Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy

Not Applicable

Completed

Brief Summary: Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group. Subjects in the Sleep Study + CPAP group will complete a sleep study (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the Apnea Hypopnea Index (AHI) ≥5 as indicated, in early and late pregnancy, whereas the other group will receive standard prenatal care. All subjects will complete a sleep study again between 8 to 12 weeks postpartum.

Detailed Description: Objective/Hypothesis: The purpose of this study is to determine if parturients identified as high risk for obstructive sleep apnea (OSA; defined as an apnea hypopnea index \[AHI\] ≥5 events/hour) who are randomized to receive an unattended sleep study during early and late pregnancy (early = between 6 and 16 weeks; late = between 27 and 33 weeks) plus initiation of CPAP therapy if the AHI ≥5 events/hour and standard prenatal care have a decreased incidence of adverse pregnancy outcomes (defined as a composite variable which includes gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm birth, low birth weight, or stillbirth) at the time of delivery when compared to a group who receives standard prenatal care only (no sleep study and CPAP initiation). At 8 to 12 months postpartum subjects in both groups will complete a sleep study.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Standard Prenatal Care group	Pre-natal care	Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.
Sleep Study + CPAP group	CPAP	Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Pregnancy Outcomes	time of delivery	Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)

Secondary Outcome Measures

Name	Time	Method
Hospital Costs at Time of Delivery	Hospital costs at time of delivery	Hospital costs at time of delivery in treatment and control group.
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)	early pregnancy (6-16 weeks)	Incidence of OSA severity in early pregnancy (6-16 weeks) in treatment group only. Data were not collected for Control group at this time point.
Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)	27-33 weeks	Incidence and severity of OSA in late pregnancy- treatment group only (27-33 weeks). Data were not collected for Control group at this time point
Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group	8-12 weeks postpartum	Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.