Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-02 @ 6:30 AM
Study NCT ID:
NCT07003503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Explore the Risk Factors for Antenatal Mental Disorders in Pregnant Women With Hyperglycemia
Sponsor:
Shenzhen Hospital of Southern Medical University
Organization:
Study Overview
Official Title:
Explore the Risk Factors for Antenatal Mental Disorders in Pregnant Women With Hyperglycemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: