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: 1. blood testing for placenta-secreted circulating markers 2. placental histopathological and immunohistochemistry examination of placental expression of markers. 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: 1. Nasal dilator strips: Participants receiving nasal dilator strips will be monitored by need for refill of supplies and periodic phone calls. 2. CPAP + nasal dilator strips: Subjects randomized to positive airway pressure (PAP) therapy will receive auto-titrating PAP. Pressure requirements will be monitored remotely and pressure modified as needed. PAP adherence will be determined subjectively and objectively. This group will also receive nasal dilator strips as described above. All subjects will receive small gift incentives such as baby-related items. Monetary incentives will also be issued at data collection points.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
262
Auto-titrating PAP + nasal dilator strips during sleep
Nasal dilator strips
The Miriam Hospital
Providence, Rhode Island, United States
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.
Time frame: 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.
Time frame: Placenta collected at time of delivery
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.
Time frame: Prior to randomization, then at approximately 3 months, and 6 months later
Change in a composite of adverse pregnancy outcomes
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
Time frame: 8 months, delivery and 2 weeks postpartum
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