NCT04187612Active, not recruiting
Association of Body Fluid Distribution With Obstructive Sleep Apnea in Pregnant Women With Body Mass Index ≥ 40 kg/m2
Association of Body Fluid Distribution With Obstructive Sleep Apnea in Pregnant Women With Body Mass Index ≥ 40 kg/m2 - A Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 52 (estimated)
- First submitted
- 26 Nov 2019
- Start date
- 2 Dec 2019
- Primary completion date
- Dec 2026
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Diseases
- Obesity
- NCT number
- NCT04187612
What you commit to
- Study type: Observational
- Planned participants: 52
- From 2 Dec 2019 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of vascular surgery in the lower limbs such as varicose vein surgery, vascular by-pass surgery or evidence of venous efficiency.
- Patients with metal implants in lower limbs or spine, due to possible interference with the leg impedance signals. 58
- Participants with diagnosed OSA treated with Continuous Positive Airway Pressure (CPAP).
Other illness
- Fluid overload states including renal disease, liver disease and congestive heart failure
- Patients requiring urgent sleep physician referral (within four weeks) due to serious medical conditions or safety critical-occupations according to the 2011 Canadian Thoracic Society (CTS) guideline 59 e.g. unstable ischemic heart disease, recent cerebrovascular disease.
- Implantable cardiac devices
Who the study is looking for
- Participants who give written informed consent
- Pregnant women in the third trimester of pregnancy
- Grade III obesity
- Patients who have prior diagnosis of OSA within the last one year, and non-compliant to treatment such as continuous positive airway pressure (CPAP), or dental appliance
- Patients suspected to have OSA based on screening questionnaire (see page 2, OSA-Diagnostic tools for further details)
Age in the registry: 16 years to 50 years · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.