Labour OnsetNCT03982654
Investigating the Physiology of Labour and Labour Onset Through Longitudinal Measurements Performed With a Wearable Sensor
A study testing Bloomlife in people with Labour Onset, run by Bloom Technologies at 2 sites in Belgium.
Trial summary
The purpose of the study is to collect data to support the development and validation of a machine learning model for the automatic detection, prediction and monitoring of labour, through the use of a wearable sensor (Bloomlife sensor) that can be easily used at home. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labour Onset
- What is being tested?
- Bloomlife
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 2 sitesBelgium
- Study dates
- 30 Mar 2018to 5 Mar 2019
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant
- Gestational age between 20 weeks and 0 days and 30 weeks and 0 days
- Willingness to participate in the study
Who cannot join
- Implanted pacemaker or any other implanted electrical device
- History of allergies to silicone-based adhesives
- Any health condition resulting in higher chance of C-section (meeting one of these criteria is sufficient to be excluded): previous history of C-section, placental abnormality, being primipara and older than 40
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Ziekenhuis Oost-Limburg
Genk, 3600
CHR de la Citadelle
Liège, 4000
About this study
Official title: Investigating the Physiology of Labour, Labour Onset and Pregnancy Outcomes in Pregnant Women, Through Longitudinal Measurements Performed With a Wearable Sensor
The purpose of the study is to collect data to support the development and validation of a machine learning model for the automatic detection, prediction and monitoring of labour, through the use of a wearable sensor (Bloomlife sensor) that can be easily used at home.
Women participating in the study will be asked to regularly record data with the Bloomlife sensor, from inclusion in the study until delivery. In addition, clinical information related to their pregnancy and delivery will be collected.
- Conditions
- Labour Onset
- Being tested
- Bloomlife
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BloomlifeDevice
Women use the Bloomlife sensor to collect data throughout their pregnancy. The collected data is stored locally in the device, but it is not used to provide any feedback to the patients or to the clinical team. Therefore the use of the device doesn't have an impact on clinical decision making and patients' care.
| Study group | Role | What they receive |
|---|---|---|
| Bloomlife | Experimental | Not described Receives: Device: Bloomlife |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy
Accuracy of the machine learning model for the automatic detection of labor, measured in terms of sensitivity and specificity in detecting labour
Measured: At delivery
Secondary outcomes (1)
Labour probability
Probability of being in labour, computed using electrophysiological signals collected with the Bloomlife sensor
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start30 Mar 2018
- Primary completion26 Nov 2018
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labour OnsetStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bloom Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilfried Gyselaers, MD, PhD, Principal investigator, Ziekenhuis Oost-LimburgFrederic Chantraine, MD, PhD, Principal investigator, CHR de la Citadelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03982654
- Sponsor's protocol ID
- WISH01
- Status last verified
- Jun 2019
- First submitted
- 20 May 2019
- Last updated
- 11 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Physiology of Labour, Labour Onset and Pregnancy Outcomes in Pregnant Women, Through Longitudinal Measurements Performed With a Wearable Sensor
- ClinicalTrials.gov ID
- NCT03982654
- Acronym / sponsor ID
- WISH01
- Conditions
- Labour Onset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Bloom TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 26 Nov 2018 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 11 Jun 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 purpose of the study is to collect data to support the development and validation of a machine learning model for the automatic detection, prediction and monitoring of labour, through the use of a wearable sensor (Bloomlife sensor) that can be easily used at home.
Women participating in the study will be asked to regularly record data with the Bloomlife sensor, from inclusion in the study until delivery. In addition, clinical information related to their pregnancy and delivery will be collected.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bloomlife | Experimental | Device: Bloomlife |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant
- Gestational age between 20 weeks and 0 days and 30 weeks and 0 days
- Willingness to participate in the study
Key exclusion criteria (3 listed)
- Implanted pacemaker or any other implanted electrical device
- History of allergies to silicone-based adhesives
- Any health condition resulting in higher chance of C-section (meeting one of these criteria is sufficient to be excluded): previous history of C-section, placental abnormality, being primipara and older than 40
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 |
|---|---|---|
| BloomlifeWomen use the Bloomlife sensor to collect data throughout their pregnancy. The collected data is stored locally in the device, but it is not used to provide any feedback to the patients or to the clinical team. Therefore the use of the device doesn't have an impact on clinical decision making and patients' care. | Device | Bloomlife |
Primary outcome
Accuracy
Time frame: At delivery
Accuracy of the machine learning model for the automatic detection of labor, measured in terms of sensitivity and specificity in detecting labour
1 secondary outcome
Labour probability
Time frame: At delivery
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 11 Jun 2019.
Related trials for Labour Onset
Not yet recruitingPhase 4
PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes
Rupture of Membranes Prior to Onset of Labor
RecruitingPhase 2
Use of Cinnamomum Verum for Induction of Labor. Double Blind Randomized Clinical Trial
Labor Onset and Length Abnormalities, First Birth
Recruiting
The SWEEP Trial: a Randomized Controlled Trial
Membrane Stripping, Cervical Ripening
Not yet recruiting
To Compare Sweeping of Membranes Versus Expectant Management for Spontaneous Onset of Labor and Vaginal Delivery.
Post-Term Pregnancy
Recruiting
The Norwegian World Health Organisation Labour Care Guide Trial (NORWEL)
Labor Dystocia, Labor Complication
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.
Wilfried Gyselaers, MD, PhD principal investigator
Ziekenhuis Oost-Limburg
Frederic Chantraine, MD, PhD principal investigator
CHR de la Citadelle
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bloomlife in people with Labour Onset, run by Bloom Technologies at 2 sites in Belgium.
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 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Accuracy (time frame: At delivery). 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 11 Jun 2019.