Diabetes Mellitus in PregnancyNCT06277258
Patient Empowerment in the Management of Gestational Diabetes Mellitus
A study testing Patient Empowerment model in people with Diabetes Mellitus in Pregnancy, run by Public Health Foundation of Bangladesh at 3 sites in Bangladesh.
Trial summary
This study is a clustered randomized controlled trial assessing the outcome of "Patient Empowerment" in the management of Gestational Diabetes Mellitus by applying the patient empowering model in the intervention group and the conventional method of treatment in the control group. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Diabetes Mellitus in Pregnancy
- What is being tested?
- Patient Empowerment model
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 3 sitesBangladesh
- Study dates
- 31 Jan 2023to 10 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Screen positive GDM cases, who have not been managed for diabetes by any means
- Gestational age from18 weeks to 36 weeks
Who cannot join
- Known history of diabetes before pregnancy
- Women with twin or multiple pregnancies
Trial locations and contacts
3 sites in 1 country.
Bangladesh3 sites
Azimpur Maternity hospital ( MCHTI)
Dhaka, 1205
Shaheed Suhrawardy Medical College (ShSMC)
Dhaka, 1207
Bangabandhu Sheikh Mujib Medical University (BSMMU)
Dhaka, 1217
About this study
Official title: Outcome of "Patient Empowerment" in the Management of Gestational Diabetes Mellitus: A Clustered Randomized Controlled Trial
This study is a clustered randomized controlled trial assessing the outcome of "Patient Empowerment" in the management of Gestational Diabetes Mellitus by applying the patient empowering model in the intervention group and the conventional method of treatment in the control group. It will be conducted in four centres in Dhaka city of Bangladesh. The primary outcome measures will be determining the frequency of good fetomaternal and neonatal outcome through glycemic control. Target of Glycemic Status: For Pregnant Mother, Fasting, 95 mg/dL (5.3 mmol/L), Two-hour postprandial,120 mg/dL (6.7 mmol/L), For Neonate glycemic status at or above 2.5 mmol/l. Maternal outcome during pregnancy - Decrease chance of antenatal infections that is Vulvovaginitis and recurrent UTI, Decrease pre-eclampsia, Decrease Antepartum Hemorrhage and Polyhydramnios. Maternal outcome in the form of mode of safe delivery- Increase frequency of vaginal delivery, Decrease chance of obstructed labour. Maternal outcome after delivery- Decrease chance of Postpartum Hemorrhage, Decrease chance of puerperal sepsis. Fetal Outcome- Less chance of Intra uterine death and prematurity. Neonatal Outcome- Less chance of Birth injury, Birth asphyxia, Perinatal death, Good Apgar score (≥ 7) in 1st and 5th minute, Less need for NICU care and Less chance of macrosomia (≥ 4 kg) at term. Fewer proportion of patients will require insulin to manage GDM. The secondary outcomes will be patient satisfaction and the patient will be a future resource person.
Read the detailed description
Procedure of Study (Including methods of intervention, measurement, estimation etc.):
Screen positive GDM patients will be recruited according to inclusion and exclusion criteria. After taking consent they will be registered for study purpose. According to computer generated randomization the health centres will be allocated and single method of management either patient empowerment or conventional method will be adopted for the whole cluster of the respective health centre. The intervention group will only receive the "Patient Empowerment' package.
The patients of intervention group, along with antenatal check-up, will go through the first session of the empowerment package on the first day of recruitment. Then they will be evaluated through structured questions to know their level of perception/ understanding and retention about the diabetes and its management. Those who will perform to get at least 80% out of 100 will be recognized as empowered. Who fail to achieve that they will be called for next seating. Patients unwilling to go through the process or failed to achieve the targeted score within three seating will be excluded. Those who fulfilled the target, they will be advised to follow the calorie and diet distribution schedule. They will be advised to return back 2 days later, with the blood sugar chart (6 times per day) by SMBG (Self-monitoring of blood glucose). The respondents will get the materials like measuring cup, hand manuals on diabetes, glucometer and chart for record keeping.
