Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
- Conditions
- PreeclampsiaObstetrical ComplicationsObstructive Sleep Apnea of Adult
- Interventions
- Other: Sleep Advice ControlDevice: Continuous Positive Airway Pressure
- Registration Number
- NCT03487185
- Lead Sponsor
- The George Washington University Biostatistics Center
- Brief Summary
A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
- Detailed Description
Emerging data support a link between sleep disordered breathing (SDB) and adverse pregnancy outcomes. In particular, women with obstructive sleep apnea (OSA) appear to be at increased risk of both hypertensive disorders of pregnancy and gestational diabetes. In the non-pregnant population, OSA is typically treated with continuous positive airway pressure (CPAP) during sleep and has been shown to reduce blood pressure in hypertensive patients. Unfortunately, data on whether maternal and neonatal outcomes could be improved with treatment of OSA during pregnancy are extremely limited. This study aims to address this knowledge gap.
A randomized controlled trial of 1,500 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 1500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sleep Advice Control Sleep Advice Control Initial sleep advice counseling alone Continuous Positive Airway Pressure Continuous Positive Airway Pressure Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling
- Primary Outcome Measures
Name Time Method Diagnosis of Hypertensive Disorders of Pregnancy Up to 14 days postpartum Subjects are considered to have the primary outcome if they meet the criteria for eclampsia, HELLP, atypical HELLP, preeclampsia, superimposed preeclampsia or antepartum gestational hypertension.
- Secondary Outcome Measures
Name Time Method Preterm birth Preterm delivery up to and less than 37 weeks gestation Preterm birth less than 34 weeks and less than 37 weeks
Cesarean Delivery At the time of delivery Delivery by cesarean section
Maternal morbidity composite Within 6 weeks postpartum Maternal morbidity composite defined as the occurrence of one of the following:
* Maternal death
* Transfusion of ≥ 4 units of PRBC within 6 weeks postpartum
* ICU admission within 6 weeks postpartumBirth weight Immediately post birth 1. Small for gestational age defined as \< 5th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data
2. Large for gestational age defined as greater than the 90th percentile for gestational age.
3. Macrosomia defined as birthweight \> 4000 gramsFetal or Neonatal Death through 72 hours postpartum Antepartum, intrapartum, or neonatal death
Gestational diabetes As soon as possible after randomization between 14 weeks, 0 days and 21 weeks, 6 days gestation Gestational diabetes by oral GTT criteria performed after randomization
Maternal adverse cardiovascular outcome composite By 6 weeks postpartum Maternal adverse cardiovascular outcome composite defined as the occurrence of one or more of the following:
* Venous thromboembolism
* New onset heart failure with ejection fraction (EF) \< 40%
* Cerebrovascular accident
* Myocardial infarction
* New onset atrial fibrillationNeonatal respiratory support within 72 hours of delivery Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation
Neonatal Seizures 72 hours post birth Neonatal seizure activity confirmed by central review
Shoulder dystocia During delivery Shoulder dystocia during delivery
Birth trauma During delivery Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
Intracranial hemorrhage Within 72 hours post delivery Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Hyperbilirubinemia Within 72 hours post delivery Hyperbilirubinemia requiring phototherapy or exchange transfusion
Hypoglycemia Within 72 hours post delivery glucose \< 35 mg/dl requiring IV therapy
NICU Stay Greater than or equal to 72 hours post birth Neonatal Intensive Care Unit stay
Neonatal encephalopathy within 72 hours of delivery Neonatal encephalopathy as defined by the NICHD Neonatal Research Network criteria
Trial Locations
- Locations (14)
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Columbia University
🇺🇸New York, New York, United States
Case Western Reserve-Metro Health
🇺🇸Cleveland, Ohio, United States
University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Ohio State University Hospital
🇺🇸Columbus, Ohio, United States
Magee Women's Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Brown Univeristy
🇺🇸Providence, Rhode Island, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
University of Texas - Houston
🇺🇸Houston, Texas, United States
Regents of the University of California San Francisco
🇺🇸San Francisco, California, United States
University of Utah Medical Center
🇺🇸Salt Lake City, Utah, United States
University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States