Study of Maternal Melatonin Supplementation to Protect Brain Development in Severe Early Preterm Fetal Growth Restriction

What this Trial Is About

Fetal growth restriction FGR affects many pregnancies and is linked to serious risks including stillbirth, preterm birth, and long-term developmental challenges such as cerebral palsy. This trial evaluates whether giving pregnant women melatonin can protect the fetal brain and improve neurodevelopmental outcomes in babies affected by early-onset severe FGR. The study is a triple-blind, randomized, placebo-controlled trial aiming to address the lack of treatments to enhance fetal wellbeing before birth. Participants will receive either melatonin tablets 10 mg three times daily for a total of 30 mg per day or matching placebo tablets three times a day. The trial includes pregnancies diagnosed with severe FGR between 23 and 31 weeks gestation. Treatment continues until birth. The study is conducted across multiple centers, with participant groups randomized based on gestational age to allow sub-analysis of early and late onset FGR. Participants will be monitored throughout pregnancy with assessments of fetal growth and placental blood flow. After birth, childrens neurodevelopment will be evaluated at 2 years of age using the Bayley-IV Cognitive scale. Researchers will also track side effects, maternal organ function, and fetal wellbeing until birth. The total participation duration varies depending on gestational age at enrollment and follow-up visits extend to 2-3 years of the childs life for outcome measurement.

Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction