HyperglycemiaNCT07003503
Explore the Risk Factors for Antenatal Mental Disorders in Pregnant Women With Hyperglycemia
An observational study of Hyperglycemia and Mental Disorder, run by Shenzhen Hospital of Southern Medical University.
Trial summary
This study aims to investigate the current situation and risk factors of adverse mental disorders in pregnant women with hyperglycemia. it could include any of the following: 18-45 years old pregnant women with hyperglycemia. The main question is to answer the risk factor for antenatal mental disorder. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Mental Disorder, Pregnancy Complications
- How many people
- 635 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants should follow inclusive and exclusive criteria.
Who may be able to join
- The pregnant woman was confirmed to have gestational diabetes through biochemical tests and glucose tolerance tests, etc.
- Possess the abilities of listening, speaking, reading, writing and comprehension, and be capable of effective communication;
- Age: 18-45 years old (including 18 and 45 years old);
- informed consent and voluntary participation in the research;
- Gestational age: 28 to 37 weeks (including 28 weeks but excluding 37 weeks).
Who cannot join
- Abnormal fetuses, multiple pregnancies;
- Other pregnancy complications and comorbidities, such as heart disease, preeclampsia, liver disease, etc.
- There is a history of mental illness or mental disorders in the past.
- Those who are unable to communicate effectively by using listening, speaking, reading and writing skills;
- Patients with diabetes mellitus complicated with pregnancy;
- Those who use psychotropic or neurotropic drugs.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to investigate the current situation and risk factors of adverse mental disorders in pregnant women with hyperglycemia. it could include any of the following: 18-45 years old pregnant women with hyperglycemia. The main question is to answer the risk factor for antenatal mental disorder. participants need to complete a self-report questionnaire.
Read the detailed description
study design: This is a cohort study which will be conducted in the Shenzhen Hospital of Southern Medical University. Inclusion criteria: ① Pregnant women were confirmed as having gestational diabetes through biochemical examinations and glucose tolerance tests, etc. ② Possess the abilities of listening, speaking, reading, writing and comprehension, and be capable of effective communication; ③ Age: 18-45 years old (including 18 and 45 years old); ④ Informed consent and voluntary participation in the research; ⑤ Gestational age: 28 to 37 weeks (including 28 weeks but excluding 37 weeks).
Exclusion criteria: ① Abnormal fetuses and multiple pregnancies; ② Other pregnancy complications and comorbidities, such as heart disease, preeclampsia, liver disease, etc. ③ There is a history of mental illness or mental disorders in the past. ④ Those who are unable to communicate effectively by using listening, speaking, reading and writing skills; ⑤ Patients with diabetes mellitus complicated with pregnancy; ⑥ Those who use psychotropic or neurotropic drugs.
sample size: According to the sample size calculation formula of multivariate analysis, N=Zα/22×P(1-P)/δ2, P was 40.38% of the incidence of depression in pregnant women with gestational diabetes mellitus (GDM) as reported in the literature. When the test level α is set at 0.05, Zα/2=1.96; δ represents the allowable error, and δ=0.05. Therefore, the sample size obtained is 370 cases. Adding a 20% invalid questionnaire rate, the sample size obtained was 444 cases.
procedure: pregnant women who were diagnosis hyperglycemia through OGTT test between 24-28 gestational weeks will be enrolled in this study. When they were admitted to obstetric department when they had gestational week greater than 32 weeks to have childbirth, researchers will sent self-repot questionnaire to them after getting consent. The sequence of data collection is in the order of hospitalization time. A QR code will be gave them, when they tickle the join button which means they would like to participant this study. After getting consent from participants, researchers need to collect social demographic and mental health information from their electric medical record. Data processing was conducted using SPSS and R. Kolmogorov-smirnov was selected to detect whether continuous variables conform to the normal distribution. A P value <0.05 was considered statistically significant.
