Follow-up of children exposed in utero to 17 alpha-hydroxyprogesterone caproate compared with placebo.
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.
Northen
Allison T
AT
Department of Obstetrics and Gynecology, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama 35294-0024, USA. anorthen@uab.edu
Norman
Gwendolyn S
GS
Anderson
Kristine
K
Moseley
Lisa
L
Divito
Michelle
M
Cotroneo
Margaret
M
Swain
Melissa
M
Bousleiman
Sabine
S
Johnson
Francee
F
Dorman
Karen
K
Milluzzi
Cynthia
C
Tillinghast
Jo-Ann
JA
Kerr
Marcia
M
Mallett
Gail
G
Thom
Elizabeth
E
Pagliaro
Susan
S
Anderson
Garland D
GD
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*
D006908:Hydroxyprogesterones; D011372:Progestins; D000077713:17 alpha-Hydroxyprogesterone Caproate