Fetal AcidemiaNCT03922854
Monitoring of Babies' Heart Rates During Labour Using Mobile Monitors
An observational study of Fetal Acidemia, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fetal Acidemia
- What is being tested?
- Non-interventional data collection only
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant population
Who may be able to join
- 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
Who cannot join
- Preterm labouring women
- Multiple pregnancy
- Involved in another study using a device or medicinal product
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Jessop Wing Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
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
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.
- Conditions
- Fetal Acidemia
- Being tested
- Non-interventional data collection only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional data collection onlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Monitor Group | Participants are recruited to this study if they have been monitored during their labour with a monica AN 24 monitor Receives: Other: Non-interventional data collection only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Recruitment period January 2018-April 2019
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.
Measured: Recruitment period January 2018-April 2019
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.
Measured: Recruitment period January 2018-April 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start10 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fetal AcidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Habiba Kapaya, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922854
- Sponsor's protocol ID
- STH19362
- Status last verified
- Jun 2022
- First submitted
- 14 Aug 2018
- Last updated
- 22 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03922854
- Acronym / sponsor ID
- STH19362
- Conditions
- Fetal Acidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Monitor Group | – | Other: Non-interventional data collection onlyParticipants are recruited to this study if they have been monitored during their labour with a monica AN 24 monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant population
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Preterm labouring women
- Multiple pregnancy
- Involved in another study using a device or medicinal product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional data collection onlyThere 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. | Other | Mobile Monitor Group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Fetal Acidemia
Not yet recruitingObservational study
Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
Not yet recruitingObservational study
Evaluation of Neonatal Acute Hypoxia at Delivery Using Fetal Physiology and Eucapnic pH Assessment
Neonatal Acidemia and Hypoxia
Recruiting
Effects of Ephedrine, Phenylephrine, Norepinephrine and Vasopressin on Contractility of Human Myometrium and Umbilical Vessels: An In-vitro Study
Hypotension
Recruiting
Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems
Fetal Hypoxia, Fetal Acidemia
Recruiting
Evaluation of the Fetal Response to Intrapartum Digital Fetal Scalp Stimulation to Identify Intrapartum Fetal Hypoxia.
Fetal Hypoxia, Fetal Monitoring
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Habiba Kapaya principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Acidemia, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sample Size (time frame: Recruitment period January 2018-April 2019). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.