Explore the Risk Factors for Antenatal Mental Disorders in Pregnant Women With Hyperglycemia

NCT07003503 | Not Yet Recruiting DMC

• 1 other identifier: NYSZYYEC2024K13OR001
• Study Type: observational
• Target: 635
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperglycemia; Mental Disorder; Pregnancy Complications

Keywords

hyperglycemia; antenatal mental disorder; pregnancy complication

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants were administered in the hospital to deliver the baby.

Secondary Outcomes (1)

• Generalized Anxiety Disorder-7 scale score (GAD-7)

  Participants were administered in the hospital to deliver the baby.

Study Arms (1)

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.

Eligibility Criteria

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

Study Population

Participants should follow inclusive and exclusive criteria.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Hospital of Southern Medical University: lead

Related Publications (8)

• 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.

  PMID: 34308317 BACKGROUND

• DOI:10.16766/j.cnki.issn.1674-4152.003467.

  BACKGROUND

• Thiele 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.

  PMID: 36045319 BACKGROUND

• Schmitt 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.

  PMID: 33252963 BACKGROUND

• Riggin 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.

  PMID: 32792108 BACKGROUND

• https://www.mdpi.com/1660-4601/17/11/3767.

  BACKGROUND

• 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.

  PMID: 35270274 BACKGROUND

• Ye 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.

  PMID: 35613728 BACKGROUND

MeSH Terms

Conditions

Hyperglycemia; Mental Disorders; Pregnancy Complications

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

zonglian guo, master

CONTACT

+8615626450423; zonglianguo@foxmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: June 4, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL