Related Experiment Video
Updated: Jul 11, 2026
Comprehensive Evaluation of the Effectiveness and Safety of Placenta-Targeted Drug Delivery Using Three Complementary Methods
Published on: September 10, 2018
Follow-up of children exposed in utero to 17 alpha-hydroxyprogesterone caproate compared with placebo
Allison T Northen1, Gwendolyn S Norman, Kristine Anderson
1Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama 35294-0024, USA. anorthen@uab.edu
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.
