Developing a comfortable fetal heart rate monitor that can be used by pregnant women

Continuous fetal heart rate monitoring using non-invasive fetal electrocardiography

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619000185167

Acronym

COMFY

Enrollment

Registered

2019-02-08

Start date

2019-02-13

Completion date

2026-10-22

Last updated

2024-11-04

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

Conditions

None listed

Brief summary

We will recruit 120 women with singleton pregnancies without cardiac abnormalities from 28 weeks gestation to term. Each participant will undergo a NI-FECG recording session with concurrently recorded CTG and tocodynamometer to ascertain a gold standard for the fetal heart activity and uterine activity.

Interventions

We are seeing whether we can obtain a reliable fetal ECG using non-invasive monitoring. We will do this by performing an ultrasound to ascertain the fetal position and then place ECG dots (electrodes) over the abdomen of pregnant women. We will obtain around 5 minutes of CTG and fetal ECG recording. Using signal processing techniques we will see whether we can remove interference to obtain a reliable continuous fetal ECG.

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

We will recruit women from 28 weeks gestation to term with a singleton pregnancy

Exclusion criteria

Fetal cardiac defects Patients with an intellectual or mental impairment

Outcome results