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The study was terminated due to insufficient recruitment.
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| Name | Class |
|---|---|
| ResMed Foundation | OTHER |
| Hebrew University Hadassah Medical School | OTHER |
| University of Rochester | OTHER |
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This study aims to evaluate the association between obstructive sleep apnea (OSA) and fetal growth restriction (FGR) and to assess the role of auto-titrated positive airway pressure (aPAP) as antenatal therapy in these patients. Pregnant patients with diagnosed FGR will be screened for OSA first by screening questionnaire and then by home sleep monitor. Of those patients diagnosed with OSA, half will be assigned to use aPAP each night when sleeping and half will not (standard care).
Fetal growth restriction (FGR) affects 5-10% of pregnancies and is one of the leading causes of perinatal morbidity and mortality.
Obstructive sleep apnea (OSA) is a common disorder in which a person's breathing pauses or becomes shallow during sleep. These periods of low oxygen lead stress and inflammation which that may be harmful to both the mother and her fetus. OSA in pregnancy has been associated with poor maternal-fetal outcomes, including low birth weight, preterm delivery, FGR, gestational hypertension/preeclampsia, gestational diabetes and higher rates of neonatal ICU admission.
Auto-titrated positive airway pressure (aPAP) is a machine that gently delivers pressurized air via a mask to keep a patient's airways free of obstruction during sleep. It is currently unclear whether treatment of OSA during pregnancy in women with known FGR can improve fetal and neonatal outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aPAP | Experimental | Nightly use of aPAP when sleeping through the date of delivery |
|
| No aPAP | No Intervention | No use of aPAP (standard of care) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S9 VPAP Adapt | Device | Auto-titrated positive airway pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Birth Weight | Weight of child at time of birth | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Age at Delivery | Gestational age at delivery | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Hincker, MD | Washington University in Saint Louis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States | ||
| Rochester University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28285426 | Background | Nardozza LM, Caetano AC, Zamarian AC, Mazzola JB, Silva CP, Marcal VM, Lobo TF, Peixoto AB, Araujo Junior E. Fetal growth restriction: current knowledge. Arch Gynecol Obstet. 2017 May;295(5):1061-1077. doi: 10.1007/s00404-017-4341-9. Epub 2017 Mar 11. | |
| 25155182 | Background | Lavie L. Oxidative stress in obstructive sleep apnea and intermittent hypoxia--revisited--the bad ugly and good: implications to the heart and brain. Sleep Med Rev. 2015 Apr;20:27-45. doi: 10.1016/j.smrv.2014.07.003. Epub 2014 Jul 24. |
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32 participants provided informed consent to participate. They underwent an obstructive sleep apnea (OSA) risk assessment questionnaire. Those screening as high risk for OSA underwent home sleep apnea testing (HSAT). Those screening as positive on the HSAT, which was defined as an apnea hypopnea index (AHI) >= 10 OR an AHI >= 5 with oxygen desaturation index >= 5, were randomized to receive aPAP or not. Of the 32 participants, only 3 met criteria for enrollment in the randomization phase.
The study has been terminated due to low enrollment after only 3 participants were randomized. Results will not be analyzed owing to the small number of participants to be randomized to receive aPAP (the intervention) or no aPAP (standard of care treatment).
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| ID | Title | Description |
|---|---|---|
| FG000 | aPAP | Nightly use of aPAP when sleeping through the date of delivery S9 VPAP Adapt: Auto-titrated positive airway pressure |
| FG001 | No aPAP | No use of aPAP (standard of care) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | aPAP | Nightly use of aPAP when sleeping through the date of delivery S9 VPAP Adapt: Auto-titrated positive airway pressure |
| BG001 | No aPAP | No use of aPAP (standard of care) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Birth Weight | Weight of child at time of birth | Of two mothers randomized to aPAP therapy, one required pre-term induction of labor for maternal safety for preeclampsia with severe features. This fetus experienced in-utero fetal demise, so birth weight was not obtained. | Posted | Mean | Full Range | grams | 1 day |
|
Approximately 9.5 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | aPAP | Nightly use of aPAP when sleeping through the date of delivery S9 VPAP Adapt: Auto-titrated positive airway pressure |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Hincker, Associate Professor of Anesthesiology | Washington University in St. Louis | 3143231312 | hinckera@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2021 | Mar 7, 2022 | Prot_SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2021 | Dec 17, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D005317 | Fetal Growth Retardation |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Prospective, parallel group, investigator-blinded, randomized controlled trial
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| Rochester |
| New York |
| 14620 |
| United States |
| Hadassah Hebrew University | West Jerusalem | Jerusalem | 9112001 | Israel |
| 34187829 | Derived | Hincker A, Nadler J, Karan S, Carter E, Porat S, Warner B, Ju YS, Ben Abdallah A, Wilson E, Lockhart EM, Ginosar Y. Sleep Apnea and Fetal Growth Restriction (SAFER) study: protocol for a pragmatic randomised clinical trial of positive airway pressure as an antenatal therapy for fetal growth restriction in maternal obstructive sleep apnoea. BMJ Open. 2021 Jun 29;11(6):e049120. doi: 10.1136/bmjopen-2021-049120. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Gestational Age at Delivery | Gestational age at delivery | Posted | Mean | Full Range | weeks (estimated gestational age) | 1 day |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | No aPAP | No use of aPAP (standard of care) | 0 | 1 | 0 | 1 | 0 | 1 |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |