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| Name | Class |
|---|---|
| Brown University | OTHER |
| Rhode Island Hospital | OTHER |
| Women and Infants Hospital of Rhode Island | OTHER |
| Brigham and Women's Hospital |
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This study is testing the hypothesis of whether continuous positive airway pressure (CPAP) therapy improves placental histopathology and secretory function. The main aims of the study are to identify shared mechanisms between obstructive sleep apnea and preeclampsia, both common highly morbid conditions.
Patients will be recruited from multiple community and hospital-based practices that care for pregnant women. Subjects will be given a physical exam, have measurements taken, answer questionnaires and then will be screened using a home sleep apnea test (HSAT) Type III device. Those diagnosed with Obstructive Sleep Apnea will then be randomized to one of two groups (below).
Both groups will have:
Both groups will answer sleep and mood questionnaires, have blood pressure, blood glucose and activity / sleep watch monitoring and will receive an educational session on pregnancy health.
Randomization groups include:
All subjects will receive small gift incentives such as baby-related items. Monetary incentives will also be issued at data collection points.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Airway Pressure | Active Comparator | Positive airway pressure and nasal dilator strips during sleep. |
|
| Nasal Dilator Strips | Placebo Comparator | Nasal dilator strips during sleep. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Airway Pressure | Device | Auto-titrating PAP + nasal dilator strips during sleep |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alterations in circulating placenta-secreted markers. | Placenta secreted markers that have been linked to preeclampsia as well as angiogenic and anti-angiogenic markers will be measured longitudinally during the course of pregnancy. | up to 6 months |
| Changes in placental histopathology for markers of malperfusion and placental expression of markers | Placental morphology and histopathology will be examined by 3 perinatal pathologists, blinded to each other's reading and to intervention arm. Immunohistochemistry will be used to examine placental expression of certain markers. | Placenta collected at time of delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 24-hour Ambulatory mean diurnal and nocturnal blood pressure measurements | A 24 blood pressure monitor will be used to measure changes in daytime and nighttime average blood pressure. | Prior to randomization, then at approximately 3 months, and 6 months later |
| Change in a composite of adverse pregnancy outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ghada Bourjeily, MD | The Miriam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital | Providence | Rhode Island | 02904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34999843 | Derived | Sanapo L, Bublitz MH, Bai A, Mehta N, Messerlian GM, Catalano P, Bourjeily G. Association between sleep disordered breathing in early pregnancy and glucose metabolism. Sleep. 2022 Apr 11;45(4):zsab281. doi: 10.1093/sleep/zsab281. | |
| 33481418 | Derived | Facco F. Sleep Duration, Sleep Timing, and Sleep Disordered Breathing-Associations With Obesity and Gestational Diabetes in Pregnancy. Clin Obstet Gynecol. 2021 Mar 1;64(1):196-203. doi: 10.1097/GRF.0000000000000587. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D009765 | Obesity |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| OTHER |
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| Nasal Dilator Strips | Other | Nasal dilator strips |
|
Pregnancy outcomes defined as gestational hypertension, gestational diabetes and preterm birth (birth prior to 37 completed weeks of pregnancy will be analyzed as a composite outcome |
| 8 months, delivery and 2 weeks postpartum |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |