Auto-PAP Therapy For Improved Fetal Growth

NCT03318003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2022-11-18

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to see whether the presence of night-time breathing disturbances ("sleep-disordered breathing") in pregnant women is related to fetal growth patterns. The hypothesis is that fetal growth slows in the 3rd trimester in women with sleep-disordered breathing. Use of a nighttime breathing therapy called auto-PAP could minimize the slowing in fetal growth.

Conditions

Interventions

DEVICE

Auto-PAP

Women will be using the Auto-PAP device nightly from randomization to end of pregnancy

Sponsors & Collaborators

Principal Investigators

  • Louise M O'Brien, PhD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2020-08-03
Completion
2020-08-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT03318003 on ClinicalTrials.gov