MedTrace Logo

Point of Care Ultrasound in Pregnant Women (PoCUS-OB)

NCT06776237 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-01-17

No results posted yet for this study

Summary

Pregnant women with gestational age more than 20 weeks are at risk of developing Obstructive Sleep Apnea (OSA). OSA is a common underdiagnosed comorbid condition in pregnant women associated with adverse maternal and fetal outcomes. It is a severe form of sleep-disordered breathing (SDB), featured with repeated episodes of airflow reduction or cessation during sleep. It exists in different severity among pregnant women and maybe worsen over the course of the pregnancy. If OSA remains untreated, it can complicate the pregnancy by developing heart failure, gestational diabetes, pre-eclampsia, eclampsia, and hypertension. To determine the OSA during pregnancy has become an important issue to reduce the morbidity related to it. Currently, Polysomnography (PSG) remains the gold standard for diagnosing OSA, but scheduling and logistics remain significant impediments to accessibility for pregnant women. Home sleep apnea tests (HST) is a promising alternative but are expensive and not widely available. Point of care ultrasonography (PoCUS) is being increasingly used across specialties. Our preliminary data support the feasibility of PoCUS in the preoperative setting and increasing the diagnostic accuracy and the specificity for moderate to severe OSA (AHI \>15 events per h) when combined with the STOP-Bang questionnaire (cut-off \>5). Given that HST shows high levels of agreement with PSG for the diagnosis of OSA and are significantly less burdensome than PSG, investigators will evaluate the PoCUS airway examination against the HST for the diagnosis of OSA in pregnant women at high risk of OSA.

Conditions

  • Obstructive Sleep Apnea (OSA)

Interventions

DIAGNOSTIC_TEST

PoCUS

Participants after getting recruited will be asked for an ultrasonography of the neck. It will take around 30 minutes. At home, participants will be asked to wear a portable sleep study device overnight, to perform home sleep study. Although these devices are noninvasive and safe, they are not routinely used as a standard of care in the pregnant patient population.

Sponsors & Collaborators

  • MOUNT SINAI HOSPITAL

    collaborator OTHER

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Mandeep Singh, MD · University Health Network, Toronto

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2026-06-01
Completion
2026-12-01

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06776237 on ClinicalTrials.gov