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

NCT07549295 | Enrolling By Invitation Phase 1

• 1 other identifier: XH-26-003
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fetal Growth Restriction (FGR)

Keywords

FGR; melatonin

Outcome Measures

Primary Outcomes (2)

• IUFD and neonatal death

  intrauterine fetal death and neonatal death

  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).

  born within 28 days

Secondary Outcomes (6)

• interval from treatment to delivery

  during the whole pregnancy

• delivery GA

  the day at delivery

• fetal growth trajectory throughout pregnancy

  during the whole pregnancy

• neonatal birth weight

  the day at delivery

• Apgar score

  the day at delivery

Other Outcomes (2)

• Long-term neurodevelopmental outcomes of the infant

  within 2 years after baby is born

• effect of melatonin on placental oxidative stress levels

  the delivery day

Study Arms (2)

melatonin group

EXPERIMENTAL

Take melatonin 10 mg orally once nightly at bedtime

Drug: Melatonin

placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Melatonin DRUG

Take melatonin 10 mg orally once nightly at bedtime

melatonin group

Placebo DRUG

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

placebo group

Eligibility Criteria

• Age: 20 Years - 43 Years
• Gender Eligibility Details: the participants are all pregnant women with FGR fetuses.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Obstetrics, Center for Prenatal Diagnosis, and Center for Fetal Medicine & Intrauterine Pediatrics; Executive Dean, Fetal Hospital (Preparatory)

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: April 24, 2026
• Study Start: January 1, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)