Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors

NCT ID: NCT03922854

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-10

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Fetal Acidemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mobile Monitor Group

Participants are recruited to this study if they have been monitored during their labour with a monica AN 24 monitor

Non-interventional data collection only

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Habiba Kapaya

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

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Jessop Wing Hospital

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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STH19362

Identifier Type: -

Identifier Source: org_study_id

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