Fetal Growth Restriction (FGR)
Conditions
Keywords
FGR, melatonin
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.
Interventions
DRUGMelatonin
Take melatonin 10 mg orally once nightly at bedtime
DRUGPlacebo
receiving a placebo (one capsule taken at bedtime, identical in appearance and size to melatonin)
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 43 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IUFD and neonatal death | during the whole pregnancy and born within 28 days | intrauterine fetal death and neonatal death |
| severe neonatal complications. | born within 28 days | severe neonatal complications ( including neonatal necroticing enterocolitis, Respiratory Distress Syndrome, neonatal septicemnia, Periventricular-intraventricular hemorrhage). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| interval from treatment to delivery | during the whole pregnancy | the interval from treatment initiation to delivery (day); |
| delivery GA | the day at delivery | gestational age at delivery (week) |
| fetal growth trajectory throughout pregnancy | during the whole pregnancy | fetal growth trajectory throughout pregnancy (slope of Z-score over time estimated using a linear mixed model, LMM); |
| neonatal birth weight | the day at delivery | neonatal birth weight(g) |
| Apgar score | the day at delivery | neonatal Apgar score |
| maternal complications | during pregnancy | including gestational hypertension, preeclampsia, and placental abruption |
Countries
China
Outcome results
None listed