Sleep ApneaNCT02651649
Pregnancy, Sleep Disordered Breathing and Peripartum Complications
A study testing Continuous Positive Airway Pressure (CPAP) in people with Sleep Apnea and Pregnancy, run by Hadassah Medical Organization.
Trial summary
Sleep disordered breathing (SDB) during pregnancy is a modifiable risk factor for poor maternal and fetal outcomes. The investigators propose a prospective observational study to assess the utility of continuous positive airway pressure (CPAP) administration (intervention) during pregnancy to reduce maternal and fetal… 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, Pregnancy
- What is being tested?
- Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2018
- 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
- i. Prepartum
- 18 years of age and older, able to provide informed consent
- Pregnant
- Diagnosis of fetal growth restriction (by ultrasound)
Who cannot join
- • Patient refusal
- Inability to provide informed consent
- Known maternal severe cardiopulmonary disease
- Known fetal anomalies
Trial locations and contacts
No sites are listed yet.
Yehuda Ginosar, M.D. contact
About this study
Official title: Is Sleep Disordered Breathing During Pregnancy a Modifiable Risk Factor for Fetal Growth Restriction?
Sleep disordered breathing (SDB) during pregnancy is a modifiable risk factor for poor maternal and fetal outcomes. The investigators propose a prospective observational study to assess the utility of continuous positive airway pressure (CPAP) administration (intervention) during pregnancy to reduce maternal and fetal morbidity. Secondarily, we will also perform a cohort study to assess the incidence of antenatal sleep-disordered breathing as measured by ambulatory sleep monitoring applied in the hospital setting.
Read the detailed description
Hypothesis:
CPAP application in SDB-diagnosed parturients will decrease fetal and maternal morbidity.
Specific Aims:
- To screen women after their first trimester of pregnancy that are at risk for carrying babies with fetal growth restriction (FGR) for presence of SDB (FGR is commonly diagnosed at 20 weeks gestation by ultrasound as standard of care) and to follow their diagnosis and treatment with CPAP, as per standard of care, for the remainder of their pregnancy or order to follow fetal and maternal outcomes.
- Screen = parturients affirm presence of snoring. b. Screen positive parturients are further assessed with 1-2 nights of ambulatory sleep and respiration monitor to confirm SDB b. SDB positive parturients are offered treatment, as per standard of care, with CPAP.
- Screen positive parturients are reassessed with 1-2 nights of ambulatory sleep monitoring (whether or not CPAP is eventually applied) at two more intervals during pregnancy (during second and third trimesters), and then 6-8 weeks after delivery.
This study is designed as a prospective observational cohort study in order establish the concurrence of the disease (SDB) as it occurs with the increased "risk" or exposure to the vulnerable state (pregnancy) and presence of diagnosed fetal growth restriction. In addition, parturients who test positive for SDB will be assessed by a pulmonologist and offered standard of care therapy with CPAP, as appropriate. CPAP use will then be followed and assessed as a mitigating intervention to blunt fetal growth restriction. This study is a pilot in that we hope to establish the incidence of co-morbidities in order to appropriately plan for an adequate sample size in future intervention studies. Given the large overall parturient population that will be available to the study team, we believe that in one calendar year we will observe sufficient patients to establish the relationship of SDB during the antenatal pregnancy and fetal growth restriction.
- Conditions
- Sleep Apnea, Pregnancy
- Being tested
- Continuous Positive Airway Pressure (CPAP)
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Device
Also called APAP, PAP
FGR diagnosed parturients who are diagnosed with OSA will be prescribed CPAP as per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Parturients with FGR/OSA who use CPAP | Experimental | Subjects who meet criteria for FGR and OSA will be referred to a pulmonologist for referral for Continuous Positive Airway Pressure (CPAP). Women who agree with CPAP and comply with therapy will be compared to women who do not wear CPAP (eg. non-compliance). Receives: Device: Continuous Positive Airway Pressure (CPAP) |
| Parturients with FGR/OSA and no CPAP | No intervention | Subjects who meet criteria for FGR and OSA will be referred to a pulmonologist for referral for CPAP. Women who agree with CPAP and comply with therapy will be compared to women who do not wear CPAP (eg. non-compliance). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Fetal Growth Restriction at Birth
expressed as a percentile of predicted weight
Measured: 6 months
Secondary outcomes (1)
Change in estimated fetal weight based on crossing nomograms
estimated growth of fetus by gestational age will be plotted and compared to group who did not receive CPAP
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
- Investigators
- Yehuda Ginosar, M.D., Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02651649
- Sponsor's protocol ID
- 0411/15/HMO
- Status last verified
- Nov 2015
- First submitted
- 25 Nov 2015
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Sleep Disordered Breathing During Pregnancy a Modifiable Risk Factor for Fetal Growth Restriction?
