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Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors

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ClinicalTrials.gov Identifier: NCT03922854
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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 Intervention/treatment
Fetal Acidemia Other: Non-interventional data collection only

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Study Type : Observational
Estimated 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 10, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : September 30, 2019

Group/Cohort 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.




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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female pregnant and being given monicar in 204 monitor
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922854


Contacts
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Contact: Habiba Kapaya 0114 22 66900 h.kapaya@sheffield.ac.uk

Locations
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United Kingdom
Jessop Wing Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Contact: Habiba Kapaya         
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Habiba Kapaya Sheffield Teaching Hospitals

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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: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acidosis
Acid-Base Imbalance
Metabolic Diseases