Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors

NCT03922854 | Completed

• 1 other identifier: STH19362
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Acidemia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

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.

Mobile Monitor Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female pregnant and being given monicar in 204 monitor
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant population

You may qualify if:

• 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

You may not qualify if:

• Preterm labouring women
• Multiple pregnancy
• Involved in another study using a device or medicinal product

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Jessop Wing Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Study Officials

• Habiba Kapaya

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: April 22, 2019
• Study Start: January 10, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)