Association of Hypertensive Disorder of Pregnancy With Sleep-disordered Breathing.

• Conditions: Hypertensive Disorder of Pregnancy; Sleep-disordered Breathing

• Registration Number: NCT04126629
• Lead Sponsor: The Cooper Health System

Brief Summary

This study aims to assess the prevalence of sleep disorder breathing in pregnant women with a singleton gestation who develop hypertensive disorder of pregnancy (HDP) compared to women without HDP, when matched for gestational age and body mass index.

Detailed Description

Sleeping disorder breathing is not only underdiagnosed in the general population, but more specifically in pregnant women. Some recent research has found an association between sleep disorder breathing and preeclampsia. Both conditions have shown to be associated with worse pregnancy outcomes. Therefore, more research is needed to find the strength of these associations. By gathering more information, this provides investigators with an opportunity to see if there is a way to slow the progression of complications in preeclampsia through the management of sleep-disordered breathing. Preeclampsia continues to be one of the top reasons for maternal mortality in the U.S. and this percentage continues to grow each year. Through the study, investigators hope to bring awareness of the comorbidity and how its similar pathogenesis can potential exacerbate complications in pregnant women.

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-15
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Study Start: 2020-01-22
• Last Update Posted: 2020-01-22
• Primary Completion: 2020-09-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• 1. Subject who is capable of consenting in English
• 2.Women with a diagnosis of a hypertensive disorder of pregnancy
• 3.Greater than 20 weeks pregnant
• 4.Singleton fetus
• 5.Inpatient

Exclusion Criteria

• 1.With acute respiratory distress, including asthma
• 2.With micrognathia and other severe craniofacial abnormalities
• 3.Active heart failure
• 4.Sepsis
• 5.Subjects in labor.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of SDB in women with HDP compared to normotensive women.	03/01/2019-03/01/2021

Trial Locations

Locations (1)

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States