Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors

Fetal Acidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922854
• Other study ID #: STH19362
• Status: Completed
• Start date: January 10, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2022
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Acidemia

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Jessop Wing Hospital	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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