After evaluating the sugar chart, if they are found poor performer they will be counselled and trained further and will have to come back again after two days. At the same time patient's satisfaction will be assessed with LIKERT scale. Frequency of further visit will depend on patient's performance.
All the respondents from both groups are supposed to come for ANC at least at monthly interval initially up to 28 weeks and then fortnightly up to 36 weeks and then weekly up to delivery; frequency of the visit may be more if necessary. For Conventional (non- intervention) group at least 2 to 3 times blood sugar level should be checked within the follow up period. Then all the pertinent variables will be recorded, analyzed as per study objective and outcome, to evaluate the effectiveness of patient empowerment in the management of GDM.
Blood sample collection:
Patients of GDM will be trained to measure their own blood sugar level (both fasting and 2 hours' postprandial) by Glucometer at home and to maintain a blood sugar chart.
Laboratory methods:
In this study design apart from routine antenatal screening tests no other additional laboratory investigation will be done unless be otherwise needed on medical ground.
Follow up of the patients:
Both the study group and comparison group will be followed up as per study protocol at monthly interval initially up to 28 weeks and then fortnightly up to 36 weeks and then weekly up to delivery; frequency of the visit may be more if necessary.
Data Collection Tools:
Pre-tested semi structured questionnaire/interview schedule and checklist.
Data Collection Procedure:
GDM cases will be enrolled in this study with taking written consent on the consent form. Data will be collected by multiple techniques like face to face interview, records, findings of physical examination and observation, information on concerned variables and will be documented. Among the variables the fasting blood sugar and 2 hours after ingestion of 75-gram glucose will be considered as baseline for detection of GDM as screening test between 14 to 34 weeks of gestation. Patient empowerment
All the clinical and investigative findings and therapeutic variables will be documented during each antenatal visit. The ANC and its frequency should be according to conventional schedule (Monthly up to 28 weeks, fortnightly up to 36 weeks and then weekly up to delivery in low risk cases and for high risk the frequency of visit will be more). In both the groups from patient's blood sugar chart, average blood sugar value will be documented monthly. Each patient will be followed up to the end of puerperium that is 6 weeks after delivery.
From each institute, data will be collected with separate registration name and number and will be stored separately.
Statistical analysis:
The data will be analyzed according to cluster randomized trial protocol; and all statistical analysis will be based on Intention to Treat (ITT) approach. Descriptive statistics will be generated for all base line and follow-up data (frequency and relative frequency for categorical data, means with standard deviations (SDs) or 95% confidence intervals (CIs) for normally distributed continuous data and for non-normal data median and interquartile ranges.
Univariable associations between baseline patient characteristics and outcome will be assessed using univariable Cox regression. All statistically significant predictors will be assessed for possible confounding. Potential confounders measured at baseline will be selected based on a directed acyclic graph (DAG) and univariate association finding. Tests based on Schoenfeld residuals will be used to identify violations of the proportional hazards assumption. Impact of intervention on for primary outcome (adverse pregnancy outcome) will be assessed using multilevel cox proportional hazard regression adjusting for plausible confounders. Multilevel modelling will include a shared frailty term in the model to account for hospital-level clustering. The between-group differences will be assessed enabling simultaneous examination of cluster and individual-level influences on outcomes. Adjustment of the result for between-cluster variation will thus be achieved. The effects of the intervention on maternal and neonatal outcomes and changes in physical activity and diet will be analysed by using generalized linear latent and mixed models and multilevel mixed-effects linear regression by fitting random effects models. All analysis will be performed in Stata S/E version 17.
Quality assurance strategy:
From research team, PI, Co-PI and other investigators and local GOB health managers will work together for effective implementation, monitoring and evaluation of interventions. They will jointly monitor the progress and oversee any deviation from the protocol.
- Conditions
- Diabetes Mellitus in Pregnancy
- Being tested
- Patient Empowerment model
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Empowerment modelOther
Session I
- Knowledge about the disease, calories \& diet distribution, physical activities, symptoms of hypoglycemia, Blood Glucose target etc.
- Training on use of glucometer and record keeping Session II
- Evaluation and interpretation of sugar level based on the sugar chart.
- Tuning of diet and exercise if needed.
