At a glance
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Outcome of "Patient Empowerment" in the Management of Gestational Diabetes Mellitus: A Clustered Randomized Controlled Trial
In Brief
A clinical study evaluating Patient Empowerment model for Diabetes Mellitus in Pregnancy. Completed, enrolled 459 participants across 3 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.