Targeted CPAP Therapy for OSA in Pregnancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02755831|
Recruitment Status : Recruiting
First Posted : April 29, 2016
Last Update Posted : September 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: CPAP Other: Pre-natal care||Not Applicable|
Objective/Hypothesis: The purpose of this study is to determine if parturients identified as high risk for OSA (defined as an apnea hypopnea index [AHI] ≥5 events/hour; risk factors:
prepregnancy BMI≥30 kg/m2, chronic hypertension, pregestational diabetes (type 1 or type 2), history of prior preeclampsia, and/or a twin gestation) 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||360 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial for a Sleep Study and Targeted CPAP Therapy for Obstructive Sleep Apnea to Reduce the Incidence Adverse Pregnancy Related Outcomes|
|Actual Study Start Date :||February 20, 2017|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Sleep Study + CPAP group (n = 180)
Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment
Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea
Standard Prenatal Care group (n=180)
Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment.
Other: Pre-natal care
Standard Pre-Natal Care
- Primary Objective [ Time Frame: 3 years ]Rate of adverse maternal outcomes.
- Secondary Objective [ Time Frame: 3 years ]Rate of adverse fetal outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755831
|Contact: Theodore C Morrison, PhDfirstname.lastname@example.org|
|Contact: Dennis L Spence, PhDemail@example.com|
|United States, California|
|Naval Medical Center||Recruiting|
|San Diego, California, United States, 92134|
|Contact: Theodore Morrison, PhD, MPH 619-532-8447 firstname.lastname@example.org|
|Principal Investigator: Lutgendorf Monica, MD|
|Sub-Investigator: Morrison Theodore, PhD|
|Sub-Investigator: Nardulli Patrick, MS|
|Study Director:||Dennis L Spence, PhD||United States Naval Medical Center, San Diego|