A Cross-sectional, Interventional, Single-arm Clinical Study for Validating the Equivalence of Bloomlife MFM-Pro to Clinical Standard-of-care for Fetal Heart Rate and Maternal Heart Rate When Performing Antepartum Fetal Monitoring
Phase: NA
Conditions: Fetal Monitoring
Sponsor: Bloom Technologies

 
  
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Clinical Investigation Plan Summary 
 
Title 
A cross-sectional, interventional, single-arm clinical study for validating the 
equivalence of Bloomlife MFM-Pro to clinical standard-of-care for fetal heart rate 
and maternal heart rate when performing antepartum fetal monitoring 
Acronym 
NST 
Protocol Number 
NST-01-2021-US 
Version 
3.0 – 23FEB2022 
Reference number 
(IRB) 
Pro00049843 
Funding 
This study is funded by Bloomlife Inc (study sponsor) 
 
 
 
 
Study Synopsis 
Population 
Non-laboring pregnant women with singleton pregnancy, at 
32 weeks of gestation or more, monitored with Bloomlife 
MFM-Pro and Cardiotocograph (CTG).  
Investigational 
Device 
Bloomlife MFM-Pro is indicated for monitoring of maternal 
and fetal physiological parameters during the antepartum 
period. It is to be used by healthcare professionals in 
hospitals, clinics, physicians' offices, antepartum rooms, 
and in the patients' home on the order of a physician. 
Bloomlife MFM-Pro is a non-invasive, wireless, external 
monitoring system used to measure fetal heart rate (fHR), 
maternal heart rate (mHR), and uterine activity during 
antepartum (non-stress) testing on pregnant women with a 
singleton pregnancy.  
The system acquires biopotential signals from abdominal 
surface electrodes and measures the fetal 
electrocardiography, maternal electrocardiography and 
electrohysterography. The sensor also acquires motion 
data through an accelerometer. It transmits the measured 
data to the Bloomlife Mobile App and to the Cloud for 
storage/processing.  
Comparison 
Reference device: Cardiotocograph 
(Philips Avalon FM30 or equivalent) 

 
  
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Objectives 
Primary objective:  
● 
To demonstrate equivalence of Bloomlife MFM-
Pro to clinical standard-of-care for fetal heart rate 
and maternal heart rate when performing 
antepartum fetal monitoring. 
Secondary objective: 
● 
To establish the safety of Bloomlife MFM-Pro. 
Exploratory objectives: 
● 
To compare measurement reliability of Bloomlife 
MFM-Pro and CTG in measuring fetal heart rate. 
● 
To compare measurement reliability of Bloomlife 
MFM-Pro and CTG in measuring maternal heart 
rate. 
● 
To study the Bloomlife MFM-Pro performance 
when compared to standard-of-care (CTG) for 
uterine activity. 
● 
To study the correlation between the Bloomlife 
MFM-Pro signal quality check result and fetal 
heart rate quality 
Endpoints 
Primary endpoints:  
● 
Extent of agreement between Bloomlife MFM-Pro 
and CTG in fetal heart rate (FHR) and maternal 
heart rate (MHR): 
○ 
95% LoA for FHR within +/- 10 bpm 
○ 
95% LoA for MHR within +/- 7 bpm 
● 
Regression analysis of MFM-Pro vs CTG for fetal 
heart rate and maternal heart rate determining if the 
bias is constant across the range of the 
measurements. 
Secondary endpoints: 
● 
Summary tables of recorded adverse events, 
serious adverse events, adverse device effects, 
device deficiencies. 
Exploratory endpoints: 
● 
Percentage of a recording with a FHR for Bloomlife 
MFM-Pro and for CTG. 
● 
Percentage of a recording with a MHR for Bloomlife 
MFM-Pro and for CTG. 
● 
Sensitivity and False Event Rate for uterine 
contractions annotated by experts based on uterine 
activity traces measured with Bloomlife MFM-Pro 
and with CTG. 

