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CompletedNo phase

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