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Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy (SLEEP)

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ClinicalTrials.gov Identifier: NCT03487185
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
The George Washington University Biostatistics Center

Brief Summary:
A randomized controlled trial of 2,700 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea of Adult Preeclampsia Obstetrical Complications Device: Continuous Positive Airway Pressure Other: Sleep Hygiene Control Not Applicable

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 2,700 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  (Clinical Trial)
Estimated Enrollment : 2700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Nulliparous women with a singleton gestation and obstructive sleep apnea (OSA) will be randomized to one of two arms at participating MFMU Network clinical center:

  • Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep hygiene counseling
  • Initial sleep hygiene counseling alone
Masking: None (Open Label)
Masking Description: This study is an unmasked randomized controlled multi-center clinical trial.
Primary Purpose: Treatment
Official Title: A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
Actual Study Start Date : July 20, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Continuous Positive Airway Pressure
Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep hygiene counseling
Device: Continuous Positive Airway Pressure
Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep hygiene counseling
Other Name: CPAP

Sleep Hygiene Control
Initial sleep hygiene counseling alone
Other: Sleep Hygiene Control
Initial sleep hygiene counseling alone




Primary Outcome Measures :
  1. Hypertensive Disorders of Pregnancy [ Time Frame: 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 :
  1. Gestational diabetes [ Time Frame: As soon as possible after randomization between 16 weeks, 0 days and 21 weeks, 6 days gestation ]
    Gestational diabetes by oral GTT criteria performed after randomization

  2. Preterm birth [ Time Frame: Preterm delivery up to and less than 37 weeks gestation ]
    Preterm birth less than 34 weeks and less than 37 weeks

  3. Cesarean Delivery [ Time Frame: At the time of delivery ]
    Delivery by cesarean section

  4. Maternal morbidity composite [ Time Frame: 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 postpartum

  5. Maternal adverse cardiovascular outcome composite [ Time Frame: 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 fibrillation

  6. Fetal or Neonatal Death [ Time Frame: through 72 hours postpartum ]
    Antepartum, intrapartum, or neonatal death

  7. Neonatal respiratory support [ Time Frame: within 72 hours of delivery ]
    Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation

  8. Birth weight [ Time Frame: 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 grams

  9. Neonatal encephalopathy [ Time Frame: within 72 hours of delivery ]
    Neonatal encephalopathy as defined by the NICHD Neonatal Research Network criteria

  10. Neonatal Seizures [ Time Frame: 72 hours post birth ]
    Neonatal seizure activity confirmed by central review

  11. Shoulder dystocia [ Time Frame: During delivery ]
    Shoulder dystocia during delivery

  12. Birth trauma [ Time Frame: During delivery ]
    Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy

  13. Intracranial hemorrhage [ Time Frame: Within 72 hours post delivery ]
    Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma

  14. Hyperbilirubinemia [ Time Frame: Within 72 hours post delivery ]
    Hyperbilirubinemia requiring phototherapy or exchange transfusion

  15. Hypoglycemia [ Time Frame: Within 72 hours post delivery ]
    glucose < 35 mg/dl requiring IV therapy

  16. NICU Stay [ Time Frame: Greater than or equal to 72 hours post birth ]
    Neonatal Intensive Care Unit stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Nulliparous (no prior delivery at or after 20 weeks 0 days of gestation).
  2. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age (see Section 3.4.2).
  3. Gestational age at randomization between 16 weeks 0 days and 21 weeks 6 days based on clinical information and evaluation of the earliest ultrasound as described in Gestational Age Determination in Section 3.4.2
  4. Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and <30.

