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

Gestational Diabetes Mellitus in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05487352
• Other study ID #: IRB-20210134-R
• Status: Active, not recruiting
• Start date: May 30, 2021
• Est. completion date: October 2022

Study information

• Verified date: August 2022
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 781
• Est. completion date: October 2022
• Est. primary completion date: May 27, 2022
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics

Intervention

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

Locations

Country	Name	City	State
China	Women's Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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