Gestational Diabetes Mellitus (GDM)NCT07717424
Assessment of Quality of Life and Psychological Factors Among Women Diagnosed With Gestational Diabetes Mellitus
An observational study of Gestational Diabetes Mellitus (GDM), run by Lovely Professional University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- How many people
- 206 participants
- Where
- 1 siteIndia
- Study dates
- 14 May 2026to 31 Dec 2026
- How long will I take part?
- 15 Days
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study will be conducted on all Pregnant females in age group of 20-40 years
Who may be able to join
- 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.
Who cannot join
- 1) Subjects not willing to participate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Harsh Kishore, M. Pharmacy (Pharmacology) contact
India1 site, 1 recruiting
- Recruiting
Christain Medical College and Hospital
Ludhiana, Punjab, 141008
Rakesh Kumar, +91 7248648989, harsh.42300149@lpu.in
About this study
Summary of Research Protocol
Title: Quality of Life and Associated Psychological Factors in Women with Gestational Diabetes Mellitus
Read more
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.
Read the detailed description
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.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- Gestational Diabetes Mellitus (GDM), Quality of life
- Medical subject headings
- Diabetes, Gestational
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 |
|---|---|---|
| Pregnancy with Gestational diabetes mellitus (GDM) | Pregnancy with without GDM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
Prevalence of Depressive Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Depressive symptoms in women with GDM will be assessed using the PHQ-9 questionnaire. Each of the 9 items is scored on a Likert scale from 0 to 3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day). Total score ranges from 0 to 27. A score of 10 or higher indicates the presence of depressive symptoms.
Measured: Baseline
Level of Perceived Social Support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
Perceived social support in women with GDM will be assessed using the MSPSS, a 12-item validated tool evaluating support from three sources: family, friends, and significant other. Each item is rated on a 7-point Likert scale (1 = very strongly disagree to 7 = very strongly agree). Average score ranges from 1 to 7. Social support is categorized as low (< 2), moderate (3-5), or high (> 5).
Measured: Baseline
To assess the association of serum Vitamin D with Gestational Diabetes Mellitus.
To assess the association of serum Vitamin D levels with the diagnosis of Gestational Diabetes Mellitus. Serum Vitamin D (ng/mL) levels will be measured in all participants at baseline. Vitamin D levels will be categorized as deficient (< 20 ng/mL), insufficient (20-29 ng/mL), or sufficient (≥ 30 ng/mL).
Measured: Baseline
To assess the association of serum Cortisol levels with Gestational Diabetes Mellitus.
Serum Cortisol levels will be measured in all participants at baseline. Cortisol levels will be categorized using a cut-off of 17.66 µg/L.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start14 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 206 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Lovely Professional University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harsh Kishore, Lovely Professional University
- Investigators
- Tapasya Dhar, Principal investigator, Christain Medical College and HospitalRakesh Kumar, PhD Pharmacology, Principal investigator, School of Pharmaceutical Sciences, Lovely Professional University, Phagwara -144411, Punjab, India,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07717424
- Sponsor's protocol ID
- REF CMC 4525
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2280326Natasha 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.
PubMed 26221580Schmidt 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.
PubMed 31269913Lawrence 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.
PubMed 21115403Anjana 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.
PubMed 21959957
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Quality of Life and Psychological Factors Among Women Diagnosed With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07717424
- Acronym / sponsor ID
- REF CMC 4525
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- Gestational Diabetes Mellitus (GDM), Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Lovely Professional UniversityUniversity, hospital or other
- Study start
- 14 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jul 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy with Gestational diabetes mellitus (GDM) | – | –Pregnancy with without GDM |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study will be conducted on all Pregnant females in age group of 20-40 years
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) Subjects not willing to participate.
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
Quality of Life as measured by the Gestational Diabetes Mellitus Quality of Life Questionnaire (GDMQ-36)
Time frame: Baseline
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.
4 secondary outcomes
Prevalence of Depressive Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
Level of Perceived Social Support as measured by the Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Baseline
To assess the association of serum Vitamin D with Gestational Diabetes Mellitus.
Time frame: Baseline
To assess the association of serum Cortisol levels with Gestational Diabetes Mellitus.
Time frame: Baseline
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 21 Jul 2026.
- Background: PubMed 2280326Zimet 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.
- Background: PubMed 26221580Natasha 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.
- Background: PubMed 31269913Schmidt 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.
- Background: PubMed 21115403Lawrence 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.
- Background: PubMed 21959957Anjana 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.
- Individual participant dataSharing planned: No
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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.
Harsh Kishore, M. Pharmacy (Pharmacology) contact
Tapasya Dhar principal investigator
Christain Medical College and Hospital
Rakesh Kumar, PhD Pharmacology principal investigator
School of Pharmaceutical Sciences, Lovely Professional University, Phagwara -144411, Punjab, India,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes Mellitus (GDM), run by Lovely Professional University at 1 site in India.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Harsh Kishore Mr, M Pharmacy (Pharmacology) (+91 724 864 8989, harsh.42300149@lpu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life as measured by the Gestational Diabetes Mellitus Quality of Life Questionnaire (GDMQ-36) (time frame: Baseline). 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 NCT07717424, which also lists 5 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 21 Jul 2026.