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

Preeclampsia Clinical Trial

— SLEEP  

Official title:

A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03487185
• Other study ID #: HD36801-SLEEP
• Secondary ID: U24HD036801UG1HD
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: The George Washington University Biostatistics Center
• Contact: Rebecca Clifton, PhD
• Phone: 301-881-9260
• Email: rclifton[@]bsc.gwu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or therapeutically, is not eligible unless the reduction occurred before 14 weeks project gestational age.

2. Gestational age at randomization between 14 weeks 0 days and 21 weeks 6 days based on clinical information and evaluation of the earliest ultrasound.

3. 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. Chronic renal disease with serum creatinine >1.3 mg/dL because the primary outcome would be pre-determined.

8. Antiphospholipid antibody syndrome, because it would compromise the primary outcome diagnosis.

9. 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.

10. Active vaginal bleeding (more than spotting) at the time of randomization.

11. Known chromosomal, genetic, major malformations or fetal demise, or planned termination of pregnancy because inclusion would compromise evaluation of secondary neonatal outcomes.

12. Known major uterine malformations associated with adverse pregnancy outcomes.

13. Current use of opiates (heroin, methadone, or other daily opioid use) due to inaccuracy of the home sleep test and inefficiency of CPAP.

14. Active drug use, alcohol use, or unstable psychiatric condition.

15. Participation in another interventional study that influences preeclampsia, hypertensive disorders of pregnancy, or GDM.

16. Prenatal care or delivery planned at a non-network center where access to the complete electronic medical record will not be available to research staff.

17. Participation in this trial in a previous pregnancy. Patients who were screened in a previous pregnancy, but not randomized, may be included.

Related Conditions & MeSH terms

• Apnea
• Obstetrical Complications
• Obstructive Sleep Apnea of Adult
• Pre-Eclampsia
• Preeclampsia
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous Positive Airway Pressure
Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling

Other:
• Sleep Advice Control
Initial sleep advice counseling alone

Locations

Country	Name	City	State
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Case Western Reserve-Metro Health	Cleveland	Ohio
United States	Ohio State University Hospital	Columbus	Ohio
United States	University of Texas Medical Branch	Galveston	Texas
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas - Houston	Houston	Texas
United States	Columbia University	New York	New York
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	University of Utah Medical Center	Salt Lake City	Utah
United States	Regents of the University of California San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
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)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 14 days postpartum
Secondary	Gestational diabetes	Gestational diabetes by oral GTT criteria performed after randomization	As soon as possible after randomization between 14 weeks, 0 days and 21 weeks, 6 days gestation
Secondary	Preterm birth	Preterm birth less than 34 weeks and less than 37 weeks	Preterm delivery up to and less than 37 weeks gestation
Secondary	Cesarean Delivery	Delivery by cesarean section	At the time of delivery
Secondary	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	Within 6 weeks postpartum
Secondary	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	By 6 weeks postpartum
Secondary	Fetal or Neonatal Death	Antepartum, intrapartum, or neonatal death	through 72 hours postpartum
Secondary	Neonatal respiratory support	Intubation, continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) for ventilation or cardiopulmonary resuscitation	within 72 hours of delivery
Secondary	Birth weight	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; Large for gestational age defined as greater than the 90th percentile for gestational age.; Macrosomia defined as birthweight > 4000 grams	Immediately post birth
Secondary	Neonatal encephalopathy	Neonatal encephalopathy as defined by the NICHD Neonatal Research Network criteria	within 72 hours of delivery
Secondary	Neonatal Seizures	Neonatal seizure activity confirmed by central review	72 hours post birth
Secondary	Shoulder dystocia	Shoulder dystocia during delivery	During delivery
Secondary	Birth trauma	Bone fractures, brachial plexus palsy, other neurologic injury, retinal hemorrhage, or facial nerve palsy	During delivery
Secondary	Intracranial hemorrhage	Intraventricular hemorrhage grades III and IV, subgaleal hematoma, subdural hematoma, or subarachnoid hematoma	Within 72 hours post delivery
Secondary	Hyperbilirubinemia	Hyperbilirubinemia requiring phototherapy or exchange transfusion	Within 72 hours post delivery
Secondary	Hypoglycemia	glucose < 35 mg/dl requiring IV therapy	Within 72 hours post delivery
Secondary	NICU Stay	Neonatal Intensive Care Unit stay	Greater than or equal to 72 hours post birth