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Status unknownNCT05487352Updated Aug 4, 2022

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

An observational study in Gestational Diabetes Mellitus in Pregnancy, sponsored by Women's Hospital School Of Medicine Zhejiang University. Status unknown at 1 site in China. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by Women's Hospital School Of Medicine Zhejiang University · Observational

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
781
Ages
20 Years to 45 Years
Sex
Female
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Study 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.

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Conditions studied

  • Gestational Diabetes Mellitus in Pregnancy

Keywords

  • gestational diabetes mellitus
  • first trimester
  • prediction model
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In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.

This study's enrollment of 781 is above the median of 198 across 270 observational studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University is the lead sponsor of 74 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
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.

Inclusion criteria

    1. Intrauterine pregnancy within 7-14 weeks of gestation
    1. 20-45 years of age
    1. Singleton pregnancy
    1. Giving informed consent and willing to participate in this study
    1. Planning to give birth in Women's Hospital School of Medicine Zhejiang University

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
781 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Otherhyperglycemia exposure in the first trimester

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

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What researchers measure

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

    Time frame: 24-28 weeks of gestation

Secondary outcomes

  1. gestational weight gain

    total weight gain from pre-pregnancy until delivery

    Time frame: before delivery

  2. gestational age at delivery

    gestational weeks at the day of delivery

    Time frame: through study completion, an average of 39 gestational weeks

  3. birthweight

    birthweight of the infant

    Time frame: within 24 hours after birth

  4. neonatal weight, height and head circumference

    baby's weight, height and head circumference at 42 days after birth

    Time frame: 42 days after birth

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Study locations

1 site
  • Women's Hospital School of Medicine Zhejiang University
    Hangzhou, Zhejiang 310006, China
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References and documents

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. PubMed 34964875 ↗
  • 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. PubMed 34883186 ↗
  • 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. PubMed 32822601 ↗
  • 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. PubMed 31296866 ↗
  • 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. PubMed 22357187 ↗
  • 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. PubMed 18463375 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05487352
Lead sponsor
Women's Hospital School Of Medicine Zhejiang University
Responsible party
Sponsor
First posted
Aug 4, 2022
Start date
May 30, 2021
Primary completion
May 27, 2022
Completion
Oct 2022 (estimated)
Last update
Aug 4, 2022

Study contacts

Dan Zhang, Dr
principal investigator · Women's Hospital School Of Medicine Zhejiang University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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