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the Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal Fetal Medicine Units Network (MFMU) and the Obstetric-Fetal Pharmacology Research Centers (OPRC) Network, Bethesda, MD
To determine the effect of antenatal pravastatin treatment in high-risk patients on child’s health and neurodevelopment.
This is a follow-up study of children born to mothers who participated in one of two consecutive pilot randomized trials of pravastatin to prevent preeclampsia. Women with prior preeclampsia requiring delivery < 34 weeks were randomly assigned to pravastatin (10 mg and 20 mg, respectively) or placebo from 12-16 weeks until delivery. For this analysis, data from the two trials were combined in a pravastatin and placebo exposed groups. Certified, trained, and blinded study personnel reviewed the child’s medical record and completed an in-person child assessment using validated motor and neurodevelopmental tests (Table 2). The parent completed the Child Behavior Checklist (CBCL).
Out of 40 children born to women enrolled in either trial, 30 (ages 2.5-6.9 years) were enrolled in this follow-up study (15 exposed to pravastatin and 15 to placebo). Table 1 summarizes pregnancy outcomes and children growth at follow-up. Obesity (BMI ≥95th percentile) was 14.3% and 26.7% in children exposed to pravastatin vs. placebo. Children born to mothers in the pravastatin group had no limitations in motor assessment compared with 2 (13.3%) children who walked with difficulty and 4 (28.6%) children who had reduced manual abilities in the placebo group. Children general cognitive assessment was 98.2 ± 16.7 vs. 89.7 ± 11.0 and a score < 85 (1 SD below mean) was 15.4% vs. 35.7% in children exposed to pravastatin vs. placebo (Table 2). There were no differences in the parents’ report on the CBCL or in the frequency of scores that are considered borderline or in the clinical/abnormal range.
This is the first follow-up study of children exposed in-utero to pravastatin for preeclampsia prevention. Although the data are limited by the original trials’ sample size, no identifiable long-term neurodevelopmental safety signal was evident with antenatal pravastatin use. Our results support the recent request by the FDA to remove the contraindication against statins in pregnancy.