Auto-PAP Therapy For Improved Fetal Growth

Pregnancy Clinical Trial

Official title:

Auto-PAP Therapy For Improved Fetal Growth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03318003
• Other study ID #: HUM00132040
• Secondary ID: N023548
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: August 3, 2020

Study information

• Verified date: November 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 3, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Pregnancy
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Heath System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	ResMed Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester	A slowing of fetal growth will be defined as a slowing of fetal growth by >=33% during the last trimester	3rd trimester
Secondary	Presence or Absence of Placental Hypoxia	The placenta will be reviewed by a pathologist to determine the presence or absence of areas of hypoxia	At delivery the placenta will be collected and processed.