 
  
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● 
Confusion matrix between the signal quality check  
result (pass or fail) and the recording quality (for the 
MFM-Pro fetal heart rate signal, over the complete 
measurement) 
Design 
National, 
prospective, 
cross-sectional, 
interventional, 
single-arm study. 
Number of subjects 
Pilot phase: up to 200 enrolled subjects 
Pivotal phase: up to 60 enrolled subjects 
Inclusion criteria 
● 
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● 
3#0'&'4*%&1(&$#(,(56()##70(&%2(8(2&/0 
● 
Singleton pregnancy 
● 
Ability to read and understand English or Spanish 
● 
Willingness to participate in the study 
Exclusion criteria 
● 
Implanted pacemaker or any other implanted 
electrical device 
● 
Plurality higher than 1 
● 
History of allergies to skin adhesives 
● 
Irritated or lesioned skin at the Bloomlife MFM-Pro 
electrodes locations 
● 
Contraindication to the use of CTG (e.g. due to 
preterm contractions) 
Enrolment criteria 
A participant is considered enrolled when their eligibility is 
confirmed, and the signal validation screening test 
(performed by the Bloomlife MFM-Pro) gives a successful 
result. 
Study duration 
Q1 2021 – Q2 2022 
Study Procedures 
Informed consent: 
Eligible participants will be asked to sign an informed 
consent form before any study-specific procedure is 
performed. 
MFM-Pro electrodes connection check & signal quality 
check: 
Once the informed consent is signed, participants are 
asked to sit on a reclined (NST) chair (or lie on a hospital 
bed). 

 
  
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The researcher prepares the patient's skin by cleaning it 
and by using medical skin-prep tape on her belly.  
The researcher proceeds with setting up the Bloomlife 
MFM-Pro system, in parallel with the CTG. The researcher 
instructs the participant to annotate perceived contractions 
by pressing a button. 
With this setup, data is collected with both devices, while 
the Bloomlife MFM-Pro performs an electrode connection 
check and signal quality check (screening test). This step 
may take up to 15 minutes. If the electrode connection 
check fails or the CTG does not capture the MHR/FHR 
signals, the measurement setup is adjusted as needed (up 
to three attempts are allowed). 
Study measurement: 
If the electrodes connection check and the CTG setup are 
successful, data is collected with both the Bloomlife MFM-
Pro and the CTG monitor for 45 minutes.  
A video of the belly and a picture of the setup may also be 
taken. 
During the data collection, the researcher uses a custom 
data visualization interface to visualize data from the CTG 
and the Bloomlife MFM-Pro, to identify issues with the 
measurement setup and annotate relevant events in the 
data collection process. 
At the end of the data collection, the Bloomlife MFM-Pro 
and CTG tracings are stored in a digital format for analysis. 
After the Bloomlife MFM-Pro data collection, relevant 
information pertaining to the subject's pregnancy and 
medical history is collected from her medical records and 
entered in the eCRF. 
Any adverse event observed during the data collection 
(signal quality check and measurement) will be recorded by 
the researcher. Information about other adverse events will 
be collected from the participant's medical records for 7 
days after the measurement. 
 
Statistical Data 
Analysis 
Limits of Agreement: 
For assessing the agreement between the Bloomlife MFM-
Pro fetal heart rate (FHR) and a standard of care 

 
  
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Cardiotocograph (CTG), we plan to estimate the 95% limits 
of agreement (LoA) according to Bland-Altman, together 
with 95% confidence intervals (95%CI).  
95% limits of agreement objectives: 
1. Fetal heart rate the 95% limits of agreement lie 
within +/- 10 bpm 
2. Maternal heart rate the 95% limits of agreement lie 
within +/- 7 bpm. 
Linear regression analysis: 
A linear regression analysis assessing the relationship 
between the bias and the magnitude of measurements will 
also be performed.   
 
 
Timeline 
Subjects are asked to participate in one data collection 
performed at the clinic. The data collection requires up to 
1.5 hours. 
A follow-up period of 7 days (after the measurement) is 
used to collect safety information. 
 
 
 
Sponsor 
Name 
Bloom Technologies NV (a daughter company of Bloomlife 
Inc) 
Address 
Schiepse Bos 6, 3600 Genk (Belgium) 
Key personnel 
Elisa Rossetti, Clinical Studies Manager 
Melissa Ingersoll, Clinical Research Associate 
Violaine Emonard, Clinical advisor 
Julien Penders, COO 
During the study, the Sponsor keeps a separate document with an updated list of the Principal 
Investigator(s) and investigation site(s). The PI and site information is submitted to the IRB at study 
submission.