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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
The George Washington University Biostatistics Center
Study ID
NCT03487185
Status
Recruiting
Apply to this trial

Conditions

  • Obstetrical Complications
  • Obstructive Sleep Apnea of Adult
  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continuous Positive Airway Pressure — DEVICE
    Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling
  • Sleep Advice Control — OTHER
    Initial sleep advice counseling alone

Study Details

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.

Key Dates

Start date
Aug 3, 2018
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 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

Primary Outcome Measure

Diagnosis of Hypertensive Disorders of Pregnancy [ Time Frame: Up to 14 days postpartum ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama - BirminghamBirminghamAlabama35233
Nancy Saxon, RN
[email protected]
205-934-1616
Alan TN Tita, MD (PRINCIPAL_INVESTIGATOR)
Regents of the University of California San FranciscoSan FranciscoCalifornia94143
Natalie Oman, MPH
[email protected]
206-718-4703
Mary Norton, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Elizabeth Rangel, MSN
[email protected]
312-503-6287
Lynn Yee, MD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Megan Loffredo, MD, CCRC
[email protected]
203-722-1058
Noelia Zork, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina - Chapel HillChapel HillNorth Carolina27599
Kelly Clark, RN
[email protected]
919-350-6117
John M Thorp, MD (PRINCIPAL_INVESTIGATOR)
Case Western Reserve-Metro HealthClevelandOhio44109
Abigail Pierse, BS
[email protected]
216-778-8443
Kelly Gibson, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University HospitalColumbusOhio43210
Anna Bartholomew, RN
[email protected]
614-685-3229
Maged Costantine, MD (PRINCIPAL_INVESTIGATOR)
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Amee Feager, RN
[email protected]
636-699-3433
Lorraine Dugoff, MD (PRINCIPAL_INVESTIGATOR)
Magee Women's Hospital of UPMCPittsburghPennsylvania15213
Jeanette Boyce, RN
[email protected]
412-527-8118
Hyagriv Simhan, MD (PRINCIPAL_INVESTIGATOR)
Brown UniveristyProvidenceRhode Island02905-
University of Texas Medical BranchGalvestonTexas77555-
Baylor College of MedicineHoustonTexas77030
Christina Reed, RN, NP
[email protected]
832-826-7377
Jia Chen, RN, CCRP
[email protected]
713-798-3798
Catherine Eppes, MD, MPH (PRINCIPAL_INVESTIGATOR)
University of Texas - HoustonHoustonTexas77030
Felecia Ortiz, RN
[email protected]
713-500-6467
Hector Mendez-Figueroa, MD (PRINCIPAL_INVESTIGATOR)
University of Utah Medical CenterSalt Lake CityUtah84132
Amber Sowles, RN, BSN, CCRP
[email protected]
801-585-5499
Torri Metz, MD (PRINCIPAL_INVESTIGATOR)

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