Group Antenatal Care for Somali Born Women

NCT03879200 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2020-11-03

No results posted yet for this study

Summary

Somali-born women comprise one of the largest groups of immigrant women of childbearing age in Sweden, with increased risks for perinatal morbidity and mortality and poor experiences of care. Midwives in antenatal care have expressed a need for development of care tailored for this group of women.

The overall aim is to develop and test the acceptability and immediate impacts of group antenatal care for Somali women residing in Sweden, in an effort to improve their experiences of antenatal care, their knowledge about childbearing and the Swedish health care system, their emotional wellbeing and ultimately, their pregnancy outcomes.

The study includes four steps:

Step I is the preparation phase including needs assessment. Step II is the intervention development and evaluation tool development phase. Step III is the intervention phase, which includes the implementation and evaluation of the intervention using historical controls.

Step IV is the process evaluation and "lessons learned". Historical controls (n=80) have received standard individual care according to the national Swedish program for antenatal care, i.e. 8-9 appointments with a midwife during a normal pregnancy. Women in the intervention group (n=80) receive Group Antenatal Care provided in group sessions in a dialogue sensitive to language and cultural issues. The sessions are led by a midwife, assisted by a trained female Somali interpreter. 15 minutes for individual checkups in privacy are provided at end of the session.

Primary outcomes: Women's overall ratings of antenatal care and views about specific aspects of care are captured by core questions in the Migrant Friendly Maternity Care Questionnaire (MFMCQ); and emotional wellbeing by the Edinburgh Postnatal Depression Scale (EPDS).

Data are collected at recruitment, in gestational week 36 and at 2 months postpartum by means of face-to face interviews or interviews by telephone by a trained bilingual research assistant.

Conditions

  • Antenatal Care
  • Immigrant
  • Pregnancy

Interventions

OTHER

Group antenatal care

Care will be provided in group sessions in dialogue sensitive to language and cultural issues. Group numbers will be around 8; the woman with partner or other companion welcome. The content of the sessions will be designed in collaboration with midwives and Somali born women, following the present parental education and findings from the focus groups. The sessions will be held at the antenatal clinic led by one or two midwife, assisted by the trained female Somali interpreter.

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER
  • La Trobe University

    collaborator OTHER
  • Dalarna University

    collaborator OTHER
  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Erica Schytt, Professor · Karolinska Institute/Centre for Clinical Research Dalarna/West Norway University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2020-05-16
Completion
2020-05-30

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03879200 on ClinicalTrials.gov