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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
      • 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
      • Bourgoin-Jallieu, France, 38300
        • Clinique St Vincent de Paul
      • Bron, France, 69500
        • Hôpital Femme Mère Enfant
      • Givors, France, 69700
        • Centre hospitalier de Givors
      • Gleizé, France, 69400
        • Centre Hospitalier de Villefranche Sur Saône Hôpital Nord-Ouest
      • Guilherand-Granges, France, 07500
        • Hôpital Privé Drôme Ardèche Clinique Pasteur
      • Lyon, France, 69317
        • Hopital De La Croix-Rousse
      • Lyon, France, 69004
        • Réseau AURORE, service de gynécologie Obstétrique, Hôpital de la Croix-Rousse
      • Lyon, France, 69007
        • Centre Hospitalier St Joseph St Luc
      • Lyon, France, 69008
        • Hôpital Privé Natecia
      • Montélimar, France, 26200
        • Ch Montelimar Ghpp
      • Oyonnax, France, 01117
        • CH du Haut-Bugey
      • Pierre-Bénite, France, 69310
        • Centre Hospitalier Lyon Sud
      • Rillieux-la-Pape, France, 69140
        • Polyclinique Lyon Nord Service Maternité (NATECIA)
      • Romans-sur-Isère, France, 26100
        • Hôpitaux Drôme Nord - Site de Romans
      • Sainte-Foy-lès-Lyon, France, 69110
        • Centre Hospitalier de Sainte Foy les Lyon
      • Valence, France, 26953
        • Centre Hospitalier de Valence
      • Vaulx-en-Velin, France, 69380
        • Clinique de l'Union
      • Vienne, France, 38209
        • Ch Vienne Lucien Hussel
      • Villeurbanne, France, 69100
        • Clinique du Tonkin
      • Vénissieux, France, 69200
        • GHM les Portes du Sud
      • Écully, France, 69130
        • Clinique du Val d'Ouest

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 23, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 13, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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