PreeclampsiaNCT01029691

Study of Positive Airway Pressure in Preeclampsia to Reduce Blood Pressure

A study testing Positive Airway Pressure in people with Preeclampsia and Hypertension, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to identify whether sleep-disordered breathing - as measured by overnight polysomnography - is associated with pre-eclampsia and to determine whether use of positive airway pressure can improve nocturnal blood pressure. Read more about this study

Who is it for?: Ages 14 years and older, women only
Conditions the study is for: Preeclampsia, Hypertension
What is being tested?: Positive Airway Pressure
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 125 participants
Where: 1 siteUnited States
Study dates: May 2009to May 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 14 years and older
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Women with preeclampsia who receive care at the University of Michigan Hospitals
No current use of PAP therapy.
Willing and able to provide informed consent.

Who cannot join

Current PAP therapy
Any medical reason why PAP therapy may not be suitable (e.g., in patients with recent head trauma).
Cognitively impaired and unable to understand informed consent.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Use of PAP in Women With Pre-eclampsia

Read the detailed description

Initial enrollment began with only women with a pre-existing diagnosis of pre-eclampsia. Part way through the study, IRB granted approval to expand recruitment to include other hypertensive diagnoses. So, in effect, a more accurate post hoc title would be Study of Positive Airway Pressure to Reduce Blood Pressure in Hypertensive Pregnancies.

Conditions: Preeclampsia, Hypertension
Being tested: Positive Airway Pressure
Keywords: Sleep disordered breathing, Preeclampsia, Positive Airway Pressure
Medical subject headings: Pre-Eclampsia, Hypertension, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Positive Airway PressureDevice
Also called PAP
Women will use positive airway pressure until delivery

Study groups in NCT01029691
Study group	Role	What they receive
Positive Airway Pressure (compliant)	Experimental	This arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night Receives: Device: Positive Airway Pressure
Standard care	No intervention	Not described
Positive Airway Pressure (non-compliant)	Experimental	No one was assigned to this arm, but for results data quality purposes, women assigned to PAP who were explicitly non-compliant (used less than 4 hours per night), were analyzed separately from women who were compliant with the PAP assignment. Receives: Device: Positive Airway Pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

Nocturnal Blood Pressure
measured by a 24 hour cuff, averaged across the night;
Measured: baseline and 1 week after PAP treatment.
Number of Participants With Worsening of Hypertension
This outcome measure's purpose was to look at the impact of the APAP on blood pressure. This was done categorically by looking at worsening of hypertension with or without escalation of antihypertensive medications.
Measured: 1-6 months after enrollment.
Severity of Sleep Disordered Breathing
Severity of sleep disordered breathing, using the apnea/hypopnea index (number of respiratory evens per hour of sleep), among participants who have or do not have nocturnal hypertension. Obstructive sleep apnea is typically considered present if the AHI is at least 5.
Measured: at baseline
Number of Participants With Sleep-disordered Breathing (SDB)
Presence or absence of SDB (defined as an apnea/hypopnea index; AHI>=5)
Measured: Baseline night 1

Secondary outcomes (3)

Gestational Age at Delivery
Measured: At delivery (within 6 months of enrollment).
Birth Weight
Measured: At delivery (within 6 months of enrollment)
NICU Admission
Number of mothers who had one (or more) babies admitted to NICU
Measured: at delivery (within 6 months of enrollment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009May 2015

First posted10 Dec 2009 (estimated)
Study startMay 2009
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PreeclampsiaStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 125 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01029691
Sponsor's protocol ID: F022873
Other IDs: 1K23HL095739-01
Status last verified: Sep 2017
First submitted: 8 Dec 2009
Last updated: 16 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated device: Yes

Publications

O'Brien LM, Bullough AS, Chames MC, Shelgikar AV, Armitage R, Guilleminualt C, Sullivan CE, Johnson TR, Chervin RD. Hypertension, snoring, and obstructive sleep apnoea during pregnancy: a cohort study. BJOG. 2014 Dec;121(13):1685-93. doi: 10.1111/1471-0528.12885. Epub 2014 May 30.
PubMed 24888772

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Preeclampsia trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of PAP in Women With Pre-eclampsia
ClinicalTrials.gov ID: NCT01029691
Acronym / sponsor ID: F022873
Conditions: Preeclampsia, Hypertension
Keywords: Sleep disordered breathing, Preeclampsia, Positive Airway Pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 125 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: May 2009
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 10 Dec 2009 (estimated)
Results: Posted 16 Oct 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Positive Airway Pressure (compliant)	Experimental	Device: Positive Airway PressureThis arm was women who used auto-titrating positive airway pressure (APAP) for at least 4 hours per night
Standard care	No intervention	–
Positive Airway Pressure (non-compliant)	Experimental	Device: Positive Airway PressureNo one was assigned to this arm, but for results data quality purposes, women assigned to PAP who were explicitly non-compliant (used less than 4 hours per night), were analyzed separately from women who were compliant with the PAP assignment.

Who may qualify

Ages: 14 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Women with preeclampsia who receive care at the University of Michigan Hospitals
No current use of PAP therapy.
Willing and able to provide informed consent.

