Gestational Diabetes Clinical Trial
Official title:
Assessment of the Effect of Postprandial Ambulation on Birth Weight Percentile in Patients With Gestational Diabetes Mellitus.
Verified date | December 2023 |
Source | Women and Infants Hospital of Rhode Island |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized controlled trial to assess the effect of routine exercise counseling compared to the recommendation for postprandial ambulation on infant birthweight among pregnant people with gestational diabetes mellitus. The primary outcome is birthweight percentile for gestational age at delivery. Secondary outcomes include feasibility and acceptability, need for metformin or insulin for glycemic control, mode of delivery, neonatal hypoglycemia. Participants will be counseled to either complete 20 minutes of walking after meals, or be counseled with routine exercise counseling of 30 minutes of low-impact 5x a week. Their activity will be tracked by "FitBit" pedometers and uploaded via bluetooth to a database for review. They will continue to receive routine obstetric and diabetes care.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | December 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Patients who are diagnosed with gestational diabetes and receive care at the Maternal Fetal Medicine Diabetes in Pregnancy Program and who are fluent in English or Spanish. Exclusion Criteria: - Pre-existing type 1 or type 2 diabetes, and those diagnosed with gestational diabetes in the first trimester. Patients who are either physically unable to ambulate or who have other contraindications to ambulation. |
Country | Name | City | State |
---|---|---|---|
United States | Women & Infants Hospital of Rhode Island | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Women and Infants Hospital of Rhode Island |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | feasibility and acceptability | Likert scale for participant experience | 3 months after the study conclusion | |
Primary | Infant birthweight percentile | Birthweight percentile for gestational age for neonatal sex | Single time point - at birth | |
Secondary | infant birthweight | birthweight measured after delivery | Single time point - at birth | |
Secondary | neonatal hypoglycemia treatment | need for PO or IV treatment for neonatal hypoglycemia | within 48 hours of birth | |
Secondary | mode of delivery | spontaneous vaginal, operative vaginal, cesarean delivery | Single time point | |
Secondary | fetal macrosomia | birthweight >4500 gm | Single time point - at birth | |
Secondary | need for insulin or metformin during pregnancy | need for initiation of anti-hyperglycemic treatment during pregnancy | from diagnosis to delivery of infant |
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