Maternal-Fetal Monitoring by Connected Abdominal Patch - MOMA
NCT ID: NCT05263427
Last Updated: 2025-12-08
Study Results
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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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-08-31
2023-11-03
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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TOCONAUTE and gold standard : cardiotocograph
TOCONAUTE
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.
Interventions
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TOCONAUTE
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Singleton
* Cephalic presentation
Exclusion Criteria
* Death in utero
* Multiple pregnancy
18 Years
45 Years
FEMALE
No
Sponsors
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Clinical Investigation Centre for Innovative Technology Network
NETWORK
BioSerenity
INDUSTRY
National Research Agency, France
OTHER
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Charles Garabedian, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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Hop Jeanne de Flandre Chu Lille
Lille, , France
Countries
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References
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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.
Other Identifiers
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2022-A00107-36
Identifier Type: OTHER
Identifier Source: secondary_id
ANR-18-CE19-0015-01
Identifier Type: OTHER
Identifier Source: secondary_id
2021_0548
Identifier Type: -
Identifier Source: org_study_id
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