Sleep Apnea SyndromesNCT01030003
Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes
An observational study of Sleep Apnea Syndromes, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of the study is to determine the prevalence of sleep-disordered breathing in pregnant women during the third trimester of pregnancy and to investigate whether this is associated with high blood pressure in the mother and/or growth retardation in the baby. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndromes
- How many people
- 1,685 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Aug 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible pregnant women are those receiving prenatal care and planning on delivering at the University of Michigan.
Who may be able to join
- Women attending obstetric clinics at University of Michigan Hospitals.
- Willing and able to provide informed consent.
- Aged 18 years or older
Who cannot join
- Aged under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Sleep-Disordered Breathing on Adverse Pregnancy Outcomes
The purpose of the study is to determine the prevalence of sleep-disordered breathing in pregnant women during the third trimester of pregnancy and to investigate whether this is associated with high blood pressure in the mother and/or growth retardation in the baby.
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Sleep-Disordered Breathing, Snoring, Pregnancy, Fetal Growth Retardation, Pre-Eclampsia
- Medical subject headings
- Sleep Apnea Syndromes, Snoring, Fetal Growth Retardation, Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal diagnosis of hypertension
Measured: 0-3 months after enrollment.
Secondary outcomes (1)
Infant birth centile
Measured: 0-3 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startJan 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,685 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Louise O'Brien, University of Michigan
- Investigators
- Louise M O'Brien, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030003
- Sponsor's protocol ID
- R000038
- Other IDs
- 1R21HL089918-01A1
- Status last verified
- Mar 2012
- First submitted
- 8 Dec 2009
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Brien LM, Bullough AS, Owusu JT, Tremblay KA, Brincat CA, Chames MC, Kalbfleisch JD, Chervin RD. Snoring during pregnancy and delivery outcomes: a cohort study. Sleep. 2013 Nov 1;36(11):1625-32. doi: 10.5665/sleep.3112.
PubMed 24179294
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sleep-Disordered Breathing on Adverse Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT01030003
- Acronym / sponsor ID
- R000038
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Sleep-Disordered Breathing, Snoring, Pregnancy, Fetal Growth Retardation, Pre-Eclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,685 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 10 Dec 2009 (estimated)
- 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.
The purpose of the study is to determine the prevalence of sleep-disordered breathing in pregnant women during the third trimester of pregnancy and to investigate whether this is associated with high blood pressure in the mother and/or growth retardation in the baby.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible pregnant women are those receiving prenatal care and planning on delivering at the University of Michigan.
Key inclusion criteria (3 listed)
- Women attending obstetric clinics at University of Michigan Hospitals.
- Willing and able to provide informed consent.
- Aged 18 years or older
Key exclusion criteria (1 listed)
- Aged under 18 years
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
Maternal diagnosis of hypertension
Time frame: 0-3 months after enrollment.
1 secondary outcome
Infant birth centile
Time frame: 0-3 months after enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
- Derived from this study: PubMed 24179294O'Brien LM, Bullough AS, Owusu JT, Tremblay KA, Brincat CA, Chames MC, Kalbfleisch JD, Chervin RD. Snoring during pregnancy and delivery outcomes: a cohort study. Sleep. 2013 Nov 1;36(11):1625-32. doi: 10.5665/sleep.3112.
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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?
An observational study of Sleep Apnea Syndromes, 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 1 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 7 Mar 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maternal diagnosis of hypertension (time frame: 0-3 months after enrollment.). 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 NCT01030003, 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 7 Mar 2012.