The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Early Screening and Intervention for Gestational Diabetes Mellitus on Pregnancy Outcomes: the TESGO Randomized Trial

Conditions
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Pregnancy Complications, Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Other: early screening and intervention
* Other: standard screening and intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 20 years old First prenatal visit before 14 weeks of GA Deliver a singleton at medical centers, including National Taiwan University Hospital (NTUH), and NTUH, Hsinchu Branch. Exclusion Criteria: Diagnosed with preexisting diabetes Twin or multiple births pregnancy Current exposure to steroids Cannot tolerate an OGTT

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early-screen Group<br>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). The time of early screening and intervention will be 6-8 weeks earlier than that of standard screening and intervention. | Other: early screening and intervention<br>* 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).<br>|
| Active Comparator: Standard-screen Group<br>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). The time of standard screening and intervention will be 6-8 weeks later than that of early screening and intervention. | Other: standard screening and intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preterm delivery | the occurrence rate of preterm delivery | 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 | 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) | 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 | 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 | 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 | 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 | 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 | This secondary outcome is measured during 3 years after delivery for eligible infants | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early screening, early intervention, gestational diabetes mellitus, pregnancy outcomes, randomized controlled trial