Community Based Doulas for Migrant Women in Labour and Birth in Sweden - a Randomised Controlled Trial
Community Based Doulas for Migrant Women in Labour and Birth in Sweden - a Randomised Controlled Trial
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.
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.
Inclusion Criteria:

 -  Nulliparous and multiparous pregnant women

 -  25-36 weeks gestation

 -  Somali-, Arabic-, Russian- or Tigrinya-speaking

 -  Cannot communicate fluently in Swedish

 -  No contra-indications for vaginal birth

 Exclusion Criteria:

 -  Planned caesarean birth

 -  Not consenting to access to their birth records

 -  17 years old or younger