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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile Monitor Group | Participants are recruited to this study if they have been monitored during their labour with a monica AN 24 monitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional data collection only | Other | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Female pregnant and being given monicar in 204 monitor
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Pregnant population
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| Name | Affiliation | Role |
|---|---|---|
| Habiba Kapaya | Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessop Wing Hospital | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
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