- ClinicalTrials.gov ID
- NCT02651649
- Acronym / sponsor ID
- 0411/15/HMO
- Conditions
- Sleep Apnea, Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Collaborators
- University of Rochester
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 Jan 2016 (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.
Sleep disordered breathing (SDB) during pregnancy is a modifiable risk factor for poor maternal and fetal outcomes. The investigators propose a prospective observational study to assess the utility of continuous positive airway pressure (CPAP) administration (intervention) during pregnancy to reduce maternal and fetal morbidity. Secondarily, we will also perform a cohort study to assess the incidence of antenatal sleep-disordered breathing as measured by ambulatory sleep monitoring applied in the hospital setting.
Detailed description
Hypothesis:
CPAP application in SDB-diagnosed parturients will decrease fetal and maternal morbidity.
Specific Aims:
- To screen women after their first trimester of pregnancy that are at risk for carrying babies with fetal growth restriction (FGR) for presence of SDB (FGR is commonly diagnosed at 20 weeks gestation by ultrasound as standard of care) and to follow their diagnosis and treatment with CPAP, as per standard of care, for the remainder of their pregnancy or order to follow fetal and maternal outcomes.
- Screen = parturients affirm presence of snoring. b. Screen positive parturients are further assessed with 1-2 nights of ambulatory sleep and respiration monitor to confirm SDB b. SDB positive parturients are offered treatment, as per standard of care, with CPAP.
- Screen positive parturients are reassessed with 1-2 nights of ambulatory sleep monitoring (whether or not CPAP is eventually applied) at two more intervals during pregnancy (during second and third trimesters), and then 6-8 weeks after delivery.
This study is designed as a prospective observational cohort study in order establish the concurrence of the disease (SDB) as it occurs with the increased "risk" or exposure to the vulnerable state (pregnancy) and presence of diagnosed fetal growth restriction. In addition, parturients who test positive for SDB will be assessed by a pulmonologist and offered standard of care therapy with CPAP, as appropriate. CPAP use will then be followed and assessed as a mitigating intervention to blunt fetal growth restriction. This study is a pilot in that we hope to establish the incidence of co-morbidities in order to appropriately plan for an adequate sample size in future intervention studies. Given the large overall parturient population that will be available to the study team, we believe that in one calendar year we will observe sufficient patients to establish the relationship of SDB during the antenatal pregnancy and fetal growth restriction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parturients with FGR/OSA who use CPAP | Experimental | Device: Continuous Positive Airway Pressure (CPAP)Subjects who meet criteria for FGR and OSA will be referred to a pulmonologist for referral for Continuous Positive Airway Pressure (CPAP). Women who agree with CPAP and comply with therapy will be compared to women who do not wear CPAP (eg. non-compliance). |
| Parturients with FGR/OSA and no CPAP | No intervention | –Subjects who meet criteria for FGR and OSA will be referred to a pulmonologist for referral for CPAP. Women who agree with CPAP and comply with therapy will be compared to women who do not wear CPAP (eg. non-compliance). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- i. Prepartum
Key exclusion criteria (4 listed)
- • Patient refusal
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 |
|---|---|---|
| Continuous Positive Airway Pressure (CPAP)Also: APAP, PAPFGR diagnosed parturients who are diagnosed with OSA will be prescribed CPAP as per standard of care. | Device | Parturients with FGR/OSA who use CPAP |
Primary outcome
Presence of Fetal Growth Restriction at Birth
Time frame: 6 months
expressed as a percentile of predicted weight
1 secondary outcome
Change in estimated fetal weight based on crossing nomograms
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
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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.
Yehuda Ginosar, M.D. contact
Yehuda Ginosar, M.D. principal investigator
Hadassah Medical Organization
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure (CPAP) in people with Sleep Apnea and Pregnancy, run by Hadassah Medical Organization.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Jan 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yehuda Ginosar, M.D. (yginosar@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Fetal Growth Restriction at Birth (time frame: 6 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 11 Jan 2016.