Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Fetal Acidemia

Intervention / Treatment
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* Other: Non-interventional data collection only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mobile Monitor Group<br>Participants are recruited to this study if they have been monitored during their labour with a monica AN 24 monitor | Other: Non-interventional data collection only<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sample Size | 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 period January 2018-April 2019 | 
| Recruitment Rate | 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. | Recruitment period January 2018-April 2019 | 
| Data Capture | 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. | Recruitment period January 2018-April 2019 |