Pregnancy outcome in women with gestational diabetes - A longitudinal study of changes in demography and treatment modalities.
Ulrika Moll, Mona Landin-Olsson, Charlotta Nilsson...
https://pubmed.ncbi.nlm.nih.gov/31654523/Actively Recruiting
Led by Region Skane · Updated on 2025-08-22
120
Participants Needed
1
Research Sites
365 weeks
Total Duration
Researchers are investigating gestational diabetes in women who have previously undergone gastric bypass surgery. The study aims to understand how continuous glucose monitoring affects treatment and pregnancy outcomes compared to regular capillary glucose measurements during the last trimester. This research focuses on glucose variability and its impact on pregnancy complications such as large for gestational age infants and small for gestational age infants, which are concerns in this group. Participants will be randomly assigned to one of two groups one using continuous glucose monitoring with the FreeStyle Libre 3 device and associated apps, and the other receiving standard care with 7-point capillary glucose measurements. Both groups will receive standard medical care, including visits to a specialized maternity care unit and weekly follow-ups with a diabetologist. Continuous glucose monitoring allows for detailed tracking of glucose fluctuations, including time in target range and episodes of high or low glucose. Throughout the study, participants will have regular glucose assessments from gestational weeks 28 to 42, with monitoring of pharmacological treatments and pregnancy outcomes such as birthweight and week of delivery. The main outcome is adverse pregnancy events measured up to five days postpartum. This study also evaluates how glucose measurements relate to treatment approaches and pregnancy health in women with gestational diabetes after gastric bypass surgery.
CONDITIONS
Gestational Diabetes After Gastric Bypass Surgery
U
Ulrika Moll, MD, PhD
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Region Skane
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From gestational week 28 to delivery (up to approximately 14 weeks)
Participants receive either continuous glucose monitoring using FreeStyle Libre 3 or standard care with 7-point capillary glucose measurement during the last trimester of pregnancy, alongside standard medical care including weekly follow-up visits by the diabetologist.
Weekly visits (in-person) for follow-up during treatment
Duration - From delivery up to 5 days postpartum
Participants are monitored for pregnancy outcomes including delivery and up to 5 days postpartum to assess the effects of glucose monitoring on pregnancy and infant health.
Approximately 1 to 2 visits around delivery and postpartum
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Ulrika Moll, Mona Landin-Olsson, Charlotta Nilsson...
https://pubmed.ncbi.nlm.nih.gov/31654523/Region Skane
Lead Sponsor