TeamBirth-SWE - a Care Process to Improve Safe and Person-centered Intrapartum Care

NCT06926504 | Recruiting

• 2 other identifiers: 2023-03517-012024-02476
• Study Type: observational
• Target: 800,000
• Locations: 1 country
• Sites: 7

Brief Summary

The primary objective of this project is to enhance understanding of intrapartum patient safety and person-centered care through the evaluation of an intervention designed to improve team communication and patient involvement during childbirth, thereby positively impacting maternal and infant health. Despite various efforts to improve safety in intrapartum care, women and their infants are still harmed. Most adverse events within intrapartum care stem from communication and teamwork failures. Despite national and international recommendations, few interventions target patient safety by incorporating person-centered care. This project will investigate the effectiveness and implementation of the TeamBirth care process developed by Ariadne Labs Boston, U.S. to improve communication and teamwork among caregivers and women during childbirth. The Swedish version of this care process (TeamBirth-SWE) was adapted, tested, and piloted at Karolinska University Hospital during 2021. Hypothesis: We hypothesize that the TeamBirth-SWE intervention will have a positive impact on interprofessional teamwork, communication, information sharing, patient involvement, and shared decision-making during labor and birth. These improvements are expected to result in improved maternal and infant outcomes, process measures i.e., patient safety climate, interprofessional collaboration, and improved patient reported measures such as patient involvement, shared-decision-making, and satisfaction with care.

Conditions

Person Centered Care; Patient Safety; Patient Satisfaction

Keywords

person-centered care; intrapartum patient safety

Outcome Measures

Primary Outcomes (2)

• Birth without major interventions or complications

  The primary outcome is a composite measure including provided by the Swedish Pregnancy register and includes the following variables: no operative birth, no postpartum haemorrhage (\>1000 ml), no severe perineal trauma, and a 5-minute Apgar score \>=7.

  From labor ward admission to discharge home, to 4 hours postpartum.

• Shared intrapartum decision-making

  Were you involved in planning and decision-making to your desired extent? Likert type question in the Swedish National Pregnancy Survey

  PREM data collected 8 weeks after birth

Secondary Outcomes (23)

• Unplanned cesarean section

  At delivery/birth

• Spontaneous vaginal birth

  From labour onset to birth of the baby

• Instrumental birth

  From labour onset to instrumental birth performed

• Postpartum bleeding

  From brith of the baby to 4 hours after birth

• Severe perineal trauma

  Diagnosed at birth to 24 hours after birth

Interventions

The care process S-TeamBirth BEHAVIORAL

The intervention consists of the entire care team conducting huddles together with the birthing woman and her partner to plan the care, using the S-TeamBirth whiteboard to communicate and visualize decisions

S-TeamBirth BEHAVIORAL

Involving the entire care team including the woman and her partner in planning the care using team huddles and the S-TeamBirth whiteboard

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population consist of all women who fulfill the inclusion criteria at the participating labor wards.

You may qualify if:

• Spontaneous onset of labor
• Induction of labort
• Gestational week \>22+0

You may not qualify if:

• Planned cesarean section
• Intrauterine Fetal Demise
• Gestational week \<22+0, .

Sponsors & Collaborators

• Karolinska Institutet: lead
• Uppsala University Hospital: collaborator
• Region Skane: collaborator
• Region Halland: collaborator
• Region Jämtland Härjedalen: collaborator
• Ariadne Labs: collaborator
• Värmland County Council, Sweden: collaborator
• Region Stockholm: collaborator

Study Sites (7)

Region Halland, labour ward Halmstad, Halmstad Hospital

Halmstad, Halland County, Sweden

RECRUITING

Region Halland, labour ward Varberg County Hospital

Varberg, Halland County, Sweden

RECRUITING

Department of Women's Health, Labour ward Östersund County Hospital

Östersund, Region Jämtland Härjedalen, Sweden

RECRUITING

Region Skåne, labour wards Lund & Malmö

Lund, Skåne County, Sweden

RECRUITING

Department of Women's Health, labour ward Uppsala University Hospital

Uppsala, Uppsala County, Sweden

RECRUITING

Department of Women's Health, Labour ward Karlstad County Hospital

Karlstad, Värmland County, Sweden

RECRUITING

Department of Women's Health, Labour ward Solna & Huddinge, Karolinska University Hospital

Stockholm, 186 43, Sweden

RECRUITING

Related Publications (17)

• Aibar L, Rabanaque MJ, Aibar C, Aranaz JM, Mozas J. Patient safety and adverse events related with obstetric care. Arch Gynecol Obstet. 2015 Apr;291(4):825-30. doi: 10.1007/s00404-014-3474-3. Epub 2014 Sep 23.

  PMID: 25245667 BACKGROUND

• Skoogh A, Hall-Lord ML, Baath C, Bojo AS. Adverse events in women giving birth in a labor ward: a retrospective record review study. BMC Health Serv Res. 2021 Oct 14;21(1):1093. doi: 10.1186/s12913-021-07109-5.

  PMID: 34649538 BACKGROUND

• Dencker A, Nilsson C, Begley C, Jangsten E, Mollberg M, Patel H, Wigert H, Hessman E, Sjoblom H, Sparud-Lundin C. Causes and outcomes in studies of fear of childbirth: A systematic review. Women Birth. 2019 Apr;32(2):99-111. doi: 10.1016/j.wombi.2018.07.004. Epub 2018 Aug 14.

  PMID: 30115515 BACKGROUND

• Hill MG, Reed KL, Brown RN; Newborn Brain Society Guidelines and Publications Committee. Perinatal asphyxia from the obstetric standpoint. Semin Fetal Neonatal Med. 2021 Aug;26(4):101259. doi: 10.1016/j.siny.2021.101259. Epub 2021 Jun 11.

