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Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour
PropEHG
1 other identifier
observational
27
1 country
1
Brief Summary
The original aspect of the methodology proposed for this study concerns the use of as many as 16 electrodes to study the propagation and coordination (or synchronization) of uterine contraction. Over the last two years, the Compiègne University of Technology and the University of Reykjavik (Iceland) teams have developed the tools required to obtain good quality signals during electrohysterography and have worked on filtering and mapping of uterine electrical activity derived from these signals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Aug 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 9, 2011
CompletedFirst Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2017
CompletedJuly 15, 2020
July 1, 2020
6.2 years
June 23, 2016
July 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
parameter H2
To demonstrate a difference of propagation of the electrical signal during a physiological contraction of pregnancy and uterine contraction during delivery. The parameter H2 (nonlinear correlation coefficient) will be used to measure propagation of the electrical signal.
H2 value measured at each contraction during 1 hour
Study Arms (2)
pregnant women not in labour
from 24 weeks of gestation until term, provided that they are not in labour Electrohysterography
women in labour
Electrohysterography
Interventions
Eligibility Criteria
pregnant women
You may qualify if:
- singleton pregnancy
You may not qualify if:
- Minor patient
- twin pregnancy or more
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Amiens
Amiens, 80054, France
Study Officials
- PRINCIPAL INVESTIGATOR
Jean GONDRY, MD, PhD
CHU Amiens
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2016
First Posted
June 27, 2016
Study Start
August 9, 2011
Primary Completion
October 10, 2017
Study Completion
October 10, 2017
Last Updated
July 15, 2020
Record last verified: 2020-07