Obstetrical ComplicationsMOMANCT05263427
Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA
A study testing TOCONAUTE in people with Obstetrical Complications and Monitoring Injury of Scalp of Newborn, run by University Hospital, Lille at 1 site in France.
Trial summary
During a previous clinical trial (RCF-abdo: 2018-A01194-51), trans-abdominal signals were collected in 90 patients at the maternity Jeanne de Flandre. This database allowed us to develop a new medical device able to measure in real time and continuously the fetal heart rate and the uterine contractions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Obstetrical Complications, Monitoring Injury of Scalp of Newborn
- What is being tested?
- TOCONAUTE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 31 Aug 2022to 3 Nov 2023
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant woman in labor
- Singleton
- Cephalic presentation
Who cannot join
- Hospitalisation for a medical termination of pregnancy
- Death in utero
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
During a previous clinical trial (RCF-abdo: 2018-A01194-51), trans-abdominal signals were collected in 90 patients at the maternity Jeanne de Flandre. This database allowed us to develop a new medical device able to measure in real time and continuously the fetal heart rate and the uterine contractions.
The goal here is to assess the performance of the device in real situation during labour.
Read more
This study will be carried out in the maternity labor ward in CHU Lille, France.
The TOCONAUTE will be placed on the mother's abdomen to capture fetal and maternal heart rate as well as the uterine contractions in parallel of the cardiotocograph.
For each of the participants, the TOCONAUTE will remain on the mother's abdomen till childbirth. This procedure will not affect the usual care of the patient.
- Being tested
- TOCONAUTE
- Keywords
- Fetal Heart Rate, Monitoring, Uterine contraction, Electrocardiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOCONAUTEDevice
Also called foetal heart rate and uterine contractions recording
This study will be carried out during delivery. The will be placed on the mother's abdomen to capture fetal and maternal heart rate as well as the uterine contractions in parallel of the cardiotocograph.
For each of the participants, the TOCONAUTE will remain on the mother's abdomen till childbirth. This procedure will not affect the usual care of the patient.
| Study group | Role | What they receive |
|---|---|---|
| TOCONAUTE and gold standard : cardiotocograph | Experimental | Not described Receives: Device: TOCONAUTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal heart rate with the TOCONAUTE
The fetal heart rate from the our device will be averaged on 3 beats and resampled at 4Hz to be comparable to the fetal heart rate from the cardiotocograph.
Both of the signals will be resynchronized and compared sample by sample with a Pearson's correlation test.
Measure of the fetal heart rate with the TOCONAUTE compared to the measure of the fetal heart rate with a cardiotocograph.
Measured: 1 year
Secondary outcomes (4)
Uterine contractions with the TOCONAUTE according to the different phase of labor.
Measure of the uterine contractions with the TOCONAUTE compared to the measure of the uterine contractions with a cardiotocograph according to the different phase of labor.
Both signals of the uterine contractions will be resynchronized and compared sample by sample with a Pearson's correlation test.
Measured: 1 year
Maternal heart rate with the TOCONAUTE
Measure of the maternal heart rate with the TOCONAUTE compared to the measure of the maternal heart rate with a cardiotocograph.
Both signals of the maternal heart rate will be resynchronized and compared sample by sample with a Pearson's correlation test.
Measured: 1 year
Fetal heart rate with the TOCONAUTE according to the different phase of labor.
Measure of the fetal heart rate with the TOCONAUTE compared to the measure of the fetal heart rate with a cardiotocograph according to the different phase of labor.
