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Completed

NCT Number: NCT03922854

Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors

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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Key information

Conditions

Fetal Acidemia

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Jessop Wing Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2019
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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