Melatonin and Perinatal Outcomes in MVM-Related Fetal Growth Restriction (MIMVMFGR) (NCT07549295) | Clinical Trial Compass
By InvitationPhase 1
Melatonin and Perinatal Outcomes in MVM-Related Fetal Growth Restriction (MIMVMFGR)
China240 participantsStarted 2023-01-01
Plain-language 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.
Who can participate
Age range20 Years – 43 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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:
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.
✕
What they're measuring
1
IUFD and neonatal death
Timeframe: during the whole pregnancy and born within 28 days
2
severe neonatal complications.
Timeframe: born within 28 days
Trial details
NCT IDNCT07549295
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
. 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.