Status:
COMPLETED
OSA in Pregnant Women With Chronic HTN
Lead Sponsor:
Duke University
Collaborating Sponsors:
Society for Obstetric Anesthesia and Perinatology
Conditions:
Sleep Apnea, Obstructive
Pregnancy
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this study is to identify whether pregnant women with chronic hypertension are at significantly higher risk of having undiagnosed OSA and should be routinely screened with home sleep te...
Eligibility Criteria
Inclusion
- Pregnant woman who are patients of:Duke Hospital, Duke Birthing Center (DBC), Duke Perinatal Durham clinic, Inpatients will be recruited from the obstetric antepartum service.
- Gestational age 10 weeks, 0 days to 20 weeks, 6 days
- 18 years or older
- English speaking
- They will be enrolled into one of two groups:-Chronic hypertension (on medication or hypertensive blood pressures documented on two clinic visits (including prior to pregnancy), -Normal blood pressure, and not on any treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group
- The two groups will be matched for body mass index to control for the effect of obesity on OSA diagnosis and HTN.
- Subjects will be not be excluded if they have an established diagnosis of OSA that is not currently being treated.
Exclusion
- Being treated for OSA
- On chronic opioids
- On alpha-blockers (which can interfere with the PAT signal)
- Have secondary HTN
- Unwilling to remove nail polish and/or shorten one nail (which can also interfere with the PAT signal)
- Have a severe allergy to latex
- Do not speak English.
Key Trial Info
Start Date :
June 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03230110
Start Date
June 16 2017
End Date
April 30 2019
Last Update
September 24 2019
Active Locations (2)
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1
Duke Hospital
Durham, North Carolina, United States, 27710
2
Duke University Medical Center
Durham, North Carolina, United States, 27710