Introduction: The efficacy and safety of tadalafil, phosphodiesterase 5 inhibitor, as the new therapeutic agent for fetal growth restriction (FGR), have been studied since 2014 in our institute. To assess the long-term effects of tadalafil, we evaluated the developmental prognosis of these 1.5 years old infants.
Materials and Methods: 24 infants whose mother had taken tadalafil for FGR during the pregnancy from July 2015 to August 2016 in Mie University Hospital were tracked at 18 months corrected age. We evaluated their body weight, height, and head circumference and the developmental test by Kyoto Scale of Psychological Development (KSPD),which is standardised developmental assessment covering the Postural-Motor (P-M), Cognitive-Adaptive (C-A) and Language-Social (L-S), and the sum score is converted to developmental quotient (DQ).
Results: Mean gestational weeks of cases was 36.1 (29-39) weeks, and mean birth weight was 1841 (874-2646) g. 3 cases of 24 cases were appropriate for gestational age and 15 cases were small for gestational age infants at the birth. 21 of 24 cases caught up on body weight within 3rd percentile at mean 5.8 months; 20 of 24 cases on height at mean 3.9 months; and all cases on head circumference at mean 3.8 months. KSPD was performed in 18 cases at 1.5 years old and mean DQ scores were 87 in total; 82 in P-M , 90 in C-A, 88 in L-S out of 100. Total DQ score in one case (5.6%) was found to be less than 70, in 5 cases (27.7%) within 70 and 85, in 11 cases (61.1%) more than 85 out of 100.
Conclusion: Infants born from tadalafil-treated mothers seem to make good progress at 1.5 years’ corrected age in growth and development.