N/A
N=108
Obstructive Sleep Apnea in Pregnancy
Sleep Apnea, Obstructive · Pregnancy · Obesity, Morbid
Bottom Line
View on ClinicalTrials.gov: NCT02383706 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants With a Negative Obstructive Sleep Apnea (OSA) Home Sleep Test Result — 61 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ApneaLink Air (Device); Berlin Quesionnaire (Behavioral); Epworth Sleepiness Scale (Behavioral); STOP-BANG questionnaire (Behavioral); Physical exam (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Negative Obstructive Sleep Apnea (OSA) Home Sleep Test Result |
61 | — |
| PRIMARY Number of Participants With a Positive Obstructive Sleep Apnea (OSA) Home Sleep Test Result |
19 | — |
| SECONDARY Post-op Minute Ventilation Following C-section |
— | — |
Summary
Obstructive sleep apnea (OSA) is a risk factor for complications during pregnancy and current screening tools for OSA have not been shown to be reliable in pregnant women. The primary aim of this study is to develop a valid screening tool to identify at-risk pregnant women, so that they can be further evaluated and treated. Women with OSA may also be at risk for respiratory complications related to opiate administration for post-cesarean delivery pain. A secondary aim of this study is to evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring.
Eligibility Criteria
Inclusion Criteria
- gestational age 24 to 35 weeks
- BMI > or equal to 40 kg/m2
- 18 years or older
Exclusion Criteria
- Non-English speaking subjects
- Established diagnosis of OSA
- chronic narcotic use
Data sourced from ClinicalTrials.gov (NCT02383706). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.