- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04446949
Maternal Health Care and Pregnancy Outcomes in Undocumented Migrant Women in Norway.
Documenting the Undocumented - The Use of Maternal Health Care and Pregnancy Outcomes in Undocumented Migrant Women in Norway.
Study Overview
Status
Intervention / Treatment
Detailed Description
Research questions and objectives
Work package 1 (WP1): What characterizes pregnant undocumented migrants attending the voluntary clinics in Oslo and Bergen from 2009 to 2020?
- Give a descriptive summary of the population of pregnant undocumented migrants seeking care (e.g. age, number of children, time stayed in Norway, work status, family network) and the medical problems they are presenting.
- Investigate the care received based on indicators such as number of antenatal visits and the extent of collaboration with or referral to other health facilities.
- Investigate the risk of pregnancy related complications (e.g. pre-eclampsia and gestational diabetes) and adverse perinatal outcomes (e.g. use of Caesarean Section and pre-term birth) in women seeking care at the clinics.
Work package 2 (WP2): Are there any consultation trends in pregnant undocumented migrants seeking emergency care at the emergency units (DEGPs) in Oslo and Bergen from 2007 to 2020?
- Give a descriptive summary of the population of undocumented migrants seeking emergency care at the DEGPs, in particular pregnant undocumented migrants seeking care.
- Investigate trends in emergency consultations at the DEGPs for pregnant undocumented migrants after the start of the voluntary clinics (2009/2014), comparing with the trends in consultations for the general population of pregnant women seeking care.
- Investigate trends in emergency consultations at the DEGPs for pregnant undocumented migrants after the start of the voluntary clinics (2009/2014), comparing to the trends in consultations for other undocumented migrants.
Work package 3 (WP3): What is the occurrence of pregnancy-related complications and adverse perinatal outcomes (as reported in the Medical Birth Registry of Norway) in patients without national identity number from 1999 to 2020?
- Investigate the prevalence of pregnancy related complications (e.g. pre-eclampsia, gestational diabetes, nutrient deficiency) in undocumented migrant women compared to foreign and Norwegian born women.
- Investigate the incidence of adverse perinatal outcomes (e.g. use of Caesarean section, pre-term birth, small for gestational age, low Apgar score) in undocumented migrant women compared with foreign and Norwegian born women.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Frode Eick, M.Phil
- Phone Number: +4793853244
- Email: Frode.Eick@bymisjon.no
Study Contact Backup
- Name: Cecilie Dahl, PhD, MPH
- Phone Number: +4740550210
- Email: Cecilie.dahl@medisin.uio.no
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- No registered Norwegian identity number
- Female
Exclusion Criteria:
- Male
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Undocumented migrants
|
Number of adverse pregnancy outcomes
|
Immigrants with Norwegian ID
|
Number of adverse pregnancy outcomes
|
Norwegian residents
|
Number of adverse pregnancy outcomes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse pregnancy outcomes
Time Frame: 1999-2020
|
From medical records and the Medical Birth Registry
|
1999-2020
|
Primary health care use by undocumented pregnant migrants
Time Frame: 2007-2020
|
From voluntary clinics and emergency units
|
2007-2020
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health care use of undocumented migrants in general
Time Frame: 2007-2020
|
From voluntary clinics and emergency units
|
2007-2020
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cecilie Dahl, PhD, MPH, University of Oslo
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 68329
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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