Exclusion Criteria:

  1. Previously prescribed, current or planned therapy for sleep apnea.
  2. Age < 18 years, because the rate of sleep apnea in this population is extremely low.
  3. Inability to sleep in a stable place with access to the CPAP machine at least 5 nights per week.
  4. Asthma requiring systemic steroid therapy for more than 14 days within the past 6 months because this population is expected to be unresponsive to CPAP therapy.
  5. Current use of prescribed sleeping pills for insomnia.
  6. Chronic medical conditions requiring oxygen supplementation (e.g. pulmonary fibrosis, pulmonary hypertension, cystic fibrosis) because this population is expected to be unresponsive to CPAP therapy.
  7. Current use of antihypertensive medication because of the difficulty in diagnosing superimposed preeclampsia.
  8. Chronic renal disease with serum creatinine >1.3 mg/dL because the primary outcome would be pre-determined.
  9. Antiphospholipid antibody syndrome, because it would compromise the primary outcome diagnosis.
  10. History of medical complications such as:

    1. Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes)
    2. Thrombocytopenia with platelet count <100,000 because of the difficulty in assessing the primary outcome.
  11. Active vaginal bleeding (more than spotting) at the time of randomization.
  12. Known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy because inclusion would compromise evaluation of secondary neonatal outcomes.
  13. Known major uterine malformations associated with adverse pregnancy outcomes.
  14. Current use of opiates (heroin, methadone, or other daily opioid use) due to inaccuracy of the home sleep test and inefficiency of CPAP.
  15. Active drug use, alcohol use, or unstable psychiatric condition.
  16. Participation in another interventional study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM.
  17. Prenatal care or delivery planned at a non-network center.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03487185


Contacts
Contact: Uma Reddy, MD 301-496-1074 reddyu@mail.nih.gov
Contact: Elizabeth Thom, PhD 301-881-9260 e_thom@bsc.gwu.edu

Locations
United States, Alabama
University of Alabama - Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Stacy Harris, RN    205-996-6262    stacylharris@uabmc.edu   
Principal Investigator: Alan TN Tita, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Gail Mallett, RN    312-503-3200    g-mallett@northwestern.edu   
Principal Investigator: William Grobman, MD         
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032
Contact: Sabine Bousleiman, RN    212-305-4348    sb1080@columbia.edu   
Principal Investigator: Cynthia Gyamfi-Bannerman, MD         
United States, North Carolina
University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Kelly Clark, RN    919-350-6117    kelly_clark@med.unc.edu   
Principal Investigator: John M Thorp, MD         
United States, Ohio
Case Western Reserve-Metro Health Recruiting
Cleveland, Ohio, United States, 44109
Contact: Wendy Dalton, RN    216-778-7533    wdalton@metrohealth.org   
Principal Investigator: Edward Chien, MD         
Ohio State University Hospital Recruiting
Columbus, Ohio, United States, 43210
Contact: Anna Bartholomew, RN    614-685-3229    anna.bartholomew@osumc.edu   
Principal Investigator: Mark Landon, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jennifer Craig, BSN    212-662-3926    jennifer.craig@uphs.upenn.edu   
Principal Investigator: Samuel Parry, MD         
Magee Women's Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Melissa Bickus, RN    412-641-4072    mbickus@mail.magee.edu   
Principal Investigator: Hyagriv Simhan, MD         
United States, Rhode Island
Brown Univeristy Recruiting
Providence, Rhode Island, United States, 02905
Contact: Donna Allard, RN    401-274-1122    dallard@wihri.org   
Principal Investigator: Dwight J Rouse, MD         
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Ashley Salazar, MSN    409-772-0312    assalaza@utmb.edu   
Principal Investigator: George R Saade, MD         
University of Texas - Houston Recruiting
Houston, Texas, United States, 77030
Contact: Felecia Ortiz, RN    713-500-6467    felecia.ortiz@uth.tmc.edu   
Principal Investigator: Suneet Chauhan, MD         
United States, Utah
University of Utah Medical Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Kim Hill, RN    801-585-7645    kim.hill@hsc.utah.edu   
Principal Investigator: Michael W Varner, MD         
Sponsors and Collaborators
The George Washington University Biostatistics Center
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Elizabeth Thom, PhD The George Washington University Biostatistics Center
Study Director: Uma Reddy NICHD Project Scientist

Responsible Party: The George Washington University Biostatistics Center
ClinicalTrials.gov Identifier: NCT03487185     History of Changes
Other Study ID Numbers: HD36801-SLEEP
U10HD036801 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The dataset will be shared per NIH policy after the completion and publication of the main analyses. Requests for datasets can be sent to mfmudatasets@bsc.gwu.edu
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by The George Washington University Biostatistics Center:
CPAP
Apnea
pregnancy

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pre-Eclampsia
Obstetric Labor Complications
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications