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Sleep Apnea and Fetal Growth Restriction (SAFER)

Primary Purpose

Obstructive Sleep Apnea, Fetal Growth Restriction, Pregnancy Related

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
S9 VPAP Adapt
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring aPAP, OSA, FGR

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 and ≤ 50
  • Fetal growth restriction (defined as fetal weight <10th percentile based on at least one routine 2nd trimester ultrasound without a subsequent increase to >15th percentile on any ultrasounds prior to enrollment)
  • Lower limit of gestational age at enrollment 22+0 weeks.
  • Upper limit of gestational age at enrollment: adequate time to complete Stages 1 and 2 and if appropriate to be randomized and receive intervention by no later than 32+0 weeks.
  • The absence of 2 minor or 1 major markers of aneuploidy.

Exclusion Criteria:

  • Other known cause of fetal growth restriction (including congenital anomalies, intrauterine infection, or multiple gestation)
  • Reversed end-diastolic flow in the umbilical artery
  • Preexisting diagnosis of OSA being treated with aPAP
  • Chronic pulmonary disease (cystic fibrosis, moderate persistent asthma)
  • Hemoglobinopathies (sickle cell anemia, thalassemia)
  • Maternal craniofacial anomalies
  • Premature rupture of membranes

Sites / Locations

  • Washington University in St. Louis
  • Rochester University Medical Center
  • Hadassah Hebrew University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

aPAP

No aPAP

Arm Description

Nightly use of aPAP when sleeping through the date of delivery

No use of aPAP (standard of care)

Outcomes

Primary Outcome Measures

Birth Weight
Weight of child at time of birth

Secondary Outcome Measures

Gestational Age at Delivery
Gestational age at delivery

Full Information

First Posted
September 7, 2019
Last Updated
March 7, 2022
Sponsor
Washington University School of Medicine
Collaborators
ResMed Foundation, The Hebrew University Hadassah Medical School, University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT04084990
Brief Title
Sleep Apnea and Fetal Growth Restriction
Acronym
SAFER
Official Title
Sleep Apnea and Fetal Growth Restriction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to insufficient recruitment.
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
July 27, 2021 (Actual)
Study Completion Date
July 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
ResMed Foundation, The Hebrew University Hadassah Medical School, University of Rochester

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Fetal Growth Restriction, Pregnancy Related
Keywords
aPAP, OSA, FGR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective, parallel group, investigator-blinded, randomized controlled trial
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aPAP
Arm Type
Experimental
Arm Description
Nightly use of aPAP when sleeping through the date of delivery
Arm Title
No aPAP
Arm Type
No Intervention
Arm Description
No use of aPAP (standard of care)
Intervention Type
Device
Intervention Name(s)
S9 VPAP Adapt
Intervention Description
Auto-titrated positive airway pressure
Primary Outcome Measure Information:
Title
Birth Weight
Description
Weight of child at time of birth
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Gestational Age at Delivery
Description
Gestational age at delivery
Time Frame
1 day

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 and ≤ 50 Fetal growth restriction (defined as fetal weight <10th percentile based on at least one routine 2nd trimester ultrasound without a subsequent increase to >15th percentile on any ultrasounds prior to enrollment) Lower limit of gestational age at enrollment 22+0 weeks. Upper limit of gestational age at enrollment: adequate time to complete Stages 1 and 2 and if appropriate to be randomized and receive intervention by no later than 32+0 weeks. The absence of 2 minor or 1 major markers of aneuploidy. Exclusion Criteria: Other known cause of fetal growth restriction (including congenital anomalies, intrauterine infection, or multiple gestation) Reversed end-diastolic flow in the umbilical artery Preexisting diagnosis of OSA being treated with aPAP Chronic pulmonary disease (cystic fibrosis, moderate persistent asthma) Hemoglobinopathies (sickle cell anemia, thalassemia) Maternal craniofacial anomalies Premature rupture of membranes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Hincker, MD
Organizational Affiliation
Washington University in Saint Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rochester University Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Hadassah Hebrew University
City
W. Jerusalem
State/Province
Jerusalem
ZIP/Postal Code
9112001
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28285426
Citation
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.
Results Reference
background
PubMed Identifier
25155182
Citation
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.
Results Reference
background
PubMed Identifier
34187829
Citation
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.
Results Reference
derived

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Sleep Apnea and Fetal Growth Restriction

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