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Patient Empowerment in the Management of Gestational Diabetes Mellitus

NCT06277258 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 459

Last updated 2025-08-13

No results posted yet for this study

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

Interventions

OTHER

Patient Empowerment model

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.

Sponsors & Collaborators

  • Public Health Foundation of Bangladesh

    lead OTHER

Principal Investigators

  • Tabassum Parveen, FCPS · Professor, Department of Fetomaternal Medicine, BSMMU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2024-10-10
Completion
2024-11-10

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06277258 on ClinicalTrials.gov