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

Khyber Medical University Peshawar

Status: Enrolling

Conditions: Gestational Diabetes

Treatments: Combination Product: Dietary intervention + Physical Activity + Monitoring; Other: Usual care

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT07336914

KMU/DIR/CTU/2025/09

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Conventional Management Group

Active Comparator group

Description:

This group receives standard care for conventional management of GDM identified via survey in government and private sectors. This includes monthly follow-up visits with basic lifestyle modification and counselling on dietary and physical acitivity assessed via questionnaires (PDAQ and PPAQ). Medication (insulin or oral agents like metformin) is only introduced if glycemic targets are not achieved through lifestyle modifications alone. Blood glucose monitoring is performed at a standard frequency (e.g., pre- and post-meal).

Treatment:

Other: Usual care

Intensive Management Group

Experimental group

Description:

This group receives a standardized, intensive multidisciplinary intervention. It includes weekly telephonic monitoring, personalized low-carbohydrate/calorie diet plans, and structured moderate and intense exercise based on their activty level. Pharmacotherapy (insulin, metformin, etc.) is initiated proactively if glucose levels are not controlled within two weeks. Enhanced fetal monitoring via frequent ultrasounds is also included to assess growth and amniotic fluid. This management involves frequent antenatal visits with pre- and post-sugar monitoring for dietary and physical therapy. Secondly, rigorous monitoring will be done using Ultrasound and repeated lab tests via a dietary and physical monthly recall questionnaire.

Treatment:

Combination Product: Dietary intervention + Physical Activity + Monitoring