Association of Hypertensive Disorder of Pregnancy With Sleep-disordered Breathing.
NCT ID: NCT04126629
Last Updated: 2020-01-22
Study Results
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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UNKNOWN
100 participants
OBSERVATIONAL
2020-01-22
2021-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
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
* 2.Women with a diagnosis of a hypertensive disorder of pregnancy
* 3.Greater than 20 weeks pregnant
* 4.Singleton fetus
* 5.Inpatient
Exclusion Criteria
* 2.With micrognathia and other severe craniofacial abnormalities
* 3.Active heart failure
* 4.Sepsis
* 5.Subjects in labor.
18 Years
FEMALE
No
Sponsors
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The Cooper Health System
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
Other Identifiers
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19-028EX
Identifier Type: -
Identifier Source: org_study_id
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