Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors
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|ClinicalTrials.gov Identifier: NCT03922854|
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
|Condition or disease||Intervention/treatment|
|Fetal Acidemia||Other: Non-interventional data collection only|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||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|
|Actual Study Start Date :||January 10, 2018|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Mobile Monitor Group
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
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.
- Sample Size [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922854
|Contact: Habiba Kapaya||0114 22 firstname.lastname@example.org|
|Jessop Wing Hospital||Recruiting|
|Sheffield, South Yorkshire, United Kingdom, S10 2JF|
|Contact: Habiba Kapaya|
|Principal Investigator:||Habiba Kapaya||Sheffield Teaching Hospitals|