Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes
Key facts
- Who runs it
- Khyber Medical University Peshawar
- Where
- Pakistan2 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 60 people enrolled
- Started
- 1 Oct 2025
- Ended
- 25 Apr 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Dietary intervention + Physical Activity + Monitoring
- Usual care
- Record updated
- 14 July 2026
Who can take part
- Age
- 18 years to 45 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Maternal age between 18-45 years
- Gestational age at enrollment 24 - 28 weeks
- Patients having Hba1c levels less then 6%
Who cannot take part
- Diabetes diagnosed prior to pregnancy
- Patients having severe hypertension
- Patients having renal diseases
- Patients using glucose altering medications
- Patients having twin pregnancies
- Patients having PCOS
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Conventional Management GroupExisting treatment, for comparison
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: Usual care
- Intensive Management GroupTreatment being tested
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: Dietary intervention + Physical Activity + Monitoring
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes: Randomized Controlled Trial.
- Record updated
- 14 July 2026