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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03487185
Recruitment Status : Recruiting
First Posted : April 3, 2018
Last Update Posted : September 10, 2019
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

Tracking Information
First Submitted Date  ICMJE March 22, 2018
First Posted Date  ICMJE April 3, 2018
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE July 20, 2018
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03487185 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2018)
  • 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
  • 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
  • Cesarean Delivery [ Time Frame: At the time of delivery ]
    Delivery by cesarean section
  • 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
  • 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
  • Fetal or Neonatal Death [ Time Frame: through 72 hours postpartum ]
    Antepartum, intrapartum, or neonatal death
  • 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
  • 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
  • Neonatal encephalopathy [ Time Frame: within 72 hours of delivery ]
    Neonatal encephalopathy as defined by the NICHD Neonatal Research Network criteria
  • Neonatal Seizures [ Time Frame: 72 hours post birth ]
    Neonatal seizure activity confirmed by central review
  • Shoulder dystocia [ Time Frame: During delivery ]
    Shoulder dystocia during delivery
  • Birth trauma [ Time Frame: During delivery ]
    Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy
  • Intracranial hemorrhage [ Time Frame: Within 72 hours post delivery ]
    Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma
  • Hyperbilirubinemia [ Time Frame: Within 72 hours post delivery ]
    Hyperbilirubinemia requiring phototherapy or exchange transfusion
  • Hypoglycemia [ Time Frame: Within 72 hours post delivery ]
    glucose < 35 mg/dl requiring IV therapy
  • NICU Stay [ Time Frame: Greater than or equal to 72 hours post birth ]
    Neonatal Intensive Care Unit stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
Official Title  ICMJE A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Nulliparous women (no prior delivery at or after 20 weeks 0 days gestation) and high risk multiparous women (previous preeclampsia or antepartum gestational hypertension) 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
Condition  ICMJE
  • Obstructive Sleep Apnea of Adult
  • Preeclampsia
  • Obstetrical Complications
Intervention  ICMJE
  • Device: Continuous Positive Airway Pressure
    Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep hygiene counseling
    Other Name: CPAP
  • Other: Sleep Hygiene Control
    Initial sleep hygiene counseling alone
Study Arms  ICMJE
  • Experimental: Continuous Positive Airway Pressure
    Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep hygiene counseling
    Intervention: Device: Continuous Positive Airway Pressure
  • Sleep Hygiene Control
    Initial sleep hygiene counseling alone
    Intervention: Other: Sleep Hygiene Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2018)
2700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Nulliparous (no prior delivery at or after 20 weeks 0 days of gestation) or multiparous with a documented history of preeclampsia or antepartum gestational hypertension.
  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 14 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rebecca Clifton, PhD 301-881-9260 rclifton@bsc.gwu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03487185
Other Study ID Numbers  ICMJE HD36801-SLEEP
U10HD036801 ( U.S. NIH Grant/Contract )
UG1HD087192 ( U.S. NIH Grant/Contract )
UG1HD087230 ( U.S. NIH Grant/Contract )
UG1HD027869 ( U.S. NIH Grant/Contract )
UG1HD034208 ( U.S. NIH Grant/Contract )
UG1HD053097 ( U.S. NIH Grant/Contract )
UG1HD040500 ( U.S. NIH Grant/Contract )
UG1HD040485 ( U.S. NIH Grant/Contract )
UG1HD040544 ( U.S. NIH Grant/Contract )
UG1HD040545 ( U.S. NIH Grant/Contract )
UG1HD040560 ( U.S. NIH Grant/Contract )
UG1HD040512 ( U.S. NIH Grant/Contract )
UG1HD027915 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party The George Washington University Biostatistics Center
Study Sponsor  ICMJE The George Washington University Biostatistics Center
Collaborators  ICMJE
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Rebecca Clifton, PhD The George Washington University Biostatistics Center
Study Director: Menachem Miodovnik, MD NICHD Project Scientist
Study Chair: Francesca Facco, MD Magee Women's Hospital of UPMC
PRS Account The George Washington University Biostatistics Center
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP