Assessment of Quality of Life and Psychological Factors Among Women Diagnosed With Gestational Diabetes Mellitus

NCT07717424 | Recruiting DMC

• 1 other identifier: REF CMC 4525
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

Brief Summary

Summary of Research Protocol Title: Quality of Life and Associated Psychological Factors in Women with Gestational Diabetes Mellitus Background: Gestational Diabetes Mellitus (GDM) is a common metabolic disorder of pregnancy characterized by glucose intolerance first recognized during pregnancy. The prevalence of GDM is increasing globally and in India due to the rising burden of obesity and diabetes. While much research has focused on the physiological and obstetric consequences of GDM, its impact on quality of life (QoL) and psychological well-being remains less explored. Women diagnosed with GDM often experience anxiety, stress, fear regarding pregnancy outcomes, and concerns about their own and their baby's health, which may negatively affect their quality of life and adherence to treatment. Research Gap: Existing studies have primarily concentrated on glycemic control and pregnancy outcomes, with limited attention to the psychosocial dimensions of GDM. The relationship between quality of life and psychological factors such as anxiety, depression, stress, and social support among women with GDM has not been adequately studied, particularly in the Indian population. Aim: To assess the quality of life among women with Gestational Diabetes Mellitus and examine its association with psychological factors. Objectives: To study the quality of life in women with GDM. To compare the quality of life between pregnant women with GDM and those without GDM. To assess associated psychological factors, including anxiety, depression, stress, and perceived social support, among women with GDM. Methodology: A comparative cross-sectional study will be conducted among pregnant women aged 20-40 years attending the OPD and IPD services of Christian Medical College \& Hospital, Ludhiana. Women diagnosed with GDM according to DIPSI criteria (2-hour post 75 g oral glucose load blood sugar ≥140 mg/dL) will constitute the study group, while pregnant women without GDM will serve as controls. Data regarding demographic characteristics, obstetric history, medical history, family history of diabetes, and socioeconomic status will be collected using a structured case record form. Socioeconomic status will be assessed using the Modified Kuppuswamy Scale. Psychological assessment will include: GAD-7 for anxiety symptoms. PHQ-9 for depressive symptoms. MSPSS for perceived social support. Quality of life will be assessed using a validated QoL questionnaire appropriate for women with GDM. Sample Size: Based on previous literature, a minimum sample size of 103 participants in each group (GDM and non-GDM) has been calculated, resulting in a total sample size of 206 participants. Statistical Analysis: Data will be analyzed using SPSS version 26.0. Quantitative variables will be compared using Student's t-test or Mann-Whitney U test, while categorical variables will be analyzed using Chi-square or Fisher's exact test. A p-value \<0.05 will be considered statistically significant. Expected Outcome: The study is expected to provide insights into the quality of life of women with GDM and identify psychological and social factors associated with poorer QoL. The findings may help healthcare providers develop holistic and patient-centered management strategies that address not only glycemic control but also the psychosocial needs of pregnant women with GDM.

Conditions

Gestational Diabetes Mellitus (GDM)

Keywords

Gestational Diabetes Mellitus (GDM); Quality of life

Outcome Measures

Primary Outcomes (1)

• Quality of Life as measured by the Gestational Diabetes Mellitus Quality of Life Questionnaire (GDMQ-36)

  Quality of life in women with Gestational Diabetes Mellitus (GDM) will be assessed using the disease-specific GDMQ-36 questionnaire. The questionnaire consists of 36 items across 5 domains: (1) concerns about high-risk pregnancy, (2) perceived constraints, (3) complications of GDM, (4) medication and treatment, and (5) support. Total score ranges from 0 to 100, with higher scores indicating better quality of life. This will be assessed in women with GDM at baseline.

  Baseline

Secondary Outcomes (4)

• Prevalence of Depressive Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)

  Baseline

• Level of Perceived Social Support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)

  Baseline

• To assess the association of serum Vitamin D with Gestational Diabetes Mellitus.

  Baseline

• To assess the association of serum Cortisol levels with Gestational Diabetes Mellitus.

  Baseline

Study Arms (1)

Pregnancy with Gestational diabetes mellitus (GDM)

Pregnancy with without GDM

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted on all Pregnant females in age group of 20-40 years

You may qualify if:

• \) All Pregnant females admitted to Christian Medical College \& Hospital, Ludhiana. (OPD+IPD).
• \) Age group between 20-40 years.
• \) Females who have given consent for the study.

You may not qualify if:

• \) Subjects not willing to participate.

Sponsors & Collaborators

• Lovely Professional University: lead

Study Sites (1)

Christain Medical College and Hospital

Ludhiana, Punjab, 141008, India

RECRUITING

Related Publications (5)

• Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.

  PMID: 2280326 BACKGROUND

• Natasha K, Hussain A, Khan AK. Prevalence of depression among subjects with and without gestational diabetes mellitus in Bangladesh: a hospital based study. J Diabetes Metab Disord. 2015 Jul 28;14:64. doi: 10.1186/s40200-015-0189-3. eCollection 2015.

  PMID: 26221580 BACKGROUND

• Schmidt CB, Voorhorst I, van de Gaar VHW, Keukens A, Potter van Loon BJ, Snoek FJ, Honig A. Diabetes distress is associated with adverse pregnancy outcomes in women with gestational diabetes: a prospective cohort study. BMC Pregnancy Childbirth. 2019 Jul 3;19(1):223. doi: 10.1186/s12884-019-2376-6.

  PMID: 31269913 BACKGROUND

• Lawrence JM. Women with diabetes in pregnancy: different perceptions and expectations. Best Pract Res Clin Obstet Gynaecol. 2011 Feb;25(1):15-24. doi: 10.1016/j.bpobgyn.2010.10.003. Epub 2010 Nov 5.

  PMID: 21115403 BACKGROUND

• Anjana RM, Pradeepa R, Deepa M, Datta M, Sudha V, Unnikrishnan R, Bhansali A, Joshi SR, Joshi PP, Yajnik CS, Dhandhania VK, Nath LM, Das AK, Rao PV, Madhu SV, Shukla DK, Kaur T, Priya M, Nirmal E, Parvathi SJ, Subhashini S, Subashini R, Ali MK, Mohan V; ICMR-INDIAB Collaborative Study Group. Prevalence of diabetes and prediabetes (impaired fasting glucose and/or impaired glucose tolerance) in urban and rural India: phase I results of the Indian Council of Medical Research-INdia DIABetes (ICMR-INDIAB) study. Diabetologia. 2011 Dec;54(12):3022-7. doi: 10.1007/s00125-011-2291-5. Epub 2011 Sep 30.

  PMID: 21959957 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Tapasya Dhar

  Christain Medical College and Hospital

  PRINCIPAL INVESTIGATOR

• Rakesh Kumar, PhD Pharmacology

  School of Pharmaceutical Sciences, Lovely Professional University, Phagwara -144411, Punjab, India,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harsh Kishore Mr, M Pharmacy (Pharmacology)

CONTACT

+91 724 864 8989; harsh.42300149@lpu.in

Harsh Kishore, M. Pharmacy (Pharmacology)

CONTACT

+91 7696660211

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 15 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD scholar

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: July 21, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)