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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,500
Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling
Initial sleep advice counseling alone
University of Alabama - Birmingham
Birmingham, Alabama, United States
Regents of the University of California San Francisco
San Francisco, California, United States
Diagnosis of Hypertensive Disorders of Pregnancy
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.
Time frame: Up to 14 days postpartum
Gestational diabetes
Gestational diabetes by oral GTT criteria performed after randomization
Time frame: As soon as possible after randomization between 14 weeks, 0 days and 21 weeks, 6 days gestation
Preterm birth
Preterm birth less than 34 weeks and less than 37 weeks
Time frame: Preterm delivery up to and less than 37 weeks gestation
Cesarean Delivery
Delivery by cesarean section
Time frame: At the time of delivery
Maternal morbidity composite
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 postpartum
Time frame: Within 6 weeks postpartum
Maternal adverse cardiovascular outcome composite
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 fibrillation
Time frame: By 6 weeks postpartum
Fetal or Neonatal Death
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Northwestern University
Chicago, Illinois, United States
Columbia University
New York, New York, United States
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Case Western Reserve-Metro Health
Cleveland, Ohio, United States
Ohio State University Hospital
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States
Brown Univeristy
Providence, Rhode Island, United States
...and 4 more locations
Antepartum, intrapartum, or neonatal death
Time frame: through 72 hours postpartum
Neonatal respiratory support
Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation
Time frame: within 72 hours of delivery
Birth weight
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 grams
Time frame: Immediately post birth
Neonatal encephalopathy
Neonatal encephalopathy as defined by the NICHD Neonatal Research Network criteria
Time frame: within 72 hours of delivery
Neonatal Seizures
Neonatal seizure activity confirmed by central review
Time frame: 72 hours post birth
Shoulder dystocia
Shoulder dystocia during delivery
Time frame: During delivery
Birth trauma
Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
Time frame: During delivery
Intracranial hemorrhage
Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
Time frame: Within 72 hours post delivery
Hyperbilirubinemia
Hyperbilirubinemia requiring phototherapy or exchange transfusion
Time frame: Within 72 hours post delivery
Hypoglycemia
glucose \< 35 mg/dl requiring IV therapy
Time frame: Within 72 hours post delivery
NICU Stay
Neonatal Intensive Care Unit stay
Time frame: Greater than or equal to 72 hours post birth