Hyperglycemia in Pregnancy
Conditions
Interventions
Intervention group:Routine regular prenatal care plus lifestyle intervention
Control group:Routine regular prenatal care
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Over 18 years of age. 2.Able to provide informed consent. 3.Singleton pregnancies. 4.An abnormal glucose metabolism determined by a blood test performed prior to 14 weeks, defined as FPG 5.1-6.9mmol/L and/or HbA1c 5.7-6.4%.
Exclusion criteria
Exclusion criteria: 1.Pregestational diabetes (diagnosed as diabetes mellitus before pregnancy, or FPG=7.0mmol/L, or HbA1c=6.5% at the first prenatal visit), impaired fasting glucose or impaired glucose tolerance diagnosed before pregnancy. 2.Plan for termination of pregnancy due to fetal anomaly identified at the first trimester scan. 3.Use of medications known to interfere with glucose metabolism (e.g. corticosteroids, antipsychotic drugs) at the time of randomisation. 4.Any other physical (serious medical conditions such as cancer, organ failure, epilepsy, paraplegia, disability) or psychological condition (e.g. learning difficulties, serious mental illness) that is likely to interfere with the conduct of the trial according to evaluation by the trial monitoring group. 5.Women currently with hyperemesis gravidarum leading to dehydration or requiring hospitalization. If persisting vomiting resolves, the patient may be reassessed for inclusion in the trial up to and including 14+6 weeks of gestation, providing all other inclusion and exclusion criteria are met.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite neonatal outcome of large-gestational age and preterm birth; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy-related hypertensive disorders;gestational diabetes mellitus;gestational hypertension;preeclampsia;Eclampsia;Prescription of hypoglycaemic drug;Preeclampsia requiring delivery before 37 weeks;Total gestational weight gain;Mode of birth;Primary caesarean;Large-for-gestational age;Preterm birth at <37 weeks of gestation;Neonatal birthweight;Small-for-gestational-age ;Gestational age at birth, weeks and days ;Neonatal hypoglycaemia;Admission to neonatal wards or intensive care unit;fetal loss <24 weeks of gestation;fetal loss =24 weeks of gestation;Termination of pregnancy;Neonatal death;Apgar score at 1min after birth;Apgar score at 5min after birth; | — |
Countries
China
Contacts
Public ContactHaitian Chen
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed