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Association of Body Fluid Distribution With Obstructive Sleep Apnea in Pregnant Women With Body Mass Index ≥ 40 kg/m2

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion dates: Dec 2025 to Dec 2026v9
  2. Primary and study completion dates: Dec 2024 to Dec 2025v8
  3. Primary and study completion dates: Dec 2023 to Dec 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v7
  4. Trial status: Suspended to Recruiting
    • Primary and study completion dates: Dec 2022 to Dec 2023
    • Site details revised
    v6
  5. Primary and study completion dates: Dec 2021 to Dec 2022v5
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  1. Primary and study completion dates: Jun 2021 to Dec 2021v4
  2. Trial status: Recruiting to Suspended Sponsor's reason: Virtual/telephone appointments for patients due to Covid restrictions have halted this research. We may resume when we have the resources…
    • Primary and study completion dates: Nov 2020 to Jun 2021
    • Site details revised
    v3
  3. Study description shortened, about 17 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Obstructive Sleep apnea (OSA) is a common and underdiagnosed condition in obese pregnant women with serious and life-threatening complications to the mother and baby. The investiators propose that a non-invasive method may be used to detect patients at risk of OSA, giving these women access to the necessary treatment to treat this condition. The method is a estimation of body water, which has been shown to be linked to OSA in the non-pregnant population. Body water is estimated by applying surface electrodes to a participant who is lying down by measuring bioimpedance through body tissues by applying a tiny current between the electrodes. The electrical stimulation is not felt by the participant and has no negative effects on mother or baby.
Trial Details
NCT Number NCT04187612
Lead Sponsor Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions
(from sponsor)		 Apnea, Obstructive Sleep, Obesity
Related terms Obesity, Sleep Apnea, Obstructive
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov