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To compare a new fetal heart rate monitoring machine with routinely used machine during delivery of baby.

Comparison of a new novel fetal heart rate monitoring device to standard cardiotocography in detecting fetal heart rate during intrapartum period. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/04/065158
Enrollment
260
Registered
2024-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: O68- Labor and delivery complicated byabnormality of fetal acid-base balance

Interventions

Intervention1: Novel Fetal Heart Rate Monitoring Device: The novel fetal heart rate ( FHR ) monitoring device extracts FHR from mother’s abdomen using photoplethysmography (PPG ) method Intervention2:

Sponsors

Rahul Bhakat
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women with singleton pregnancy. 2. Gestation more than or equal to 32 weeks. 3. Admission in labour ward with labour pains.

Exclusion criteria

Exclusion criteria: 1. Presence of antenatally detected major fetal anomaly. 2. Intrauterine death.

Design outcomes

Primary

MeasureTime frame
1. Agreement between the two devices in detecting Fetal heart rate. 2. Correlation coefficient between the two devices in detecting Fetal heart rate. Timepoint: Measurement of fetal heart rate for continuous 6 minutes during first and / or second stage of labour only once at enrollment.

Secondary

MeasureTime frame
5. APGAR at 1 and 5 minutes 6. Degree of resuscitation requiredTimepoint: Neonates after delivery till resuscitation is required;Decision taken regarding delivery of fetusTimepoint: Measurement of fetal heart rate continuously for 6 minutes during first/ second stage of labour during delivery once at the time of enrollment.;Detection of abnormal fetal heart rate/ Fetal distressTimepoint: Fetal heart rate will be continuously measured for 6 minutes during first/ second stage of labour during delivery once.;Number of device adjustments requiredTimepoint: During continuos measurement of fetal heart rate for 6 minutes during first/ second stage of labour.;Patient/ provider device satisfactionTimepoint: During continuous measurement of fetal heart rate for 6 minutes during first/ second stage of labour once.

Countries

India

Contacts

Public ContactS Mangala Bharathi

Madras Medical College

drmangalabharathi@gmail.com9840786836

Outcome results

None listed

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