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Sleep Apnea and Fetal Growth Restriction (SAFER)

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ClinicalTrials.gov Identifier: NCT04084990
Recruitment Status : Recruiting
First Posted : September 11, 2019
Last Update Posted : July 2, 2020
Sponsor:
Collaborators:
ResMed Foundation
The Hebrew University Hadassah Medical School
University of Rochester School of Medicine and Dentistry
Information provided by (Responsible Party):
Alexander M. Hincker, Washington University School of Medicine

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Fetal Growth Restriction Pregnancy Related Device: S9 VPAP Adapt Phase 3

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, parallel group, investigator-blinded, randomized controlled trial
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sleep Apnea and Fetal Growth Restriction
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: aPAP
Nightly use of aPAP when sleeping through the date of delivery
Device: S9 VPAP Adapt
Auto-titrated positive airway pressure

No Intervention: No aPAP
No use of aPAP (standard of care)



Primary Outcome Measures :
  1. Birth weight [ Time Frame: 1 day ]
    Weight of child at time of birth


Secondary Outcome Measures :
  1. Gestational age at delivery [ Time Frame: 1 day ]
    Gestational age at delivery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 and ≤ 50
  • Fetal growth restriction (defined as <10th percentile based on routine second trimester ultrasound)
  • Gestational age 22 to 28 completed weeks in the absence of 2 minor or 1 major markers of aneuploidy.

Exclusion Criteria:

  • Multiple gestation
  • Other known cause of fetal growth restriction (including congenital anomalies or intrauterine infection)
  • Preexisting diagnosis of OSA being treated with aPAP
  • Chronic pulmonary disease (cystic fibrosis, moderate persistent asthma)
  • Hemoglobinopathies (sickle cell anemia, thalassemia)
  • Craniofacial anomalies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084990


Contacts
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Contact: Ellen Lockhart, MD 314-454-8707 elockhart@wustl.edu
Contact: Alexander Hincker, MD 314-362-2628 hinckera@wustl.edu

Locations
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United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Ellen Lockhart, MD         
Sponsors and Collaborators
Washington University School of Medicine
ResMed Foundation
The Hebrew University Hadassah Medical School
University of Rochester School of Medicine and Dentistry
Investigators
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Principal Investigator: Ellen Lockhart, MD Washington University in Saint Louis
Publications:
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Responsible Party: Alexander M. Hincker, Assistant Professor, Department of Anesthesiology, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04084990    
Other Study ID Numbers: 201908162
First Posted: September 11, 2019    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Alexander M. Hincker, Washington University School of Medicine:
aPAP
OSA
FGR
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Fetal Growth Retardation
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Fetal Diseases
Pregnancy Complications
Growth Disorders
Pathologic Processes