NCT02412696Active, not recruiting
Positive Airway Pressure, Sleep Apnea, and the Placenta (PAP-SAP)
Placental Role in Mediating Adverse Outcomes in Obstructive Sleep Apnea
Source: ClinicalTrials.gov · Last updated 22 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 262 (estimated)
- First submitted
- 21 Jan 2015
- Start date
- 1 Jun 2015
- Primary completion date
- 1 Aug 2020
- Lead sponsor
- The Miriam Hospital
- Diseases
- Obesity
- NCT number
- NCT02412696
What you commit to
- Study type: Interventional
- Planned participants: 262
- From 1 Jun 2015 to the primary completion date, 1 Aug 2020
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inability to tolerate PAP therapy
Other illness
- Serious physical or mental illness or condition that would affect participation
- Advanced cardiac disease or arrhythmias that may benefit from PAP therapy
- Chronic lung disease and / or respiratory failure.
- Severe hypertension at enrollment
Other
- Unable to meet inclusion criteria, Incompetent cervix / cerclage (likelihood of severe preterm delivery affecting study aims)
- Drowsy driving
- Severe hypoxemia on sleep study
- Twin pregnancies
- Fetuses with congenital anomalies
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Miriam Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.