Clinical trial

Positive Airway Pressure, Sleep Apnea, and the Placenta (PAP-SAP)

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT02412696

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersNot accepted

ConditionObstructive Sleep Apnea, Pregnancy, Obesity, Preeclampsia, Sleep

Full registry criteria

Inclusion Criteria: * Pregnant snorers without obstructive sleep apnea, have a BMI \>30 kg/m2 at recruitment * \>18 years of age * \<13 completed weeks of gestation (confirmed by last menstrual period or early pregnancy dating ultrasound during qualification) * Intention to reside locally and deliver at Women and Infants Hospital of Rhode Island * Ability to give informed consent. Exclusion Criteria: * Unable to meet inclusion criteria, Incompetent cervix / cerclage (likelihood of severe preterm delivery affecting study aims) * Inability to tolerate PAP therapy * Serious physical or mental illness or condition that would affect participation * Drowsy driving * Severe hypoxemia on sleep study * Advanced cardiac disease or arrhythmias that may benefit from PAP therapy * Chronic lung disease and / or respiratory failure. * Twin pregnancies * Fetuses with congenital anomalies * Severe hypertension at enrollment

Treatments and study arms

Positive Airway Pressure

Device

Auto-titrating PAP + nasal dilator strips during sleep

Nasal Dilator Strips

Other

Nasal dilator strips

Primary outcomes

Alterations in circulating placenta-secreted markers.up to 6 months

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.

Changes in placental histopathology for markers of malperfusion and placental expression of markersPlacenta collected at time of delivery

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The Miriam Hospital🇺🇸 Providence, Rhode Island, United States

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