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CompletedNCT03922854Updated Jun 22, 2022

Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors

An observational study in Fetal Acidemia, sponsored by Sheffield Teaching Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-22.

Sponsored by Sheffield Teaching Hospitals NHS Foundation Trust · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Fetal Acidemia
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In context

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust is the lead sponsor of 213 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pregnant population

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNon-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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Recruitment period January 2018-April 2019

  2. 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.

    Time frame: Recruitment period January 2018-April 2019

  3. 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.

    Time frame: Recruitment period January 2018-April 2019

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Study locations

1 site
  • Jessop Wing Hospital
    Sheffield, South Yorkshire S10 2JF, United Kingdom
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03922854
Responsible party
Sponsor
First posted
Apr 22, 2019
Start date
Jan 10, 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Jun 22, 2022

Study contacts

Habiba Kapaya
principal investigator · Sheffield Teaching Hospitals NHS Foundation Trust

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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