Trial · NCT05651347
Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
NCT05651347, Phase 3, Recruiting, Monash University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction. Trials, record NCT05651347. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05651347
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction
- NCT number
- NCT05651347
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 336 participants, estimated
- Lead sponsor
- Monash University
- Conditions
- Fetal Growth Retardation, Stillbirth and Fetal Death, Pregnancy Preterm
- Interventions
- Placebo, Melatonin 10 MG
- First posted
- 2022-12-15
- Last updated
- 2025-06-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neurodevelopmental performance at 2 years of life among survivors of early onset FGR. | 24-36 months corrected age | The primary outcome will be identified by a change in the Bayley-IV Cognitive score of 5 or more points. |
| Secondary | Incidence of patient reported side effects and adverse events with melatonin use in pregnancy | From randomisation until cessation of trial medication at birth, assessed for up to 18 weeks. | Maternal side effect profiles experienced, such as symptoms of abdominal cramps, flushing, migraines, gastrointestinal disturbance. This will be collected from the patient medication diary completed during treatment with reported side effects expressed as incidence (% patients). |
| Secondary | Incidence of patient reported daytime somnolence with melatonin use in pregnancy | From randomisation until cessation of trial medication at birth, assessed for up to 18 weeks. | Maternal symptoms of drowsiness, obtained from the patient completed medication diary, will be expressed as an average somnolence score (scale 1-10). |
| Secondary | Rate of altered maternal end-organ performance with melatonin supplementation | Pre-intervention until 2 weeks post-commencement of intervention | Haematological and biochemical investigations undertaken pre- and post- commencement of trial medication will be used to assess the rate of change in maternal end-organ function, particularly renal and liver function. |
| Secondary | Impact of melatonin on fetal growth | From randomisation until birth, for up to 17 weeks | The antenatal use of melatonin on estimated fetal growth (grams) will be assessed using ultrasound biometry parameters performed fortnightly following trial recruitment until birth. The fetal growth trajectory across gestation will be compared to the placebo group. |
| Secondary | Impact of melatonin on fetoplacental Dopplers | From randomisation until birth, assessed for up to 17 weeks | The antenatal use of melatonin on fetoplacental Dopplers performed fortnightly following trial recruitment until birth. The incidence of abnormal fetoplacental Doppler indices will be reported according to gestational age |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31230020 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05651347
GET https://conductscience.org/api/trials/v1/NCT05651347/registered