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

Hemodynamic changes and baroreflex gain in the supine hypotensive syndrome.

OBJECTIVE: The purpose of this study was to determine whether supine hypotensive syndrome is caused by a decreased baroreflex gain that results in inadequate compensatory responses to restore cardiac output. STUDY DESIGN: Ten third-trimester gravid women with symptoms that were suggestive of supine hypotensive syndrome and 10 control subjects without symptoms were studied. Patients were studied initially for 30 minutes in the lateral recumbent position with continuous heart rate, blood pressure, external cardiotocography, and cardiac output determinations every 5 minutes. After 30 minutes, the patient was repositioned supine for up to an additional 30 minutes, and all measurements were repeated similarly. This lateral-supine sequence was repeated twice or until symptoms precluded further testing. RESULTS: The two groups were demographically similar. With maternal position change to supine, cardiac output (-2.7 L/min vs -1.0 L/min, P =.04) and mean arterial blood pressure (-10.7 mm Hg vs -2.5 mm Hg, P =.03) were respectively lower, and heart rate (+26.9 vs +14.4 beats/min, P =.04) was higher in the subjects with supine hypotensive syndrome than in the control subjects. Baroreflex gain, however, did not differ between the subjects with supine hypotensive syndrome and control subjects (P =.26). CONCLUSION: We were unable to demonstrate a decrease in baroreflex gain as a possible cause of supine hypotensive syndrome. Inadequate pelvic collateral circulation that leads to a greater decrease in cardiac output may be causative in the syndrome.