Mayo Clinic
Rochester, Minnesota, 55901, United States
NCT Number: NCT04979312
The purpose of this research is to examine the beneficial effects of regular, non-invasive, glucose (sugar) assessment on glucose (sugar) and blood pressure regulation during pregnancy to help in predicting gestational diabetes and preeclampsia.
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Notify Me18 year–45 year
Female
Interventional
Not applicable
Rochester, Minnesota, 55901, United States
This is an open-label pilot trial for the LabClasp combined with standard clinical care compared to standard clinical on [glucose] and blood pressure during pregnancy. Potential study participants will be pre-screened using questionnaires and review of their clinical records. Once the consent has been obtained, participants will undergo screening to confirm eligibility. Subjects who meet all criteria will be randomized to either LC+SC or SC cohorts for 24-39wks depending upon their gestational duration at enrollment. Study measures including anthropometrics, surveys/questionnaires, 24hr ABPM, accelerometry, and an oral glucose tolerance test (OGTT). Furthermore, the investigators will obtain repeated (annual) subject information including vitals, labs, medications, and development of cardiometabolic disorders for up to 10yrs in follow-up by reviewing Mayo Clinic medical records.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will complete up to 10 measurements per day with potentially more before and during their OGTT using the LabClasp
Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30
Blood Glucose will be measured in Mmol/L
Time frame: Baseline
Systolic Blood Pressure will be measured in mmHg
Time frame: Baseline
Diastolic Blood Pressure will be measured in mmHg
Time frame: Baseline
The Pittsburgh Sleep Quality Index measures the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
Mayo Clinic
Other
Predictive Role of Non-Invasive Glucose Assessment During Pregnancy: A Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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