Patient Empowerment in the Management of Gestational Diabetes Mellitus

NCT06277258 | Completed DMC

• 1 other identifier: BSMMU/2022/9656
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 3

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.

Conditions

Diabetes Mellitus in Pregnancy

Outcome Measures

Primary Outcomes (3)

• 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.

  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)

  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,

  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

  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

Study Arms (2)

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.

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.

Interventions

Patient Empowerment model OTHER

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.

Patient Empowerment Model

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Known history of diabetes before pregnancy
• Women with twin or multiple pregnancies

Sponsors & Collaborators

• Public Health Foundation of Bangladesh: lead

Study Sites (3)

Azimpur Maternity hospital ( MCHTI)

Dhaka, 1205, Bangladesh

Location

Shaheed Suhrawardy Medical College (ShSMC)

Dhaka, 1207, Bangladesh

Location

Bangabandhu Sheikh Mujib Medical University (BSMMU)

Dhaka, 1217, Bangladesh

Location

Related Publications (27)

• 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/

  PMID: 24199271 BACKGROUND

• 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.

  PMID: 32425566 BACKGROUND

• 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.

  PMID: 20015659 BACKGROUND

• 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.

  PMID: 32013909 BACKGROUND

• 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.

  PMID: 32855709 BACKGROUND

• 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.

  PMID: 30103263 BACKGROUND

• 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.

  PMID: 15951574 BACKGROUND

• 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.

  PMID: 26879305 BACKGROUND

• 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.

  PMID: 28090541 BACKGROUND

• 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.

  PMID: 33298413 BACKGROUND

• 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.

  PMID: 20190296 BACKGROUND

• 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.

  PMID: 22140323 BACKGROUND

• 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.

  PMID: 23947320 BACKGROUND

• 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.

  PMID: 26056493 BACKGROUND

• 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.

  PMID: 26131321 BACKGROUND

• 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.

  PMID: 19011170 BACKGROUND

• 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.

  PMID: 28644881 BACKGROUND

• 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.

  PMID: 19454538 BACKGROUND

• Reader DM. Medical nutrition therapy and lifestyle interventions. Diabetes Care. 2007 Jul;30 Suppl 2:S188-93. doi: 10.2337/dc07-s214.

  PMID: 17596470 BACKGROUND

• 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.

  PMID: 27188046 BACKGROUND

• 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.

  PMID: 31126174 BACKGROUND

• 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.

  PMID: 19875553 BACKGROUND

• 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.

  PMID: 17596476 BACKGROUND

• 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.

  PMID: 15818714 BACKGROUND

• 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.

  PMID: 27822972 BACKGROUND

• 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.

  PMID: 31798901 BACKGROUND

• 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.

  PMID: 30782883 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

• Tabassum Parveen, FCPS

  Professor, Department of Fetomaternal Medicine, BSMMU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: At the end of the study, the outcome will be assessed by blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Member

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: February 26, 2024
• Study Start: January 31, 2023
• Primary Completion: October 10, 2024
• Study Completion: November 10, 2024
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (3)