Childbirth ProblemsEVA (ECE)NCT03687879
Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum
An observational study of Childbirth Problems and Pregnancy Related, run by Hospices Civils de Lyon at 26 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Childbirth Problems, Pregnancy Related, Behavior Problem
- What is being tested?
- Questionnaires
- How many people
- 799 participants
- Where
- 26 sitesFrance
- Study dates
- 17 Sep 2018to 13 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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 .
Who may be able to join
- major women
- who understand french language
Who cannot join
- Women refusing to participate
- having given birth at home
- whose fetus or newborn has died
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
Hôpital Privé d'Ambérieu
Ambérieu-en-Bugey, 01500
Polyclinique du Beaujolais
Arnas, 69480
CH d'ARDECHE MERIDIONALE
Aubenas, 07200
CH de BOURG EN BRESSE - Pôle Mère Enfant
Bourg-en-Bresse, 01012
Centre Hospitalier Pierre Oudot
Bourgoin, 38300
Clinique St Vincent de Paul
Bourgoin, 38300
Hôpital Femme Mère Enfant
Bron, 69500
Clinique du Val D'ouest
Écully, 69130
Centre Hospitalier de Givors
Givors, 69700
Centre Hospitalier de Villefranche Sur Saône Hôpital Nord-Ouest
Gleizé, 69400
Hôpital Privé Drôme Ardèche Clinique Pasteur
Guilherand-Granges, 07500
Réseau AURORE, service de gynécologie Obstétrique, Hôpital de la Croix-Rousse
Lyon, 69004
Centre Hospitalier St Joseph St Luc
Lyon, 69007
Hôpital Prive Natecia
Lyon, 69008
Hôpital de La Croix-Rousse
Lyon, 69317
Ch Montelimar Ghpp
Montélimar, 26200
CH du HAUT-BUGEY
Oyonnax, 01117
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69310
Polyclinique Lyon Nord Service Maternité (NATECIA)
Rillieux-la-Pape, 69140
Hôpitaux Drôme Nord - Site de Romans
Romans-sur-Isère, 26100
Centre Hospitalier de Sainte Foy les Lyon
Sainte-Foy-lès-Lyon, 69110
Centre Hospitalier de Valence
Valence, 26953
Clinique de l'Union
Vaulx-en-Velin, 69380
Ghm Les Portes Du Sud
Vénissieux, 69200
Ch Vienne Lucien Hussel
Vienne, 38209
Clinique du Tonkin
Villeurbanne, 69100
About this study
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.
- Conditions
- Childbirth Problems, Pregnancy Related, Behavior Problem
- Being tested
- Questionnaires
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Reporting of 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 among women giving birth in one of the 26 maternity hospitals in the period of observation period.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women reporting inappropriate behavior
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.
Measured: about 1 week
Proportion of women reporting inappropriate behavior
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.
Measured: at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start17 Sep 2018
- Primary completion23 Nov 2018
- Study completion13 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childbirth ProblemsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 799 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687879
- Sponsor's protocol ID
- 69HCL18_0172
- Acronym
- EVA (ECE)
- Status last verified
- Aug 2019
- First submitted
- 21 Sep 2018
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Evaluation of the Childbirth Experience: From Pregnancy to Postpartum
- ClinicalTrials.gov ID
- NCT03687879
- Acronym / sponsor ID
- EVA (ECE) / 69HCL18_0172
- Conditions
- Childbirth Problems, Pregnancy Related, Behavior Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 799 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 17 Sep 2018 (actual)
- Primary completion
- 23 Nov 2018 (actual)
- Study completion
- 13 Jan 2019 (actual)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (2 listed)
- major women
- who understand french language
Key exclusion criteria (3 listed)
- Women refusing to participate
- having given birth at home
- whose fetus or newborn has died
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesReporting of 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 among women giving birth in one of the 26 maternity hospitals in the period of observation period. | Other | – |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childbirth Problems and Pregnancy Related, run by Hospices Civils de Lyon at 26 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women reporting inappropriate behavior (time frame: about 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.