Pregnancy RelatedSAOSPRONOSNCT05725642
Prevalence Study and Identification of Factors Prognosis of Obstructive Sleep Apnea Syndrome Sleep in Pregnant Women
An observational study of Pregnancy Related, run by GCS Ramsay Santé pour l'Enseignement et la Recherche.
Trial summary
The exact prevalence of sleep-disordered breathing in pregnant women is not known. The results of a analysis of a small cohort of 105 pregnant women adjusted to body mass index estimate a prevalence of 8.4% in first quarter and 19.7% in the third quarter. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Polysomnography
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 30 Nov 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women
Who may be able to join
- Pregnant woman aged 18 and over.
- Pregnant woman who has not yet completed her consultation of the 1st quarter.
- Woman accepting the achievement of, at most, 2 polysomnographies.
- Affiliated participant or beneficiary of a security regime social.
- Participant having been informed of the study and not objecting to the use of her data.
- Authorization to collect and use the baby's data.
Who cannot join
- Participation in another clinical study.
- Participant with protected status: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
- Participant hospitalized without consent
About this study
The exact prevalence of sleep-disordered breathing in pregnant women is not known. The results of a analysis of a small cohort of 105 pregnant women adjusted to body mass index estimate a prevalence of 8.4% in first quarter and 19.7% in the third quarter.
In this context, this study proposes to assess the prevalence of sleep-disordered breathing in pregnant women of the Private Hospital of the Loire and to identify the risks associated with these disorders by systematically proposing a polysomnography.
Read the detailed description
Pregnancy brings physical and hormonal changes and sleep is impaired by heartburn, cramps, frequent urination, fetal movements... Snoring is commonly observed in pregnant women at the end of the second and third trimester. Snoring can be a manifestation of OSAS. It has been shown that the apnea-hypopnea index (AHI) increases during pregnancy, at the third quarter. Physiological changes associated with pregnancy increase the risk of OSAS. In pregnant women, sleep deprivation leads to increased risk of gestational diabetes, high blood pressure, preeclampsia and antenatal depression, but also a risk of premature delivery or having a child with a delay in growth.
Finally, the exact prevalence of sleep-disordered breathing in pregnant women is not known. The results of a analysis of a small cohort of 105 pregnant women adjusted to body mass index estimate a prevalence of 8.4% in first quarter and 19.7% in the third quarter.
In this context, this study proposes to assess the prevalence of sleep-disordered breathing in pregnant women of the Private Hospital of the Loire and to identify the risks associated with these disorders by systematically proposing a polysomnography.
- Conditions
- Pregnancy Related
- Being tested
- Polysomnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
Polysomnography
What is being measured
The primary outcome is the main question the study is designed to answer.
OSAS Diagnosis with polysomnography
Diagnosis of OSAS with polysomnography, prior to the study, or during the first 2 trimesters of pregnancy
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Jul 2024 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Why it stopped: Feasibility issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725642
- Sponsor's protocol ID
- 2022-A00981-42
- Acronym
- SAOSPRONOS
- Status last verified
- Aug 2026
- First submitted
- 2 Feb 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Study and Identification of Factors Prognosis of Obstructive Sleep Apnea Syndrome Sleep in Pregnant Women
- ClinicalTrials.gov ID
- NCT05725642
- Acronym / sponsor ID
- SAOSPRONOS / 2022-A00981-42
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Feasibility issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 13 Feb 2023 (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.
The exact prevalence of sleep-disordered breathing in pregnant women is not known. The results of a analysis of a small cohort of 105 pregnant women adjusted to body mass index estimate a prevalence of 8.4% in first quarter and 19.7% in the third quarter.
In this context, this study proposes to assess the prevalence of sleep-disordered breathing in pregnant women of the Private Hospital of the Loire and to identify the risks associated with these disorders by systematically proposing a polysomnography.
Detailed description
Pregnancy brings physical and hormonal changes and sleep is impaired by heartburn, cramps, frequent urination, fetal movements... Snoring is commonly observed in pregnant women at the end of the second and third trimester. Snoring can be a manifestation of OSAS. It has been shown that the apnea-hypopnea index (AHI) increases during pregnancy, at the third quarter. Physiological changes associated with pregnancy increase the risk of OSAS. In pregnant women, sleep deprivation leads to increased risk of gestational diabetes, high blood pressure, preeclampsia and antenatal depression, but also a risk of premature delivery or having a child with a delay in growth.
Finally, the exact prevalence of sleep-disordered breathing in pregnant women is not known. The results of a analysis of a small cohort of 105 pregnant women adjusted to body mass index estimate a prevalence of 8.4% in first quarter and 19.7% in the third quarter.
In this context, this study proposes to assess the prevalence of sleep-disordered breathing in pregnant women of the Private Hospital of the Loire and to identify the risks associated with these disorders by systematically proposing a polysomnography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women
Key inclusion criteria (6 listed)
- Pregnant woman aged 18 and over.
- Pregnant woman who has not yet completed her consultation of the 1st quarter.
- Woman accepting the achievement of, at most, 2 polysomnographies.
- Affiliated participant or beneficiary of a security regime social.
- Participant having been informed of the study and not objecting to the use of her data.
Key exclusion criteria (3 listed)
- Participation in another clinical study.
- Participant with protected status: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
- Participant hospitalized without 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 |
|---|---|---|
| PolysomnographyPolysomnography | Other | – |
Primary outcome
OSAS Diagnosis with polysomnography
Time frame: 9 months
Diagnosis of OSAS with polysomnography, prior to the study, or during the first 2 trimesters of pregnancy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by GCS Ramsay Santé pour l'Enseignement et la Recherche.
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 6 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: withdrawn, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
OSAS Diagnosis with polysomnography (time frame: 9 months). 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 20 Aug 2026.