- Discussion about the challenges faced by the patient during maintenance of sugar level.
Session III \& ongoing
- Tuning of the diet based on calories, evaluation of the understanding
- Assessment of patient satisfaction
- Assessment of patients' knowledge and skill to designate her as "Empowered"
Assurance and counseling of patient and family will be rendered in each session.
| Study group | Role | What they receive |
|---|---|---|
| Patient Empowerment Model | Experimental | Patients will be empowered to manage gestational diabetes mellitus themselves by acquiring knowledge and skill to monitor blood sugar levels, adjusting meals and daily activities. Receives: Other: Patient Empowerment model |
| Standard of care | No intervention | Patients will get the conventional way of management where patients get advice about a diet chart with a fixed menu and injection of insulin to control blood sugar levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with adverse maternal pregnancy outcome
Maternal pregnancy outcome are antenatal infection, Preeclampsia, polyhydramnios, Ante and post partum Haemorrhage, Puerperal sepsis. Maternal death.
Measured: Monthly from enrolment day up to 28 weeks of gestation, fortnightly from 28 weeks to 36 weeks of gestation, weekly from 36 weeks of gestation up to delivery, during delivery, Within 24 hours of delivery, 1 week, 2 weeks & 6 weeks of delivery
Number of Participants with adverse foetal outcome
Adverse foetal outcome include prematurity, Birth injury, Birth asphyxia, Perinatal death, NICU admission macrosomia (≥ 4 kg) at term, hypoglycaemia (≤ 2.5 mmol/l)
Measured: During delivery, After delivery- within 24 hours
Number of Participants with adequate glycaemic control
Adequate glycaemic control include (a) 80% of blood glucose reading of the month with in normal range. (b) No requirement of insulin or pharmacological agents to manage GDM,
Measured: Monthly from enrollment day upto 28 weeks of gestation, fortnightly from 28 weeks to 36 weeks of gestation, weekly from 36 weeks of gestation upto delivery
Secondary outcomes (1)
Maternal satisfaction
Patient satisfaction will be assessed through the LIKERT rating scale ranging from strongly satisfied to strongly dissatisfied. The maximum value is 5 which means the patient is strongly satisfied with the service and the minimum value is 1 wchich means the patient is strongly dissatisfied.
Measured: Monthly from enrollment day upto 28 weeks of gestation, fortnightly from 28 weeks to 36 weeks of gestation, weekly from 36 weeks of gestation upto delivery, during delivery, Within 24 hours of delivery, 1 week, 2 weeks & 6 weeks of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start31 Jan 2023
- Primary completion10 Oct 2024
- Study completion10 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus in PregnancyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Public Health Foundation of Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tabassum Parveen, Public Health Foundation of Bangladesh
- Investigators
- Tabassum Parveen, FCPS, Principal investigator, Professor, Department of Fetomaternal Medicine, BSMMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277258
- Sponsor's protocol ID
- BSMMU/2022/9656
- Status last verified
- Aug 2025
- First submitted
- 15 Dec 2022
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan of data sharing before completion of study, if required then will be done with the prior permission of the funding agency
Publications
Diagnostic Criteria and Classification of Hyperglycaemia First Detected in Pregnancy. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK169024/
PubMed 24199271Biswas A, Dalal K, Abdullah ASM, Rahman AKMF, Halim A. Gestational Diabetes: Exploring the Perceptions, Practices and Barriers of the Community and Healthcare Providers in Rural Bangladesh: A Qualitative Study. Diabetes Metab Syndr Obes. 2020 Apr 23;13:1339-1348. doi: 10.2147/DMSO.S238523. eCollection 2020.
PubMed 32425566Rieck S, Kaestner KH. Expansion of beta-cell mass in response to pregnancy. Trends Endocrinol Metab. 2010 Mar;21(3):151-8. doi: 10.1016/j.tem.2009.11.001. Epub 2009 Dec 16.
PubMed 20015659Muche AA, Olayemi OO, Gete YK. Effects of gestational diabetes mellitus on risk of adverse maternal outcomes: a prospective cohort study in Northwest Ethiopia. BMC Pregnancy Childbirth. 2020 Feb 3;20(1):73. doi: 10.1186/s12884-020-2759-8.
