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NCT Number: NCT06776237

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Toronto, Ontario, M5T 2S8, Canada

Location contact

Abdel Basit Al Hawwari, MSN, RN

CONTACT

[email protected]

4166035800 ext. 3959

Mandeep Singh, MBBS, FRCPC

PRINCIPAL_INVESTIGATOR

About this study

This project is to define the range of mouth and tongue dimensions and to visualize airway structures by using ultrasound. Given that Home sleep apnea tests (HST) shows high levels of accuracy for the diagnosis of Obstructive sleep apnea (OSA), investigators hypothesize that the Point of care ultrasonography (PoCUS) airway examination against the HST for the diagnosis of OSA in pregnant women at the high-risk can,

  • reliably visualize upper airway structures that are responsible for OSA;
  • objectively measure airway soft tissue thickness and dimensions; and
  • identify pregnant women with moderate-severe OSA.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion criteria
  • 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 will be eligible for inclusion.

High risk of OSA will be defined as outlined by Facco et al. and recommended by recently updated guidelines (i.e., score ≥ 75) (8).

  • Exclusion criteria i) past history of oral, head or neck surgery (e.g., corrective surgery for OSA) ii) active head and neck disease (e.g., cancer, infection, radiotherapy etc.) iii) inability to perform HST per instruction iv) patients with diagnosed OSA on CPAP therapy

Treatment and study plan

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.

Primary outcomes

  1. Areas Under the Curve (AUC)

    Time frame: One Day

    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.

Secondary outcomes

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

    Time frame: One Day

    i) The inter-rater reliability for measuring each one of the airway parameters ii) The association between each US parameter and OSA severity level (none/mild/moderate/severe) iii) The association between each US parameter and OSA diagnosis derived from PSG

Study contacts

Contact information is provided by the study sponsor or research team.

Abdel Basit Al Hawwari

CONTACT

[email protected]

4166035800 ext. 3959

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • MOUNT SINAI HOSPITAL

Registry information

Official study title

Point of Care Ultrasound (PoCUS) as a Tool to Evaluate Patients at High Risk of Obstructive Sleep Apnea in the Obstetric Population

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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