Obstructive Sleep Apnea, Pregnancy
Conditions
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.
Interventions
DEVICEAuto-PAP
Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
Sponsors
ResMed Foundation
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Auto-PAP Therapy Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy | 21 |
| No Therapy No treatment | 22 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | fetal loss | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Auto-PAP Therapy | No Therapy | Total |
|---|---|---|---|
| Age, Continuous | 29.7 years STANDARD_DEVIATION 4.4 | 34.4 years STANDARD_DEVIATION 4.2 | 32.2 years STANDARD_DEVIATION 4.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 20 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| gestational age at enrollment | 17.1 weeks STANDARD_DEVIATION 4.4 | 17.2 weeks STANDARD_DEVIATION 4.1 | 17.1 weeks STANDARD_DEVIATION 4.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 1 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 14 Participants | 20 Participants | 34 Participants |
| Region of Enrollment United States | 21 participants | 22 participants | 43 participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 22 |
| other Total, other adverse events | 0 / 21 | 0 / 22 |
| serious Total, serious adverse events | 0 / 21 | 2 / 22 |
Outcome results
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
Time frame: 3rd trimester
Population: Because the latter part of the study was overlapping March 2020, some women did not get all of their research ultrasounds. Data below is shared for all women for whom at least one 3rd trimester ultrasound is available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Auto-PAP Therapy | Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester | 8 Participants |
| No Therapy | Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester | 8 Participants |
p-value: 0.92Chi-squared
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
Time frame: At delivery the placenta will be collected and processed.
Population: Some placentas were not collected and sent to pathology as intended, perhaps in part because of fewer staff available during the COVID inflected months.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Auto-PAP Therapy | Presence or Absence of Placental Hypoxia | Hypoxia determinations | 1 Participants |
| Auto-PAP Therapy | Presence or Absence of Placental Hypoxia | Non-hypoxia determinations | 12 Participants |
| No Therapy | Presence or Absence of Placental Hypoxia | Hypoxia determinations | 4 Participants |
| No Therapy | Presence or Absence of Placental Hypoxia | Non-hypoxia determinations | 11 Participants |