RESUMEN
BACKGROUND: English ivy (Hedera helix) is commonly used to reduce productive cough symptoms by acting as expectorant therapy. The safety of Hedera helix extract during pregnancy was not established yet. This study aims to determine the safety of English ivy leaf extract on newborns. OBJECTIVES: To determine the weight, APGAR (Activity-Pulse-Grimace-Appearance-Respiration) score, and health status of the newborns among the studied groups. METHODS: A retrospective multicenter cohort study was conducted during the fourth quarter of 2020 on 245 pregnant women and their newborns in two hospitals located in Riyadh, Saudi Arabia. The women were divided into an exposed group (N = 165) who used English ivy leaf extract syrup during pregnancy, and a control group (N = 80) who were not using any natural-pharmaceutical product for cough. RESULTS: The mean weight of the newborns in the exposed group was 3 kg compared to 2.8 kg in the control group (p-value < 0.05). The median APGAR score of the newborns in the exposed group was 8.5/10 compared to 8.0/10 in the control group (p-value > 0.05). There were no significant differences regarding the percentages of full-term and preterm newborns in the exposed and control groups (78.8% vs. 76.3%, and 21.0% vs. 24.0%, respectively, odds ratio [OR] = 0.86, 95% confidence interval [CI] = 0.45-1.63, p-value > 0.05). Regarding the newborns' health complications reported, there was no statistical difference in the percentages of full-term newborns diagnosed with at least one health complication between the exposed and control groups (0.6 vs. 3.8, OR = 0.15, 95% CI = 0.01-1.47, p-value > 0.05). CONCLUSION: Hedera helix (English ivy) leaf extract syrup was safe to be used in short term during pregnancy for the fetus.