Fetal Growth Restriction (FGR)Phase 1MIMVMFGRNCT07549295
Melatonin and Perinatal Outcomes in MVM-Related Fetal Growth Restriction (MIMVMFGR)
A Phase 1 study testing Melatonin in people with Fetal Growth Restriction (FGR), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of melatonin in the treatment of early-onset severe maternal vascular malperfusion-related fetal growth restriction (MVM-FGR), and to determine its effects on fetal growth and perinatal outcomes. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- Fetal Growth Restriction (FGR)
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Nov 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Singleton pregnancy
- intact membranes
- detectable fetal cardiac activity, and normal fetal movements.
- 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.
- Willingness to participate in the study, ability to comply with the observation and treatment protocol, and provision of written informed consent.
Who cannot join
- Presence of severe acute or chronic maternal diseases that make continuation of pregnancy unsafe.
- Fetal structural anomalies, genetic abnormalities, or intrauterine infections.
- 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).
- 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.
- Individuals with legally defined disabilities (including visual impairment, hearing impairment, speech impairment, intellectual disability, mental disorders, or physical disability) and patients with psychiatric illness.
- Participation in another clinical trial within the past 3 months.
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- A history of smoking more than 10 cigarettes per day within 3 months prior to screening.
- Suspected or confirmed alcohol or substance abuse.
- Known allergy to melatonin or any component of the investigational product.
- Any other condition that, in the investigator's judgment, makes the participant unsuitable for this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
Official title: A Randomized Controlled Clinical Trial to Explore the Effectiveness of Melatonin as a Perinatal Intervention in Maternal Vascular Malperfusion-Associated Fetal Growth Restriction
The goal of this clinical trial is to evaluate the efficacy and safety of melatonin in the treatment of early-onset severe maternal vascular malperfusion-related fetal growth restriction (MVM-FGR), and to determine its effects on fetal growth and perinatal outcomes. The study will enroll pregnant women with singleton pregnancies diagnosed with severe MVM-FGR between 24+0 and 31+6 weeks of gestation.
The main questions it aims to answer are:
Read more
- Whether melatonin treatment can reduce the incidence of a composite adverse neonatal outcome, including neonatal death and severe neonatal complications.
- Whether melatonin treatment can improve pregnancy and neonatal outcomes, including the interval from treatment initiation to delivery, gestational age at delivery, fetal growth trajectory throughout pregnancy (Z-score slope over time estimated using linear mixed models), neonatal birthweight, Apgar scores, neonatal complications (such as respiratory distress syndrome), maternal adverse events (such as hypertensive disorders of pregnancy), and placental pathological findings.
Researchers will compare participants receiving a placebo (one capsule taken at bedtime, identical in appearance and size to melatonin) with those receiving melatonin to determine whether melatonin improves these maternal and neonatal outcomes.
Participants will:
- Take melatonin 10 mg orally once nightly at bedtime.
- Conditions
- Fetal Growth Restriction (FGR)
- Being tested
- Melatonin, Placebo
- Keywords
- FGR, melatonin
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Take melatonin 10 mg orally once nightly at bedtime
PlaceboDrug
receiving a placebo (one capsule taken at bedtime, identical in appearance and size to melatonin)
| Study group | Role | What they receive |
|---|---|---|
| melatonin group | Experimental | Take melatonin 10 mg orally once nightly at bedtime Receives: Drug: Melatonin |
| placebo group | Placebo comparator | receiving a placebo (one capsule taken at bedtime, identical in appearance and size to melatonin) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IUFD and neonatal death
intrauterine fetal death and neonatal death
Measured: during the whole pregnancy and born within 28 days
severe neonatal complications.
severe neonatal complications ( including neonatal necroticing enterocolitis, Respiratory Distress Syndrome, neonatal septicemnia, Periventricular-intraventricular hemorrhage).
