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

NCT ID: NCT04126629

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-22

Study Completion Date

2021-09-01

Brief Summary

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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

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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.

Conditions

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Hypertensive Disorder of Pregnancy Sleep-disordered Breathing

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normotensive Group

Subject will be allocated to the experimental group based on the clinical characteristics of their blood pressure. This will be the normotensive group. Every attempt will be made to stratify both groups equally between second and third trimesters.

No interventions assigned to this group

Hypertensive Group

Subject will be allocated to the experimental group based on the clinical characteristics of their blood pressure. This will be the hypertensive group.Every attempt will be made to stratify both groups equally between second and third trimesters.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Cooper Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meena Khandelwal, MD

Role: PRINCIPAL_INVESTIGATOR

Cooper Health System

Locations

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Cooper University Hospital

Camden, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elena Safronova, MD

Role: CONTACT

856-968-7547

Facility Contacts

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Elena Safronova, MD

Role: primary

856-968-7547

References

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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.

Reference Type BACKGROUND
PMID: 27926645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29523262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29031756 (View on PubMed)

Other Identifiers

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19-028EX

Identifier Type: -

Identifier Source: org_study_id

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