General information: Categorical variables are represented by frequency and percentage (%); For continuous variables, if they conform to a normal distribution, the mean ± standard deviation (x±SD) is used; otherwise, the median and interquartile range (M, IQR) are used.
LASSO regression analysis: LASSO regression analysis was conducted based on the questionnaire results of the modeling group. Taking whether adverse psychology occurred as the dependent variable and the questionnaire items of risk factors for adverse psychology in pregnant women with gestational diabetes mellitus (GDM) as independent variables, R was used to preliminarily screen the risk factors through tenfold cross-validation of LASSO regression.
Binary Logistic regression analysis: Taking the occurrence of adverse psychology as the dependent variable and the risk factors initially screened out by LASSO regression analysis as the independent variables (with independent variable assignment), binary Logistic regression analysis was conducted on the data of the modeling group. The Hosmer-Lemeshow test was conducted for goodness-of-fit examination. A p > 0.05 indicated a good fit of the model. Collinearity test: The variance inflation factor (VIF) is used for the collinearity test to detect the degree of correlation among the independent variables. A VIF > 10 indicates a strong collinearity.
Quality control Train data collectors to accurately assess the usage methods of the tools; After the data is collected and organized, it is checked and entered by two people to ensure the accuracy of the data.
③ Data analysis was conducted by two independent researchers. In case of any discrepancy, it was verified by a third independent researcher.
- Conditions
- Hyperglycemia, Mental Disorder, Pregnancy Complications
- Keywords
- hyperglycemia, antenatal mental disorder, pregnancy complication
- Medical subject headings
- Hyperglycemia, Mental Disorders, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pregnant women with hyperglycemia | Inclusion criteria: ① Pregnant women were confirmed as having gestational diabetes through biochemical examinations and glucose tolerance tests, etc. ② Possess the abilities of listening, speaking, reading, writing and comprehension, and be capable of effective communication; ③ Age: 18-45 years old (including 18 and 45 years old); ④ Informed consent and voluntary participation in the research; ⑤ Gestational age: 28 to 37 weeks (including 28 weeks but excluding 37 weeks). Exclusion criteria: ① Abnormal fetuses and multiple pregnancies; ② Other pregnancy complications and comorbidities, such as heart disease, preeclampsia, liver disease, etc. ③ There is a history of mental illness or mental disorders in the past. ④ Those who are unable to communicate effectively by using listening, speaking, reading and writing skills; ⑤ Patients with diabetes mellitus complicated with pregnancy; ⑥ Those who use psychotropic or neurotropic drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient health questionnaire -9 (PHQ-9) score
In the first, second and third trimesters, due to the government's policy, all pregnancies need to complete a EDSS if they want. When the pregnancies were diagnosed with hyperglycemia, a consent form was sent to them. After getting consent from them, researchers will retrospectively collect their medical records and EDSS scores in the government system when the participants were administrated in hospital to deliver the baby.
the interpretation of PHQ-9: Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
Measured: Participants were administered in the hospital to deliver the baby.
Secondary outcomes (1)
Generalized Anxiety Disorder-7 scale score (GAD-7)
In the first, second and third trimesters, due to the government's policy, all pregnancies need to complete a GAD-7 if they want. When the pregnancies were diagnosed with hyperglycemia, a consent form was sent to them. After getting consent from them, researchers will retrospectively collect their medical records and EDSS scores in the government system when the participants were administrated in hospital to deliver the baby.
interpretation for GAD-7: It's a self-administered questionnaire with 7 questions, each scored from 0 to 3, totaling a possible score of 21. Scores of 5, 10, and 15 are often used as cut-offs to indicate mild, moderate, and severe anxiety, respectively.
Measured: Participants were administered in the hospital to deliver the baby.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start30 Jun 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies 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
- Retrospective
- Enrolment
- 635 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hospital of Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zonglian Guo, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003503
- Sponsor's protocol ID
- NYSZYYEC2024K13OR001
- Status last verified
- May 2025
- First submitted
- 22 Apr 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: protocol
Publications
DOI:10.16766/j.cnki.issn.1674-4152.003467.