Key exclusion criteria (3 listed)

Current PAP therapy
Any medical reason why PAP therapy may not be suitable (e.g., in patients with recent head trauma).
Cognitively impaired and unable to understand informed consent.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Positive Airway PressureAlso: PAPWomen will use positive airway pressure until delivery	Device	Positive Airway Pressure (compliant), Positive Airway Pressure (non-compliant)

Primary outcome

Nocturnal Blood Pressure
Time frame: baseline and 1 week after PAP treatment.
measured by a 24 hour cuff, averaged across the night;
Number of Participants With Worsening of Hypertension
Time frame: 1-6 months after enrollment.
This outcome measure's purpose was to look at the impact of the APAP on blood pressure. This was done categorically by looking at worsening of hypertension with or without escalation of antihypertensive medications.
Severity of Sleep Disordered Breathing
Time frame: at baseline
Severity of sleep disordered breathing, using the apnea/hypopnea index (number of respiratory evens per hour of sleep), among participants who have or do not have nocturnal hypertension. Obstructive sleep apnea is typically considered present if the AHI is at least 5.
Number of Participants With Sleep-disordered Breathing (SDB)
Time frame: Baseline night 1
Presence or absence of SDB (defined as an apnea/hypopnea index; AHI>=5)

3 secondary outcomes

Gestational Age at Delivery
Time frame: At delivery (within 6 months of enrollment).
Birth Weight
Time frame: At delivery (within 6 months of enrollment)
NICU Admission
Time frame: at delivery (within 6 months of enrollment)

Results and safety

Results posted to the registry on 16 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Compliant Users APAP	20	20
Non-Compliant APAP	27	16
Standard of Care	77	77

Primary outcome: Nocturnal Blood Pressure

Time frame: baseline and 1 week after PAP treatment.. Mean (Standard Deviation). Unit: mmHg

Measure	Positive Airway Pressure Adherent n = 20	Positive Airway Pressure Non Adherent n = 16	Standard Care n = 0
Baseline Nocturnal Systolic	128.2 (9.8)	124.7 (8.9)	–
Baseline Nocturnal Diastolic	70.6 (8.0)	68.8 (8.3)	–
1 week Systolic	127.7 (9.3)	125.3 (8.5)	–
1 week Diastolic	70.9 (8.4)	69.3 (7.4)	–

Positive Airway Pressure Adherent vs Positive Airway Pressure Non Adherent vs Standard Care: p = 0.45, t-test, 2 sided
Positive Airway Pressure Adherent vs Positive Airway Pressure Non Adherent vs Standard Care: p = 0.66, t-test, 2 sided
Positive Airway Pressure Adherent vs Positive Airway Pressure Non Adherent vs Standard Care: p = 0.61, t-test, 2 sided

Population analysed: The standard of care group did not have nocturnal blood pressure monitoring as they were not assigned to use a positive airway pressure device

Primary outcome: Number of Participants With Worsening of Hypertension

Time frame: 1-6 months after enrollment.. Number. Unit: participants

Measure	Positive Airway Pressure Adherent n = 20	Positive Airway Pressure Non Adherent n = 16	Standard Care n = 76
Value	11	9	57

Positive Airway Pressure Adherent vs Positive Airway Pressure Non Adherent vs Standard Care: p = 0.085, Chi-squared

Population analysed: One woman in the standard of care group died during pregnancy and is therefore not included in this analysis.

Primary outcome: Severity of Sleep Disordered Breathing

Time frame: at baseline. Mean (Standard Deviation). Unit: apnea/hypopnea index

Measure	Nocturnal Hypertension n = 29	No Nocturnal Hypertension n = 14
Value	15.6 (25.9)	2.7 (1.9)

Nocturnal Hypertension vs No Nocturnal Hypertension: p = 0.012, t-test, 2 sided

Population analysed: This reflects only the n=43 women who underwent baseline sleep study (n=7 of whom did not go on to receive APAP therapy) prior to assignment to PAP therapy. The standard of care group did not have a baseline sleep study and are therefore not represented here. Of these n=43 women, n=36 received PAP therapy (n=20 were adherent and n=16 were not).

Primary outcome: Number of Participants With Sleep-disordered Breathing (SDB)

Time frame: Baseline night 1. Count of participants. Unit: Participants

Measure	Nocturnal Hypertension n = 29	No Nocturnal Hypertension n = 14
Value	14	3

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: from start of intervention until 30 days after intervention (generally 30 days after delivery). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Positive Airway Pressure	2 of 36 (5.6%)	0 of 36 (0%)	0 of 36
Standard Care	1 of 77 (1.3%)	0 of 77 (0%)	1 of 77

Limitations and caveats (from the sponsor): These tables represent full basic analysis of all the participants enrolled without adjustment for confounding variables. Future publications will present more complex subsequent analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24888772O'Brien LM, Bullough AS, Chames MC, Shelgikar AV, Armitage R, Guilleminualt C, Sullivan CE, Johnson TR, Chervin RD. Hypertension, snoring, and obstructive sleep apnoea during pregnancy: a cohort study. BJOG. 2014 Dec;121(13):1685-93. doi: 10.1111/1471-0528.12885. Epub 2014 May 30.

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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.

Louise M O'Brien, PhD principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Positive Airway Pressure in people with Preeclampsia and Hypertension, run by University of Michigan 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 16 Oct 2017. 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?

Yes. Results are posted in the registry (first posted 16 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nocturnal Blood Pressure (time frame: baseline and 1 week after PAP treatment.). The study lists 4 primary outcomes in all. 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 NCT01029691, which also lists 1 linked publication.

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 16 Oct 2017.