PubMed 32013909Zhuang W, Lv J, Liang Q, Chen W, Zhang S, Sun X. Adverse effects of gestational diabetes-related risk factors on pregnancy outcomes and intervention measures. Exp Ther Med. 2020 Oct;20(4):3361-3367. doi: 10.3892/etm.2020.9050. Epub 2020 Jul 27.
PubMed 32855709Martis R, Crowther CA, Shepherd E, Alsweiler J, Downie MR, Brown J. Treatments for women with gestational diabetes mellitus: an overview of Cochrane systematic reviews. Cochrane Database Syst Rev. 2018 Aug 14;8(8):CD012327. doi: 10.1002/14651858.CD012327.pub2.
PubMed 30103263Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
PubMed 15951574Moreno-Castilla C, Mauricio D, Hernandez M. Role of Medical Nutrition Therapy in the Management of Gestational Diabetes Mellitus. Curr Diab Rep. 2016 Apr;16(4):22. doi: 10.1007/s11892-016-0717-7.
PubMed 26879305Luczynski W, Glowinska-Olszewska B, Bossowski A. Empowerment in the Treatment of Diabetes and Obesity. J Diabetes Res. 2016;2016:5671492. doi: 10.1155/2016/5671492. Epub 2016 Dec 20.
PubMed 28090541American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S15-S33. doi: 10.2337/dc21-S002.
PubMed 33298413International Association of Diabetes and Pregnancy Study Groups Consensus Panel; Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva Ad, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848. No abstract available.
PubMed 20190296Bener A, Saleh NM, Al-Hamaq A. Prevalence of gestational diabetes and associated maternal and neonatal complications in a fast-developing community: global comparisons. Int J Womens Health. 2011;3:367-73. doi: 10.2147/IJWH.S26094. Epub 2011 Nov 7.
PubMed 22140323Kim SY, Saraiva C, Curtis M, Wilson HG, Troyan J, Sharma AJ. Fraction of gestational diabetes mellitus attributable to overweight and obesity by race/ethnicity, California, 2007-2009. Am J Public Health. 2013 Oct;103(10):e65-72. doi: 10.2105/AJPH.2013.301469. Epub 2013 Aug 15.
PubMed 23947320Gupta Y, Kalra B, Baruah MP, Singla R, Kalra S. Updated guidelines on screening for gestational diabetes. Int J Womens Health. 2015 May 19;7:539-50. doi: 10.2147/IJWH.S82046. eCollection 2015.
PubMed 26056493Agarwal MM. Gestational diabetes mellitus: An update on the current international diagnostic criteria. World J Diabetes. 2015 Jun 25;6(6):782-91. doi: 10.4239/wjd.v6.i6.782.
PubMed 26131321
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of "Patient Empowerment" in the Management of Gestational Diabetes Mellitus: A Clustered Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06277258
- Acronym / sponsor ID
- BSMMU/2022/9656
- Conditions
- Diabetes Mellitus in Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Public Health Foundation of BangladeshUniversity, hospital or other
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Nov 2024 (actual)
- First posted
- 26 Feb 2024 (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.
This study is a clustered randomized controlled trial assessing the outcome of "Patient Empowerment" in the management of Gestational Diabetes Mellitus by applying the patient empowering model in the intervention group and the conventional method of treatment in the control group. It will be conducted in four centres in Dhaka city of Bangladesh. The primary outcome measures will be determining the frequency of good fetomaternal and neonatal outcome through glycemic control. Target of Glycemic Status: For Pregnant Mother, Fasting, 95 mg/dL (5.3 mmol/L), Two-hour postprandial,120 mg/dL (6.7 mmol/L), For Neonate glycemic status at or above 2.5 mmol/l. Maternal outcome during pregnancy - Decrease chance of antenatal infections that is Vulvovaginitis and recurrent UTI, Decrease pre-eclampsia, Decrease Antepartum Hemorrhage and Polyhydramnios. Maternal outcome in the form of mode of safe delivery- Increase frequency of vaginal delivery, Decrease chance of obstructed labour. Maternal outcome after delivery- Decrease chance of Postpartum Hemorrhage, Decrease chance of puerperal sepsis. Fetal Outcome- Less chance of Intra uterine death and prematurity. Neonatal Outcome- Less chance of Birth injury, Birth asphyxia, Perinatal death, Good Apgar score (≥ 7) in 1st and 5th minute, Less need for NICU care and Less chance of macrosomia (≥ 4 kg) at term. Fewer proportion of patients will require insulin to manage GDM. The secondary outcomes will be patient satisfaction and the patient will be a future resource person.
