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A device to monitor the babys heart rate and contractions of the uterus during labour

Keyar foetal heart rate and uterine contraction monitoring device in the detection of foetal distress during intra-partum period

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/10/021622
Enrollment
300
Registered
2019-10-14
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

Health Condition 1: O76- Abnormality in fetal heart rate and rhythm complicating labor and delivery Health Condition 2: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium

Interventions

Intervention1: nil: nil

Sponsors

Janitri Innovations Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pregnant woman > 18 years of age 2. Gestational age between 37+0 to 40+6 weeks 3. Cephalic presentation in labour 4. Both low and high risk pregnancies 5. Ability to understand study information and willing to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Multiple pregnancy 2. Congenital anomalies of the foetus 3. Patient admitted with false labour pain 4. Patient undergoing elective caesarean sections 5. Any other condition of the mother or foetus where in, the investigator feels the participant is not eligible for the study.

Design outcomes

Primary

MeasureTime frame
sensitivity and specificity of Keyar device with standard cardiotocogram to detect foetal distress during active labourTimepoint: 6 months

Secondary

MeasureTime frame
To compare FHR, beat to beat variability measured using Keyar device with standard cardiotocogramTimepoint: 6 months

Countries

India

Contacts

Public ContactDr Alben Sigamani

Mazumdar shaw Medical Center, Narayana Hrudayalaya.

drlavanya_kiran@yahoo.com9632812007

Outcome results

None listed

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