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

Not Applicable
Conditions
Health Condition 1: O76- Abnormality in fetal heart rate and rhythm complicating labor and deliveryHealth Condition 2: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium
Registration Number
CTRI/2019/10/021622
Lead Sponsor
Janitri Innovations Pvt Ltd
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
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

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.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
sensitivity and specificity of Keyar device with standard cardiotocogram to detect foetal distress during active labourTimepoint: 6 months
Secondary Outcome Measures
NameTimeMethod
To compare FHR, beat to beat variability measured using Keyar device with standard cardiotocogramTimepoint: 6 months
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