Glucose and Blood Pressure During Pregnancy

Mayo Clinic

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

TRIPLE

Conditions

Gestational Diabetes Pre-Eclampsia Blood Pressure

Interventions

LabClaspDEVICE

Subjects will complete up to 10 measurements per day with potentially more before and during their OGTT using the LabClasp

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Blood Glucose

Blood Glucose will be measured in Mmol/L

Time frame: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30

Systolic Blood Pressure

Systolic Blood Pressure will be measured in mmHg

Time frame: Baseline

Diastolic Blood Pressure

Diastolic Blood Pressure will be measured in mmHg

Time frame: Baseline

Secondary Outcomes

Pittsburgh sleep study quality index

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.

Time frame: Baseline

Data from ClinicalTrials.gov

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