Apnea, Obstructive SleepNCT03509805
Sleep Apnea Syndrome in Obese Women During Pregnancy
A study testing polysomnography in people with Apnea, Obstructive Sleep and Pregnancy Complications, run by University Hospital, Lille at 1 site in France.
Trial summary
Excess weight or obesity is associated with an increased risk of health disorders: high blood pressure, diabetes, cardiovascular risks, dyslipidemia and sleep apneas. During pregnancy in obese women, the risk of preeclampsia increases by three and the risk of fetal death in utero by five. 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
- Apnea, Obstructive Sleep, Pregnancy Complications, Pre-Eclampsia
- What is being tested?
- polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2010to 14 Mar 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age >18 years
- BMI > 35
- > 24th weeks of pregnancy
- informed consent,
- health assurance
Who cannot join
- no informed consent
- twin pregnancy or more
- no health assurance
Trial locations and contacts
1 site in 1 country.
About this study
Excess weight or obesity is associated with an increased risk of health disorders: high blood pressure, diabetes, cardiovascular risks, dyslipidemia and sleep apneas. During pregnancy in obese women, the risk of preeclampsia increases by three and the risk of fetal death in utero by five. Snoring and Obstructive sleep apnea (OSA) may be associated with increased risk of adverse pregnancy outcomes, including maternal cardio pulmonary status, fetal heart rate and fetal acidosis-basis status by recurrent upper-airway obstruction, hypoventilation, and intermittent nocturnal hypoxia. Reports in pregnancy have identified in association with OSA and preeclampsia, intrauterine growth restriction and stillbirth.
The prevalence of OSA among women is estimated to be 2-5%, but it remains underdiagnosed during pregnancy. In sleep apnea syndrome, a few data have shown better pregnancy and fetal outcome with the use continuous positive airway pressure (CPAP) therapy.
the hypothesis is in obese pregnant women that there could be a significant association between sleep apnea syndrome and hypertensive disorders, preeclampsia and adverse fetal outcomes This is a prospective study of Women with a body mass index of 35 kg.m2 or greater. The aim of this study is to determinate the prevalence of sleep apnea syndrome in obese pregnant women and the benefit of CPAP on the maternal and fetal outcome.
- Being tested
- polysomnography
- Keywords
- sleep apnea syndrome, obesity, pregnancy, preeclampsia
- Medical subject headings
- Sleep Apnea, Obstructive, Pregnancy Complications, Pre-Eclampsia, Obesity, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnographyDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| OSA in obese patient during pregnancy | Experimental | OSA in polysomnography Receives: Diagnostic Test: polysomnography |
| no OSA in obese patient during pregnancy | Experimental | no OSA in polysomnography Receives: Diagnostic Test: polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria
Measured: during the sleep time, an average 8 hours
Secondary outcomes (2)
occurrence of vascular disease
High blood pressure (HTAG), Essential or chronic hypertension, preeclampsia, Severe preeclampsia
Measured: from inclusion at the beginning of the management of pregnancy to delivery
Evaluation of fetal impact by correlation of birth weight to gestational age
Measured: from inclusion at the beginning of the management of pregnancy to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start1 Sep 2010
- Primary completion14 Mar 2017
- Study completion14 Mar 2017
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 Apnea, Obstructive SleepStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Frédérique Dalmas, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509805
- Sponsor's protocol ID
- 2008_32
- Other IDs
- 2009-A01018-49
- Status last verified
- Oct 2018
- First submitted
- 24 Apr 2018
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ghesquiere L, Deruelle P, Ramdane Y, Garabedian C, Charley-Monaca C, Dalmas AF. Obstructive sleep apnea in obese pregnant women: A prospective study. PLoS One. 2020 Sep 8;15(9):e0238733. doi: 10.1371/journal.pone.0238733. eCollection 2020.
PubMed 32898189
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea Syndrome in Obese Women During Pregnancy
- ClinicalTrials.gov ID
- NCT03509805
- Acronym / sponsor ID
- 2008_32
- Keywords
- sleep apnea syndrome, obesity, pregnancy, preeclampsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 14 Mar 2017 (actual)
- Study completion
- 14 Mar 2017 (actual)
- First posted
- 26 Apr 2018 (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.
Excess weight or obesity is associated with an increased risk of health disorders: high blood pressure, diabetes, cardiovascular risks, dyslipidemia and sleep apneas. During pregnancy in obese women, the risk of preeclampsia increases by three and the risk of fetal death in utero by five. Snoring and Obstructive sleep apnea (OSA) may be associated with increased risk of adverse pregnancy outcomes, including maternal cardio pulmonary status, fetal heart rate and fetal acidosis-basis status by recurrent upper-airway obstruction, hypoventilation, and intermittent nocturnal hypoxia. Reports in pregnancy have identified in association with OSA and preeclampsia, intrauterine growth restriction and stillbirth.
The prevalence of OSA among women is estimated to be 2-5%, but it remains underdiagnosed during pregnancy. In sleep apnea syndrome, a few data have shown better pregnancy and fetal outcome with the use continuous positive airway pressure (CPAP) therapy.
the hypothesis is in obese pregnant women that there could be a significant association between sleep apnea syndrome and hypertensive disorders, preeclampsia and adverse fetal outcomes This is a prospective study of Women with a body mass index of 35 kg.m2 or greater. The aim of this study is to determinate the prevalence of sleep apnea syndrome in obese pregnant women and the benefit of CPAP on the maternal and fetal outcome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OSA in obese patient during pregnancy | Experimental | Diagnostic Test: polysomnographyOSA in polysomnography |
| no OSA in obese patient during pregnancy | Experimental | Diagnostic Test: polysomnographyno OSA in polysomnography |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age >18 years
- BMI > 35
- > 24th weeks of pregnancy
- informed consent,
- health assurance
Key exclusion criteria (3 listed)
- no informed consent
- twin pregnancy or more
- no health assurance
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 |
|---|---|---|
| polysomnography | Diagnostic test | OSA in obese patient during pregnancy, no OSA in obese patient during pregnancy |
Primary outcome
Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria
Time frame: during the sleep time, an average 8 hours
2 secondary outcomes
occurrence of vascular disease
Time frame: from inclusion at the beginning of the management of pregnancy to delivery
Evaluation of fetal impact by correlation of birth weight to gestational age
Time frame: from inclusion at the beginning of the management of pregnancy to delivery
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 22 Apr 2026.
- Results publication: PubMed 32898189Ghesquiere L, Deruelle P, Ramdane Y, Garabedian C, Charley-Monaca C, Dalmas AF. Obstructive sleep apnea in obese pregnant women: A prospective study. PLoS One. 2020 Sep 8;15(9):e0238733. doi: 10.1371/journal.pone.0238733. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Anne-Frédérique Dalmas, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polysomnography in people with Apnea, Obstructive Sleep and Pregnancy Complications, run by University Hospital, Lille at 1 site 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 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 22 Apr 2026. 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 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?
Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria (time frame: during the sleep time, an average 8 hours). 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 NCT03509805, 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 22 Apr 2026.