Trial Outcomes & Findings for Auto-PAP Therapy For Improved Fetal Growth (NCT NCT03318003)
NCT ID: NCT03318003
Last Updated: 2022-11-18
Results Overview
A slowing of fetal growth will be defined as a slowing of fetal growth by \>=33% during the last trimester
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
43 participants
Primary outcome timeframe
3rd trimester
Results posted on
2022-11-18
Participant Flow
Participant milestones
| Measure |
Auto-PAP Therapy
Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
|
No Therapy
No treatment
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Auto-PAP Therapy
Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
|
No Therapy
No treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
fetal loss
|
0
|
1
|
Baseline Characteristics
Auto-PAP Therapy For Improved Fetal Growth
Baseline characteristics by cohort
| Measure |
Auto-PAP Therapy
n=21 Participants
Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
|
No Therapy
n=22 Participants
No treatment
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.7 years
STANDARD_DEVIATION 4.4 • n=99 Participants
|
34.4 years
STANDARD_DEVIATION 4.2 • n=107 Participants
|
32.2 years
STANDARD_DEVIATION 4.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
22 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
gestational age at enrollment
|
17.1 weeks
STANDARD_DEVIATION 4.4 • n=99 Participants
|
17.2 weeks
STANDARD_DEVIATION 4.1 • n=107 Participants
|
17.1 weeks
STANDARD_DEVIATION 4.2 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3rd trimesterPopulation: 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.
A slowing of fetal growth will be defined as a slowing of fetal growth by \>=33% during the last trimester
Outcome measures
| Measure |
Auto-PAP Therapy
n=18 Participants
Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
|
No Therapy
n=21 Participants
No treatment
|
|---|---|---|
|
Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 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.
The placenta will be reviewed by a pathologist to determine the presence or absence of areas of hypoxia
Outcome measures
| Measure |
Auto-PAP Therapy
n=13 Participants
Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
|
No Therapy
n=15 Participants
No treatment
|
|---|---|---|
|
Presence or Absence of Placental Hypoxia
Hypoxia determinations
|
1 Participants
|
4 Participants
|
|
Presence or Absence of Placental Hypoxia
Non-hypoxia determinations
|
12 Participants
|
11 Participants
|
Adverse Events
Auto-PAP Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Therapy
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Auto-PAP Therapy
n=21 participants at risk
Auto-PAP: Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
|
No Therapy
n=22 participants at risk
No treatment
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Demise
|
0.00%
0/21 • through delivery up to a maximum of 33 weeks
|
9.1%
2/22 • Number of events 2 • through delivery up to a maximum of 33 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place