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NCT02814344 Clinical Trial

Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour

Pregnancy Clinical Trial

— PropEHG  

Official title:
Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02814344
Other study ID # PI10-PR-GONDRY
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date August 9, 2011
Est. completion date October 10, 2017

Study information
Verified date July 2020
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 27
Est. completion date October 10, 2017
Est. primary completion date October 10, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- singleton pregnancy

Exclusion Criteria:

- Minor patient

- twin pregnancy or more

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Electrohysterography

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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