Hypertensive Disorder of PregnancyNCT04126629
Association of Hypertensive Disorder of Pregnancy With Sleep-disordered Breathing.
An observational study of Hypertensive Disorder of Pregnancy and Sleep-disordered Breathing, run by Cooper Norcross Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertensive Disorder of Pregnancy, Sleep-disordered Breathing
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2020to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Pregnant women with a singleton gestation who are admitted to Cooper University Hospital that are greater than 20 weeks pregnant.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cooper University Hospital
Camden, New Jersey, 08193
Elena Safronova, MD, 856-968-7547, safronova-elena@cooperhealth.edu
Meena Khandelwal, MD
About this study
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.
Read the 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.
- Keywords
- Hypertensive Disorder of Pregnancy, Sleep-disordered Breathing, HDP, SDB
- Medical subject headings
- Toxemia, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of SDB in women with HDP compared to normotensive women.
Measured: 03/01/2019-03/01/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start22 Jan 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meena Khandelwal, MD, Principal investigator, Cooper Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126629
- Sponsor's protocol ID
- 19-028EX
- Status last verified
- Jan 2020
- First submitted
- 11 Oct 2019
- Last updated
- 22 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27926645Louis 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.
PubMed 29523262Bourjeily 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.
PubMed 29031756
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Hypertensive Disorder of Pregnancy With Sleep-disordered Breathing.
- ClinicalTrials.gov ID
- NCT04126629
- Acronym / sponsor ID
- 19-028EX
- Keywords
- Hypertensive Disorder of Pregnancy, Sleep-disordered Breathing, HDP, SDB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- 22 Jan 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with a singleton gestation who are admitted to Cooper University Hospital that are greater than 20 weeks pregnant.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of SDB in women with HDP compared to normotensive women.
Time frame: 03/01/2019-03/01/2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Background: PubMed 27926645Facco 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.
- Background: PubMed 29523262Louis 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.
- Background: PubMed 29031756Bourjeily 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meena Khandelwal, MD principal investigator
Cooper Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Disorder of Pregnancy and Sleep-disordered Breathing, run by Cooper Norcross Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elena Safronova, MD (856-968-7547, safronova-elena@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of SDB in women with HDP compared to normotensive women. (time frame: 03/01/2019-03/01/2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04126629, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.