NCT06926504|Recruiting
TeamBirth-SWE - a Care Process to Improve Safe and Person-centered Intrapartum Care
TeamBirth - an Intervention to Improve Patient Safety and Person-centered Care During Childbirth
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TeamBirth - an Intervention to Improve Patient Safety and Person-centered Care During Childbirth
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · The Swedish Research Council
NIH
observational
800,000
1 country
7
Study Start
February 5, 2024
Actual (reported)Primary Completion
September 5, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 5, 2024
Actual (reported)March 26, 2025
Actual (reported)April 13, 2025
Actual (reported)September 5, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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
Involving the entire care team including the woman and her partner in planning the care using team huddles and the S-TeamBirth whiteboard
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study population consist of all women who fulfill the inclusion criteria at the participating labor wards.
Region Halland, labour ward Halmstad, Halmstad Hospital
Halmstad, Halland County, Sweden
Region Halland, labour ward Varberg County Hospital
Varberg, Halland County, Sweden
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.
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.
First Submitted
March 26, 2025
First Posted
April 13, 2025
Study Start
February 5, 2024
Actual (reported)Primary Completion
September 5, 2028
EstimatedEffectivenness and Implementation of an Intervention to Improve Primary Care Patient Safety
Contact the study team to confirm eligibility.
Department of Women's Health, Labour ward Östersund County Hospital
Östersund, Region Jämtland Härjedalen, Sweden
Region Skåne, labour wards Lund & Malmö
Lund, Skåne County, Sweden
Department of Women's Health, labour ward Uppsala University Hospital
Uppsala, Uppsala County, Sweden
Department of Women's Health, Labour ward Karlstad County Hospital
Karlstad, Värmland County, Sweden
Department of Women's Health, Labour ward Solna & Huddinge, Karolinska University Hospital
Stockholm, 186 43, Sweden
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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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 13, 2025
Record last verified: 2025-03
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