NCT02814344

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2011

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

6.2 years

First QC Date

June 23, 2016

Last Update Submit

July 13, 2020

Conditions

Keywords

labour

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

Device: Electrohysterography

women in labour

Electrohysterography

Device: Electrohysterography

Interventions

pregnant women not in labourwomen in labour

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Study Officials

  • Jean GONDRY, MD, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

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

Locations