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Clinical testing of the mobile-phone based fetal monitoring device

m-CTG: A low cost mobile-phone cardiotocograph device for antenatal and intrapartum monitoring to prevent perinatal mortality in low resource settings

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/11/010699
Enrollment
850
Registered
2017-11-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O94-O9A- Other obstetric conditions, not elsewhere classified Health Condition 2: null- Pregnant women

Interventions

None listed

Sponsors

Grand Challenges Canada
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria 1. Group 1: Pregnant women admitted for delivery 1.1. Inclusion criteria 1.1.1 Age: >18 years ââ?¬â?? 45 years 1.1.2 Parity: any 1.1.3 Gestation age: 37 weeks to 41 weeks 1.1.4 Fetus: Singleton 1.1.5 Risk status: low risk 1.1.6 Labour status: in active labour in first stage of labour of spontaneous onset 2. Group 2. Pregnant women with high risk factors in third trimester 2.1 Inclusion criteria 2.1.1 Age: >18 years ââ?¬â?? 45 years 2.1.2 Parity: any 2.1.3 Gestation age: ââ?°Â¥ 32 weeks 2.1.4 Fetus: Singleton 2.1.5 Labour status: not in active labour

Exclusion criteria

Exclusion criteria: Exclusion criteria 1. Group 1: Pregnant women admitted for delivery 1.2.1 Women with age outside the range 1.2.2. Women with gestation status outside the range 1.2.3 Women with high risk factors (hypertension, IUGR, oligohydramnios, gestational diabetes, known fetal malformations, multiple gestations) 1.2.4 Women with a medical/systemic disease (cardiac, neurological, respiratory any other systemic disease other than those listed in high risk obstetric condition) 1.2.5 Women with induced labour 1.2.6 Women on drugs at the time of screening/ taken in last 24 hours (tocolytic drugs) 1.2.7 Not given written informed consent 2. Group 2. Pregnant women with high risk factors in third trimester 2.2 Exclusion criteria 2.2.1 Women with age outside the range 2.2.2 Women with gestation status outside the range 2.2.3 Women in active labour 2.2.4 Women taken any tocolytic drug in last 24 hours 2.2.5 Not given written informed consent

Design outcomes

Primary

MeasureTime frame
Group 1: Pregnant women in labour - Completion of the CTG recordings and - delivery of the newborn 2. Group 2: Pregnant women in 3rd trimester - Completion of the CTG recordingsTimepoint: Group 1: Pregnant women in labour - Completion of the CTG recordings and - delivery of the newborn 2. Group 2: Pregnant women in 3rd trimester - Completion of the CTG recordings

Secondary

MeasureTime frame
Agreement between the CTG readings obtained by the standard CTG device and mCTG deviceTimepoint: one time point of CTG recording using the two types of CTG devices

Countries

India

Contacts

Public ContactManoja Kumar Das

The INCLEN Trust International

manoj@inclentrust.org011-47730000

Outcome results

None listed

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