NCT04126629

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 22, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

7 months

First QC Date

October 11, 2019

Last Update Submit

January 21, 2020

Conditions

Hypertensive Disorder of PregnancySleep-disordered Breathing

Keywords

Hypertensive Disorder of PregnancySleep-disordered BreathingHDPSDB

Outcome Measures

Primary Outcomes (1)

  • Prevalence of SDB in women with HDP compared to normotensive women.

    03/01/2019-03/01/2021

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women with a singleton gestation who are admitted to Cooper University Hospital that are greater than 20 weeks pregnant.

You may qualify if:

  • \. Subject who is capable of consenting in English
  • Women with a diagnosis of a hypertensive disorder of pregnancy
  • Greater than 20 weeks pregnant
  • Singleton fetus
  • Inpatient

You may not qualify if:

  • With acute respiratory distress, including asthma
  • With micrognathia and other severe craniofacial abnormalities
  • Active heart failure
  • Sepsis
  • Subjects in labor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08193, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 27926645BACKGROUND

  • 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.

    PMID: 29523262BACKGROUND

  • 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.

    PMID: 29031756BACKGROUND

MeSH Terms

Conditions

ToxemiaSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

InfectionsApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Meena Khandelwal, MD

    Cooper Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Safronova, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 15, 2019

Study Start

January 22, 2020

Primary Completion

September 1, 2020

Study Completion

September 1, 2021

Last Updated

January 22, 2020

Record last verified: 2020-01

Locations

US(1)