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Group Antenatal Care for Somali Born Women

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ClinicalTrials.gov Identifier: NCT03879200
Recruitment Status : Terminated (Limited time frame and financial resources. The anticipated increase of eligable migrant women did not occur during the period because of changes in migration policies.)
First Posted : March 18, 2019
Last Update Posted : November 3, 2020
Sponsor:
Collaborators:
Uppsala University
La Trobe University
Dalarna University
Information provided by (Responsible Party):
Erica Schytt, Karolinska Institutet

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.


Condition or disease Intervention/treatment Phase
Antenatal Care Immigrant Pregnancy Other: Group antenatal care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Recruitment of controls conducted meanwhile developing the intervention in collaborations with Somali born women, partners, midwives and project steering group.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Group Antenatal Care for Somali Born Women: a Feasibility Study Including Intervention Development and Evaluation
Actual Study Start Date : May 25, 2018
Actual Primary Completion Date : May 16, 2020
Actual Study Completion Date : May 30, 2020

Arm Intervention/treatment
No Intervention: Standard Individual care
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.
Experimental: Group antenatal care
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
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.




Primary Outcome Measures :
  1. Women's overall rating of antenatal care [ Time Frame: 2 months postpartum ]
    In general, were you happy with the healthcare you received? Always vs Often, Sometimes, Seldom, Never

  2. Women's emotional wellbeing [ Time Frame: 2 months postpartum ]
    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.

  3. Women's emotional wellbeing [ Time Frame: Late pregnancy and 2 months postpartum ]
    Edinburgh Postnatal Depression Scale, mean values


Secondary Outcome Measures :
  1. Number of visits [ Time Frame: patient records. Just before the birth ]
    The Adequacy of Prenatal Care Utilization Index (APCUI)

  2. Social support [ Time Frame: 2 months postpartum ]
    sum of 6 items (inspired by the Pregnancy Risk Assessment Monitoring System (PRAMS))

  3. Social support [ Time Frame: Gestational week 36 ]
    sum of 7 items (inspired by the PRAMS)

  4. Worries about the upcoming birth [ Time Frame: Gestational week 36 ]
    Cambridge Worry Scale. Single item questions (not a summated rating scale). Not worried, a little worried, very worried

  5. Anemia during pregnancy [ Time Frame: Gestational week 36 ]
    Patient record data: yes/no

  6. Induction of labour [ Time Frame: Before active phase ]
    Patient record data: Induction (yes/no)

  7. Mode of birth [ Time Frame: At birth ]
    Patient record data: Mode of birth: normal vaginal, instrumental vaginal, elective caesarean, emergency caesarean

  8. Epidural analgesia for labour pain [ Time Frame: During active phase of labour ]
    Patient record data: yes/no

  9. Apgar score <7 [ Time Frame: At 5 minutes after the birth ]
    Patient record data

  10. Need for neonatal infant intensive care (NICU) [ Time Frame: within 7 days from birth ]
    Patient record data: yes/no



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03879200


Locations
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Sweden
The Antenatal Clinic, Domnarvet
Borlänge, Sweden
The Antenatal Care Clinic, Spånga-Tensta
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Uppsala University
La Trobe University
Dalarna University
Investigators
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Principal Investigator: Erica Schytt, Professor Karolinska Institute/Centre for Clinical Research Dalarna/West Norway University
Additional Information:
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Responsible Party: Erica Schytt, Associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03879200    
Other Study ID Numbers: Group Antenatal Care, Somali
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No