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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
IUFD and neonatal death
intrauterine fetal death and neonatal death
Time frame: 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).
Time frame: born within 28 days
interval from treatment to delivery
the interval from treatment initiation to delivery (day);
Time frame: during the whole pregnancy
delivery GA
gestational age at delivery (week)
Time frame: 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);
Time frame: during the whole pregnancy
neonatal birth weight
neonatal birth weight(g)
Time frame: the day at delivery
Apgar score
neonatal Apgar score
Time frame: the day at delivery
maternal complications
including gestational hypertension, preeclampsia, and placental abruption
Time frame: during pregnancy
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