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Comparison of a novel fetal heart rate monitor (Fetal Lite) against a gold standard technology to check accuracy & reliability.

Prospective cross sectional comparative study to determine validity and reliability of the Fetal Lite electronic fetal monitor

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/08/035617
Enrollment
150
Registered
2021-08-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Fetal Lite: Fetal Lite is a next generation, A.I.-powered, fetal heart rate (FHR) monitor, based on fetal ECG signal extraction technology, for mothers in labour or post 37 weeks of ges

Sponsors

InnAccel Technologies Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Mothers with singleton pregnancies, post 37 weeks of gestational age

Exclusion criteria

Exclusion criteria: 1. Mothers with any known skin allergies to ECG electrodes/ biocompatible skin adhesive 2. Unavailability of space on maternal abdomen for both devices to be placed simultaneously 3. Refusal of consent

Design outcomes

Primary

MeasureTime frame
Accuracy and reliability of Fetal heart rate & Uterine activity algorithmTimepoint: By end of trial—

Secondary

MeasureTime frame
1. Comparison of interpretation provided by Fetal Lite system and by a gynecologist 2. Ability of the system to provide ambulation to a pregnant motherTimepoint: By end of trial—

Countries

India

Contacts

Public ContactMegha Singh

InnAccel Technologies Pvt. Ltd.

megha@innaccel.com9886138452

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026