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

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Cooper University Health Care

Status

Unknown

Conditions

Sleep-disordered Breathing
Hypertensive Disorder of Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT04126629
19-028EX

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

Normotensive Group
Description:
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
Description:
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.

Trial contacts and locations

1

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Central trial contact

Elena Safronova, MD

Data sourced from clinicaltrials.gov

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