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

NCT03461640 | Completed

• 1 other identifier: K63135016
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Labor Pain; Satisfaction, Consumer; Language; Birth Depression; Childbirth Problems

Outcome Measures

Primary Outcomes (2)

• Maternal wellbeing

  Maternal wellbeing as measured with the Edinburgh Postnatal Depression Scale (EPDS) (comparisons of mean values)

  6-8 weeks post partum

• Women's overall ratings of labour care

  Single item question:In general, were you happy with the healthcare you received? Very happy to No, not so happy.

  6-8 weeks post partum

Secondary Outcomes (8)

• Experience of birth

  6-8 weeks postpartum

• Epidural analgesia

  Immediately after the birth

• Length of labour

  Immediately after the birth

• Mode of birth

  Immediately after the birth

• Apgar score

  5 minutes after the birth

Study Arms (2)

Community-based doula support for labour

EXPERIMENTAL

Women will receive support from a Community-based doula (CBD) plus standard labour support. Women will meet twice with the CBD 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. The CBD will then stay with her throughout her labour and birth and support her with interpretation/Communication with the staff and emotional and instrumental support. The CBD-support will be in addition to any other support people she may have, such as her partner. Note: Women partner and/or other support people to accompany throughout her childbirth will be allowed, regardless of their trial allocation. CBDs will be recruited, trained and employed by non-profit organization MIRA, using well-tested processes.

Other: Community-based doula support for labour; Behavioral: Standard labour support

Standard labour support

ACTIVE COMPARATOR

Standard labour support by health care providers only. Women allocated to the comparison arm of the trial will receive standard intrapartum care as provided at their chosen hospital of birth. That is emotional, information and instrumental support from a helping nurse or a midwife or in some cases a doctor. The support includes caring actions, such as comforting, massage, information and presence. Note: Women partner and/or other support people to accompany throughout her childbirth will be allowed, regardless of their trial allocation.

Other: Community-based doula support for labour; Behavioral: Standard labour support

Interventions

Community-based doula support for labour OTHER

CBDs will be recruited, trained and employed by non-profit organization MIRA. 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.

Community-based doula support for labour; Standard labour support

Standard labour support BEHAVIORAL

Standard labour support by health care providers only. Women allocated to the comparison arm of the trial will receive standard intrapartum care as provided at their chosen hospital of birth. That is emotional, information and instrumental support from a helping nurse or a midwife or in some cases a doctor. The support includes caring actions, such as comforting, massage, information and presence. Note: Women partner and/or other support people to accompany throughout her childbirth will be allowed, regardless of their trial allocation.

Community-based doula support for labour; Standard labour support

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nulliparous and multiparous pregnant women
• weeks gestation
• Somali-, Arabic-, Russian- or Tigrinya-speaking
• Cannot communicate fluently in Swedish
• No contra-indications for vaginal birth

You may not qualify if:

• Planned caesarean birth
• Not consenting to access to their birth records
• years old or younger

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Erica Schytt

Stockholm, Sweden

Location

Related Publications (2)

• Schytt E, Wahlberg A, Eltayb A, Tsekhmestruk N, Small R, Lindgren H. Community-based bilingual doula support during labour and birth to improve migrant women's intrapartum care experiences and emotional well-being-Findings from a randomised controlled trial in Stockholm, Sweden [NCT03461640]. PLoS One. 2022 Nov 18;17(11):e0277533. doi: 10.1371/journal.pone.0277533. eCollection 2022.

  PMID: 36399476 DERIVED

• Schytt E, Wahlberg A, Eltayb A, Small R, Tsekhmestruk N, Lindgren H. Community-based doula support for migrant women during labour and birth: study protocol for a randomised controlled trial in Stockholm, Sweden (NCT03461640). BMJ Open. 2020 Feb 18;10(2):e031290. doi: 10.1136/bmjopen-2019-031290.

  PMID: 32075823 DERIVED

MeSH Terms

Conditions

Labor Pain; Consumer Behavior; Language

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Communication

Study Officials

• Erica Schytt, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 12, 2018
• Study Start: March 10, 2018
• Primary Completion: May 5, 2020
• Study Completion: May 5, 2020
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)