A Randomized Controlled Clinical Trial to Explore the Effectiveness of Melatonin as a Perinatal Intervention in Maternal Vascular Malperfusion-Associated Fetal Growth Restriction
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- IUFD and neonatal death
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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:
- •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.
排除标准
- •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.
研究组 & 干预措施
melatonin group
Take melatonin 10 mg orally once nightly at bedtime
干预措施: Melatonin (Drug)
placebo group
receiving a placebo (one capsule taken at bedtime, identical in appearance and size to melatonin)
干预措施: Placebo (Drug)
结局指标
主要结局
IUFD and neonatal death
时间窗: during the whole pregnancy and born within 28 days
intrauterine fetal death and neonatal death
severe neonatal complications.
时间窗: born within 28 days
severe neonatal complications ( including neonatal necroticing enterocolitis, Respiratory Distress Syndrome, neonatal septicemnia, Periventricular-intraventricular hemorrhage).
次要结局
- 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)
- maternal complications(during pregnancy)
研究者
Luming Sun
Director, Department of Obstetrics, Center for Prenatal Diagnosis, and Center for Fetal Medicine & Intrauterine Pediatrics; Executive Dean, Fetal Hospital (Preparatory)
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine