Condition category
Pregnancy and Childbirth
Date applied
05/09/2016
Date assigned
12/10/2016
Last edited
21/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Healthcare during pregnancy and childbirth have been found to be very different between migrants and the host population. Studies have reported that there is a higher risk of preterm bitch and complications (such as low birth weight and/or the need for care in hospital) in the migrant population. These findings are in line with the Swiss literature of the last two decades. In a recent study, Villadsen and colleagues suggested that the increased risk of negative pregnancy and childbirth outcomes might be among others due to inadequate provision and use of care. To use health care adequately health literacy (the ability to obtain, read and understand information about healthcare) is crucial. Therefore the first important step for pregnant women and their families is to find information and services, which are useful to ensure good health for mother and child. To our knowledge, until now no study in Switzerland has evaluated what information during pregnancy are useful for Swiss and migrant women. The aim of this study therefore is to find out the kind of information used and rated as beneficial by migrant and Swiss women during pregnancy and childbirth.

Who can participate?
Women aged 18 years and over who are at least 36 weeks pregnant or who are in the first 12 months after having given birth in the city of Zurich or Geneva.

What does the study involve?
All women are invited to complere a structured, anonymous questionnaire about their knowledge and use of healthcare resources during their pregnancy, as well as their opinions about the care they received. The questionnaire takes around 20 minutes to complete. The results of the study are then compared between Swiss nationals and migrant women.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved for those taking part in this study.

Where is the study run from?
1. University Hospitals of Geneva (Switzerland)
2. University Hospital Zurich (Switzerland)

When is the study starting and how long is it expected to run for?
January 2016 to December 2016

Who is funding the study?
University Hospital Geneva (Switzerland)

Who is the main contact?
Dr Nicole Schmidt

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicole Schmidt

ORCID ID

Contact details

Department of Obstetrics
University Hospital Geneva
30 Boulevard de la Cluse
Geneva
1205
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2016-00513

Study information

Scientific title

Utilization and utility of pregnancy information for women during pregnancy in the cantons of Geneva an Zurich

Acronym

COMIRES TAK

Study hypothesis

Non-Swiss women use less or other information during pregnancy than Swiss nationals and participate less in pregnancy activities.

Ethics approval

1. Ethical Commission of the Canton of Geneva, 09/06/2016, ref: 2016-00513
2. Ethical Commission of the University Hospital of Zurich, 09/06/2016

Study design

Prospective cross sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pregnancy

Intervention

The study will be conducted at the postpartum or the antenatal clinic ward in the Department of Obstetrics at the University Hospital of Geneva or the University of Zurich respectively. All women who fullfill the inclusion criteria will be invited after written consent to respond to a structured questionnaire exploring the knowledge and utilization of obstetric resources, but also experiences of care recieved. The questionnaire will be available in 8 of the predominant languages of the study site. The time to fill out the survey is approximatley 20 minutes.
There is no follow up after completion of the study survey.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Information utilized by participants and participation in birth preparation activities is measured through the structured questionnaire designed for the purpose of this study at the study visit.

Secondary outcome measures

Feelings of being well-informed and by what means is measured though the structured questionnaire designed for the purpose of this study at the study visit.

Overall trial start date

01/01/2016

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women who are at least 18 years of age
2. Women who are at least 36 weeks pregnant or who are in the first 12 months after having given birth in the city of Zurich or Geneva

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

420

Participant exclusion criteria

1. Women who have experienced stillbirth or whose baby is currently hospitalized at the neonatal ward
2. Women who are pregnant but hospitalized at the antenatal ward because of medical problems during their pregnancy

Recruitment start date

20/06/2016

Recruitment end date

30/10/2016

Locations

Countries of recruitment

Switzerland

Trial participating centre

University Hospital Geneva
Departement of Obstetrics 30 Boulevard de la Cluse
Geneva
1205
Switzerland

Trial participating centre

University Hospital Zurich
Departement of Obstetrics Frauenklinikstrasse 10
Zurich
8091
Switzerland

Sponsor information

Organisation

Federal Office of Health

Sponsor details

Hessstrasse 27E
Bern
3003
Switzerland

Sponsor type

Government

Website

www.bag.admin.ch

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Geneva

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of a paper discussing the difference in the utilization of information during pregnancy and participation in pregnancy activities between Swiss-nationals and non-Swiss-nationals.

Intention to publish date

30/06/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes