- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03687879
Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum (EVA (ECE))
August 14, 2019 updated by: Hospices Civils de Lyon
Women report inappropriate health professional behaviour towards them during pregnancy or childbirth on social networks.
However, to date, no data are available to estimate the number of women concerned.
These data are necessary to characterize these behaviours to get out of this polemic and build a reflection on the improvement of the patient relationship and the emotional security of women.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
799
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ambérieu-en-Bugey, France, 01500
- Hôpital Privé d'Ambérieu
-
Arnas, France, 69480
- Polyclinique du Beaujolais
-
Aubenas, France, 07200
- CH d'Ardèche méridionale
-
Bourg-en-Bresse, France, 01012
- CH de BOURG EN BRESSE - Pôle Mère Enfant
-
Bourgoin-Jallieu, France, 38300
- Centre hospitalier Pierre Oudot
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Bourgoin-Jallieu, France, 38300
- Clinique St Vincent de Paul
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Bron, France, 69500
- Hôpital Femme Mère Enfant
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Givors, France, 69700
- Centre hospitalier de Givors
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Gleizé, France, 69400
- Centre Hospitalier de Villefranche Sur Saône Hôpital Nord-Ouest
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Guilherand-Granges, France, 07500
- Hôpital Privé Drôme Ardèche Clinique Pasteur
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Lyon, France, 69317
- Hopital de la Croix-Rousse
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Lyon, France, 69004
- Réseau AURORE, service de gynécologie Obstétrique, Hôpital de la Croix-Rousse
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Lyon, France, 69007
- Centre Hospitalier St Joseph St Luc
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Lyon, France, 69008
- Hôpital Privé Natecia
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Montélimar, France, 26200
- Ch Montelimar Ghpp
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Oyonnax, France, 01117
- CH du Haut-Bugey
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Pierre-Bénite, France, 69310
- Centre Hospitalier Lyon Sud
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Rillieux-la-Pape, France, 69140
- Polyclinique Lyon Nord Service Maternité (NATECIA)
-
Romans-sur-Isère, France, 26100
- Hôpitaux Drôme Nord - Site de Romans
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Sainte-Foy-lès-Lyon, France, 69110
- Centre Hospitalier de Sainte Foy les Lyon
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Valence, France, 26953
- Centre Hospitalier de Valence
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Vaulx-en-Velin, France, 69380
- Clinique de l'Union
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Vienne, France, 38209
- Ch Vienne Lucien Hussel
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Villeurbanne, France, 69100
- Clinique du Tonkin
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Vénissieux, France, 69200
- GHM les Portes du Sud
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Écully, France, 69130
- Clinique du Val d'Ouest
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
All women having given birth of a living child, whatever the term, on 1 week of observation in one of the 26 maternity units participating .
Description
Inclusion Criteria:
- major women
- who understand french language
Exclusion Criteria:
- Women refusing to participate
- having given birth at home
- whose fetus or newborn has died
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of women reporting inappropriate behavior
Time Frame: about 1 week
|
An inappropriate behavior, also called "obstetric violence" is defined by medical gestures or acts, speech, embarrassing or hurtful attitudes during pregnancy follow-up or during hospitalization outside childbirth, or during childbirth or immediate after birth. Womens will compleat a questionnaire to report this inappropriate behavior at the exit of the maternity. |
about 1 week
|
Proportion of women reporting inappropriate behavior
Time Frame: at 2 months
|
An inappropriate behavior, also called "obstetric violence" is defined by medical gestures or acts, speech, embarrassing or hurtful attitudes reported by womens with a questionnaire 2 months after exit of the maternity.
|
at 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 17, 2018
Primary Completion (Actual)
November 23, 2018
Study Completion (Actual)
January 13, 2019
Study Registration Dates
First Submitted
September 21, 2018
First Submitted That Met QC Criteria
September 24, 2018
First Posted (Actual)
September 27, 2018
Study Record Updates
Last Update Posted (Actual)
August 15, 2019
Last Update Submitted That Met QC Criteria
August 14, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL18_0172
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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