Clinical trial NCT04446949: Maternal Health Care and Pregnancy Outcomes in Undocumented Migrant Women in Norway.
Official title: Documenting the Undocumented - The Use of Maternal Health Care and Pregnancy Outcomes in Undocumented Migrant Women in Norway.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Transients and Migrants
Primary Health Care
Pregnancy Outcome
Keywords: Norway
Emergency care
Medical Birth Registry
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Norwegian Women's Public Health Association (NKS)
name: Oslo Church City Mission
name: Red Cross
name: Department of Emergency General Practice (DEGP) Oslo and Bergen
First posted: 2020-06-25
Enrollment: 70000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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)

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.

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.

Eligibility criteria: Inclusion Criteria:

* No registered Norwegian identity number
* Female

Exclusion Criteria:

* Male

Primary outcomes:
measure: Adverse pregnancy outcomes
timeFrame: 1999-2020
measure: Primary health care use by undocumented pregnant migrants
timeFrame: 2007-2020
Secondary outcomes:
measure: Health care use of undocumented migrants in general
timeFrame: 2007-2020
Other outcomes:
Locations:
Study officials:
affiliation: University of Oslo
name: Cecilie Dahl, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: