Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03461640 |
| Other study ID # |
K63135016 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 10, 2018 |
| Est. completion date |
May 5, 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
One initiative to address communication problems between migrant women not fluent in Swedish
and caregivers throughout childbirth is to provide language assistance, cultural
interpretation and labour support to the woman through Community Based Doulas (CBDs). CBDs
are bilingual women from migrant communities trained by midwives to provide cultural,
language and labour support to migrant women throughout their labour and birth.
The study will evaluate the effectiveness of community-based doula support for improving the
intrapartum care experiences and postnatal wellbeing of Somali-, Tigrinya -, Arabic- and
Russian-speaking migrant women giving birth in Stockholm, Sweden.
The randomisation ratio will be 1:1; CBD support in addition to standard intrapartum care or
standard intrapartum care. Women allocated to receive CBD support in addition to standard
intrapartum care (intervention group), will be contacted by a Somali, Arabic-, Russian- or
Tigrinya-speaking CBD as appropriate, and arrangements will be made for the doula and the
women to meet twice prior to the birth to get to know each other and discuss the woman's
wishes regarding support in labour and what the CBD can offer. Each woman will then contact
her CBD when she goes into labour and the CBD will attend hospital with her and stay with her
throughout labour and birth, in addition to any other support people she may have, such as
her partner. Women allocated to the comparison arm of the trial will receive standard
intrapartum care as provided at their chosen hospital of birth.
The hypothesis is that women randomised to receive CBD support in labour will rate their care
for labour and birth more highly and have better emotional wellbeing (lower mean scores on
the Edinburgh Postnatal Depression Scale) two months after birth than women allocated to
standard care.
Description:
In Sweden, the proportion of births to migrant women has more than doubled over the last four
decades, from 10% in 1973 to 28% in 2015. Migrant women are at increased risk of adverse
pregnancy outcomes as low birth weight, infant small for gestational age , congenital
malformations, stillbirth, neonatal morbidity and mortality and also obstetric interventions,
such as induction of labour and caesarean section. Unfamiliarity with the health care system,
language barriers, knowledge gaps and cultural issues are all obstacles that play a vital
role in migrant women deprivation from achieving the standard maternal health care.
Migrant women have shown to consistently rate their maternity care more negatively in
contrast with Swedish women, mainly due to lack of knowledge on how Swedish health care
system is functioning and providing care which consequently cause communication difficulties,
in addition to discrimination and prejudicial staff attitudes. Migrant women reported being
left alone in labour, and feeling fearful, insecure and unsupported. Factors to be targeted
to improve experiences of care and pregnancy outcomes include; breaking down language
barriers and bridging cultural gaps, increasing familiarity with and enhancing understanding
of Swedish maternity care, and empowering women's sense of safety and confidence in giving
birth.
In Sweden, migration of women of childbearing age has increased most rapidly from Somalia and
from a number of Arabic-speaking countries and also Eritrea and Russia. Somali women are
known to be at highest risk of perinatal morbidity and mortality, they have problems engaging
with Swedish antenatal care and because of communication and language barriers they reported
to have the poorer experiences of care regarding labour and birth. Like Somali-women, many
Arabic-speaking and Tigrinya-speaking women (from Eritrea) have relocated in Sweden after
traumatic experiences of war and conflict. They, and the Russian women, constitute a growing
group of women giving birth in Sweden with little knowledge of how Swedish maternity care
operates and facing major communication barriers.
One initiative that has addressed communication problems between migrant women and the
caregivers throughout childbirth was to provide language assistance and labour support , the
Community Based Doula (Doula och kulturtolk) Project. CBDs are bilingual women from migrant
communities trained by expert midwives to provide support for migrant women in labour and
birth. CBDs meet twice with the migrant women prior to the birth, accompany her throughout
the labour and provide emotional, physical support and communication; and language
assistance; they meet again for follow up twice after the childbirth. Two small qualitative
evaluations, conducted in the early years of the program, indicate high levels of
satisfaction among supported women and midwives.
Current evidence supports the potential for CBDs to play an important role in improving
continuity for migrant women during labour and birth, enhancing their experiences of birth
and of care, as improving their pregnancy outcomes. Good physical and emotional support in
labour is known to improve a range of outcomes; greater maternal satisfaction with care, less
use of analgesia, shorter labours, lower rates of caesarean section and more spontaneous
vaginal birth - with no adverse effects for women or infants.
Worldwide, no randomised controlled trials of doula support for migrant women have been
reported, though two US non-randomised studies are relevant. One evaluated a hospital-based
doula service provided to 123 of 348 Somali women giving birth in the study period. Lower
rates of caesarean section (17% vs 26%) and greater satisfaction with care were found among
the doula-supported Somali women17. Staff also felt more confident to care for Somali women
when an English-speaking Somali doula was present. A second retrospective cohort study (n=11
471) evaluated a community doula program in an urban, culturally diverse setting and found a
small but statistically significant reduction in caesarean section among women cared for by a
midwife and a doula, compared with a midwife alone (15% vs 18%)18. Studies of midwives' views
of working alongside labour companions have been positive14, 18.
In the Swedish setting, more robust and specific evidence is needed to support decisions
whether to implement CBDs for migrant women at large-scale or not. Therefore, to evaluate the
effectiveness of doula support to Somali, Eritrean, Arabic and Russian-speaking migrants we
will here conduct a randomized controlled trial in Stockholm.
