Home » Trials » SLCTR/2024/026
Study of agreement between Paxxy fetal heart rate and maternal heart rate monitoring with CTG and pulse oximetry.
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SLCTR Registration Number
SLCTR/2024/026
Date of Registration
The date of last modification
Mar 17, 2025
Trial Status
Scientific Title of Trial
Study of agreement between Paxxy fetal heart rate and maternal heart rate monitoring with CTG and pulse oximetry.
Public Title of Trial
A study to determine the comparability between the Paxxy monitor compared to CTG and pulse oximetry in monitoring fetal and maternal heart rates among term mothers with uncomplicated singleton pregnancy – single arm study
Disease or Health Condition(s) Studied
Fetal heart rate and maternal heart rate
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1307-5976
Any other number(s) assigned to the trial and issuing authority
EC-24-020: FoM, UoC
What is the research question being addressed?
Is the fetal heart rate and maternal heart rate monitoring with the Paxxy monitor comparable to standard monitoring with CTG and Pulse oximeter in pregnant mothers?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Diagnostic
Study Phase
Not Applicable
Intervention(s) planned
Study setting is the professorial obstetric unit of de Soysa Hospital for Women
Recruitment: The patients will be recruited by the research assistant and house officers in the ward who will explain the study details and obtain consent from the patients.
The subject is allowed to sit, slightly reclining. A standard CTG with cardiac and Toco probes will be applied over the subject’s abdomen using the standard CTG machine belts by a qualified midwife. The recording will be taken for 20 minutes. All health care management decision will be based on this CTG recording and clinical team decisions. The patient is allowed to mobilize after this step.
Following 5 minutes break the Paxxy wearable device is placed on the abdomen of the subject. The arrangement of the electrodes will be documented. If the patient consents to photo-documentation of the arrangement, then a de-identified photo of the sensor arrangement will be taken and stored electronically. The purpose of the image is to assess the overall abdominal coverage. Recording with Paxxy is done for further 20 minutes. Mother will be connected to a pulse oximeter for the recording of MHR during the given time. At the conclusion of the recording, the pads will be removed from the subject. Pads will also be removed at patient request at any time during the study procedure.
Monitoring will be conducted by a qualified midwife who will apply the standard CTG and by the research team for the Paxxy device. The research team includes the principal investigator, co-investigators, and research assistants.
Technical Details: • Sensors: Acoustic sensors, ECG sensors, and accelerometers. • Placement: Incorporated into a wearable garment. • Power: Built-in power bank (5V DC 2000mAH). • Connectivity: Connected to a remote computer via WiFi. • Signal Processing: ECG signals are digitized at 500 samples per second and processed using various filters and independent component analysis to determine FHR and MHR.
Inclusion criteria
• All term mothers (37+0 - 41+7) presenting to the professorial unit of De Soysa Hospital for Women. • Have clinical indications for fetal monitoring. • Age 18-45 years.
Exclusion criteria
Multiple pregnancy
Fetal growth restriction
Hypertension and diabetes in pregnancy
BMI>30
Significant uterine anomalies such as didelphys or bicornuate uterus (Women with small ,clinically insignificant anomalies such as uterine fibroids are not excluded)
Inability to fit both Paxxy and CTG due to fetal position.
Known allergy to ECG pad adhesive.
Primary outcome(s)
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1.
Agreement between Paxxy FHR with CTG and Paxxy MHR with pulse oximetry MHR will be analysed. The correlation and mean difference (95% confidence interval [CI]) between Paxxy and CTG measures of FHR and between PXXY and pulse oximeter measured MHR will be calculated. Bland Altman plots will be generated to show the agreement between the two monitoring methods. This will be done by plotting the difference in measurement between the two methods vs the average in measurement of the two methods |
[ Initial monitoring for 20 minutes with a standard CTG will be done after admission to ward. After about 5 minutes of mobilisation of the mother Paxxy monitoring and pulse oxymeter monitoring will be done for further 20 minutes. ] |
Secondary outcome(s)
|
1.
None |
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Target number/sample size
30
Countries of recruitment
Sri Lanka
Anticipated start date
2024-08-12
Anticipated end date
2024-08-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Paxxy LLC
Regulatory approvals
NMRA
Status
Approved
Date of Approval
2024-04-19
Approval number
EC-24-020
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Colombo, Sri Lanka |
| Institutional Address: | Ethics Review Committee, Faculty of Medicine, University of Colombo, PO Box 271, Kynsey Road, Colombo 08, Sri Lanka |
| Telephone: | +94112695300 (Ext. 240) |
| Email: | erc@med.cmb.ac.lk |
Contact person for Scientific Queries/Principal Investigator
Indunil Piyadigama
Senior lecturer, Department of Obstetrics and Gynaecology,Faculty of Medicine,University of Colombo
Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Colombo
0772004130
indunil@obg.cmb.ac.lk
Contact Person for Public Queries
Indunil Piyadigama
Senior lecturer, Department of Obstetrics and Gynaecology,Faculty of Medicine,University of Colombo
Department of Obstetrics and Gynaecology, Faculty of Medicine, University of Colombo
0772004130
indunil@obg.cmb.ac.lk
Primary study sponsor/organization
Paxxy FMS LLC
Lead Engineer
18291 North Pima Road, Suite 110,Box 293,Scottsdale AZ 85255, United States
+1 (602) 315-0001
glen@thepaxxy.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
Yes
IPD sharing plan description
All individual participant data collected during the trial after de-identification will be shared. Study protocol, statistical analysis plan, analytic code will be available from beginning 3 months and ending 5 years following article publication to researchers who provide a methodologically sound proposal. Data will be available to achieve the aims in an approved proposal and for individual participant data meta- analysis. Proposals should be directed to indunil@obg.cmb.ac.lk. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years from the time of publication. Information regarding submitting proposals and accessing data may be obtained by contacting indunil@obg.cmb.ac.lk.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
