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Enrolling by Invitation

NCT Number: NCT07549295

Melatonin and Perinatal Outcomes in MVM-Related Fetal Growth Restriction (MIMVMFGR)

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.

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Key information

Conditions

Fetal Growth Restriction (FGR) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

20 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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:
  • 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

  • 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.
  • 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.

Treatment and study plan

Melatonin

Drug

Take melatonin 10 mg orally once nightly at bedtime

Placebo

Drug

receiving a placebo (one capsule taken at bedtime, identical in appearance and size to melatonin)

Primary outcomes

  1. IUFD and neonatal death

    Time frame: during the whole pregnancy and born within 28 days

    intrauterine fetal death and neonatal death

  2. severe neonatal complications.

    Time frame: born within 28 days

    severe neonatal complications ( including neonatal necroticing enterocolitis, Respiratory Distress Syndrome, neonatal septicemnia, Periventricular-intraventricular hemorrhage).

Secondary outcomes

  1. interval from treatment to delivery

    Time frame: during the whole pregnancy

    the interval from treatment initiation to delivery (day);

  2. delivery GA

    Time frame: the day at delivery

    gestational age at delivery (week)

  3. fetal growth trajectory throughout pregnancy

    Time frame: during the whole pregnancy

    fetal growth trajectory throughout pregnancy (slope of Z-score over time estimated using a linear mixed model, LMM);

  4. neonatal birth weight

    Time frame: the day at delivery

    neonatal birth weight(g)

  5. Apgar score

    Time frame: the day at delivery

    neonatal Apgar score

  6. maternal complications

    Time frame: during pregnancy

    including gestational hypertension, preeclampsia, and placental abruption

Other outcomes

  1. Long-term neurodevelopmental outcomes of the infant

    Time frame: within 2 years after baby is born

    Incidence of cerebral palsy, and neurodevelopmental assessment (the Bayley Scales of Infant and Toddler Development).

  2. effect of melatonin on placental oxidative stress levels

    Time frame: the delivery day

    placental Malondialdehyde (MDA) levels, superoxide dismutase (SOD), and placental growth factor (PlGF) activity

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

A Randomized Controlled Clinical Trial to Explore the Effectiveness of Melatonin as a Perinatal Intervention in Maternal Vascular Malperfusion-Associated Fetal Growth Restriction

Acronym: MIMVMFGR

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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