Sleep Apnea and Fetal Growth Restriction

NCT04084990 | Terminated Phase 3 Results DMC FDA Device

• 1 other identifier: 201908162
• Study Type: interventional
• Target: 3
• Locations: 2 countries
• Sites: 3

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).

Conditions

Obstructive Sleep Apnea; Fetal Growth Restriction; Pregnancy Related

Keywords

aPAP; OSA; FGR

Outcome Measures

Primary Outcomes (1)

• Birth Weight

  Weight of child at time of birth

  1 day

Secondary Outcomes (1)

• Gestational Age at Delivery

  1 day

Study Arms (2)

aPAP

EXPERIMENTAL

Nightly use of aPAP when sleeping through the date of delivery

Device: S9 VPAP Adapt

No aPAP

NO INTERVENTION

No use of aPAP (standard of care)

Interventions

S9 VPAP Adapt DEVICE

Auto-titrated positive airway pressure

aPAP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• ResMed Foundation: collaborator
• Hebrew University Hadassah Medical School: collaborator
• University of Rochester: collaborator

Study Sites (3)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Rochester University Medical Center

Rochester, New York, 14620, United States

Location

Hadassah Hebrew University

West Jerusalem, Jerusalem, 9112001, Israel

Location

Related Publications (3)

• 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.

  PMID: 28285426 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.

  PMID: 25155182 BACKGROUND

• 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.

  PMID: 34187829 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Fetal Growth Retardation

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Alexander Hincker, Associate Professor of Anesthesiology
• Organization: Washington University in St. Louis

hinckera@wustl.edu

3143231312

Study Officials

• Alexander Hincker, MD

  Washington University in Saint Louis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Anesthesiology

Model Details: Prospective, parallel group, investigator-blinded, randomized controlled trial

Study Record Dates

• First Submitted: September 7, 2019
• First Posted: September 11, 2019
• Study Start: November 18, 2019
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: March 9, 2022
• Results First Posted: March 9, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

US (2); IL (1)