Delanerolle G, Phiri P, Zeng Y, Marston K, Tempest N, Busuulwa P, Shetty A, Goodison W, Muniraman H, Duffy G, Elliot K, Maclean A, Majumder K, Hirsch M, Rathod S, Raymont V, Shi JQ, Hapangama DK. A systematic review and meta-analysis of gestational diabetes mellitus and mental health among BAME populations. EClinicalMedicine. 2021 Jul 14;38:101016. doi: 10.1016/j.eclinm.2021.101016. eCollection 2021 Aug.
PubMed 34308317Thiele GA, Ryan DM, Oberlander TF, Hanley GE. Preconception mental health and the relationship between antenatal depression or anxiety and gestational diabetes mellitus: a population-based cohort study. BMC Pregnancy Childbirth. 2022 Aug 31;22(1):670. doi: 10.1186/s12884-022-05002-5.
PubMed 36045319Schmitt A, Bendig E, Baumeister H, Hermanns N, Kulzer B. Associations of depression and diabetes distress with self-management behavior and glycemic control. Health Psychol. 2021 Feb;40(2):113-124. doi: 10.1037/hea0001037. Epub 2020 Nov 30.
PubMed 33252963Riggin L. Association Between Gestational Diabetes and Mental Illness. Can J Diabetes. 2020 Aug;44(6):566-571.e3. doi: 10.1016/j.jcjd.2020.06.014. Epub 2020 Jun 22.
PubMed 32792108https://www.mdpi.com/1660-4601/17/11/3767.
Mazumder T, Akter E, Rahman SM, Islam MT, Talukder MR. Prevalence and Risk Factors of Gestational Diabetes Mellitus in Bangladesh: Findings from Demographic Health Survey 2017-2018. Int J Environ Res Public Health. 2022 Feb 23;19(5):2583. doi: 10.3390/ijerph19052583.
PubMed 35270274Ye W, Luo C, Huang J, Li C, Liu Z, Liu F. Gestational diabetes mellitus and adverse pregnancy outcomes: systematic review and meta-analysis. BMJ. 2022 May 25;377:e067946. doi: 10.1136/bmj-2021-067946.
PubMed 35613728
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Risk Factors for Antenatal Mental Disorders in Pregnant Women With Hyperglycemia
- ClinicalTrials.gov ID
- NCT07003503
- Acronym / sponsor ID
- NYSZYYEC2024K13OR001
- Conditions
- Hyperglycemia, Mental Disorder, Pregnancy Complications
- Keywords
- hyperglycemia, antenatal mental disorder, pregnancy complication
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 635 participants (estimated)
- Lead sponsor
- Shenzhen Hospital of Southern Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 Jun 2025 (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.
This study aims to investigate the current situation and risk factors of adverse mental disorders in pregnant women with hyperglycemia. it could include any of the following: 18-45 years old pregnant women with hyperglycemia. The main question is to answer the risk factor for antenatal mental disorder. participants need to complete a self-report questionnaire.
Detailed description
study design: This is a cohort study which will be conducted in the Shenzhen Hospital of Southern Medical University. Inclusion criteria: ① Pregnant women were confirmed as having gestational diabetes through biochemical examinations and glucose tolerance tests, etc. ② Possess the abilities of listening, speaking, reading, writing and comprehension, and be capable of effective communication; ③ Age: 18-45 years old (including 18 and 45 years old); ④ Informed consent and voluntary participation in the research; ⑤ Gestational age: 28 to 37 weeks (including 28 weeks but excluding 37 weeks).
