Recruiting

Observational Study

Sponsor:

The Cooper Health System

Code:

NCT04126629

Conditions

Hypertensive Disorder of Pregnancy

Sleep-disordered Breathing

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Hypertensive Disorder of Pregnancy

Sleep-disordered Breathing

Study ID

NCT04126629

Start date

Jan 22, 2020

Status verified date

Jan, 2020

Completion date

Sep 1, 2021

Anticipated

Primary completion date

Sep 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Prevalence of SDB in women with HDP compared to normotensive women. [ Time Frame: 03/01/2019-03/01/2021 ]

Central Contacts and Locations

Central contacts

Elena Safronova, MD

856-968-7547safronova-elena@cooperhealth.edu

Locations

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08193

Contacts

Elena Safronova, MD

856-968-7547safronova-elena@cooperhealth.edu

Principal Investigator:

Meena Khandelwal, MD

More Information

Sponsor

The Cooper Health System

Last update posted

Jan 22, 2020

Last verified

Jan, 2020

Keywords

  • Hypertensive Disorder of Pregnancy
  • Sleep-disordered Breathing
  • HDP
  • SDB

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2020-01-22.