Clinical trial NCT06277258: Patient Empowerment in the Management of Gestational Diabetes Mellitus
Official title: Outcome of "Patient Empowerment" in the Management of Gestational Diabetes Mellitus: A Clustered Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus in Pregnancy
Lead sponsor: Public Health Foundation of Bangladesh
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 388
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Screen positive GDM cases, who have not been managed for diabetes by any means
2. Gestational age from18 weeks to 36 weeks

Exclusion Criteria:

1. Known history of diabetes before pregnancy
2. Women with twin or multiple pregnancies

Primary outcomes:
measure: Number of Participants with adverse maternal pregnancy outcome
timeFrame: 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
measure: Number of Participants with adverse foetal outcome
timeFrame: During delivery, After delivery- within 24 hours
measure: Number of Participants with adequate glycaemic control
timeFrame: 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:
measure: Maternal satisfaction
timeFrame: 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
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Azimpur Maternity hospital ( MCHTI)
city: Dhaka
country: Bangladesh
facility: Shaheed Suhrawardy Medical College (ShSMC)
city: Dhaka
country: Bangladesh
facility: Bangabandhu Sheikh Mujib Medical University (BSMMU)
Study officials:
affiliation: Professor, Department of Fetomaternal Medicine, BSMMU
name: Tabassum Parveen, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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/
citation: Biswas 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.
citation: Rieck 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.
citation: Muche 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.
citation: Zhuang 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.
citation: Martis 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.
citation: Crowther 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.
citation: Moreno-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.
citation: Luczynski 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.
citation: American 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.
citation: International 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.
citation: Bener 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.
citation: Kim 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.
citation: Gupta 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.
citation: Agarwal 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.
citation: HAPO Study Cooperative Research Group. Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: associations with neonatal anthropometrics. Diabetes. 2009 Feb;58(2):453-9. doi: 10.2337/db08-1112. Epub 2008 Nov 14.
citation: Herath H, Herath R, Wickremasinghe R. Gestational diabetes mellitus and risk of type 2 diabetes 10 years after the index pregnancy in Sri Lankan women-A community based retrospective cohort study. PLoS One. 2017 Jun 23;12(6):e0179647. doi: 10.1371/journal.pone.0179647. eCollection 2017.
citation: O'Kane MJ, Pickup J. Self-monitoring of blood glucose in diabetes: is it worth it? Ann Clin Biochem. 2009 Jul;46(Pt 4):273-82. doi: 10.1258/acb.2009.009011. Epub 2009 May 19.
citation: Reader DM. Medical nutrition therapy and lifestyle interventions. Diabetes Care. 2007 Jul;30 Suppl 2:S188-93. doi: 10.2337/dc07-s214.
citation: Carolan-OIah MC. Educational and intervention programmes for gestational diabetes mellitus (GDM) management: An integrative review. Collegian. 2016;23(1):103-14. doi: 10.1016/j.colegn.2015.01.001.
citation: Mohebbi B, Tol A, Sadeghi R, Mohtarami SF, Shamshiri A. Self-management Intervention Program Based on the Health Belief Model (HBM) among Women with Gestational Diabetes Mellitus: A Quazi-Experimental Study. Arch Iran Med. 2019 Apr 1;22(4):168-173.
citation: Boutati EI, Raptis SA. Self-monitoring of blood glucose as part of the integral care of type 2 diabetes. Diabetes Care. 2009 Nov;32 Suppl 2(Suppl 2):S205-10. doi: 10.2337/dc09-S312.
citation: Jovanovic L, Pettitt DJ. Treatment with insulin and its analogs in pregnancies complicated by diabetes. Diabetes Care. 2007 Jul;30 Suppl 2:S220-4. doi: 10.2337/dc07-s220. No abstract available.
citation: Lapolla A, Dalfra MG, Fedele D. Insulin therapy in pregnancy complicated by diabetes: are insulin analogs a new tool? Diabetes Metab Res Rev. 2005 May-Jun;21(3):241-52. doi: 10.1002/dmrr.551.
citation: Wei Y, Yang H, Zhu W, Hod M, Hadar E. Adverse pregnancy outcome among women with pre-gestational diabetes mellitus: a population-based multi-centric study in Beijing. J Matern Fetal Neonatal Med. 2017 Oct;30(20):2395-2397. doi: 10.1080/14767058.2016.1250257. Epub 2016 Nov 8.
citation: Zheng Y, Shen Y, Jiang S, Ma X, Hu J, Li C, Huang Y, Teng Y, Bao Y, Zhou J, Hu G, Tao M. Maternal glycemic parameters and adverse pregnancy outcomes among high-risk pregnant women. BMJ Open Diabetes Res Care. 2019 Nov 13;7(1):e000774. doi: 10.1136/bmjdrc-2019-000774. eCollection 2019.
citation: Bashir M, Baagar K, Naem E, Elkhatib F, Alshaybani N, Konje JC, Abou-Samra AB. Pregnancy outcomes of early detected gestational diabetes: a retrospective comparison cohort study, Qatar. BMJ Open. 2019 Feb 19;9(2):e023612. doi: 10.1136/bmjopen-2018-023612.