Context: Women with gestational diabetes have excessive fetus growth weeks earlier than the screening period recommended currently, suggesting that earlier screening and intervention may improve pregnancy outcomes and the health of the offspring. Objective: To determine if early screening and intervention could alter pregnancy outcomes, the incidence of maternal diabetes after delivery, and growth and development of the offspring, compared to the standard group. Design, Setting, Participants: We will conduct a multi-center open-label randomized controlled trial in 2068 pregnant women, who deliver a singleton and who have not been diagnosed with overt diabetes mellitus at National Taiwan University Hospital (NTUH) and NTUH Hsinchu Branch from 2018 to 2020. Interventions: Gestational diabetes mellitus (GDM) is diagnosed by a 75g 2-hour OGTT at 18-20 weeks of GA for the early-screening group and at 24-28 weeks for the standard-screening group. The diagnostic cutoffs are according to the IADPSG criteria. GDM is diagnosed if one of the plasma glucose levels at fasting, 1-hour, and 2-hour during OGTT is above 92 mg/dL, 180 mg/dL, or 153 mg/dL respectively. Subjects who are diagnosed with GDM receive lifestyle intervention and self-monitoring of blood glucose. Pharmacological therapies are given when the target of glycemic control is not achieved within 4-6 weeks. Main Outcome Measure: The primary outcome is a composite measure of pregnancy outcomes, including primary CS, birth weight \>90th percentile, neonatal hypoglycemia, cord serum C-peptide \>90th percentile, pregnancy-induced hypertension, preeclampsia, and birth trauma. The primary outcome is measured within the entire period of perinatal and neonatal intensive-care units (NICU) stay for infants and the entire period of gestation for pregnant women after randomization. Conclusion: This study will test our hypothesis that early screening and intervention of GDM improves pregnancy outcomes as compared to standard practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
967
The early screening group will be screened by a 75g 2-hour oral glucose tolerance test (OGTT) at 18-20 weeks of gestational age (GA). Gestational diabetes mellitus (GDM) is diagnosed according to the IADPSG criteria. Subjects diagnosed with GDM will receive nutrition counseling, and lifestyle intervention. Pharmacologic therapies exclusively with human insulin or insulin analogues will be given when the target of glycemic control is not achieved within 4 weeks. The process of screening and intervention in the early screening group is all the same with that in the standard screening group. The only difference between two groups is the time of screening and intervention (18-20 weeks vs. 24-28 weeks of GA).
The standard screening group will be screened by a 75g 2-hour oral glucose tolerance test (OGTT) at 24-28 weeks of gestational age (GA). Gestational diabetes mellitus (GDM) is diagnosed according to the International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria, ie. if one of the plasma glucose levels at fasting, 1-hour, and 2-hour during OGTT is above 92 mg/dL, 180 mg/dL, and 153 mg/dL, respectively. Subjects diagnosed with GDM will receive nutrition counseling, and lifestyle intervention. Pharmacologic therapies exclusively with human insulin or insulin analogues will be given when the target of glycemic control is not achieved within 4 weeks.
Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan, Taiwan
TESGO composite outcome
the occurrence rate of any of the following adverse outcome, including primary cesarean section (CS), birth weight \>90th percentile, cord serum C-peptide ≥90th percentile, neonatal hypoglycemia, pregnancy-induced hypertension, preeclampsia, birth trauma, hypoglycemia, cord serum C-peptide \>90th percentile, gestational hypertension, preeclampsia and birth trauma
Time frame: The primary outcome is measured within the entire period of perinatal and NICU stay for infants and the entire period of gestation for pregnant women after randomization, an average of 10 months
Preterm delivery
the occurrence rate of preterm delivery
Time frame: This secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months
Jaundice
the occurrence rate of newborns with jaundice
Time frame: This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
Admission to NICU
the occurrence rate of newborns who need to be admitted to neonatal intensive care unit (NICU)
Time frame: This secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
Fetal death or stillbirth
the occurrence rate of fetal death or stillbirth
Time frame: This secondary outcome is measured within the entire period of perinatal and NICU stay for infants and the entire period of gestation for pregnant women after randomization, an average of 10 months
Fetal growth during pregnancy
measurement of fetal growth during pregnancy recorded by ultrasonography
Time frame: The secondary outcome is measured within the entire period of gestation for pregnant women after randomization, an average of 10 months
Neonatal adiposity
measurement of neonatal adiposity recorded by skinfold caliper
Time frame: The secondary outcome is measured within the entire period of perinatal and NICU stay for infants, an average of 2 weeks
Maternal incident diabetes
the incidence of maternal diabetes after delivery
Time frame: This secondary outcome is measured during 3 years after delivery for eligible women
The growth and development of the offspring
measurement of the growth and development of the offspring, including body height, body weight, head circumference, and records of any major disease
Time frame: This secondary outcome is measured during 3 years after delivery for eligible infants
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.