ObesityGOSNCT02029859
Sleep Apnea, Obesity and Pregnancy
A study testing Polygraphic examination in people with Obesity and Pregnancy, run by University Hospital, Rouen at 4 sites in France.
Trial summary
Main objective: Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients . Secondary objectives : Identify risk factors for OSA during pregnancy (age, parity, high blood pressure, snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Polygraphic examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 4 sitesFrance
- Study dates
- Apr 2011to Mar 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >35
- Pregnancy after 30 Weeks of amenorhea
- Age > 18
- Signed consentment
- Nationnal Health Program affiliation
Who cannot join
- Twin or more pregnancy
- Imprecise term
- Artificial insemination with donor gametes
- Proved thrombophilia
- chronic renal failure
- Previously treated (with CPAP) obstructive sleep apnea syndrom
Trial locations and contacts
4 sites in 1 country.
France4 sites
Angers University Hospital
Angers, 49000
Caen University Hospital
Caen, 14000
Le Havre Hospital
Le Havre, 76290
Rouen University Hospital
Rouen, 76000
About this study
Main objective:
Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients .
Read more
Secondary objectives :
- Identify risk factors for OSA during pregnancy (age, parity, high blood pressure, snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) .
- Compare perinatal morbidity among obese patients with OSA in late pregnancy with case-controls.
- Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy.
Material and methods
Characteristics of the study:
- Interventional biomedical research
- Prospective Multicenter nonrandomized study
Flow chart
- Patients will be included between 30 and 36 weeks of amenorrhea (WA) .
- Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck circumferrence, treated high blood pressure.
- As recommended in France, the main test results during the pregnancy follow-up will be recorded.
- At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score.
- Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA. This screening can be performed as an outpatient.
- In case of proven OSA patients will be offered an appropriate care by today's standards.
- Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months after childbirth in case of OSA during pregnancy.
- Being tested
- Polygraphic examination
- Keywords
- pregnancy (after 30 weeks of amenorhea), obesity (BMI>35), sleep apnea syndrom, preeclampsy, intrauterine growth restriction
- Medical subject headings
- Obesity, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polygraphic examinationProcedure or surgery
Polygraphic examination between 30 and 36 weeks of amenorhea
| Study group | Role | What they receive |
|---|---|---|
| Prevalence of obstructive sleep apnea syndrome | Experimental | Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients .
Polygraphic examination between 30 and 36 weeks of amenorhea Receives: Procedure: Polygraphic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep apnea syndrom prevalence
Polygraphic examination for all subjects will determine the sleep apnea syndrom prevalence during late pregnancy (after 30 weeks of amenorhea) for severe obese women (BMI>35).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startApr 2011
- Primary completionJul 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loic Marpeau, PHD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029859
- Sponsor's protocol ID
- 2009/070/HP
- Acronym
- GOS
- Status last verified
- Jun 2015
- First submitted
- 6 Jan 2014
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea, Obesity and Pregnancy
- ClinicalTrials.gov ID
- NCT02029859
- Acronym / sponsor ID
- GOS / 2009/070/HP
- Keywords
- pregnancy (after 30 weeks of amenorhea), obesity (BMI>35), sleep apnea syndrom, preeclampsy, intrauterine growth restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Jan 2014 (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.
Main objective:
Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients .
Secondary objectives :
- Identify risk factors for OSA during pregnancy (age, parity, high blood pressure, snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) .
- Compare perinatal morbidity among obese patients with OSA in late pregnancy with case-controls.
- Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy.
Material and methods
Characteristics of the study:
- Interventional biomedical research
- Prospective Multicenter nonrandomized study
Flow chart
- Patients will be included between 30 and 36 weeks of amenorrhea (WA) .
- Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck circumferrence, treated high blood pressure.
- As recommended in France, the main test results during the pregnancy follow-up will be recorded.
- At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score.
- Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA. This screening can be performed as an outpatient.
- In case of proven OSA patients will be offered an appropriate care by today's standards.
- Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months after childbirth in case of OSA during pregnancy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevalence of obstructive sleep apnea syndrome | Experimental | Procedure: Polygraphic examinationDetermine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients . Polygraphic examination between 30 and 36 weeks of amenorhea |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- BMI >35
- Pregnancy after 30 Weeks of amenorhea
- Age > 18
- Signed consentment
- Nationnal Health Program affiliation
Key exclusion criteria (6 listed)
- Twin or more pregnancy
- Imprecise term
- Artificial insemination with donor gametes
- Proved thrombophilia
- chronic renal failure
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 |
|---|---|---|
| Polygraphic examinationPolygraphic examination between 30 and 36 weeks of amenorhea | Procedure or surgery | Prevalence of obstructive sleep apnea syndrome |
Primary outcome
Sleep apnea syndrom prevalence
Time frame: 6 weeks
Polygraphic examination for all subjects will determine the sleep apnea syndrom prevalence during late pregnancy (after 30 weeks of amenorhea) for severe obese women (BMI>35).
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 3 Jun 2015.
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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.
Loic Marpeau, PHD principal investigator
University Hospital, Rouen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polygraphic examination in people with Obesity and Pregnancy, run by University Hospital, Rouen at 4 sites in France.
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 6 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 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Sleep apnea syndrom prevalence (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2015.