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Sleep Apnea and Fetal Growth Restriction

NCT04084990 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-03-09

Study results available
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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

Interventions

DEVICE

S9 VPAP Adapt

Auto-titrated positive airway pressure

Sponsors & Collaborators

  • ResMed Foundation

    collaborator OTHER

  • Hebrew University Hadassah Medical School

    collaborator OTHER

  • University of Rochester

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Alexander Hincker, MD · Washington University in Saint Louis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-18
Primary Completion
2021-07-27
Completion
2021-07-27
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04084990 on ClinicalTrials.gov