Transients and MigrantsNCT04446949
Maternal Health Care and Pregnancy Outcomes in Undocumented Migrant Women in Norway.
An observational study of Transients and Migrants and Primary Health Care, run by University of Oslo.
Trial summary
Little research on the health service utilization and the health situation of undocumented pregnant migrants has been performed previously, and it is essential to obtain more information on the services given, and to examine whether residency status is a risk factor in maternal and perinatal health among migrants.This… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Transients and Migrants, Primary Health Care, Pregnancy Outcome
- What is being tested?
- Register follow-up
- How many people
- 70,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2021to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: WP1: Women attending voluntary clinics for primary care to undocumented migrants in Oslo and Bergen WP2: Patients without a national ID receiving treatment at the emergency care units in Oslo and Bergen WP3: Women registered to give birth in the Medical Birth Registry of Norway (probably undocumented migrants without a Norwegian ID, Norwegian residents with an immigration background, Norwegian-born women)
Who may be able to join
- No registered Norwegian identity number
- Female
Who cannot join
- Male
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Documenting the Undocumented - The Use of Maternal Health Care and Pregnancy Outcomes in Undocumented Migrant Women in Norway.
Little research on the health service utilization and the health situation of undocumented pregnant migrants has been performed previously, and it is essential to obtain more information on the services given, and to examine whether residency status is a risk factor in maternal and perinatal health among migrants.This project will give new knowledge on undocumented women seeking care at the voluntary clinics and the emergency clinics (DEGPs) in Oslo and Bergen, their health care needs, and the medical follow-up they are provided. The project will present new knowledge by showing trends in undocumented pregnant migrants care seeking compared to general trends among other migrants and Norwegian residents. It will also give new knowledge on pregnancy outcomes and perinatal health in undocumented migrants compared to foreign and Norwegian born women. This approach has not previously been used to study undocumented migrants in Norway, and there are very few similar studies in other European countries. Cause and effect relations are rarely claimed in findings from observational epidemiologic studies, however the information from three different sources (voluntary clinics, emergency clinics and Medical Birth Registry) will give an overall picture of the use of primary health care in undocumented pregnant migrants, as well as a comparative assessment of maternal outcomes in this population. The proposed research will also give important knowledge on how to conduct quantitative research in a population that is difficult to reach, and that is not commonly included in research.
Read the 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.
- Being tested
- Register follow-up
- Keywords
- Norway, Emergency care, Medical Birth Registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Register follow-upOther
Number of adverse pregnancy outcomes
| Study group | Role | What they receive |
|---|---|---|
| Undocumented migrants | Not described Receives: Other: Register follow-up | |
| Immigrants with Norwegian ID | Not described Receives: Other: Register follow-up | |
| Norwegian residents | Not described Receives: Other: Register follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse pregnancy outcomes
From medical records and the Medical Birth Registry
Measured: 1999-2020
Primary health care use by undocumented pregnant migrants
From voluntary clinics and emergency units
Measured: 2007-2020
Secondary outcomes (1)
Health care use of undocumented migrants in general
From voluntary clinics and emergency units
Measured: 2007-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study startJan 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transients and MigrantsStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 70,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Women's Public Health Association (NKS), Oslo Church City Mission, Red Cross, Department of Emergency General Practice (DEGP) Oslo and Bergen
- Responsible party
- Principal investigator, Cecilie Dahl, University of Oslo
- Investigators
- Cecilie Dahl, PhD, MPH, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446949
- Sponsor's protocol ID
- 68329
- Status last verified
- Jun 2020
- First submitted
- 22 Jun 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not allowed to share IPD due to GDPR regulations and Norwegian Law.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Documenting the Undocumented - The Use of Maternal Health Care and Pregnancy Outcomes in Undocumented Migrant Women in Norway.
- ClinicalTrials.gov ID
- NCT04446949
- Acronym / sponsor ID
- 68329
- Keywords
- Norway, Emergency care, Medical Birth Registry
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70,000 participants (estimated)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Norwegian Women's Public Health Association (NKS), Oslo Church City Mission, Red Cross, Department of Emergency General Practice (DEGP) Oslo and Bergen
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 25 Jun 2020 (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.
Little research on the health service utilization and the health situation of undocumented pregnant migrants has been performed previously, and it is essential to obtain more information on the services given, and to examine whether residency status is a risk factor in maternal and perinatal health among migrants.This project will give new knowledge on undocumented women seeking care at the voluntary clinics and the emergency clinics (DEGPs) in Oslo and Bergen, their health care needs, and the medical follow-up they are provided. The project will present new knowledge by showing trends in undocumented pregnant migrants care seeking compared to general trends among other migrants and Norwegian residents. It will also give new knowledge on pregnancy outcomes and perinatal health in undocumented migrants compared to foreign and Norwegian born women. This approach has not previously been used to study undocumented migrants in Norway, and there are very few similar studies in other European countries. Cause and effect relations are rarely claimed in findings from observational epidemiologic studies, however the information from three different sources (voluntary clinics, emergency clinics and Medical Birth Registry) will give an overall picture of the use of primary health care in undocumented pregnant migrants, as well as a comparative assessment of maternal outcomes in this population. The proposed research will also give important knowledge on how to conduct quantitative research in a population that is difficult to reach, and that is not commonly included in research.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Undocumented migrants | – | Other: Register follow-up |
| Immigrants with Norwegian ID | – | Other: Register follow-up |
| Norwegian residents | – | Other: Register follow-up |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- WP1: Women attending voluntary clinics for primary care to undocumented migrants in Oslo and Bergen WP2: Patients without a national ID receiving treatment at the emergency care units in Oslo and Bergen WP3: Women registered to give birth in the Medical Birth Registry of Norway (probably undocumented migrants without a Norwegian ID, Norwegian residents with an immigration background, Norwegian-born women)
Key inclusion criteria (2 listed)
- No registered Norwegian identity number
- Female
Key exclusion criteria (1 listed)
- Male
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 |
|---|---|---|
| Register follow-upNumber of adverse pregnancy outcomes | Other | Immigrants with Norwegian ID, Norwegian residents, Undocumented migrants |
Primary outcome
Adverse pregnancy outcomes
Time frame: 1999-2020
From medical records and the Medical Birth Registry
Primary health care use by undocumented pregnant migrants
Time frame: 2007-2020
From voluntary clinics and emergency units
1 secondary outcome
Health care use of undocumented migrants in general
Time frame: 2007-2020
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: No. We are not allowed to share IPD due to GDPR regulations and Norwegian Law.
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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.
Cecilie Dahl, PhD, MPH principal investigator
University of Oslo
Questions about this trial
What is this clinical trial studying?
An observational study of Transients and Migrants and Primary Health Care, run by University of Oslo.
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 1 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: opening soon, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frode Eick, M.Phil (+4793853244, Frode.Eick@bymisjon.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse pregnancy outcomes (time frame: 1999-2020). 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 25 Jun 2020.