NCT03687879

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
799

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

26 active sites

Status
completed

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

September 17, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 13, 2019

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

2 months

First QC Date

September 21, 2018

Last Update Submit

August 14, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    at 2 months

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 .

You may qualify if:

  • major women
  • who understand french language

You may not qualify if:

  • Women refusing to participate
  • having given birth at home
  • whose fetus or newborn has died

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Hôpital Privé d'Ambérieu

Ambérieu-en-Bugey, 01500, France

Location

Polyclinique du Beaujolais

Arnas, 69480, France

Location

CH d'ARDECHE MERIDIONALE

Aubenas, 07200, France

Location

CH de BOURG EN BRESSE - Pôle Mère Enfant

Bourg-en-Bresse, 01012, France

Location

Centre Hospitalier Pierre Oudot

Bourgoin, 38300, France

Location

Clinique St Vincent de Paul

Bourgoin, 38300, France

Location

Hôpital Femme Mère Enfant

Bron, 69500, France

Location

Clinique du Val D'ouest

Écully, 69130, France

Location

Centre Hospitalier de Givors

Givors, 69700, France

Location

Centre Hospitalier de Villefranche Sur Saône Hôpital Nord-Ouest

Gleizé, 69400, France

Location

Hôpital Privé Drôme Ardèche Clinique Pasteur

Guilherand-Granges, 07500, France

Location

Réseau AURORE, service de gynécologie Obstétrique, Hôpital de la Croix-Rousse

Lyon, 69004, France

Location

Centre Hospitalier St Joseph St Luc

Lyon, 69007, France

Location

Hôpital Prive Natecia

Lyon, 69008, France

Location

Hôpital de La Croix-Rousse

Lyon, 69317, France

Location

Ch Montelimar Ghpp

Montélimar, 26200, France

Location

CH du HAUT-BUGEY

Oyonnax, 01117, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69310, France

Location

Polyclinique Lyon Nord Service Maternité (NATECIA)

Rillieux-la-Pape, 69140, France

Location

Hôpitaux Drôme Nord - Site de Romans

Romans-sur-Isère, 26100, France

Location

Centre Hospitalier de Sainte Foy les Lyon

Sainte-Foy-lès-Lyon, 69110, France

Location

Centre Hospitalier de Valence

Valence, 26953, France

Location

Clinique de l'Union

Vaulx-en-Velin, 69380, France

Location

Ghm Les Portes Du Sud

Vénissieux, 69200, France

Location

Ch Vienne Lucien Hussel

Vienne, 38209, France

Location

Clinique du Tonkin

Villeurbanne, 69100, France

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 27, 2018

Study Start

September 17, 2018

Primary Completion

November 23, 2018

Study Completion

January 13, 2019

Last Updated

August 15, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations