Plain-English translation of NCT05651347 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.
This trial is testing whether melatonin, a naturally occurring hormone in the body, can help protect a baby's developing brain when pregnancy complications limit fetal growth. Researchers believe melatonin may reduce brain injury in babies by acting as a powerful protector against cell damage. Half of pregnant women in the study will receive melatonin, and half will receive a placebo (inactive pill), to see if this treatment can improve long-term brain health in newborns.
Babies with severe growth restriction due to placental problems often experience brain injury, and current treatments only help in the final hours before birth. This medication crosses the placenta easily and could potentially protect the baby's brain over weeks before delivery, filling an important gap in how doctors care for these high-risk pregnancies.
You likely qualify if…
You likely don't qualify if…
If you qualify and enroll, you will take three tablets daily (either melatonin or placebo—you won't know which) from enrollment until delivery. Neither you, your doctor, nor the research team will know whether you're taking the active medication or placebo. You'll continue your regular prenatal care and monitoring, and researchers will follow your baby's development after birth to track any differences between the two groups.
AI-generated summary from trial data · Aug 20, 2026 · Not medical advice
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