Gestational Diabetes Mellitus in PregnancyNCT05487352
Diagnostic Analysis of Oral Glucose Tolerance Test in Early Pregnancy for Gestational Diabetes Mellitus
An observational study of Gestational Diabetes Mellitus in Pregnancy, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- hyperglycemia exposure in the first trimester
- Type of treatment
- Pill or oral medicine
- How many people
- 781 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2021to Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
About this study
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
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.
- Being tested
- hyperglycemia exposure in the first trimester
- Keywords
- gestational diabetes mellitus, first trimester, prediction model
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperglycemia exposure in the first trimesterOther
The exposure means the hyperglycemia identified by the 75g oral glucose tolerance test before the 14 weeks of gestation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24-28 weeks of gestation
Secondary outcomes (4)
gestational weight gain
total weight gain from pre-pregnancy until delivery
Measured: before delivery
gestational age at delivery
gestational weeks at the day of delivery
Measured: through study completion, an average of 39 gestational weeks
birthweight
birthweight of the infant
Measured: within 24 hours after birth
neonatal weight, height and head circumference
baby's weight, height and head circumference at 42 days after birth
Measured: 42 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start30 May 2021
- Primary completion27 May 2022
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 781 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Zhang, Dr, Principal investigator, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487352
- Sponsor's protocol ID
- IRB-20210134-R
- Status last verified
- Aug 2022
- First submitted
- 21 Jul 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 34964875Wang 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 34883186Saravanan 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 32822601McIntyre 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 31296866Catalano 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 22357187HAPO 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05487352
- Acronym / sponsor ID
- IRB-20210134-R
- Keywords
- gestational diabetes mellitus, first trimester, prediction model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 781 participants (actual)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- Oct 2022 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperglycemia in the first trimester | – | Other: hyperglycemia exposure in the first trimesterThe 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. |
| 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperglycemia exposure in the first trimesterThe exposure means the hyperglycemia identified by the 75g oral glucose tolerance test before the 14 weeks of gestation | Other | hyperglycemia in the first trimester |
Primary outcome
gestational diabetes mellitus
Time frame: 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
4 secondary outcomes
gestational weight gain
Time frame: before delivery
gestational age at delivery
Time frame: through study completion, an average of 39 gestational weeks
birthweight
Time frame: within 24 hours after birth
neonatal weight, height and head circumference
Time frame: 42 days after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Background: PubMed 34964875American 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.
- Background: PubMed 34883186Wang 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.
- Background: PubMed 32822601Saravanan 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.
- Background: PubMed 31296866McIntyre 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.
- Background: PubMed 22357187Catalano 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.
- Background: PubMed 18463375HAPO 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Zhang, Dr principal investigator
Women's Hospital School Of Medicine Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus in Pregnancy, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gestational diabetes mellitus (time frame: 24-28 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05487352, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.