Measured: 1 year
Fetal stress index (Heart rate variability index reflecting parasympathetic fluctuation)
Feasibility of the measure of the Fetal stress index (Heart rate variability index reflecting parasympathetic fluctuation)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start31 Aug 2022
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstetrical ComplicationsStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, BioSerenity, National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Charles Garabedian, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263427
- Sponsor's protocol ID
- 2021_0548
- Other IDs
- 2022-A00107-36, ANR-18-CE19-0015-01
- Acronym
- MOMA
- Status last verified
- Dec 2025
- First submitted
- 21 Feb 2022
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wojtanowski A, Garabedian C, Charlier P, Prot P, Ghesquiere L, De Jonckheere J. Intrapartum monitoring of the fetal heart rate using transabdominal electrocardiography: A reliability and accuracy study. J Gynecol Obstet Hum Reprod. 2025 May;54(5):102942. doi: 10.1016/j.jogoh.2025.102942. Epub 2025 Mar 16.
PubMed 40101837
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA
- ClinicalTrials.gov ID
- NCT05263427
- Acronym / sponsor ID
- MOMA / 2021_0548
- Keywords
- Fetal Heart Rate, Monitoring, Uterine contraction, Electrocardiogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network, BioSerenity, National Research Agency, France
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 2 Mar 2022 (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.
During a previous clinical trial (RCF-abdo: 2018-A01194-51), trans-abdominal signals were collected in 90 patients at the maternity Jeanne de Flandre. This database allowed us to develop a new medical device able to measure in real time and continuously the fetal heart rate and the uterine contractions.
The goal here is to assess the performance of the device in real situation during labour.
This study will be carried out in the maternity labor ward in CHU Lille, France.
The TOCONAUTE will be placed on the mother's abdomen to capture fetal and maternal heart rate as well as the uterine contractions in parallel of the cardiotocograph.
For each of the participants, the TOCONAUTE will remain on the mother's abdomen till childbirth. This procedure will not affect the usual care of the patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TOCONAUTE and gold standard : cardiotocograph | Experimental | Device: TOCONAUTE |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant woman in labor
- Singleton
- Cephalic presentation
Key exclusion criteria (3 listed)
- Hospitalisation for a medical termination of pregnancy
- Death in utero
- Multiple pregnancy
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 |
|---|---|---|
| TOCONAUTEAlso: foetal heart rate and uterine contractions recordingThis study will be carried out during delivery. The will be placed on the mother's abdomen to capture fetal and maternal heart rate as well as the uterine contractions in parallel of the cardiotocograph. For each of the participants, the TOCONAUTE will remain on the mother's abdomen till childbirth. This procedure will not affect the usual care of the patient. | Device | TOCONAUTE and gold standard : cardiotocograph |
Primary outcome
Fetal heart rate with the TOCONAUTE
Time frame: 1 year
The fetal heart rate from the our device will be averaged on 3 beats and resampled at 4Hz to be comparable to the fetal heart rate from the cardiotocograph. Both of the signals will be resynchronized and compared sample by sample with a Pearson's correlation test. Measure of the fetal heart rate with the TOCONAUTE compared to the measure of the fetal heart rate with a cardiotocograph.
4 secondary outcomes
Uterine contractions with the TOCONAUTE according to the different phase of labor.
Time frame: 1 year
Maternal heart rate with the TOCONAUTE
Time frame: 1 year
Fetal heart rate with the TOCONAUTE according to the different phase of labor.
Time frame: 1 year
Fetal stress index (Heart rate variability index reflecting parasympathetic fluctuation)
Time frame: 1 year
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 8 Dec 2025.
- Results publication: PubMed 40101837Wojtanowski A, Garabedian C, Charlier P, Prot P, Ghesquiere L, De Jonckheere J. Intrapartum monitoring of the fetal heart rate using transabdominal electrocardiography: A reliability and accuracy study. J Gynecol Obstet Hum Reprod. 2025 May;54(5):102942. doi: 10.1016/j.jogoh.2025.102942. Epub 2025 Mar 16.
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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.
Charles Garabedian, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TOCONAUTE in people with Obstetrical Complications and Monitoring Injury of Scalp of Newborn, run by University Hospital, Lille at 1 site in France.
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 8 Dec 2025. 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 France. 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?
Fetal heart rate with the TOCONAUTE (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05263427, which also lists 1 linked publication.
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 8 Dec 2025.