Prepregnancy obesity
Conditions
Interventions
CGM group:Continuous glucose monitoring guided glycemic management plus routine prenatal care
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Pregnant women with prepregnancy obesity, defined as a body mass index (BMI) >=28.0 kg/m^2 within 3 months before pregnancy; 2.Singleton pregnancy; 3.Gestational age before 14+6 weeks at enrollment; 4.Maternal age >=18 years; 5.Able to receive regular antenatal care, plan to deliver at the study center, and complete study follow-up; 6.Voluntarily agree to participate in the study and provide written informed consent;
Exclusion criteria
Exclusion criteria: 1.Pre-existing diabetes or prediabetes before pregnancy, including impaired fasting glucose or impaired glucose tolerance; 2.Prior use of a continuous glucose monitoring device during the current pregnancy; 3.Severe anemia or other chronic wasting diseases or serious systemic diseases, such as hepatic or renal dysfunction, immune system diseases, or malignant tumors; 4.Bleeding tendency, severe allergy to sensor materials or medical adhesive tape, or a previous condition contraindicating the use of CGM devices; 5.Any other condition that, in the opinion of the recruiting investigator, makes the participant unsuitable for this study or unsuitable for CGM use;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of gestational diabetes mellitus; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glucose levels during the 75 g oral glucose tolerance test in mid-pregnancy;Incidence of preterm birth;Continuous glucose monitoring data;Mode of delivery and cesarean delivery rate;Changes in gut microbiota;Neonatal birth weight and incidence of macrosomia;Gestational weight gain outcomes;Changes in maternal dietary behaviors;Early biomarkers for gestational diabetes mellitus in pregnant women with obesity;Incremental cost-effectiveness ratio;Biomarkers in placenta, umbilical cord blood, and umbilical cord;Incidence of hypertensive disorders of pregnancy;Maternal glucose and lipid metabolic indicators during pregnancy; | — |
Countries
China
Contacts
Public ContactYang Huixia
Peking University First Hospital
Outcome results
None listed