Detailed description
Procedure of Study (Including methods of intervention, measurement, estimation etc.):
Screen positive GDM patients will be recruited according to inclusion and exclusion criteria. After taking consent they will be registered for study purpose. According to computer generated randomization the health centres will be allocated and single method of management either patient empowerment or conventional method will be adopted for the whole cluster of the respective health centre. The intervention group will only receive the "Patient Empowerment' package.
The patients of intervention group, along with antenatal check-up, will go through the first session of the empowerment package on the first day of recruitment. Then they will be evaluated through structured questions to know their level of perception/ understanding and retention about the diabetes and its management. Those who will perform to get at least 80% out of 100 will be recognized as empowered. Who fail to achieve that they will be called for next seating. Patients unwilling to go through the process or failed to achieve the targeted score within three seating will be excluded. Those who fulfilled the target, they will be advised to follow the calorie and diet distribution schedule. They will be advised to return back 2 days later, with the blood sugar chart (6 times per day) by SMBG (Self-monitoring of blood glucose). The respondents will get the materials like measuring cup, hand manuals on diabetes, glucometer and chart for record keeping.
After evaluating the sugar chart, if they are found poor performer they will be counselled and trained further and will have to come back again after two days. At the same time patient's satisfaction will be assessed with LIKERT scale. Frequency of further visit will depend on patient's performance.
All the respondents from both groups are supposed to come for ANC at least at monthly interval initially up to 28 weeks and then fortnightly up to 36 weeks and then weekly up to delivery; frequency of the visit may be more if necessary. For Conventional (non- intervention) group at least 2 to 3 times blood sugar level should be checked within the follow up period. Then all the pertinent variables will be recorded, analyzed as per study objective and outcome, to evaluate the effectiveness of patient empowerment in the management of GDM.
Blood sample collection:
Patients of GDM will be trained to measure their own blood sugar level (both fasting and 2 hours' postprandial) by Glucometer at home and to maintain a blood sugar chart.
Laboratory methods:
In this study design apart from routine antenatal screening tests no other additional laboratory investigation will be done unless be otherwise needed on medical ground.
Follow up of the patients:
Both the study group and comparison group will be followed up as per study protocol at monthly interval initially up to 28 weeks and then fortnightly up to 36 weeks and then weekly up to delivery; frequency of the visit may be more if necessary.
Data Collection Tools:
Pre-tested semi structured questionnaire/interview schedule and checklist.
Data Collection Procedure:
GDM cases will be enrolled in this study with taking written consent on the consent form. Data will be collected by multiple techniques like face to face interview, records, findings of physical examination and observation, information on concerned variables and will be documented. Among the variables the fasting blood sugar and 2 hours after ingestion of 75-gram glucose will be considered as baseline for detection of GDM as screening test between 14 to 34 weeks of gestation. Patient empowerment
All the clinical and investigative findings and therapeutic variables will be documented during each antenatal visit. The ANC and its frequency should be according to conventional schedule (Monthly up to 28 weeks, fortnightly up to 36 weeks and then weekly up to delivery in low risk cases and for high risk the frequency of visit will be more). In both the groups from patient's blood sugar chart, average blood sugar value will be documented monthly. Each patient will be followed up to the end of puerperium that is 6 weeks after delivery.
From each institute, data will be collected with separate registration name and number and will be stored separately.
Statistical analysis:
The data will be analyzed according to cluster randomized trial protocol; and all statistical analysis will be based on Intention to Treat (ITT) approach. Descriptive statistics will be generated for all base line and follow-up data (frequency and relative frequency for categorical data, means with standard deviations (SDs) or 95% confidence intervals (CIs) for normally distributed continuous data and for non-normal data median and interquartile ranges.