Aim To evaluate the effectiveness of community-based doula support for improving the
intrapartum care experiences and postnatal wellbeing of Somali, Eritrean, Arabic and
Russian-speaking migrant women giving birth in Stockholm.
Hypotheses
1. That women randomised to receive CBD support in labour will rate their care for labour
and birth more highly and have better emotional wellbeing (lower mean scores on the
Edinburgh Postnatal Depression Scale) two months after birth than women allocated to
standard care.
2. That midwives and obstetricians caring for women randomised to receive CBD support will
rate their provision of care more positively than when caring for women not supported.
Methods We plan a randomised controlled trial as a prospective evaluation of CBD support for
migrant women in Stockholm, something not achieved when the original CBD program commenced in
Gothenburg in 2008. The proposed trial will provide further and more rigorous evidence about
the effectiveness of CBDs for improving migrant women's experiences of care and ultimately
pregnancy outcomes for both mothers and infants. The study is designed to meet the CONSORT
guidelines for reporting of randomised trials16 and will be registered in Clinical Trials.
Participants Migrant women from Somali, Tigrinya, Arabic and Russian-speaking countries will
be recruited.
Inclusion criteria: Nulliparous and multiparous pregnant women between 25-36 weeks gestation,
who are 18 years or older and from Somali-, Arabic-, Russian- and Tigrinya-speaking countries
with no contra-indications for vaginal birth and cannot communicate fluently in Swedish.
Exclusion criteria: Women <18 years or women for whom a caesarean birth is planned and women
not consenting to access to their birth records.
Recruitment: All Somali-, Arabic-, Russian and Tigrinya-speaking women cover the inclusion
criteria and will participate in the study. They will be recruited with the assistance of
interpreters during antenatal care visits between 25 and 36 weeks gestation.
Intervention - Community Based Doulas support Women allocated to receive CBD support will be
contacted by an either a Somali, Arabic-, Russian- or Tigrinya-speaking CBD as appropriate,
and arrangements made for them to meet twice prior to the birth to get to know each other and
discuss the woman's wishes regarding support in labour and what the CBD can offer. Each woman
will then contact her CBD when she goes into labour and the CBD will attend hospital with her
and stay with her throughout her labour and birth, in addition to any other support people
she may have, such as her partner.
CBDs will be recruited, trained and employed by non-profit organization MIRA, using
well-tested processes. A total of 10 CBDs will be employed for the four migrant groups,
ensuring the possibility of back-up when needed. Training content will cover the physiology
of childbirth and strategies for providing effective continuous support in labour, as well as
practical strategies for helping with communication/interpreting to enhance communication
between women and midwives and discussion of CBD roles and boundaries. CBDs will be employed
on an hourly basis to enable flexibility in timely provision of support to women in labour.
Support for CBDs will be provided by an experienced midwife.
Comparison - standard intrapartum care Women allocated to the comparison arm of the trial
will receive standard intrapartum care as provided at their chosen hospital of birth.
Women partner and/or other support people to accompany throughout her childbirth will be
allowed, regardless of their trial allocation.
Randomisation and blinding Women will be randomly allocated to the intervention or control
group utilising a computerised randomisation schedule. The randomisation ratio will be 1:1,
CBD support to usual care, with block sizes of 4 or 6 distributed randomly. Allocations will
be prepared in sealed, opaque envelopes accessible in a central location for antenatal
recruiting midwives to access. Participants cannot be blinded in this study, however data
collection and analysis will be undertaken blinded to group allocation.
Primary outcomes Women's ratings of care for labour and birth and maternal emotional
wellbeing. Single item question from the Migrant Friendly Maternity Care Questionnaire
(MFMCQ) will be used to assess women's ratings of care the Edinburgh Postnatal Depression
Scale (the EPDS) will be used to assess maternal wellbeing.
Secondary outcomes Epidural analgesia, length of labour from admission and mode of birth.
Data will be retrieved from hospital patient records will enable assessment of birth
outcomes.
Data collection Trained bilingual researcher and research assistants will collect data on
women's experiences of care by telephone or face-to-face interviews as appropriate, conducted
at base-line and two months after birth. Birth outcome data for all trial participants will
be extracted from patient records.
Sample size To detect an increase in women's ratings of intrapartum care from an expected 30%
rating care as very good among those receiving usual care (based on estimates from studies of
migrant women not fluent in the host country language) 22-24 to 53% in those receiving CBD
support, (equal to Swedish speaking women in a national population based study) with 80%
power and an alpha of 20%, 69 women in each group are needed. To have similar power to detect
differences in mean scores on the Edinburgh Postnatal Depression Scale (a hypothesised
reduction from a mean of 8.0 in the comparison group - similar to that found in studies of
migrant women, to 6.0 in the intervention group - similar to that found in Swedish
population-based studies), 63 women are required in each arm. Allowing for 20% loss to
follow-up at the time of follow-up data collection with women two months postpartum, we
expect to have outcome data on views of care and depressive symptoms for at least 100 women
in each trial arm.
Statistical analysis First step of analysis will check the comparability of the groups, then
the intervention group will be compared with the control group testing trial hypotheses and
using intention to treat analyses. Odds ratios and 95% confidence intervals will then be
estimated. If there are baseline differences on key participant characteristics (such as age,
marital status, and medical conditions) between trial arms, logistic regression analyses will
be performed adjusting for these differences. Comparison of means will be undertaken using
t-tests where data are normally distributed, or medians compared using Mann-Whitney U tests
used if not.
