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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors

Clinicaltrials.gov identifier NCT03922854

Recruitment Status Active, not recruiting

First Posted April 22, 2019

Last update posted August 21, 2019

Study Description

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.

  • Condition or Disease:Fetal Acidemia
  • Intervention/Treatment: Other: Non-interventional data collection only
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Observational
  • Actual Enrollment: 200 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • 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
  • Actual Study Start Date: January 2018
  • Estimated Primary Completion Date: December 2019
  • Estimated Study Completion Date: December 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: 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
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.
Outcome Measures
  • Primary Outcome Measures: 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Pregnant population
Criteria

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

Contacts and Locations
Contacts
Locations

United Kingdom, South Yorkshire
Jessop Wing Hospital
Sheffield

Sponsors and Collaborators

Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

Principal Investigator: Habiba Kapaya Sheffield Teaching Hospitals

More Information
  • Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
  • ClinicalTrials.gov Identifier: NCT03922854 History of Changes
  • Other Study ID Numbers: STH19362
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: August 21, 2019
  • Last Verified: August 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No