Maternal obesity (pre-pregnancy BMI >=30 kg/m2) Maternal obesity
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Pregnant women with pre-pregnancy body mass index (BMI) >=30 kg/m2 and a singleton pregnancy
Exclusion criteria
Exclusion criteria: Maternal criteria >Pre-existing diabetes mellitus or overt diabetes diagnosed during pregnancy >Current use of insulin or oral antidiabetic medications >Pregnancies complicated by maternal heart disease >Current smoking or alcohol consumption >Participation in another interventional or clinical trial Fetal criteria >Known fetal chromosomal abnormalities diagnosed by NIPT, chorionic villus sampling, or amniocentesis >Suspected fetal infection associated with fetal growth restriction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of infants with birth weight below the 10th percentile for gestational age | — |
Secondary
| Measure | Time frame |
|---|---|
| Total gestational weight gain Proportion of participants achieving the target gestational weight gain Incidence of gestational diabetes mellitus (GDM) Incidence of hypertensive disorders of pregnancy (HDP) Rate of emergency cesarean section Rate of operative vaginal delivery (forceps or vacuum delivery) Neonatal anthropometric measurements (birth weight [g], length [cm], and gestational age) Proportion of heavy-for-dates infants Changes in maternal body composition up to 1 month postpartum Changes in dietary patterns assessed by the Brief-type Self-administered Diet History Questionnaire (BDHQ) | — |
Contacts
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences