Fetal growth restriction
Conditions
Interventions
Control group:Pill of the same appearance but without any effect
Experimental group:Take melatonin capsules
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 43 Years
Inclusion criteria
Inclusion criteria: 1. The pregnant woman's age is between 20 and 43 years old. 2. Singleton pregnancy, with intact fetal membranes, fetal heartbeats, and good fetal movements. 3. The pregnancy duration is between 24+0 weeks and 31+6 weeks, and it is diagnosed as isolated placental perfusion disorder-induced fetal growth restriction (MVM-FGR): 1) The estimated fetal weight or abdominal circumference is less than the 10th percentile of the same gestational age, and the uterine artery pulsation index (UtA-PI) or umbilical artery pulsation index (UA-PI) is >= the 95th percentile; 2) Or umbilical blood flow is absent/inverted (regardless of the estimated weight). 4. Voluntarily participated in this study, cooperated with observation and treatment, and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Presence of severe acute or chronic maternal diseases contraindicating continuation of pregnancy; 2.Fetal structural anomalies, genetic abnormalities, or intrauterine infections; 3.Imminent need for pregnancy termination prior to enrollment, such as absent a-wave in the ductus venosus, preterminal cardiotocography (CTG), or biophysical profile (BPP); 4.Use of low-molecular-weight heparin, aspirin, sildenafil, or traditional Chinese medicine for miscarriage prevention within 1 month prior to enrollment; 5.Legally defined disabilities (e.g., visual, auditory, speech, intellectual, psychiatric, or physical disabilities) or psychiatric disorders; 6.Participation in another clinical trial within the past 3 months; 7.History of smoking more than 10 cigarettes per day within 3 months prior to screening; 8.Suspected or confirmed alcohol or drug abuse; 9.Known allergy to melatonin or any component of the study drug; 10.Any other condition deemed by the investigator to make the subject unsuitable for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Newborns with Complicated Adverse Outcomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time interval between medication administration and delivery;Pregnancy weeks of delivery;The growth trajectory throughout the entire pregnancy period;Birth weight of the newborn;Apgar score;Newborn complications;Maternal adverse event;Placental pathological test results; | — |
Countries
China
Contacts
Public ContactLuming Sun
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed