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

Sponsor
University of Oslo (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04446949
Collaborator
Norwegian Women's Public Health Association (NKS) (Other), Oslo Church City Mission (Other), Red Cross (Other), Department of Emergency General Practice (DEGP) Oslo and Bergen (Other)
70,000
85

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Register follow-up

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?

  2. 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.

  3. 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.

  4. 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.

  5. 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?

  6. Give a descriptive summary of the population of undocumented migrants seeking emergency care at the DEGPs, in particular pregnant undocumented migrants seeking care.

  7. 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.

  8. 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.

  9. 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?

  10. 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.

  11. 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

Study Type:
Observational
Anticipated Enrollment :
70000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Documenting the Undocumented - The Use of Maternal Health Care and Pregnancy Outcomes in Undocumented Migrant Women in Norway.
Anticipated Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Feb 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Undocumented migrants

Other: Register follow-up
Number of adverse pregnancy outcomes

Immigrants with Norwegian ID

Other: Register follow-up
Number of adverse pregnancy outcomes

Norwegian residents

Other: Register follow-up
Number of adverse pregnancy outcomes

Outcome Measures

Primary Outcome Measures

  1. Adverse pregnancy outcomes [1999-2020]

    From medical records and the Medical Birth Registry

  2. Primary health care use by undocumented pregnant migrants [2007-2020]

    From voluntary clinics and emergency units

Secondary Outcome Measures

  1. Health care use of undocumented migrants in general [2007-2020]

    From voluntary clinics and emergency units

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • No registered Norwegian identity number

  • Female

Exclusion Criteria:
  • Male

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Oslo
  • Norwegian Women's Public Health Association (NKS)
  • Oslo Church City Mission
  • Red Cross
  • Department of Emergency General Practice (DEGP) Oslo and Bergen

Investigators

  • Principal Investigator: Cecilie Dahl, PhD, MPH, University of Oslo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cecilie Dahl, Dr. Cecilie Dahl, University of Oslo
ClinicalTrials.gov Identifier:
NCT04446949
Other Study ID Numbers:
  • 68329
First Posted:
Jun 25, 2020
Last Update Posted:
Jun 25, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cecilie Dahl, Dr. Cecilie Dahl, University of Oslo

Study Results

No Results Posted as of Jun 25, 2020