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Not yet recruitingNCT04446949Updated Jun 25, 2020

Maternal Health Care and Pregnancy Outcomes in Undocumented Migrant Women in Norway.

An observational study in Transients and Migrants, Primary Health Care and Pregnancy Outcome, sponsored by University of Oslo. Not yet recruiting. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-06-25.

Sponsored by University of Oslo · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
70,000
Ages
18 Years to 50 Years
Sex
Female
01

Study 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 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

  1. Work package 1 (WP1): What characterizes pregnant undocumented migrants attending the voluntary clinics in Oslo and Bergen from 2009 to 2020?

    1. 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.
    2. 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.
    3. 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.
  2. 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?

    1. Give a descriptive summary of the population of undocumented migrants seeking emergency care at the DEGPs, in particular pregnant undocumented migrants seeking care.
    2. 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.
    3. 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.
  3. 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?

    1. 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.
    2. 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.
02

Conditions studied

  • Transients and Migrants
  • Primary Health Care
  • Pregnancy Outcome

Keywords

  • Norway
  • Emergency care
  • Medical Birth Registry
03

In context

Lead sponsor

University of Oslo is the lead sponsor of 176 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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)

Inclusion criteria

  • No registered Norwegian identity number
  • Female

Exclusion criteria

Exclusion Criteria:

  • Male
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
70,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Undocumented migrants

    Other: Register follow-up

  • Immigrants with Norwegian ID

    Other: Register follow-up

  • Norwegian residents

    Other: Register follow-up

Interventions

  • OtherRegister follow-up

    Number of adverse pregnancy outcomes

06

What researchers measure

Primary outcomes

  1. Adverse pregnancy outcomes

    From medical records and the Medical Birth Registry

    Time frame: 1999-2020

  2. Primary health care use by undocumented pregnant migrants

    From voluntary clinics and emergency units

    Time frame: 2007-2020

Secondary outcomes

  1. Health care use of undocumented migrants in general

    From voluntary clinics and emergency units

    Time frame: 2007-2020

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — We are not allowed to share IPD due to GDPR regulations and Norwegian Law.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04446949
Lead sponsor
University of Oslo
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
Cecilie Dahl (Dr. Cecilie Dahl, University of Oslo) — Principal investigator
First posted
Jun 25, 2020
Start date
Jan 2021 (estimated)
Primary completion
Dec 2023 (estimated)
Completion
Feb 2028 (estimated)
Last update
Jun 25, 2020

Study contacts

Frode Eick, M.Phil
Contact
Frode.Eick@bymisjon.no
+4793853244
Cecilie Dahl, PhD, MPH
Contact
Cecilie.dahl@medisin.uio.no
+4740550210
Cecilie Dahl, PhD, MPH
principal investigator · University of Oslo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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