Clinical testing of the mobile-phone based fetal monitoring device

Not Applicable

Completed

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

• Registration Number: CTRI/2017/11/010699
• Lead Sponsor: Grand Challenges Canada

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-01-31
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 910

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: � 32 weeks

2.1.4 Fetus: Singleton

2.1.5 Labour status: not in active labour

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

Study & Design

• Study Type: Observational
• Study Design: Not specified