Diagnostic Analysis of Oral Glucose Tolerance Test in Early Pregnancy for Gestational Diabetes Mellitus
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| hyperglycemia in the first trimester 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
The exposure means the hyperglycemia identified by the 75g oral glucose tolerance test before the 14 weeks of gestation
|
| euglycemia in the first trimester 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. |
Outcome Measures
Primary Outcome Measures
- gestational diabetes mellitus [24-28 weeks of gestation]
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
Secondary Outcome Measures
- gestational weight gain [before delivery]
total weight gain from pre-pregnancy until delivery
- gestational age at delivery [through study completion, an average of 39 gestational weeks]
gestational weeks at the day of delivery
- birthweight [within 24 hours after birth]
birthweight of the infant
- neonatal weight, height and head circumference [42 days after birth]
baby's weight, height and head circumference at 42 days after birth
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Intrauterine pregnancy within 7-14 weeks of gestation
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- 20-45 years of age
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- Singleton pregnancy
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- Giving informed consent and willing to participate in this study
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- Planning to give birth in Women's Hospital School of Medicine Zhejiang University
Exclusion Criteria:
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- Pre-existing diabetes
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- Taking medications that may affect blood glucose levels within one month
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- Participating in other intervention studies
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- Recurrent abortion, threatened abortion, cervical incompetence or fetal malformation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Women's Hospital School of Medicine Zhejiang University | Hangzhou | Zhejiang | China | 310006 |
Sponsors and Collaborators
- Women's Hospital School Of Medicine Zhejiang University
Investigators
- Principal Investigator: Dan Zhang, Dr, Women's Hospital School Of Medicine Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
- American Diabetes Association Professional Practice Committee. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S17-S38. doi: 10.2337/dc22-S002.
- Catalano PM, McIntyre HD, Cruickshank JK, McCance DR, Dyer AR, Metzger BE, Lowe LP, Trimble ER, Coustan DR, Hadden DR, Persson B, Hod M, Oats JJ; HAPO Study Cooperative Research Group. The hyperglycemia and adverse pregnancy outcome study: associations of GDM and obesity with pregnancy outcomes. Diabetes Care. 2012 Apr;35(4):780-6. doi: 10.2337/dc11-1790. Epub 2012 Feb 22.
- HAPO Study Cooperative Research Group, Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- McIntyre HD, Catalano P, Zhang C, Desoye G, Mathiesen ER, Damm P. Gestational diabetes mellitus. Nat Rev Dis Primers. 2019 Jul 11;5(1):47. doi: 10.1038/s41572-019-0098-8. Review.
- Saravanan P; Diabetes in Pregnancy Working Group; Maternal Medicine Clinical Study Group; Royal College of Obstetricians and Gynaecologists, UK. Gestational diabetes: opportunities for improving maternal and child health. Lancet Diabetes Endocrinol. 2020 Sep;8(9):793-800. doi: 10.1016/S2213-8587(20)30161-3. Epub 2020 Aug 18. Review.
- Wang H, Li N, Chivese T, Werfalli M, Sun H, Yuen L, Hoegfeldt CA, Elise Powe C, Immanuel J, Karuranga S, Divakar H, Levitt N, Li C, Simmons D, Yang X; IDF Diabetes Atlas Committee Hyperglycaemia in Pregnancy Special Interest Group. IDF Diabetes Atlas: Estimation of Global and Regional Gestational Diabetes Mellitus Prevalence for 2021 by International Association of Diabetes in Pregnancy Study Group's Criteria. Diabetes Res Clin Pract. 2022 Jan;183:109050. doi: 10.1016/j.diabres.2021.109050. Epub 2021 Dec 6.
- IRB-20210134-R