Measured: born within 28 days
Secondary outcomes (6)
interval from treatment to delivery
the interval from treatment initiation to delivery (day);
Measured: during the whole pregnancy
delivery GA
gestational age at delivery (week)
Measured: the day at delivery
fetal growth trajectory throughout pregnancy
fetal growth trajectory throughout pregnancy (slope of Z-score over time estimated using a linear mixed model, LMM);
Measured: during the whole pregnancy
neonatal birth weight
neonatal birth weight(g)
Measured: the day at delivery
Apgar score
neonatal Apgar score
Measured: the day at delivery
maternal complications
including gestational hypertension, preeclampsia, and placental abruption
Measured: during pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Jan 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal Growth Restriction (FGR)Studies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luming Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549295
- Sponsor's protocol ID
- XH-26-003
- Acronym
- MIMVMFGR
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be publicly posted in a repository. After publication of the main study results, de-identified IPD may be made available upon reasonable request to the study investigators by email, subject to review of the request, institutional approvals, applicable regulations, and data use agreements intended to protect participant privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial to Explore the Effectiveness of Melatonin as a Perinatal Intervention in Maternal Vascular Malperfusion-Associated Fetal Growth Restriction
- ClinicalTrials.gov ID
- NCT07549295
- Acronym / sponsor ID
- MIMVMFGR / XH-26-003
- Conditions
- Fetal Growth Restriction (FGR)
- Keywords
- FGR, melatonin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy and safety of melatonin in the treatment of early-onset severe maternal vascular malperfusion-related fetal growth restriction (MVM-FGR), and to determine its effects on fetal growth and perinatal outcomes. The study will enroll pregnant women with singleton pregnancies diagnosed with severe MVM-FGR between 24+0 and 31+6 weeks of gestation.
The main questions it aims to answer are:
- Whether melatonin treatment can reduce the incidence of a composite adverse neonatal outcome, including neonatal death and severe neonatal complications.
- Whether melatonin treatment can improve pregnancy and neonatal outcomes, including the interval from treatment initiation to delivery, gestational age at delivery, fetal growth trajectory throughout pregnancy (Z-score slope over time estimated using linear mixed models), neonatal birthweight, Apgar scores, neonatal complications (such as respiratory distress syndrome), maternal adverse events (such as hypertensive disorders of pregnancy), and placental pathological findings.
Researchers will compare participants receiving a placebo (one capsule taken at bedtime, identical in appearance and size to melatonin) with those receiving melatonin to determine whether melatonin improves these maternal and neonatal outcomes.
Participants will:
- Take melatonin 10 mg orally once nightly at bedtime.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| melatonin group | Experimental | Drug: MelatoninTake melatonin 10 mg orally once nightly at bedtime |
| placebo group | Placebo comparator | Drug: Placeboreceiving a placebo (one capsule taken at bedtime, identical in appearance and size to melatonin) |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Singleton pregnancy
- intact membranes
- detectable fetal cardiac activity, and normal fetal movements.
- 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.
Key exclusion criteria (10 listed)
- Presence of severe acute or chronic maternal diseases that make continuation of pregnancy unsafe.
- Fetal structural anomalies, genetic abnormalities, or intrauterine infections.
- 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).
- 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.
- Individuals with legally defined disabilities (including visual impairment, hearing impairment, speech impairment, intellectual disability, mental disorders, or physical disability) and patients with psychiatric illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninTake melatonin 10 mg orally once nightly at bedtime | Drug | melatonin group |
| Placeboreceiving a placebo (one capsule taken at bedtime, identical in appearance and size to melatonin) | Drug | placebo group |
Primary outcome
IUFD and neonatal death
Time frame: during the whole pregnancy and born within 28 days
intrauterine fetal death and neonatal death
severe neonatal complications.
Time frame: born within 28 days
severe neonatal complications ( including neonatal necroticing enterocolitis, Respiratory Distress Syndrome, neonatal septicemnia, Periventricular-intraventricular hemorrhage).
6 secondary outcomes
interval from treatment to delivery
Time frame: during the whole pregnancy
delivery GA
Time frame: the day at delivery
fetal growth trajectory throughout pregnancy
Time frame: during the whole pregnancy
neonatal birth weight
Time frame: the day at delivery
Apgar score
Time frame: the day at delivery
maternal complications
Time frame: during pregnancy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be publicly posted in a repository. After publication of the main study results, de-identified IPD may be made available upon reasonable request to the study investigators by email, subject to review of the request, institutional approvals, applicable regulations, and data use agreements intended to protect participant privacy and confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Melatonin in people with Fetal Growth Restriction (FGR), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IUFD and neonatal death (time frame: during the whole pregnancy and born within 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.