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

NCT06776237 | Not Yet Recruiting

• 1 other identifier: 23-5451
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

OSA,Pregnancy,Women,HST,Ultrasound

Outcome Measures

Primary Outcomes (1)

• Areas Under the Curve (AUC)

  The primary outcome will be the difference in Areas Under the Curve (AUC) for each US parameter compared to the AUC of the HST obtained using the Receiver Operating Characteristic (ROC) curves for moderate to severe OSA defined as AHI \> 15.

  One Day

Secondary Outcomes (1)

• The inter-rater reliability for measuring each one of the airway parameters

  One Day

Interventions

PoCUS DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women ≥ 18 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Investigators aim to recruit 100 pregnant women ≥ 18 years of age at \> 20 weeks of gestation, ASA physical status I - IV, with untreated recently diagnosed (within the previous 12 months) OSA or at high risk of OSA

You may qualify if:

• Pregnant women ≥ 18 years of age
• at \> 20 weeks of gestation
• ASA physical status I - IV
• High risk of OSA will be defined as outlined by Facco et al. and recommended by recently updated guidelines (i.e., score ≥ 75) (8).

Sponsors & Collaborators

• University Health Network, Toronto: lead
• MOUNT SINAI HOSPITAL: collaborator

Study Sites (1)

Toronto Western Hospital (TWH)-University Health Network (UHN)

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Mandeep Singh, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdel Basit Al Hawwari

CONTACT

4166035800; abdelbasit.alhawwari@uhn.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 15, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)