Glucose and Blood Pressure During Pregnancy

Not Applicable

Not yet recruiting

• Conditions: Blood Pressure; Gestational Diabetes; Pre-Eclampsia
• Interventions: Device: LabClasp

• Registration Number: NCT04979312
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-07-14
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-07-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-12
• Study Start: 2024-07
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 90

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
  • Target disease or condition: pregnancy
  • Individuals with treated hypertension, prehypertension, and dyslipidemia will be allowed to participate in the study
  • Ability to provide written informed consent

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LabClasp+Standard of care	LabClasp	-

Primary Outcome Measures

Name	Time	Method
Blood Glucose	Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 30	Blood Glucose will be measured in Mmol/L
Systolic Blood Pressure	Baseline	Systolic Blood Pressure will be measured in mmHg
Diastolic Blood Pressure	Baseline	Diastolic Blood Pressure will be measured in mmHg

Secondary Outcome Measures

Name	Time	Method
Pittsburgh sleep study quality index	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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States