Skip to main content
OpenTrials
Completed

NCT Number: NCT07336914

Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hayatabad Medical Complex, Peshawar, Khyber Pakhtunkhwa, Pakistan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Maternal age between 18-45 years
  • Gestational age at enrollment 24 - 28 weeks
  • Patients having Hba1c levels less then 6%

Exclusion criteria

  • Patients having twin pregnancies
  • Patients having PCOS
  • Diabetes diagnosed prior to pregnancy
  • Patients having severe hypertension
  • Patients having renal diseases
  • Patients using glucose altering medications

Treatment and study plan

Dietary intervention + Physical Activity + Monitoring

Combination Product

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.

Usual Care

Other

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.

Primary outcomes

  1. Change in HbA1c Levels

    Time frame: Baseline (24-28 weeks), Late Pregnancy/Delivery (37-38 weeks), Postpartum (42-45 weeks)

    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.

  2. Physical Activity Level (PAQ)

    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)

    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.

Secondary outcomes

  1. Fasting or Random Blood Glucose Levels

    Time frame: Baseline; Delivery; 6-12 weeks postpartum

    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.

  2. Serum Insulin 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.

    Insulin is measured using chemiluminescent immunoassay. A fasting insulin level >25 μIU/mL indicates hyperinsulinemia.

  3. Serum CMPF

    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 quantified using ELISA or mass spectrometry. Reported as a continuous variable; higher values indicate increased furan fatty acid levels.

  4. Total Cholesterol

    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 measured using enzymatic colorimetric assay; interpreted according to pregnancy-adjusted reference ranges.

  5. LDL Cholesterol

    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 measured directly or calculated using Friedewald formula; optimal levels <100 mg/dL.

  6. HDL Cholesterol

    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 analyzed using direct enzymatic methods; low HDL defined as <50 mg/dL in pregnancy.

  7. Serum Creatinine

    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 measured using Jaffe or enzymatic assay; pregnancy reference range 0.4-0.8 mg/dL.

  8. Complete Blood Count (CBC)

    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.

    Includes hemoglobin, white blood cells, and platelet counts measured via automated hematology analyzer.

  9. Amniotic Fluid Index (AFI)

    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.

    AFI measured using obstetric ultrasound; values <8 cm indicate oligohydramnios, >25 cm polyhydramnios.

  10. Estimated Fetal Weight (EFW)

    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.

    EFW calculated using Hadlock fetal biometry formula; macrosomia defined as >4000 g.

  11. Mode of Delivery

    Time frame: Delivery (37-38 weeks)

    Newborn weight measured using a calibrated digital scale. Low birth weight <2500 g; macrosomia >4000 g.

  12. Neonatal Jaundice

    Time frame: Postpartum (42-45 days)

    Defined as total serum bilirubin >5 mg/dL in the first 24 hours or above age-specific nomogram.

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Collaborators

  • Hayatabad Medical Complex
  • Northwest General Hospital and Research centre

Registry information

Official study title

Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes: Randomized Controlled Trial.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.