Exclusion criteria: ① Abnormal fetuses and multiple pregnancies; ② Other pregnancy complications and comorbidities, such as heart disease, preeclampsia, liver disease, etc. ③ There is a history of mental illness or mental disorders in the past. ④ Those who are unable to communicate effectively by using listening, speaking, reading and writing skills; ⑤ Patients with diabetes mellitus complicated with pregnancy; ⑥ Those who use psychotropic or neurotropic drugs.
sample size: According to the sample size calculation formula of multivariate analysis, N=Zα/22×P(1-P)/δ2, P was 40.38% of the incidence of depression in pregnant women with gestational diabetes mellitus (GDM) as reported in the literature. When the test level α is set at 0.05, Zα/2=1.96; δ represents the allowable error, and δ=0.05. Therefore, the sample size obtained is 370 cases. Adding a 20% invalid questionnaire rate, the sample size obtained was 444 cases.
procedure: pregnant women who were diagnosis hyperglycemia through OGTT test between 24-28 gestational weeks will be enrolled in this study. When they were admitted to obstetric department when they had gestational week greater than 32 weeks to have childbirth, researchers will sent self-repot questionnaire to them after getting consent. The sequence of data collection is in the order of hospitalization time. A QR code will be gave them, when they tickle the join button which means they would like to participant this study. After getting consent from participants, researchers need to collect social demographic and mental health information from their electric medical record. Data processing was conducted using SPSS and R. Kolmogorov-smirnov was selected to detect whether continuous variables conform to the normal distribution. A P value <0.05 was considered statistically significant.
General information: Categorical variables are represented by frequency and percentage (%); For continuous variables, if they conform to a normal distribution, the mean ± standard deviation (x±SD) is used; otherwise, the median and interquartile range (M, IQR) are used.
LASSO regression analysis: LASSO regression analysis was conducted based on the questionnaire results of the modeling group. Taking whether adverse psychology occurred as the dependent variable and the questionnaire items of risk factors for adverse psychology in pregnant women with gestational diabetes mellitus (GDM) as independent variables, R was used to preliminarily screen the risk factors through tenfold cross-validation of LASSO regression.
Binary Logistic regression analysis: Taking the occurrence of adverse psychology as the dependent variable and the risk factors initially screened out by LASSO regression analysis as the independent variables (with independent variable assignment), binary Logistic regression analysis was conducted on the data of the modeling group. The Hosmer-Lemeshow test was conducted for goodness-of-fit examination. A p > 0.05 indicated a good fit of the model. Collinearity test: The variance inflation factor (VIF) is used for the collinearity test to detect the degree of correlation among the independent variables. A VIF > 10 indicates a strong collinearity.
Quality control Train data collectors to accurately assess the usage methods of the tools; After the data is collected and organized, it is checked and entered by two people to ensure the accuracy of the data.
③ Data analysis was conducted by two independent researchers. In case of any discrepancy, it was verified by a third independent researcher.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnant women with hyperglycemia | – | –Inclusion criteria: ① Pregnant women were confirmed as having gestational diabetes through biochemical examinations and glucose tolerance tests, etc. ② Possess the abilities of listening, speaking, reading, writing and comprehension, and be capable of effective communication; ③ Age: 18-45 years old (including 18 and 45 years old); ④ Informed consent and voluntary participation in the research; ⑤ Gestational age: 28 to 37 weeks (including 28 weeks but excluding 37 weeks). Exclusion criteria: ① Abnormal fetuses and multiple pregnancies; ② Other pregnancy complications and comorbidities, such as heart disease, preeclampsia, liver disease, etc. ③ There is a history of mental illness or mental disorders in the past. ④ Those who are unable to communicate effectively by using listening, speaking, reading and writing skills; ⑤ Patients with diabetes mellitus complicated with pregnancy; ⑥ Those who use psychotropic or neurotropic drugs. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants should follow inclusive and exclusive criteria.
Key inclusion criteria (5 listed)
- The pregnant woman was confirmed to have gestational diabetes through biochemical tests and glucose tolerance tests, etc.
