Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors

Determining the Predictive Utility of Short-term Variation (STV) of Fetal Heart Rate (FHR) for Fetal Acidaemia, and the Feasibility of Using This for Decision Making in High-risk Women During Labour

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03922854

Enrollment

200

Registered

2019-04-22

Start date

2018-01-10

Completion date

2019-12-31

Last updated

2022-06-22

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

Conditions

Fetal Acidemia

Brief summary

The study has been designed as a prospective, non-randomised, single centre study to determine the predictive utility of Short Term Variation (STV) of the Fetal Heart Rate (FHR)from the intrapartum FHR data collected using the portable fetal ECG monitor (Monica AN24) in women requiring continuous monitoring during labour due to antenatal or intrapartum risk factors.

Interventions

OTHERNon-interventional data collection only

There is no clinical intervention. This study is just capturing data from devices used part of routine clinical care. The results of this data collection will be analysed to inform study results.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Singleton term pregnant labouring women during established labour (cervix \>3cm dilated, regular uterine contractions \>3:10 minutes) * Written informed consent * At least 18 years of age

Exclusion criteria

* Preterm labouring women * Multiple pregnancy * Involved in another study using a device or medicinal product

Design outcomes

Primary

Measure	Time frame	Description
Sample Size	Recruitment period January 2018-April 2019	This is a feasibility study with a primary objective to establish design of a large multi-centre study. Outcome measure is percentage number of participants to have a umbilical blood cord gas PH level below 7.20. This will inform the statistical sample for the larger study.
Recruitment Rate	Recruitment period January 2018-April 2019	This is a feasibility study with a primary objective to establish design of a large multi-centre study. Outcome measure is how many participants recruited per month this will inform how many centre's will be required to deliver statistical sample size for larger study.
Data Capture	Recruitment period January 2018-April 2019	This is a feasibility study with a primary objective to establish design of a large multi-centre study. Outcome measure is number of completed data sets. A complete data set equals more than one hour of recorded data from mobile fetal heart rate monitor and arterial umbilical cord blood gas level taken. This will inform estimated sample size for larger study.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026