- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04126629
Association of Hypertensive Disorder of Pregnancy With Sleep-disordered Breathing.
January 21, 2020 updated by: The Cooper Health System
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.
Study Overview
Status
Unknown
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Elena Safronova, MD
- Phone Number: 856-968-7547
- Email: safronova-elena@cooperhealth.edu
Study Locations
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New Jersey
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Camden, New Jersey, United States, 08193
- Recruiting
- Cooper University Hospital
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Contact:
- Elena Safronova, MD
- Phone Number: 856-968-7547
- Email: safronova-elena@cooperhealth.edu
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Principal Investigator:
- Meena Khandelwal, MD
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Sub-Investigator:
- Elena Safronova, MD
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Sub-Investigator:
- Claudia Rugama, BS
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Sub-Investigator:
- Jonathan Kass, MD
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Sub-Investigator:
- Alexander Santangelo, BA
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant women with a singleton gestation who are admitted to Cooper University Hospital that are greater than 20 weeks pregnant.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Prevalence of SDB in women with HDP compared to normotensive women.
Time Frame: 03/01/2019-03/01/2021
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03/01/2019-03/01/2021
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Meena Khandelwal, MD, Cooper Health System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 22, 2020
Primary Completion (Anticipated)
September 1, 2020
Study Completion (Anticipated)
September 1, 2021
Study Registration Dates
First Submitted
October 11, 2019
First Submitted That Met QC Criteria
October 11, 2019
First Posted (Actual)
October 15, 2019
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 21, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Infections
- Respiratory Tract Diseases
- Apnea
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Hypertension, Pregnancy-Induced
- Sleep Apnea Syndromes
- Toxemia
- Hypertension
- Disease
- Respiratory Aspiration
- Pre-Eclampsia
- Pregnancy Complications
Other Study ID Numbers
- 19-028EX
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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