Univariable associations between baseline patient characteristics and outcome will be assessed using univariable Cox regression. All statistically significant predictors will be assessed for possible confounding. Potential confounders measured at baseline will be selected based on a directed acyclic graph (DAG) and univariate association finding. Tests based on Schoenfeld residuals will be used to identify violations of the proportional hazards assumption. Impact of intervention on for primary outcome (adverse pregnancy outcome) will be assessed using multilevel cox proportional hazard regression adjusting for plausible confounders. Multilevel modelling will include a shared frailty term in the model to account for hospital-level clustering. The between-group differences will be assessed enabling simultaneous examination of cluster and individual-level influences on outcomes. Adjustment of the result for between-cluster variation will thus be achieved. The effects of the intervention on maternal and neonatal outcomes and changes in physical activity and diet will be analysed by using generalized linear latent and mixed models and multilevel mixed-effects linear regression by fitting random effects models. All analysis will be performed in Stata S/E version 17.
Quality assurance strategy:
From research team, PI, Co-PI and other investigators and local GOB health managers will work together for effective implementation, monitoring and evaluation of interventions. They will jointly monitor the progress and oversee any deviation from the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Empowerment Model | Experimental | Other: Patient Empowerment modelPatients will be empowered to manage gestational diabetes mellitus themselves by acquiring knowledge and skill to monitor blood sugar levels, adjusting meals and daily activities. |
| Standard of care | No intervention | –Patients will get the conventional way of management where patients get advice about a diet chart with a fixed menu and injection of insulin to control blood sugar levels. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Screen positive GDM cases, who have not been managed for diabetes by any means
- Gestational age from18 weeks to 36 weeks
Key exclusion criteria (2 listed)
- Known history of diabetes before pregnancy
- Women with twin or multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Empowerment modelSession I * Knowledge about the disease, calories \& diet distribution, physical activities, symptoms of hypoglycemia, Blood Glucose target etc. * Training on use of glucometer and record keeping Session II * Evaluation and interpretation of sugar level based on the sugar chart. * Tuning of diet and exercise if needed. * Discussion about the challenges faced by the patient during maintenance of sugar level. Session III \& ongoing * Tuning of the diet based on calories, evaluation of the understanding * Assessment of patient satisfaction * Assessment of patients' knowledge and skill to designate her as "Empowered" Assurance and counseling of patient and family will be rendered in each session. | Other | Patient Empowerment Model |
Primary outcome
Number of Participants with adverse maternal pregnancy outcome
Time frame: Monthly from enrolment day up to 28 weeks of gestation, fortnightly from 28 weeks to 36 weeks of gestation, weekly from 36 weeks of gestation up to delivery, during delivery, Within 24 hours of delivery, 1 week, 2 weeks & 6 weeks of delivery
Maternal pregnancy outcome are antenatal infection, Preeclampsia, polyhydramnios, Ante and post partum Haemorrhage, Puerperal sepsis. Maternal death.
Number of Participants with adverse foetal outcome
Time frame: During delivery, After delivery- within 24 hours
Adverse foetal outcome include prematurity, Birth injury, Birth asphyxia, Perinatal death, NICU admission macrosomia (≥ 4 kg) at term, hypoglycaemia (≤ 2.5 mmol/l)
Number of Participants with adequate glycaemic control
Time frame: Monthly from enrollment day upto 28 weeks of gestation, fortnightly from 28 weeks to 36 weeks of gestation, weekly from 36 weeks of gestation upto delivery
Adequate glycaemic control include (a) 80% of blood glucose reading of the month with in normal range. (b) No requirement of insulin or pharmacological agents to manage GDM,
1 secondary outcome
Maternal satisfaction
Time frame: Monthly from enrollment day upto 28 weeks of gestation, fortnightly from 28 weeks to 36 weeks of gestation, weekly from 36 weeks of gestation upto delivery, during delivery, Within 24 hours of delivery, 1 week, 2 weeks & 6 weeks of delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Background: PubMed 24199271Diagnostic Criteria and Classification of Hyperglycaemia First Detected in Pregnancy. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK169024/
- Background: PubMed 32425566Biswas A, Dalal K, Abdullah ASM, Rahman AKMF, Halim A. Gestational Diabetes: Exploring the Perceptions, Practices and Barriers of the Community and Healthcare Providers in Rural Bangladesh: A Qualitative Study. Diabetes Metab Syndr Obes. 2020 Apr 23;13:1339-1348. doi: 10.2147/DMSO.S238523. eCollection 2020.
