Comparing Neonatal Outcome Following the Use of Ondansetron versus Vitamin B6 in Pregnant Females with Morning Sickness: A Randomized Clinical Trial

Pregnancy-related nausea and vomiting or morning sickness with an overall prevalence rate of 80% is commonly appeared at the eighth week and frequently disappeared in most pregnant females at the 16th week of gestation. The severe form of the condition named hyperemesis occurs in one per 200 to 300 pregnancies; it is accompanied by dehydration, electrolyte instability and nutritional deficits and needs medical interventions. Limited data are available on harmful effects of common antiemetic medications used within pregnancy on human neonates. The current study aimed to compare the effects of ondansetron and vitamin B6 on neonatal outcome in pregnant females with pregnancy-related nausea and vomiting. Neonatal outcome included the probable difference in neonates’ gestational age, weight, height, head circumference and frequency of apparent congenital anomalies. This randomized double-blinded clinical trial was conducted on 188 primipara singleton pregnant females with pregnancy-related nausea and vomiting who referred to state healthcare centers of Zabol, Iran, in 2014. The pregnant females were randomly assigned to receive drug packages including ondansetron tablets (4 mg) or vitamin B6 tablets (40 mg) and patients were instructed to take one tablet twice daily. Females were followed up until delivery and neonatal outcomes including any congenital anomaly, weight, height and head circumference at birth were assessed. There was no difference between the groups in the mean age of mother and the mean age of gestation. No differences were found between the groups regarding birth weight (3006.93 ± 441.86 versus 2949.65 ± 457.36 g, P= 0.67), height at birth (49.50 ± 1.45 versus 48.97 ± 1.47 cm, P= 0.75) and head circumference at birth (34.23 ± 1.22 versus 33.88 ± 1.26 cm, P = 0.56). No neonatal anomaly was observed in the two groups. No significant differences were observed between the groups based on the neonatal outcome including neonatal anthropometric parameters and lack of congenital anomaly.