Clinical trial
Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth…
NCT05651347 · Monash University, Other · Recruiting
Key facts
| NCT number | NCT05651347 |
|---|---|
| Title | Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction |
| Official title | A Triple-blinded, Randomized, Parallel-group Placebo-controlled Trial to Assess the Impact of Maternal Antenatal Melatonin Supplementation on Early Childhood Neurodevelopmental Outcomes in the Setting of Severe Preterm Fetal Growth Restriction |
| Acronym | PROTECTMe |
| Lead sponsor | Monash University, Other |
| Collaborators | National Health and Medical Research Council, Australia Cerebral Palsy Alliance Equity Trustees |
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Fetal Growth Retardation, Stillbirth and Fetal Death, Pregnancy Preterm |
| Intervention type | Drug, Other |
| Interventions | Placebo, Melatonin 10 MG |
| Enrollment | 336 |
| Start date | May 29, 2019 |
| Primary completion | Apr 30, 2027 |
| Completion | Apr 30, 2027 |
| First posted | Dec 15, 2022 |
| Last update posted | Jun 6, 2025 |
| Countries | Australia, New Zealand |
At a glance
- 10–99 Study sites
- No Results posted
- 10–99 FDA inspections linked to this trial
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: