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

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

Recruiting
18-45 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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

Study details
    Gestational Diabetes

NCT07336914

Khyber Medical University Peshawar

1 February 2026

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