Trial Outcomes & Findings for A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring (NCT NCT04915131)
NCT ID: NCT04915131
Last Updated: 2023-10-18
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
121 participants
Primary outcome timeframe
5 minutes
Results posted on
2023-10-18
Participant Flow
Participant milestones
| Measure |
Bloomlife MFM-Pro, Pilot Phase
The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study.
|
Bloomlife MFM-Pro, Pivotal Phase
The pivotal phase of the study was aimed at validating that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
61
|
|
Overall Study
Analysis Population
|
54
|
56
|
|
Overall Study
COMPLETED
|
60
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Performing Antepartum Fetal Monitoring
Baseline characteristics by cohort
| Measure |
Bloomlife MFM-Pro, Pilot Phase
n=60 Participants
The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study.
|
Bloomlife MFM-Pro, Pivotal Phase
n=61 Participants
The pivotal phase of the study was aimed at validating that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.9 years
STANDARD_DEVIATION 6.31 • n=99 Participants
|
30.4 years
STANDARD_DEVIATION 5.69 • n=107 Participants
|
30.1 years
STANDARD_DEVIATION 6.01 • n=206 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
121 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
|
24 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Pre-pregnancy Body Mass Index (BMI)
|
30.7 kg/m^2
STANDARD_DEVIATION 7.81 • n=99 Participants
|
33.19 kg/m^2
STANDARD_DEVIATION 7.776 • n=107 Participants
|
31.96 kg/m^2
STANDARD_DEVIATION 7.89 • n=206 Participants
|
|
Gestational Age
|
35.8 weeks
STANDARD_DEVIATION 1.96 • n=99 Participants
|
35.51 weeks
STANDARD_DEVIATION 2.102 • n=107 Participants
|
35.65 weeks
STANDARD_DEVIATION 2.04 • n=206 Participants
|
PRIMARY outcome
Timeframe: 5 minutesPopulation: The Analysis Population includes all enrolled patients without major protocol deviations or technical failure
Outcome measures
| Measure |
Bloomlife MFM-Pro, Pilot Phase
n=54 Participants
The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study.
|
Bloomlife MFM-Pro, Pivotal Phase
n=56 Participants
The pivotal phase of the study was aimed at validating that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring."
|
|---|---|---|
|
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate
Lower Limit of Agreement
|
-5.46 BPM
Interval -5.57 to -5.36
|
-5.57 BPM
Interval -6.92 to -4.16
|
|
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Fetal Heart Rate
Upper Limit of Agreement
|
6.04 BPM
Interval 5.93 to 6.14
|
6.04 BPM
Interval 4.75 to 7.27
|
PRIMARY outcome
Timeframe: 5 minutesPopulation: Analysis Population includes all enrolled patients without major protocol deviation or technical failure.
Outcome measures
| Measure |
Bloomlife MFM-Pro, Pilot Phase
n=54 Participants
The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study.
|
Bloomlife MFM-Pro, Pivotal Phase
n=56 Participants
The pivotal phase of the study was aimed at validating that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring."
|
|---|---|---|
|
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate
Lower Limit of Agreement
|
-2.27 BPM
Interval -2.51 to -2.03
|
-1.84 BPM
Interval -2.05 to -1.66
|
|
Extent of Agreement Between Bloomlife MFM-Pro and CTG in Maternal Heart Rate
Upper Limit of Agreement
|
3.56 BPM
Interval 3.32 to 3.8
|
2.67 BPM
Interval 2.38 to 2.98
|
Adverse Events
Bloomlife MFM-Pro, Pilot Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Bloomlife MFM-Pro, Pivotal Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bloomlife MFM-Pro, Pilot Phase
n=60 participants at risk
The pilot phase of the study was aimed at testing the Bloomlife MFM-Pro device prior to validation in the pivotal phase of the study.
|
Bloomlife MFM-Pro, Pivotal Phase
n=61 participants at risk
The pivotal phase of the study was aimed at validating that the Bloomlife MFM-Pro is equivalent to clinical standard-of-care for fetal heart rate and maternal heart rate when performing antepartum fetal monitoring.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Discomfort at electrode location
|
0.00%
0/60 • Measurement time + 7-day follow-up period
Bloomlife MFM-Pro is a safe, non-invasive device that measures standard physiological parameters. Risk assessment and management was performed in compliance with ISO 14791 standard. The anticipated adverse device effects involved with the use of the device include skin irritations and sensitization, which is considered a minor physical risks directly related to the use of Bloomlife MFM-Pro. The risk of mortality and serious adverse events is considered negligible.
|
1.6%
1/61 • Number of events 1 • Measurement time + 7-day follow-up period
Bloomlife MFM-Pro is a safe, non-invasive device that measures standard physiological parameters. Risk assessment and management was performed in compliance with ISO 14791 standard. The anticipated adverse device effects involved with the use of the device include skin irritations and sensitization, which is considered a minor physical risks directly related to the use of Bloomlife MFM-Pro. The risk of mortality and serious adverse events is considered negligible.
|
|
Skin and subcutaneous tissue disorders
Irritation between two measurement electrodes
|
1.7%
1/60 • Number of events 1 • Measurement time + 7-day follow-up period
Bloomlife MFM-Pro is a safe, non-invasive device that measures standard physiological parameters. Risk assessment and management was performed in compliance with ISO 14791 standard. The anticipated adverse device effects involved with the use of the device include skin irritations and sensitization, which is considered a minor physical risks directly related to the use of Bloomlife MFM-Pro. The risk of mortality and serious adverse events is considered negligible.
|
0.00%
0/61 • Measurement time + 7-day follow-up period
Bloomlife MFM-Pro is a safe, non-invasive device that measures standard physiological parameters. Risk assessment and management was performed in compliance with ISO 14791 standard. The anticipated adverse device effects involved with the use of the device include skin irritations and sensitization, which is considered a minor physical risks directly related to the use of Bloomlife MFM-Pro. The risk of mortality and serious adverse events is considered negligible.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place