Could a sleep hormone help unborn babies grow?
NCT ID NCT07549295
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving melatonin to pregnant women with a severe form of fetal growth restriction can help their babies. The trial will involve 240 women who will take either melatonin or a placebo nightly. Researchers will track baby growth, pregnancy length, and newborn health to see if melatonin reduces serious complications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Melatonin
- What this could lead to
- If it works, this could point toward a simple, safe treatment to help babies with severe growth restriction grow better and have fewer complications.
- What could go wrong
- This is an early phase 1 trial, so it is primarily testing safety. The dose and timing may not be optimal, and the results may not apply to all cases of fetal growth restriction.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 43 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Singleton pregnancy 2. intact membranes 3. detectable fetal cardiac activity, and normal fetal movements. 4. Diagnosis of isolated maternal vascular malperfusion-related fetal growth restriction (MVM-FGR) between 24+0 and 31+6 weeks of gestation, defined as: 1\) Estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile for gestational age, and uterine artery pulsatility index (UtA-PI) or umbilical artery pulsatility index (UA-PI) ≥95th percentile; or 2) Absent or reversed end-diastolic flow in the umbilical artery, regardless of estimated fetal weight. (5) Willingness to participate in the study, ability to comply with the observation and treatment protocol, and provision of written informed consent. Exclusion Criteria: 1. Presence of severe acute or chronic maternal diseases that make continuation of pregnancy unsafe. 2. Fetal structural anomalies, genetic abnormalities, or intrauterine infections. 3. Immediate need for pregnancy termination prior to enrollment, such as absent a-wave in the ductus venosus, preterminal cardiotocography (CTG), or a critically abnormal biophysical profile (BPP). 4. Treatment within 1 month prior to enrollment with medications such as low-molecular-weight heparin, aspirin, sildenafil, or traditional Chinese medicine aimed at preventing miscarriage or supporting pregnancy. 5. Individuals with legally defined disabilities (including visual impairment, hearing impairment, speech impairment, intellectual disability, mental disorders, or physical disability) and patients with psychiatric illness. 6. Participation in another clinical trial within the past 3 months. 7. A history of smoking more than 10 cigarettes per day within 3 months prior to screening. 8. Suspected or confirmed alcohol or substance abuse. 9. Known allergy to melatonin or any component of the investigational product. 10. Any other condition that, in the investigator's judgment, makes the participant unsuitable for this clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Blood test may pinpoint cause of stunted fetal growth
- Can a blood test or eye scan predict pregnancy risks?
- New ultrasound tech could spot hidden placental problems in pregnancy
- Tiny placental particles may hold key to pregnancy complications
- AI-Powered ultrasound aims to predict risks in pregnancy complication