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

ConditionsObstructive Sleep Apnea of AdultPreeclampsiaObstetrical Complications
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe George Washington University Biostatistics Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Diagnosis with mild to moderate OSA as defined by an AHI score ≥ 5 and <30.

Disqualifiers

Previously prescribed, current or planned therapy for sleep apnea.

Age < 18 years, because the rate of sleep apnea in this population is extremely low.

Inability to sleep in a stable place with access to the CPAP machine at least 5 nights per week.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuous Positive Airway Pressure

    Device

    Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling

  • Sleep Advice Control

    Other intervention

    Initial sleep advice counseling alone

Treatment groups

1,500 Participants
are divided into 2 treatment groups
Group A: Continuous Positive Airway PressureExperimental treatment 1 intervention
Group B: Sleep Advice ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 14 days postpartum

Secondary outcomes

1

Gestational diabetes

Gestational diabetes by oral GTT criteria performed after randomization

Time frame
As soon as possible after randomization between 14 weeks, 0 days and 21 weeks, 6 days gestation
2

Preterm birth

Preterm birth less than 34 weeks and less than 37 weeks

Time frame
Preterm delivery up to and less than 37 weeks gestation
3

Cesarean Delivery

Delivery by cesarean section

Time frame
At the time of delivery
4

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

Time frame
Within 6 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The George Washington University Biostatistics Center

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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