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

Conditions

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

Study Locations

  • United States
    • New Jersey
      • Camden, New Jersey, United States, 08193
        • Recruiting
        • Cooper University Hospital
        • Contact:
        • Principal Investigator:
          • Meena Khandelwal, MD
        • Sub-Investigator:
          • Elena Safronova, MD
        • Sub-Investigator:
          • Claudia Rugama, BS
        • Sub-Investigator:
          • Jonathan Kass, MD
        • Sub-Investigator:
          • Alexander Santangelo, BA

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
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
03/01/2019-03/01/2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cooper Health System

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

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

Keywords

Additional Relevant MeSH Terms

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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