Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
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
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
This study is an unmasked randomized controlled multi-center clinical trial.

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • CPAP
Other
Sleep Hygiene Control
Initial sleep hygiene counseling alone
  • Other: Sleep Hygiene Control
    Initial sleep hygiene counseling alone

Recruiting Locations

University of Texas Medical Branch
Galveston, Texas 77555
Contact:
Ashley Salazar, MSN
409-772-0312
assalaza@utmb.edu

More Details

NCT ID
NCT03487185
Status
Recruiting
Sponsor
The George Washington University Biostatistics Center

Study Contact

Rebecca Clifton, PhD
301-881-9260
rclifton@bsc.gwu.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.