According to the latest guidelines of the International Federation of Gynecology and Obstetrics (FIGO), LGA is defined as a newborn with a birth weight greater than or equal to the 90th percentile of the same gestational age. It can cause multiple complications for the mother and fetus, not only increasing the risk of dystocia, labor block, postpartum hemorrhage, and chorioamnionitis, but also inc
Conditions
Interventions
Part One: Observation Group:NA
Part Two: Control Group:Nutritional guidance, same as the experimental group's guidelines
Part Two: Test Group:Lifestyle intervention based on smart bracelets: (1) activity and exercise guidance
(2) personalized sleep advice
(3) nutritional guidance. The guid
Sponsors
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Pregnant women aged betwen 18-45 years; 2. Singleton pregnancies with a gestational age of less than 14 weeks and planned to be delivered in this research center; 3. The subjects were fully informed of the research process and signed the informed consent; 4. Subjects can be follow-up as planned; 5. Pregnant women who meet the above conditions and have one or more of the following high-risk factors: age >=35 years; pre-pregnancy BMI >=24 kg/m²; assisted reproduction; PCOS; recurrent spontaneous abortion; history of mid-pregnancy abortion, spontaneous premature birth before 34 weeks of pregnancy; history of cervical surgery or hysteroscopic surgery; short pregnancy interval: pregnancy interval <6 months; history of LGA birth; history of pre-pregnancy diabetes, gestational diabetes, or family history of diabetes.
Exclusion criteria
Exclusion criteria: 1. twins or multiple pregnancies; 2. severe internal and external diseases (including cancer, liver disease, kidney disease, immune diseases, etc.); 3. patients with severe infections; 4. limb disabilities or deficiencies that affect the wearing of wearable devices/or the inability to effectively or safely collect information; 5. other surgeries/treatment plans that may affect the subjects' compliance with this study; 6. subjects participating in other clinical studies and have not yet reached the study endpoints; 7. unable to complete the expected study follow-up for any known reason; 8. refusal to sign the informed consent form;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Large for Gestational Age, LGA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gestational age at delivery;Neonatal weight;Stillbirth rate;Incidence rate of anxiety;Incidence rate of low birth weight infants;Spontaneous preterm birth rate;Incidence rate of gestational diabetes mellitus;Cesarean section rate;Incidence rate of composite neonatal complications;Perinatal mortality rate;Incidence rate of gestational hypertension-preeclampsia;Vaginal delivery rate with assistance;Incidence rate of neonatal asphyxia;Incidence rate of depression; | — |
Countries
China
Contacts
Public ContactHao Ying
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Outcome results
None listed