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

Sleep-disordered Breathing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04126629
• Other study ID #: 19-028EX
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Disease
• Hypertension
• Hypertensive Disorder of Pregnancy
• Pre-Eclampsia
• Pregnancy Complications
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep-disordered Breathing
• Toxemia

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