Auto-PAP Therapy For Improved Fetal Growth

Not Applicable

Completed

• Conditions: Pregnancy; Obstructive Sleep Apnea
• Interventions: Device: Auto-PAP

• Registration Number: NCT03318003
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-13
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-23
• Study Start: 2017-12-01
• Primary Completion: 2020-08-03
• Study Completion: 2020-08-03
• Disposition First Submitted: 2021-07-31
• Disposition First Submitted QC: 2021-07-31
• Disposition First Posted: 2021-08-03
• Results First Submitted: 2021-12-27
• Results First Submitted QC: 2021-12-27
• Results First Posted: 2022-01-25
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auto-PAP Therapy	Auto-PAP	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester	3rd trimester	A slowing of fetal growth will be defined as a slowing of fetal growth by \>=33% during the last trimester

Secondary Outcome Measures

Name	Time	Method
Presence or Absence of Placental Hypoxia	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

Trial Locations

Locations (1)

University of Michigan Heath System; 🇺🇸 Ann Arbor, Michigan, United States