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

NCT05487352 | Unknown

• 1 other identifier: IRB-20210134-R
• Study Type: observational
• Target: 781
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy

Keywords

gestational diabetes mellitus; first trimester; prediction model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• gestational weight gain

  before delivery

• gestational age at delivery

  through study completion, an average of 39 gestational weeks

• birthweight

  within 24 hours after birth

• neonatal weight, height and head circumference

  42 days after birth

Study Arms (2)

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

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.

Interventions

hyperglycemia exposure in the first trimester OTHER

The exposure means the hyperglycemia identified by the 75g oral glucose tolerance test before the 14 weeks of gestation

hyperglycemia in the first trimester

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects were confirmed "intrauterine live birth" by ultrasound examination and were during 7-14 weeks of gestation confirmed by the combination of their last menstrual period and nuchal translucency ultrasound examination.

You may qualify if:

• \. Intrauterine pregnancy within 7-14 weeks of gestation
• \. 20-45 years of age
• \. Singleton pregnancy
• \. Giving informed consent and willing to participate in this study
• \. Planning to give birth in Women's Hospital School of Medicine Zhejiang University

You may not qualify if:

• \. Pre-existing diabetes
• \. Taking medications that may affect blood glucose levels within one month
• \. Participating in other intervention studies
• \. Recurrent abortion, threatened abortion, cervical incompetence or fetal malformation

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

Related 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.

  PMID: 34964875 BACKGROUND

• 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.

  PMID: 34883186 BACKGROUND

• 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.

  PMID: 32822601 BACKGROUND

• 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.

  PMID: 31296866 BACKGROUND

• 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.

  PMID: 22357187 BACKGROUND

• 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.

  PMID: 18463375 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood was collected from subjects and divided into plasma and blood cells by centrifugation for preservation

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Dan Zhang, Dr

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: August 4, 2022
• Study Start: May 30, 2021
• Primary Completion: May 27, 2022
• Study Completion: October 1, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

CN (1)