Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03879200 |
| Other study ID # |
Group Antenatal Care, Somali |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 25, 2018 |
| Est. completion date |
May 30, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Karolinska Institutet |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Group antenatal care is developed in collaboration with Somali women, midwives and a
reference group; to suit Somali born women's needs. The intervention is now evaluated for
feasibility, acceptability and sustainability, by means of a historically controlled trial.
The study is a non-randomized feasibility study in which the intervention and material has
been developed parallel to the data collection for the control group; i.e. the historical
controls receiving standard care.
Specific objectives for the study are;
1. To establish with Somali-born women and antenatal caregivers the acceptability and
feasibility of group antenatal care and to develop an appropriate model in order to
improve outcomes for Somali-born women;
2. To establish appropriate recruitment and data collection procedures and outcome measures
in consultation with the Somali community and with care providers in order to evaluate
the new model; and
3. To implement and evaluate an agreed model of group antenatal care in partnership with
the Somali community and antenatal caregivers.
Methods:
Step I was the preparation phase, including needs assessment, the development of contextual
understanding and building a logic model for the project. A project steering group comprised
of research team members, antenatal care midwives and representatives of the Somali community
in Borlänge and North Stockholm was formed, to inform the intervention and the study. Somali
born women in local community settings were encountered to develop a fuller understanding of
issues and concerns about pregnancy and birth in a new country. The idea of group antenatal
care was also discussed with women antenatal care midwives for its relevance, attractiveness
and feasibility, and further how to best evaluate such a model. Focus group discussions were
conducted with the following groups: 1) Somali born mothers 2) Somali born fathers; all with
recent birth giving experience in Sweden, and 3) antenatal care midwives in multi-cultural
settings in Sweden. The discussions were tape recorded and analysed by means of thematic
analyses.
Step II was the intervention development and evaluation tool development phase. The knowledge
gained in the first step, was used to develop an appropriate Group Antenatal Care model in
dialogue with the project steering group and midwives. The participating midwives
participated in a two days education about group antenatal care facilitation of group
discussions, with input from the Steering Group representatives and findings in the focus
groups discussions to enhance their understanding. Participating interpreters were oriented
in the Swedish antenatal care system and the concept of group antenatal care. During this
phase information material regarding the study and the intervention, a manual for midwives
and tools for data collection were developed, and data collection for the historical controls
receiving standard care commenced.
Step III is the intervention phase, which has commenced. In this phase the implementation and
evaluation of the intervention is taking place.
The intervention and intervention group: Group antenatal care
The intervention is a developed group antenatal care to suit Somali women. Group antenatal
care follows the same guidelines as for individual care but with content tailored according
to findings in phase 1; i.e. based on person centred principles and dialogue by the use of
motivational interviewing in group. The main-part of the care is provided in group sessions
in a dialogue sensitive to language and cultural issues. Group numbers are around 8; the
woman and if she wishes, her partner and/or other chosen companion. The sessions is led by a
midwife, assisted by the trained female Somali interpreter/advocate. Two midwives takes turns
leading the sessions for continuity and back-up. Sessions will be held in the antenatal
clinic. Information and discussions include for instance sharing of information about being
pregnant and giving birth in Somalia and Sweden, differences in health care, role of and
trust in midwives and doctors, complications during pregnancy, labour and birth, and healthy
diet during pregnancy. One hour will be allocated for individual meetings with one of the
midwives (the same every time) in the clinic while the group members can chat and socialise.
The midwife will document attendance and compile a summary of the discussions in a checklist.
Primary outcomes: Women's overall rating of antenatal care and views about specific aspects
of care are captured by a core question in the Migrant Friendly Maternity Care Questionnaire
(MFMCQ) developed by the Reproductive Outcomes And Migration international research
collaboration (team members Small and Essen involved), now also translated and culturally
validated in Somali (by Essen) and available for use in this study. Women's emotional
wellbeing is measured by the EPDS, available in a Somali translation, but not yet fully
validated requiring further cultural validation as part of the development work for this
study.
Secondary outcomes: Adequate number of visits are measured by the The Adequacy of Prenatal
Care Utilization Index (APCUI), i.e. expected number of visits in relation to actual number
adjusted for gestational week at booking visit and delivery). Social support during
pregnancy, worries about the upcoming birth and knowledge about different aspects of
maternity care are assessed in interviews with women. Information about birth events and
infant health will be retrieved from patient records.
Data collection: The baseline measurement is conducted at recruitment, around gestational
week 20. A research assistant contacts women for a face-to-face interview in a place of their
choice. The interview follows the first questionnaire (Q1) including questions on background
(education, occupation), migration (time in country, reason for migration, migration status,
language) and social support, knowledge of the health system, pregnancy and birth and
expectations about the up-coming birth.
Follow-up interviews will take place around gestational week 36 and at two months postpartum
using a second and third questionnaire (Q2, Q3) with questions from the MFMCQ about
experiences of care received during the pregnancy and birth and attendance at parent
education classes. Maternal and infant data will be retrieved from the patient record and
include the following: gestational age at the first visit, Hemoglobin, S-Ferritin, weight
gain, relevant health conditions, total number of antenatal care visits, attendance at parent
education, mode of birth, interventions (induction of labour, pain relief including epidural,
oxytocin), blood loss, diagnoses (mother) and gestational age, birth weight, small for
gestational age, large for gestational age, head circumference, Apgar score, umbilical cord
pH, and the need for neonatal intensive care (infant). Midwives' experiences of different
aspects of the intervention will be collected by means of individual interviews.
Control group: Historical controls: Individual care
Individual care follow the present model of care according to the national Swedish program
for antenatal care, i.e.8-9 appointments with a midwife during a normal pregnancy. The visits
are scheduled for 30 minutes and include information and regular pregnancy check-ups. Women
are offered classes that provide preparation for birth and parenthood according to the same
guidelines and the present routine at the clinic. Midwives are the primary caregivers and
they meet the same women throughout pregnancy. Obstetricians and general practitioners will
have a consultant role.
Recruitment for both intervention and control groups:
In line with the actual birth rates and recruitment of one third of the Somali women at both
sites, 80 women have been recruited as historical controls (2017-2018) and 80 will
participate in the new model (2018-2019). Inclusion criteria are Somali born women 18 years
of age or beyond, both nulliparous and multiparous, <25 gestational weeks giving consent to
access their patient record data. The only exclusion criterion is severe medical problem(s)
requiring individual care only, as determined by the participating clinical practice.Women
are invited to participate with the help of bilingual research assistants and receive verbal
and written information in Somali about the study. A small gift will be offered for their
baby in appreciation for taking part.
Analyses:
Differences will be described as odds ratios and 95% confidence intervals after estimation by
means of logistic regression analyses. Comparison of means will be undertaken using t-tests
where data are normally distributed, or medians compared using Mann-Whitney U tests if not.
Step IV consists of a process evaluation using a mixed methods approach with data collection
conducted throughout the study. The process evaluation will address whether the intervention
was carried out according to plan, what was achieved, if and what adaptations were needed,
who was reached by the intervention, any unexpected events and to understand the mechanisms
of impact and what mediated these mechanisms. The process evaluation will also address
contextual factors.
