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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04126629
Other study ID # 19-028EX
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 22, 2020
Est. completion date September 1, 2021

Study information

Verified date January 2020
Source The Cooper Health System
Contact Elena Safronova, MD
Phone 856-968-7547
Email safronova-elena@cooperhealth.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 1, 2021
Est. primary completion date September 1, 2020
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Locations

Country Name City State
United States Cooper University Hospital Camden New Jersey

Sponsors (1)

Lead Sponsor Collaborator
The Cooper Health System

Country where clinical trial is conducted

United States, 

References & Publications (3)

Bourjeily G, Danilack VA, Bublitz MH, Lipkind H, Muri J, Caldwell D, Tong I, Rosene-Montella K. Obstructive sleep apnea in pregnancy is associated with adverse maternal outcomes: a national cohort. Sleep Med. 2017 Oct;38:50-57. doi: 10.1016/j.sleep.2017.06.035. Epub 2017 Jul 26. — View Citation

Facco FL, Parker CB, Reddy UM, Silver RM, Koch MA, Louis JM, Basner RC, Chung JH, Nhan-Chang CL, Pien GW, Redline S, Grobman WA, Wing DA, Simhan HN, Haas DM, Mercer BM, Parry S, Mobley D, Hunter S, Saade GR, Schubert FP, Zee PC. Association Between Sleep-Disordered Breathing and Hypertensive Disorders of Pregnancy and Gestational Diabetes Mellitus. Obstet Gynecol. 2017 Jan;129(1):31-41. doi: 10.1097/AOG.0000000000001805. — View Citation

Louis JM, Koch MA, Reddy UM, Silver RM, Parker CB, Facco FL, Redline S, Nhan-Chang CL, Chung JH, Pien GW, Basner RC, Grobman WA, Wing DA, Simhan HN, Haas DM, Mercer BM, Parry S, Mobley D, Carper B, Saade GR, Schubert FP, Zee PC. Predictors of sleep-disordered breathing in pregnancy. Am J Obstet Gynecol. 2018 May;218(5):521.e1-521.e12. doi: 10.1016/j.ajog.2018.01.031. Epub 2018 Feb 2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of SDB in women with HDP compared to normotensive women. 03/01/2019-03/01/2021
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