Effect of Adjuvant Melatonin in Preventing Preeclampsia in Women with Moderate to High-Risk Factor: A Randomised Clinical Trial.

Abstract

Objective: Preeclampsia is a serious disorder characterised by elevated blood pressure and damage to various maternal organs; it is recognised as one of the leading causes of maternal and foetal mortality. This study aims to evaluate the adjunctive effect of melatonin in preventing preeclampsia in women with moderate to high-risk for this disorder.

Materials and methods: This randomised, triple-blind, controlled clinical trial enrolled pregnant women with moderate to high-risk factor for preeclampsia who visited the clinics at Kashan University of Medical Sciences, Kashan, Iran. Convenience sampling and randomised block allocation provided a sample size of 70 participants per group. The intervention group received 80 mg of aspirin along with 10 mg of melatonin, while the control group received aspirin with a placebo. Data on demographic, obstetric characteristics, and patient outcomes were recorded in relevant checklists. The data were analysed using SPSS version 17.

Results: There was no significant difference between the intervention and control groups in mean systolic and diastolic blood pressures at admission, hospitalisation, or delivery (P>0.05). Aspirin plus melatonin compared to aspirin plus placebo did not result in a statistically significant difference in delivery outcomes (P=0.453). The incidence of preeclampsia also demonstrated no significant difference between the two groups (P=0.357). Additionally, the mean gestational age was not significantly different between the groups (P=0.572). Regarding neonatal outcomes, no significant difference was observed in Apgar scores at one and five minutes (P>0.05). Similarly, there was no significant difference in mean head circumference, length, and birth weight of the newborns between the groups (P>0.05).

Conclusion: Although melatonin has shown promising results in laboratory studies, these effects were not significantly observed in pregnant women. Further studies are needed to confirm the effects of melatonin in preventing preeclampsia (registration number: IRCT20230930059563N1).