Group Antenatal Care for Somali Born Women

NCT03879200 | Terminated

• 1 other identifier: Group Antenatal Care, Somali
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (3)

• Women's overall rating of antenatal care

  In general, were you happy with the healthcare you received? Always vs Often, Sometimes, Seldom, Never

  2 months postpartum

• Women's emotional wellbeing

  Edinburgh Postnatal Depression Scale . 10-item scale. Depressive symptoms cut-off 11/12, according to validation in Swedish women. Not yet validated in Somali migrant women in Sweden.

  2 months postpartum

• Women's emotional wellbeing

  Edinburgh Postnatal Depression Scale, mean values

  Late pregnancy and 2 months postpartum

Secondary Outcomes (10)

• Number of visits

  patient records. Just before the birth

• Social support

  2 months postpartum

• Social support

  Gestational week 36

• Worries about the upcoming birth

  Gestational week 36

• Anemia during pregnancy

  Gestational week 36

Study Arms (2)

Standard Individual care

NO INTERVENTION

Historical controls Individual care follows standard individual Swedish antenatal care, i.e.8-9 30 minutes appointments with a midwife during a normal pregnancy including information and regular pregnancy check-ups. Women are offered classes (3 x 2 hours) that provide preparation for birth and parenthood according to the same guidelines. Obstetricians and general practitioners have a consultant role.

Group antenatal care

EXPERIMENTAL

Group antenatal care will follow the same guidelines as for individual care but with tailored content provided in language supported group sessions.

Other: Group antenatal care

Interventions

Group antenatal care OTHER

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.

Group antenatal care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Somali born women, both nulliparous and multiparous, \<23 gestational weeks giving consent to access their patient record data

You may not qualify if:

• Severe medical problem(s) requiring individual care only, as determined by the participating clinical practice

Sponsors & Collaborators

• Karolinska Institutet: lead
• Uppsala University: collaborator
• La Trobe University: collaborator
• Dalarna University: collaborator

Study Sites (2)

The Antenatal Clinic, Domnarvet

Borlänge, Sweden

Location

The Antenatal Care Clinic, Spånga-Tensta

Stockholm, Sweden

Location

Related Publications (2)

• Ahrne M, Byrskog U, Essen B, Andersson E, Small R, Schytt E. Group antenatal care compared with standard antenatal care for Somali-Swedish women: a historically controlled evaluation of the Hooyo Project. BMJ Open. 2023 Jan 25;13(1):e066000. doi: 10.1136/bmjopen-2022-066000.

  PMID: 36697050 DERIVED

• Ahrne M, Byrskog U, Essen B, Andersson E, Small R, Schytt E. Group antenatal care (gANC) for Somali-speaking women in Sweden - a process evaluation. BMC Pregnancy Childbirth. 2022 Sep 21;22(1):721. doi: 10.1186/s12884-022-05044-9.

  PMID: 36131237 DERIVED

Related Links

• Website for the project

Study Officials

• Erica Schytt, Professor

  Karolinska Institute/Centre for Clinical Research Dalarna/West Norway University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Recruitment of controls conducted meanwhile developing the intervention in collaborations with Somali born women, partners, midwives and project steering group.

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: March 18, 2019
• Study Start: May 25, 2018
• Primary Completion: May 16, 2020
• Study Completion: May 30, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)