Clinical trial NCT03230110: OSA in Pregnant Women With Chronic HTN
Official title: Obstructive Sleep Apnea Among Pregnant Women With Chronic Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Pregnancy
Hypertension
Keywords: Sleep disordered breathing
Obstructive sleep apnea
Hypertension
Pregnancy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Society for Obstetric Anesthesia and Perinatology
First posted: 2017-07-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will recruit 120 adult pregnant subjects between 10-20 weeks gestation from Duke Hospital and clinics in Durham, NC over a 20-month period. They will be enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood pressures documented on two 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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of OSA in pregnant women with chronic HTN
timeFrame: 20 months
measure: Prevalence of OSA in pregnant women who are normotensive and BMI-matched to women with chronic HTN
timeFrame: 20 months
Secondary outcomes:
measure: Apnea-hypopnea indices in pregnant women with untreated OSA and cHTN
timeFrame: 20 months
measure: Apnea-hypopnea indices in pregnant women with untreated OSA and normotensive.
timeFrame: 20 months
measure: Oxygen-desaturation indices in pregnant women with untreated OSA and cHTN
timeFrame: 20 months
measure: Oxygen-desaturation indices in pregnant women with untreated OSA and normotensive.
timeFrame: 20 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Hospital
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Medical Center, Dept Anesthesiology
name: Jennifer Dominguez, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: