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| Name | Class |
|---|---|
| Society for Obstetric Anesthesia and Perinatology | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Hypretension in Pregnancy | Pregnant subjects between 10-20 weeks gestation with chronic hypertension (on medication or hypertensive blood pressures documented at 2 clinic visits) |
| |
| Normotensive in Pregnancy | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WP200U home sleep study device | Diagnostic Test | WP200U, is a Type III, wrist-worn, FDA-approved home sleep testing device that utilizes finger plethysmography (peripheral arterial tone, oxyhemoglobin saturation and heart rate), actigraphy (movement), acoustic decibel detection (snoring volume), and accelerometry (body position) to help diagnose sleep-related breathing disorders (including snoring), and to give information about sleep stages and position during actual sleep time. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of OSA in pregnant women with chronic HTN | 20 months | |
| Prevalence of OSA in pregnant women who are normotensive and BMI-matched to women with chronic HTN | 20 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
Limited to pregnant women
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Dominguez, MD, MHS | Duke University Medical Center, Dept Anesthesiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Hospital | Durham | North Carolina | 27710 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36355613 | Derived | Dominguez JE, Grotegut CA, Wright MC, Habib AS. Obstructive Sleep Apnea Among Gravidas With Chronic Hypertension Compared to Matched Controls: A Prospective Cohort Study. Anesth Analg. 2023 Feb 1;136(2):205-214. doi: 10.1213/ANE.0000000000006223. Epub 2022 Nov 10. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006973 | Hypertension |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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Serum
|
|
| 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 |
| Durham |
| North Carolina |
| 27710 |
| United States |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |