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Completed

NCT Number: NCT03318003

Auto-PAP Therapy For Improved Fetal Growth

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Pregnancy Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Heath System

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 18 years old;
  • no more than 20 weeks pregnant;
  • pregnant with one baby;
  • found to have sleep-disordered breathing as measured by a sleep study. If you are found to have severe sleep apnea on the sleep study you will be referred for clinical care instead of participating in the study.

Exclusion criteria

  • more than 20 weeks pregnant;
  • pregnant with twins, triplets, or more babies;
  • a current smoker, drink alcohol, or use recreational drugs;
  • currently using positive-airway pressure therapy for treatment of obstructive sleep apnea;
  • diagnosed with certain conditions such as bullous lung disease, a bypassed upper airway, pneumothorax (collapsed lung), pneumocephalus (leak of cerebrospinal fluid, the fluid that the brain and spine float in), if you have had recent trauma, or recent nasal surgery.

Treatment and study plan

Auto-PAP

Device

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

Primary outcomes

  1. Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester

    Time frame: 3rd trimester

    A slowing of fetal growth will be defined as a slowing of fetal growth by >=33% during the last trimester

Secondary outcomes

  1. Presence or Absence of Placental Hypoxia

    Time frame: At delivery the placenta will be collected and processed.

    The placenta will be reviewed by a pathologist to determine the presence or absence of areas of hypoxia

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • ResMed Foundation

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2017
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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