S
authors: Bousleiman
authors: Francee
authors: F
authors: Johnson
authors: Karen
authors: K
authors: Dorman
authors: Cynthia
authors: C
authors: Milluzzi
authors: Jo-Ann
authors: JA
authors: Tillinghast
authors: Marcia
authors: M
authors: Kerr
authors: Gail
authors: G
authors: Mallett
authors: Elizabeth
authors: E
authors: Thom
authors: Susan
authors: S
authors: Pagliaro
authors: Garland D
authors: GD
authors: Anderson
mesh_terms: D000077713:17 alpha-Hydroxyprogesterone Caproate; D002657:Child Development / Q000187:drug effects*; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006908:Hydroxyprogesterones / Q000009:adverse effects*; D007231:Infant, Newborn; D009420:Nervous System / Q000254:growth & development*; D011247:Pregnancy; D011262:Pregnancy Trimester, Second; D011263:Pregnancy Trimester, Third; D011297:Prenatal Exposure Delayed Effects; D011372:Progestins / Q000009:adverse effects*
chemical_list: D006908:Hydroxyprogesterones; D011372:Progestins; D000077713:17 alpha-Hydroxyprogesterone Caproate