gestional diabetes mellitus
Conditions
Interventions
intervention group:nutrition intervention
control group:standard care
Sponsors
International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Pregnant women who will do antenatal care and delivered at the International Peace Maternal and Child Health Hospital or Xinhua Hospital or Shanghai Fengxian District Central Hospital; (2) The GDM predictive model predicts this pregnant women in the high-risk group;Risk probability of GDM = 1/[1+exp(-b)]; b = (-14.2334 + (0.0681*age) + (0.5005* blood triglyceride level in early pregnancy, mmol/L) + (2.8165* fasting blood glucose level in early pregnancy, mmol/L) + (1.1062*family history of diabetes in first-degree relatives) + (1.6925* HbA1c, %) +(0.4349*multiple pregnancy) +(2.6181* personal history of GDM).The pregnant women who are selected to be at high-risk of GDM by the predictive model (calculated risk probability >=0.13) can be recruited in our study. (3) Pregnant women before 13+6 weeks of pregnancy; (4) Ability to read, understand and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) Hypertension, HIV-positive, measurable hepatitis B or C viral load, positive for hepatitis B core or e antigen, positive for hepatitis C core antigen. Women who are known to suffer from heart disease and who have limited or no function, beta-thalassemia, cystic fibrosis,Systemic lupus erythematosus and other autoimmune diseases, History of chemotherapy,thyroid diseases requiring medication. (2) Pregestational diabetes mellitus (including patients diagnosed with diabetes before pregnancy; fasting blood glucose >= 7.0mmol/L in early pregnancy; or glycated hemoglobin >= 6.5%; or typical hyperglycemia symptoms or hyperglycemia crisis with optional blood glucose >=11.1mmol/L); (3) Currently, drugs that affect blood sugar, such as metformin and glucocorticoids, are used; (4) Known major fetal malformations; (5) Drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of gestational diabetes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Average glucose level (3rd trimester);Average Hba1c (3rd trimester);1 hour glucose tolerance test result;2 hour glucose tolerance test result;Lipid profile (3rd trimester);Gestational weight gain;Hemoglobin (3rd trimester);Adherence to the intervention;Requirement for insulin;Total daily insulin dose;Hypertensive disorders of pregnancy;Premature rupture of membranes;Placental abruption;Mode of birth;Birth complication;Blood loss during birth;Maternal mortality;Infant sex;Birthweight;Birth length;Apgar score;Gestational age at birth;Macrosomia;Small for gestational age;Preterm birth;Neonatal hypoglycaemia;Miscarriage;Livebirth;Stillbirth;Neonatal mortality;postpartum haemorrhage;shoulder dystocia;bone fracture;bronchial plexus injury;neonatal respiratory distress;pathological jaundice;neonatal intensive care unit admission;congenital malformation;fasting plasma insulin;insulin resistance;fasting glucose at OGTT;average energy intake;nutrients intake;large for gestational age; | — |
Countries
China
Contacts
Public ContactHefeng Huang
International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
Outcome results
None listed