Pregnancy information utilized by pregnant women in the cantons of Geneva and Zurich

ISRCTN	ISRCTN10997593
DOI	https://doi.org/10.1186/ISRCTN10997593
Secondary identifying numbers	2016-00513

Submission date: 05/09/2016
Registration date: 12/10/2016
Last edited: 21/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Nicole Schmidt
Scientific

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

Study information

Study design	Prospective cross sectional study
Primary study design	Observational
Secondary study design	Cross sectional study
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Utilization and utility of pregnancy information for women during pregnancy in the cantons of Geneva an Zurich
Study acronym	COMIRES TAK
Study objectives	Non-Swiss women use less or other information during pregnancy than Swiss nationals and participate less in pregnancy activities.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/01/2016
Completion date	31/12/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	420
Key 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
Key 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
Date of first enrolment	20/06/2016
Date of final enrolment	30/10/2016

Locations

Countries of recruitment

Switzerland

Study participating centres

University Hospital Geneva

Departement of Obstetrics
30 Boulevard de la Cluse
Geneva
1205
Switzerland

University Hospital Zurich

Departement of Obstetrics
Frauenklinikstrasse 10
Zurich
8091
Switzerland

Sponsor information

Federal Office of Health
Government

Hessstrasse 27E
Bern
3003
Switzerland

Website	www.bag.admin.ch
"ROR"	https://ror.org/01qtc5416

Funders

Funder type

Hospital/treatment centre

University Hospital Geneva

No information available

Results and Publications

Intention to publish date	30/06/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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.
IPD sharing plan