- Background: PubMed 20015659Rieck S, Kaestner KH. Expansion of beta-cell mass in response to pregnancy. Trends Endocrinol Metab. 2010 Mar;21(3):151-8. doi: 10.1016/j.tem.2009.11.001. Epub 2009 Dec 16.
- Background: PubMed 32013909Muche AA, Olayemi OO, Gete YK. Effects of gestational diabetes mellitus on risk of adverse maternal outcomes: a prospective cohort study in Northwest Ethiopia. BMC Pregnancy Childbirth. 2020 Feb 3;20(1):73. doi: 10.1186/s12884-020-2759-8.
- Background: PubMed 32855709Zhuang W, Lv J, Liang Q, Chen W, Zhang S, Sun X. Adverse effects of gestational diabetes-related risk factors on pregnancy outcomes and intervention measures. Exp Ther Med. 2020 Oct;20(4):3361-3367. doi: 10.3892/etm.2020.9050. Epub 2020 Jul 27.
- Background: PubMed 30103263Martis R, Crowther CA, Shepherd E, Alsweiler J, Downie MR, Brown J. Treatments for women with gestational diabetes mellitus: an overview of Cochrane systematic reviews. Cochrane Database Syst Rev. 2018 Aug 14;8(8):CD012327. doi: 10.1002/14651858.CD012327.pub2.
- Background: PubMed 15951574Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
- Background: PubMed 26879305Moreno-Castilla C, Mauricio D, Hernandez M. Role of Medical Nutrition Therapy in the Management of Gestational Diabetes Mellitus. Curr Diab Rep. 2016 Apr;16(4):22. doi: 10.1007/s11892-016-0717-7.
- Background: PubMed 28090541Luczynski W, Glowinska-Olszewska B, Bossowski A. Empowerment in the Treatment of Diabetes and Obesity. J Diabetes Res. 2016;2016:5671492. doi: 10.1155/2016/5671492. Epub 2016 Dec 20.
- Background: PubMed 33298413American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S15-S33. doi: 10.2337/dc21-S002.
- Background: PubMed 20190296International Association of Diabetes and Pregnancy Study Groups Consensus Panel; Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, Damm P, Dyer AR, Leiva Ad, Hod M, Kitzmiler JL, Lowe LP, McIntyre HD, Oats JJ, Omori Y, Schmidt MI. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010 Mar;33(3):676-82. doi: 10.2337/dc09-1848. No abstract available.
- Background: PubMed 22140323Bener A, Saleh NM, Al-Hamaq A. Prevalence of gestational diabetes and associated maternal and neonatal complications in a fast-developing community: global comparisons. Int J Womens Health. 2011;3:367-73. doi: 10.2147/IJWH.S26094. Epub 2011 Nov 7.
- Individual participant dataSharing planned: No. No plan of data sharing before completion of study, if required then will be done with the prior permission of the funding agency
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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. This study is not recruiting at the moment.
Tabassum Parveen, FCPS principal investigator
Professor, Department of Fetomaternal Medicine, BSMMU
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Empowerment model in people with Diabetes Mellitus in Pregnancy, run by Public Health Foundation of Bangladesh at 3 sites in Bangladesh.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bangladesh. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with adverse maternal pregnancy outcome (time frame: Monthly from enrolment day up to 28 weeks of gestation, fortnightly from 28 weeks to 36 weeks of gestation, weekly from 36 weeks of gestation up to delivery, during delivery, Within 24 hours of delivery, 1 week, 2 weeks & 6 weeks of delivery). The study lists 3 primary outcomes in all. 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 NCT06277258, which also lists 27 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 13 Aug 2025.