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

Summary

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.

Conditions

• Gestational Diabetes

Interventions

COMBINATION_PRODUCT

Dietary intervention + Physical Activity + Monitoring

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.

OTHER

Usual care

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.

Sponsors & Collaborators

• Northwest General Hospital and Research centre

  collaborator NETWORK

• Hayatabad Medical Complex

  collaborator OTHER_GOV

• Khyber Medical University Peshawar

  lead OTHER

Principal Investigators

• Dr Kausar Tayyab, PhD* · Institute of Basic Medical Sciences, Khyber Medical University

• Dr Rubina Nazli, PhD · Institute of Basic Medical Sciences, Khyber Medical University

• Dr Arshad Hussain, PhD · Northwest General Hospital, Peshawar

• Dr Ehtesham, PhD · Institute of Basic Medical Sciences, Khyber Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2026-03-30

Completion

2026-04-25

Countries

• Pakistan

Study Locations