Clinical trial NCT04126629: Association of Hypertensive Disorder of Pregnancy With Sleep-disordered Breathing.
Official title: Association of Hypertensive Disorder of Pregnancy With Sleep-disordered Breathing.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertensive Disorder of Pregnancy
Sleep-disordered Breathing
Keywords: Hypertensive Disorder of Pregnancy
Sleep-disordered Breathing
HDP
SDB
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence of SDB in women with HDP compared to normotensive women.
timeFrame: 03/01/2019-03/01/2021
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
Study officials:
affiliation: Cooper Health System
name: Meena Khandelwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.