Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors

Completed

• Conditions: Fetal Acidemia
• Interventions: Other: Non-interventional data collection only

• Registration Number: NCT03922854
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-10
• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2019-04-17
• Study First Posted: 2019-04-22
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mobile Monitor Group	Non-interventional data collection only	Participants are recruited to this study if they have been monitored during their labour with a monica AN 24 monitor

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Jessop Wing Hospital; 🇬🇧 Sheffield, South Yorkshire, United Kingdom