OSA in Pregnant Women With Chronic HTN

Completed

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 tests. The investigators will recruit 120 pregnant subjects between 10-20 weeks gestation from the Duke High Risk Obstetrics Clinic over a 20-month period. They will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented at 3 clinic visits); 2) 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 BMI to control for the effect of obesity on OSA diagnosis and cHTN. The primary hypothesis, that OSA prevalence differs between patients with chronic HTN and normotensive controls, will be assessed with a two-group two-sided Fisher's exact test. A Fisher's exact test with a 0.05 two-sided significance level will have 92% power to detect the difference between a normotensive OSA rate of 0.10 and a chronic hypertensive OSA rate of 0.40 when the sample size in each group is 50. There are no risks associated with the use of the home sleep test device, but subjects that have a severe latex allergy should not participate, as the device

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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.

Arm && Interventions

Group	Intervention	Description
Normotensive in Pregnancy	WP200U home sleep study device	Pregnant subjects between 10-20 weeks gestation with normal blood pressure, and not on any treatment for chronic hypertension and no history of chronic hypertension, and matched for body mass index (+/- 3 kg/m2) with the chronic hypertension group.
Chronic Hypretension in Pregnancy	WP200U home sleep study device	Pregnant subjects between 10-20 weeks gestation with chronic hypertension (on medication or hypertensive blood pressures documented at 2 clinic visits)

Primary Outcome Measures

Name	Time	Method
Prevalence of OSA in pregnant women who are normotensive and BMI-matched to women with chronic HTN	20 months
Prevalence of OSA in pregnant women with chronic HTN	20 months

Secondary Outcome Measures

Name	Time	Method
Oxygen-desaturation indices in pregnant women with untreated OSA and cHTN	20 months
Oxygen-desaturation indices in pregnant women with untreated OSA and normotensive.	20 months
Apnea-hypopnea indices in pregnant women with untreated OSA and cHTN	20 months
Apnea-hypopnea indices in pregnant women with untreated OSA and normotensive.	20 months

Locations (2): Duke Hospital
🇺🇸
Durham, North Carolina, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States

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