Gestational Diabetes Mellitus in Pregnancy Clinical Trial
Official title:
Effects of Telerehabilitation Exercise Program on Maternal Antenatal Glycemic Control in Women With Gestational Diabetes.
Gestational diabetes is in which high blood glucose concentration results from body's inability to create enough insulin to fulfil the needs of pregnancy. It appears in week between 24 to 28 and and raises the mothers and Childs risk of problems. It is thought to affect about 1 in 7 pregnancies worldwide. Through these remote exercise sessions the study evaluates the effectiveness of tele rehabilitation in improving glycemic management during pregnancy.The results will help clarify how telehealth intervention can best support GDM patient's maternal health outcomes.
Status | Not yet recruiting |
Enrollment | 62 |
Est. completion date | January 31, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility | Inclusion Criteria: - Women aged 20 to 35 years - Gestational age between 20-28weeks - diagnosed with Gestational diabetes mellitus through oral glucose tolerance test (OGTT) - Primigravida and multigravida - able to do 6 6-minute walk tests under a severity level of 6 on the Borg scale of breathlessness. - Patients or caregivers have and able to use an electronic device (PC, tablet or smartphone) - Who signed informed consent Exclusion Criteria: - Previously diagnosed T1DM or T2DM - High-risk pregnancy conditions contraindicating exercise as per ACOG guidelines - Patients taking insulin regularly. - Patients with fetal anomalies diagnosed at 20 th week. - Multiple gestation (twin or triplets) |
Country | Name | City | State |
---|---|---|---|
Pakistan | Pakistan Railway hospital | Rawalpindi | Punjab |
Lead Sponsor | Collaborator |
---|---|
Riphah International University |
Pakistan,
Bung P, Artal R, Khodiguian N. [Regular exercise therapy in disorders of carbohydrate metabolism in pregnancy--results of a prospective, randomized longitudinal study]. Geburtshilfe Frauenheilkd. 1993 Mar;53(3):188-93. doi: 10.1055/s-2007-1023663. German. — View Citation
Munoz-Tomas MT, Burillo-Lafuente M, Vicente-Parra A, Sanz-Rubio MC, Suarez-Serrano C, Marcen-Roman Y, Franco-Sierra MA. Telerehabilitation as a Therapeutic Exercise Tool versus Face-to-Face Physiotherapy: A Systematic Review. Int J Environ Res Public Health. 2023 Feb 28;20(5):4358. doi: 10.3390/ijerph20054358. — View Citation
Stafne SN, Salvesen KA, Romundstad PR, Eggebo TM, Carlsen SM, Morkved S. Regular exercise during pregnancy to prevent gestational diabetes: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):29-36. doi: 10.1097/AOG.0b013e3182393f86. — View Citation
Tobias DK, Zhang C, van Dam RM, Bowers K, Hu FB. Physical activity before and during pregnancy and risk of gestational diabetes mellitus: a meta-analysis. Diabetes Care. 2011 Jan;34(1):223-9. doi: 10.2337/dc10-1368. Epub 2010 Sep 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood sugar fasting | It is a diagnostic tool to assess person bloods sugar control and screen for diabetes and pre diabetes, is a fundamental measure of blood glucose levels in a fasting state, typically measured after an overnight fast. It provides insights into a person's current blood sugar status and is often used for diagnosing and monitoring diabetes. | Baseline to 2nd,4th,6th and 8th week | |
Primary | Blood sugar random | Random blood sugar, is a fundamental measure of blood glucose levels after a meal, it will be done 2 hours postprandial. | Baseline to 2nd,4th,6th and 8th week | |
Primary | HbA1c: Glycated hemoglobin | This test provides an estimate over average blood glucose level over past two to three months. It is a critical clinical marker used to assess long-term blood sugar control in individuals with diabetes. It measures the percentage of hemoglobin in the blood that has glucose attached to it. | Baseline to 12th week |
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