Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| melatonin group | Experimental | Take melatonin 10 mg orally once nightly at bedtime |
|
| placebo group | Placebo Comparator | receiving a placebo (one capsule taken at bedtime, identical in appearance and size to melatonin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | Take melatonin 10 mg orally once nightly at bedtime |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| interval from treatment to delivery | the interval from treatment initiation to delivery (day); | during the whole pregnancy |
| delivery GA | gestational age at delivery (week) |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term neurodevelopmental outcomes of the infant | Incidence of cerebral palsy, and neurodevelopmental assessment (the Bayley Scales of Infant and Toddler Development). | within 2 years after baby is born |
| effect of melatonin on placental oxidative stress levels |
Inclusion Criteria:
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:
the participants are all pregnant women with FGR fetuses.
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200092 | China |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
receiving a placebo (one capsule taken at bedtime, identical in appearance and size to melatonin) |
|
| 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); | during the whole pregnancy |
| neonatal birth weight | neonatal birth weight(g) | the day at delivery |
| Apgar score | neonatal Apgar score | the day at delivery |
| maternal complications | including gestational hypertension, preeclampsia, and placental abruption | during pregnancy |
placental Malondialdehyde (MDA) levels, superoxide dismutase (SOD), and placental growth factor (PlGF) activity |
| the delivery day |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |