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Quality of Life and Psychological Factors in Women with Gestational Diabetes Mellitus

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Study Aim

This study aims to observe and understand the quality of life in women with Gestational Diabetes Mellitus, using a specific questionnaire (GDMQ-36) to assess various aspects such as concerns about high-risk pregnancy, perceived constraints, complications of GDM, medication and treatment, and support.

What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Urogenital Diseases+6

+ Diabetes Mellitus

+ Endocrine System Diseases

From 20 to 40 Years
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: May 2026
See protocol details

Summary

Principal SponsorLovely Professional University
Study ContactHarsh Kishore Mr, M Pharmacy (Pharmacology)More contacts
Last updated: July 21, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 14, 2026

Actual date on which the first participant was enrolled.

Diabetes is a major public health problem in India with prevalence rates reported to be between 4.6% and 14% in urban areas, and 1.7% and 13.2% in rural areas(1). Gestational diabetes mellitus (GDM) is a transient metabolic disorder, characterized by hyperglycemia that occurs and is first diagnosed during pregnancy, and is expected to resolve after childbirth (2). The onset of GDM puts a heavy strain on the positive connotation of pregnancy and is accompanied by feelings of fear, anxiety, uncertainty, a sense of losing control, elevated levels of stress, a poorer perception of one's health, reduced self-worth, and impaired QoL (3). Diabetes-specific instruments disregard the fact that women suffering from GDM expect their condition as temporarily limited to their pregnancy, unlike the chronic nature of diabetes mellitus type one or type two (4). The usage of numerous different types of questionnaires for QoL assessment leads to inconsistent study findings on this topic, resulting in heterogeneous recommendations. Accordingly, it seems reasonable to establish a solid foundation for further research by developing and validating an appropriate patient-reported outcome measure for QoL assessments in GDM. Mokhlesi et al (5) have completed important work by introducing the Persian questionnaire GDMQ-36 for the assessment of disease-specific QoL in women with GDM, which has been proven to be reliable and valid for the Iranian population. To our knowledge, it is so far the only questionnaire worldwide tailored to the QoL of gestational diabetics that incorporates all the mentioned aspects due to the fact that it is exactly tailored to the needs as well as disease- and treatment-related challenges gestational diabetics are facing. It contains 36 questions and consists of five aspects: (1) concerns about high-risk pregnancy, (2) perceived constraints, (3) complications of GDM, (4) medication and treatment, and (5) support In managing Gestational Diabetes Mellitus (GDM) is the lack of studies that explore how a woman's personal living conditions and biopsychosocial factors affect her adherence to treatment and overall quality of life (QoL). Aspects such as fear of hypoglycemia or concerns about fetal health can influence a woman's acceptance of treatment, even if the treatment is medically effective. Research is needed to understand how these personal and psychosocial factors impact a woman's ability to follow treatment plans and how improving QoL can enhance treatment adherence. By focusing on personalized care that takes these factors into account, Present study help create more effective and supportive treatment strategies for women with GDM.

Principal SponsorLovely Professional University
Study ContactHarsh Kishore Mr, M Pharmacy (Pharmacology)More contacts
Last updated: July 21, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

206 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 20 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesDiabetes MellitusEndocrine System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsMetabolic DiseasesNutritional and Metabolic DiseasesPregnancy ComplicationsGlucose Metabolism DisordersDiabetes, Gestational

Criteria

Inclusion Criteria: * 1\) All Pregnant females admitted to Christian Medical College \& Hospital, Ludhiana. (OPD+IPD). 2\) Age group between 20-40 years. 3\) Females who have given consent for the study. Exclusion Criteria: * 1\) Subjects not willing to participate.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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Christain Medical College and Hospital

Ludhiana, IndiaOpen Christain Medical College and Hospital in Google Maps
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One Study Center