  PMID: 34175240 BACKGROUND

• Kurinczuk JJ, White-Koning M, Badawi N. Epidemiology of neonatal encephalopathy and hypoxic-ischaemic encephalopathy. Early Hum Dev. 2010 Jun;86(6):329-38. doi: 10.1016/j.earlhumdev.2010.05.010. Epub 2010 Jun 16.

  PMID: 20554402 BACKGROUND

• Wu M, Tang J, Etherington C, Walker M, Boet S. Interventions for improving teamwork in intrapartem care: a systematic review of randomised controlled trials. BMJ Qual Saf. 2020 Jan;29(1):77-85. doi: 10.1136/bmjqs-2019-009689. Epub 2019 Oct 10.

  PMID: 31601734 BACKGROUND

• Liberati EG, Tarrant C, Willars J, Draycott T, Winter C, Kuberska K, Paton A, Marjanovic S, Leach B, Lichten C, Hocking L, Ball S, Dixon-Woods M; SCALING Authorship Group. Seven features of safety in maternity units: a framework based on multisite ethnography and stakeholder consultation. BMJ Qual Saf. 2021 Jun;30(6):444-456. doi: 10.1136/bmjqs-2020-010988. Epub 2020 Sep 25.

  PMID: 32978322 BACKGROUND

• Aggarwal R, Plough A, Henrich N, Galvin G, Rucker A, Barnes C, Berry W, Golen T, Shah NT. The design of "TeamBirth": A care process to improve communication and teamwork during labor. Birth. 2021 Dec;48(4):534-540. doi: 10.1111/birt.12566. Epub 2021 Jul 9.

  PMID: 34245054 BACKGROUND

• Weiseth A, Plough A, Aggarwal R, Galvin G, Rucker A, Henrich N, Miller K, Subramanian L, Hawrusik R, Berry W, Gullo S, Spigel L, Dever K, Loveless D, Graham K, Paek B, Shah NT. Improving communication and teamwork during labor: A feasibility, acceptability, and safety study. Birth. 2022 Dec;49(4):637-647. doi: 10.1111/birt.12630. Epub 2022 Mar 1.

  PMID: 35233810 BACKGROUND

• Neergheen VL, Chaer LE, Plough A, Curtis E, Paterson VJ, Short T, Bright A, Lipsitz S, Murphy A, Miller K, Subramanian L, Radichel E, Ervin J, Castleman L, Brown E, Yeboah T, Simas TM, Terk D, Vedam S, Shah N, Weiseth A. Assessing patient autonomy in the context of TeamBirth, a quality improvement intervention to improve shared decision-making during labor and birth. Birth. 2024 Dec;51(4):855-866. doi: 10.1111/birt.12857. Epub 2024 Aug 14.

  PMID: 39140579 BACKGROUND

• Bernal JL, Cummins S, Gasparrini A. Interrupted time series regression for the evaluation of public health interventions: a tutorial. Int J Epidemiol. 2017 Feb 1;46(1):348-355. doi: 10.1093/ije/dyw098.

  PMID: 27283160 BACKGROUND

• Vedam S, Stoll K, Rubashkin N, Martin K, Miller-Vedam Z, Hayes-Klein H, Jolicoeur G; CCinBC Steering Council. The Mothers on Respect (MOR) index: measuring quality, safety, and human rights in childbirth. SSM Popul Health. 2017 Jan 19;3:201-210. doi: 10.1016/j.ssmph.2017.01.005. eCollection 2017 Dec.

  PMID: 29349217 BACKGROUND

• Vedam S, Stoll K, Taiwo TK, Rubashkin N, Cheyney M, Strauss N, McLemore M, Cadena M, Nethery E, Rushton E, Schummers L, Declercq E; GVtM-US Steering Council. The Giving Voice to Mothers study: inequity and mistreatment during pregnancy and childbirth in the United States. Reprod Health. 2019 Jun 11;16(1):77. doi: 10.1186/s12978-019-0729-2.

  PMID: 31182118 BACKGROUND

• Walker KF, Dencker A, Thornton JG. Childbirth experience questionnaire 2: Validating its use in the United Kingdom. Eur J Obstet Gynecol Reprod Biol X. 2019 Oct 3;5:100097. doi: 10.1016/j.eurox.2019.100097. eCollection 2020 Jan.

  PMID: 32021972 BACKGROUND

• Waterson P, Carman EM, Manser T, Hammer A. Hospital Survey on Patient Safety Culture (HSPSC): a systematic review of the psychometric properties of 62 international studies. BMJ Open. 2019 Sep 4;9(9):e026896. doi: 10.1136/bmjopen-2018-026896.

  PMID: 31488465 BACKGROUND

• Tilden VP, Eckstrom E, Dieckmann NF. Development of the assessment for collaborative environments (ACE-15): A tool to measure perceptions of interprofessional "teamness". J Interprof Care. 2016 May;30(3):288-94. doi: 10.3109/13561820.2015.1137891. Epub 2016 Mar 30.

  PMID: 27029641 BACKGROUND

• Ford E, Ayers S, Wright DB. Measurement of maternal perceptions of support and control in birth (SCIB). J Womens Health (Larchmt). 2009 Feb;18(2):245-52. doi: 10.1089/jwh.2008.0882.

  PMID: 19183096 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse Midwife, Associate professor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 13, 2025
• Study Start: February 5, 2024
• Primary Completion (Estimated): September 5, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 13, 2025

Record last verified: 2025-03

Locations

SE (7)