Diagnostic Analysis of Oral Glucose Tolerance Test in Early Pregnancy for Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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The aim of this study is to explore the diagnostic efficacy of oral glucose tolerance test in early pregnancy and establish the prediction model for gestational diabetes mellitus, so as to provide the optimal screening of gestational diabetes mellitus in the first trimester. The treatment started when the pregnancy was confirmed by transvaginal ultrasound (around 6 weeks of gestation) and continued until 42 days postpartum. The study is a single center, prospective cohort study. A total of 781 participants within 14 weeks of gestation were recruited.

Official Title
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Diagnostic Efficiency Analysis of Oral Glucose Tolerance Test and Prediction Model Establishment in the First Trimester for Gestational Diabetes Mellitus: a Prospective Cohort Study

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Other: hyperglycemia exposure in the first trimester


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Intrauterine pregnancy within 7-14 weeks of gestation 2. 20-45 years of age 3. Singleton pregnancy 4. Giving informed consent and willing to participate in this study 5. Planning to give birth in Women's Hospital School of Medicine Zhejiang University Exclusion Criteria: 1. Pre-existing diabetes 2. Taking medications that may affect blood glucose levels within one month 3. Participating in other intervention studies 4. Recurrent abortion, threatened abortion, cervical incompetence or fetal malformation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| hyperglycemia in the first trimester<br>The 75g oral glucose tolerance test was performed before 14 weeks of gestation, and any of the fasting, 1-hour and 2-hours blood glucose was ≥ 5.1, 10.0 and 8.5 mmol/L, respectively. | Other: hyperglycemia exposure in the first trimester<br>* The exposure means the hyperglycemia identified by the 75g oral glucose tolerance test before the 14 weeks of gestation<br>|
| euglycemia in the first trimester<br>The 75g oral glucose tolerance test was performed before 14 weeks of gestation, and the fasting, 1-hour and 2-hours blood glucose were all < 5.1, 10.0 and 8.5 mmol/L, respectively. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gestational diabetes mellitus | any of the fasting, 1-hour and 2-hour blood glucose ≥ 5.1, 10.0, 8.5 mmol/L, respectively, in the 75g oral glucose tolerance test during 24-28 weeks of gestation | 24-28 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gestational weight gain | total weight gain from pre-pregnancy until delivery | before delivery | 
| gestational age at delivery | gestational weeks at the day of delivery | through study completion, an average of 39 gestational weeks | 
| birthweight | birthweight of the infant | within 24 hours after birth | 
| neonatal weight, height and head circumference | baby's weight, height and head circumference at 42 days after birth | 42 days after birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes mellitus, first trimester, prediction model