COntinuous fetal heart rate Monitoring using non-invasive Fetal electrocardiographY 2 (COMFY 2)

Not Applicable

• Conditions: stillbirth; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy

• Registration Number: ACTRN12621001260819
• Lead Sponsor: niversity of Melbourne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-17
• Last Update Posted: 27 September 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 510

Inclusion Criteria

We will recruit women from 24 weeks gestation to term with a singleton or twin pregnancy

Exclusion Criteria

Patients with an intellectual or mental impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to assess the accuracy of our portable fetal ECG device against the CTG. [We will recruit women at various gestations in their pregnancy (24 weeks or more) and obtain a recording of the fetal heart activity and uterine activity during their CTG study.];Assess the length of time that a fetal ECG is detected over a 24 hour period. [24 hour time frame];Examine the accuracy of our fetal ECG device over 24 hours compared to the Monica Fetal Monitoring device over 24 hours. [24 hours for our fetal ECG device and 24 hours for the Monica. ]

Secondary Outcome Measures

Name	Time	Method
The secondary objective will be to examine the accuracy of our fetal ECG over a range of gestational ages. [This will be done on all participants at gestations from 24 weeks to term and collected immediately.];We will assess the acceptability of a wearable fetal ECG device before and after the study using a questionnaire. the questionnaire has been developed specifically for this study. [This will occur immediately on recruitment to the study]