- Possess the abilities of listening, speaking, reading, writing and comprehension, and be capable of effective communication;
- Age: 18-45 years old (including 18 and 45 years old);
- informed consent and voluntary participation in the research;
- Gestational age: 28 to 37 weeks (including 28 weeks but excluding 37 weeks).
Key exclusion criteria (6 listed)
- Abnormal fetuses, multiple pregnancies;
- Other pregnancy complications and comorbidities, such as heart disease, preeclampsia, liver disease, etc.
- There is a history of mental illness or mental disorders in the past.
- Those who are unable to communicate effectively by using listening, speaking, reading and writing skills;
- Patients with diabetes mellitus complicated with pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
patient health questionnaire -9 (PHQ-9) score
Time frame: Participants were administered in the hospital to deliver the baby.
In the first, second and third trimesters, due to the government's policy, all pregnancies need to complete a EDSS if they want. When the pregnancies were diagnosed with hyperglycemia, a consent form was sent to them. After getting consent from them, researchers will retrospectively collect their medical records and EDSS scores in the government system when the participants were administrated in hospital to deliver the baby. the interpretation of PHQ-9: Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively.
1 secondary outcome
Generalized Anxiety Disorder-7 scale score (GAD-7)
Time frame: Participants were administered in the hospital to deliver the baby.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- BackgroundDOI:10.16766/j.cnki.issn.1674-4152.003467.
- Results publication: PubMed 34308317Delanerolle G, Phiri P, Zeng Y, Marston K, Tempest N, Busuulwa P, Shetty A, Goodison W, Muniraman H, Duffy G, Elliot K, Maclean A, Majumder K, Hirsch M, Rathod S, Raymont V, Shi JQ, Hapangama DK. A systematic review and meta-analysis of gestational diabetes mellitus and mental health among BAME populations. EClinicalMedicine. 2021 Jul 14;38:101016. doi: 10.1016/j.eclinm.2021.101016. eCollection 2021 Aug.
- Results publication: PubMed 36045319Thiele GA, Ryan DM, Oberlander TF, Hanley GE. Preconception mental health and the relationship between antenatal depression or anxiety and gestational diabetes mellitus: a population-based cohort study. BMC Pregnancy Childbirth. 2022 Aug 31;22(1):670. doi: 10.1186/s12884-022-05002-5.
- Results publication: PubMed 33252963Schmitt A, Bendig E, Baumeister H, Hermanns N, Kulzer B. Associations of depression and diabetes distress with self-management behavior and glycemic control. Health Psychol. 2021 Feb;40(2):113-124. doi: 10.1037/hea0001037. Epub 2020 Nov 30.
- Results publication: PubMed 32792108Riggin L. Association Between Gestational Diabetes and Mental Illness. Can J Diabetes. 2020 Aug;44(6):566-571.e3. doi: 10.1016/j.jcjd.2020.06.014. Epub 2020 Jun 22.
- Results publicationhttps://www.mdpi.com/1660-4601/17/11/3767.
- Results publication: PubMed 35270274Mazumder T, Akter E, Rahman SM, Islam MT, Talukder MR. Prevalence and Risk Factors of Gestational Diabetes Mellitus in Bangladesh: Findings from Demographic Health Survey 2017-2018. Int J Environ Res Public Health. 2022 Feb 23;19(5):2583. doi: 10.3390/ijerph19052583.
- Results publication: PubMed 35613728Ye W, Luo C, Huang J, Li C, Liu Z, Liu F. Gestational diabetes mellitus and adverse pregnancy outcomes: systematic review and meta-analysis. BMJ. 2022 May 25;377:e067946. doi: 10.1136/bmj-2021-067946.
- Individual participant dataSharing planned: Yes. protocol
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia and Mental Disorder, run by Shenzhen Hospital of Southern Medical University.
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 6 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: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zonglian guo, master (+8615626450423, zonglianguo@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient health questionnaire -9 (PHQ-9) score (time frame: Participants were administered in the hospital to deliver the baby.). 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 NCT07003503, which also lists 8 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 Jun 2025.