Glucose and Blood Pressure During Pregnancy

Mayo Clinic

Status: Suspended

Conditions: Pre-Eclampsia; Gestational Diabetes; Blood Pressure

Treatments: Device: LabClasp

Study type: Interventional

Funder types: Other

Identifiers

NCT04979312

21-000284

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age range: 18-45 years (inclusive)
• Body mass index (BMI) ≤40kg/m2
• >1 risk factor for GDM
• <16wks gestation
• Gender: only females will be recruited into this study
• Ability to provide written informed consent

Exclusion criteria

• Presence of chronic kidney disease (creatinine >2.5mg/dL) and/or active cancer
• Smoking
• Multiple pregnancies
• Congenital abnormalities
• Use of chronic medications which influence blood [glucose] or [insulin]
• Subsequent diagnosis of GDM or preeclampsia

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

LabClasp+Standard of care

Experimental group

Treatment:

Device: LabClasp

Standard of care

No Intervention group