Conventional vs intensive management for gestational diabetes
Effect of Conventional vs Intensive Management on Gestational Diabetes and Maternal Fetal Outcomes: Randomized Controlled Trial.
This project will test whether more intensive diet, exercise, and monitoring improves blood sugar control and pregnancy outcomes for women with gestational diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Khyber Medical University Peshawar Academic / other |
| Locations | 2 sites (Peshawar, Khyber Pakhtunkhwa and 1 other locations) |
| Trial ID | NCT07336914 on ClinicalTrials.gov |
What this trial studies
This randomized trial will enroll 60 pregnant women diagnosed with gestational diabetes at 24–28 weeks and randomly assign them to conventional care or an intensive management program. Conventional care includes standard counselling and monthly follow-up, while the intensive arm receives personalized diet and exercise plans, more frequent visits, and stricter glycemic targets with closer monitoring. Outcomes tracked include glucose levels, HbA1c, the biomarker CMPF, and rates of maternal and neonatal complications through pregnancy and postpartum. Data will be analyzed to determine whether the intensive approach leads to better metabolic control and clinical outcomes than usual care.
Who should consider this trial
Good fit: Women aged 18–45 with gestational diabetes diagnosed at 24–28 weeks and HbA1c below 6% are ideal candidates.
Not a fit: People with preexisting diabetes, twin pregnancies, PCOS, severe hypertension, renal disease, or on glucose‑altering medications are excluded and unlikely to benefit from results.
Why it matters
Potential benefit: If successful, the intensive approach could improve maternal blood sugar control and reduce pregnancy and newborn complications.
How similar studies have performed: Previous randomized and lifestyle intervention studies have shown modest improvements in glycemic control and reduced need for medication with intensive lifestyle management, though effects on neonatal outcomes have been variable.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Peshawar, Khyber Pakhtunkhwa and 1 other locations
- Hayatabad Medical Complex — Peshawar, Khyber Pakhtunkhwa, Pakistan (Not_yet_recruiting)
- Northwest General Hospital — Peshawar, Khyber Pakhtunkhwa, Pakistan (Recruiting)
Study contacts
- Principal investigator: Dr Kausar Tayyab, PhD* — Institute of Basic Medical Sciences, Khyber Medical University
- Study coordinator: Dr Kausar Tayyab, PhD*
- Email: kausar.tayyab1234@gmail.com
- Phone: +923338645454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.