This study involved two management protocols to manage diabetes in pregnancy. Sixty patients having GDM will be recruited on the basis of the OGTT and randomly allocated to two management groups. One group of patients will receive counselling and the conventional method of management. while the other group will receive a tailored diet plan and physical activity with low caloric and moderate intense exercises. Both groups will receive a dietary plan based on their sugar levels weekly basis and physical activity with pharmacotherapy to adjust their sugar levels, while the intensive group will have rigorous monitoring on a monthly basis and frequent visits with repeated lab checks. This will help us to reduce short and long-term complications with improved maternal and neonatal outcomes.
This randomized controlled trial aims to compare the efficacy of conventional versus intensive management strategies for Gestational Diabetes Mellitus (GDM) and their impact on maternal and fetal outcomes. The study will enrol 60 pregnant women diagnosed with GDM at 24-28 weeks of gestation. Participants will be randomly assigned to either a conventional group, which receives standard monthly follow-up and counselling, or an intensive group, which receives proactive weekly monitoring, personalised diet and exercise plans, and stricter glycemic targets. The primary outcomes include differences in glycemic control (glucose, HbA1c), levels of the biomarker CMPF, and the incidence of maternal and neonatal complications. Data will be collected throughout pregnancy and postpartum, and analyzed using statistical methods in SPSS to determine the superior management approach for improving health outcomes in GDM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Dietary modifications will follow an 1800-kilocalorie structured plan that includes breakfast, two snacks, lunch, and dinner. The plan will focus on low carbohydrate intake with restrictions on lean options. Adherence will be closely monitored, with a monthly adherence questionnaire (PDAQ) to ensure tight blood sugar control. In terms of physical activity, a structured exercise plan will incorporate household activities, occupational tasks, and various levels of exercise, ranging from light to moderate and intense. Strict monitoring and follow-up will be conducted monthly using the Physical Activity Adherence Questionnaire (PAAQ). Secondly, short acting and long acting insulin dose and frquency will be monitored.
General advice and recommendations for a low glycemic diet include a flexible and adjusted daily calorie intake, structured meals without a fixed menu. Patients should be educated about healthy choices and empowered to manage their own health. Exercise recommendations should be tailored to the participant's activity level, with routine ANC counseling and no standard follow-up process. If lifestyle modifications are ineffective in controlling glycemic levels, glucophage and human insulin R will be prescribed.
Hayatabad Medical Complex
Peshawar, Khyber Pakhtunkhwa, Pakistan
Northwest General Hospital
Peshawar, Khyber Pakhtunkhwa, Pakistan
Change in HbA1c Levels
HbA1c is measured using high-performance liquid chromatography (HPLC). Values will be compared from baseline to delivery/late pregnancy and postpartum to assess improvement or deterioration in glycemic control.
Time frame: Baseline (24-28 weeks), Late Pregnancy/Delivery (37-38 weeks), Postpartum (42-45 weeks)
Physical Activity Level (PAQ)
Physical activity is assessed using the Physical Activity Questionnaire (PAQ), an ordinal scale ranging from 1 to 5. A score ≤2 indicates sedentary activity, while a score ≥3 indicates active physical activity levels. Higher scores reflect greater physical activity engagement.
Time frame: Conventional Management: Baseline, Delivery (37-38 weeks), Postpartum (42-45 weeks) Intensive Management: Baseline, 2nd Visit (32-34 weeks), 3rd Visit (36-38 weeks), 4th Visit (40-42 weeks), Postpartum (42-45 weeks)
Fasting or Random Blood Glucose Levels
Blood glucose is measured using the enzymatic glucose oxidase method. A fasting value ≥92 mg/dL is considered abnormal, and a random value ≥200 mg/dL suggests hyperglycemia.
Time frame: Baseline; Delivery; 6-12 weeks postpartum
Serum Insulin Levels
Insulin is measured using chemiluminescent immunoassay. A fasting insulin level \>25 μIU/mL indicates hyperinsulinemia.
Time frame: Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum.
Serum CMPF
Serum CMPF quantified using ELISA or mass spectrometry. Reported as a continuous variable; higher values indicate increased furan fatty acid levels.
Time frame: Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum.
Total Cholesterol
Total cholesterol measured using enzymatic colorimetric assay; interpreted according to pregnancy-adjusted reference ranges.
Time frame: Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum.
LDL Cholesterol
LDL measured directly or calculated using Friedewald formula; optimal levels \<100 mg/dL.
Time frame: Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum.
HDL Cholesterol
HDL analyzed using direct enzymatic methods; low HDL defined as \<50 mg/dL in pregnancy.
Time frame: Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum.
Serum Creatinine
Serum creatinine measured using Jaffe or enzymatic assay; pregnancy reference range 0.4-0.8 mg/dL.
Time frame: Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum.
Complete Blood Count (CBC)
Includes hemoglobin, white blood cells, and platelet counts measured via automated hematology analyzer.
Time frame: Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum.
Amniotic Fluid Index (AFI)
AFI measured using obstetric ultrasound; values \<8 cm indicate oligohydramnios, \>25 cm polyhydramnios.
Time frame: Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum.
Estimated Fetal Weight (EFW)
EFW calculated using Hadlock fetal biometry formula; macrosomia defined as \>4000 g.
Time frame: Conventional Care Group: Baseline, Delivery. Intensive Care Group: Baseline, 32-34 weeks gestation, 36-38 weeks gestation, 40-42 weeks gestation, 6-12 weeks postpartum.
Mode of Delivery
Newborn weight measured using a calibrated digital scale. Low birth weight \<2500 g; macrosomia \>4000 g.
Time frame: Delivery (37-38 weeks)
Neonatal Jaundice
Defined as total serum bilirubin \>5 mg/dL in the first 24 hours or above age-specific nomogram.
Time frame: Postpartum (42-45 days)
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