The Cesarean Study: Optimizing Cesarean Sections and Improving Patient-Healthcare Provider Trust Using Evidence Informed Recommendations

NCT07759622 | Recruiting

• 1 other identifier: 2025-05909-01
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean section (CS) rates have rapidly increased worldwide, with projections suggesting that by 2030, one in every three births will be by CS (1). In Sweden, rates have more than doubled from 9% in the 1990s, to 20% in 2024 (2). While CS can be a life-saving procedure when medically indicated, non-essential CS increase the risk of complications and have been linked to increased maternal morbidity and even death, neonatal respiratory issues, and longer recovery times (3). They also place added strain on already burdened healthcare systems by increasing the use of medical resources and staff capacity. The purpose of this project is to evaluate the use of the "Cesarean Bundle", a three-part intervention designed to improve patient-clinician communication and trust. Primary Aim: To evaluate the impact of the "Cesarean Bundle" in improving patient-clinician communication and trust compared to standard care. Hypothesis: Use of the "Cesarean Bundle" will improve patients' trust in their healthcare providers. Secondary Aim: To evaluate whether adoption of the "Cesarean Bundle" is associated with changes in cesarean section rates, especially among low-risk obstetric populations. Hypothesis: Implementation of the "Cesarean Bundle" will be associated with a reduction in overall cesarean section rates, particularly among low-risk pregnancies.

Conditions

Cesarean Birth

Keywords

Cesarean Section; Planned Cesarean; Cesarean Bundle; Decision Support Tool; Shared Decision-Making; Patient-Clinician Communication; Patient Trust; Maternal Outcomes; Neonatal Outcomes; Pregnancy; Obstetrics; Vaginal Birth; Robson Classification; Implementation Science; Health Care Quality Improvement

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Trust in the Care Team

  Patient-Reported Trust in the Care Team Measured using the Health Care Relationship Trust Scale-Revised (HCRTS-R), a validated questionnaire assessing patients' trust in their healthcare providers following consultation for planned cesarean section. Each of the survey's 13 items is scored individually on a five-point scale (0 to 4), where the item score reflects the patient's immediate assessment of specific relational experiences, such as active listening, truth-telling, and respect for privacy. After converting one reverse-worded question to ensure that higher numbers consistently reflect stronger alignment with positive relational attributes, the individual item scores are summed to generate a cumulative total score ranging from 0 to 52. Within this spectrum, the higher the score, the better the reported trust and communication.

  Pilot: 12-18 months; Actual study 48 months

Secondary Outcomes (4)

• Cesarean section rates

  Pilot: 12-18 months. Actual study: 48-54 months as some cesarean section may be reported at later date after the pregnancy has led to the birth of the baby.

• Maternal outcome

  Pilot: 12-18 months. Main study: 48-54 months as some maternal outcomes may be reported at later date after the pregnancy has led to the birth of the baby.

• Neonatal outcome

  Pilot: 12-18 months. Actual study: 48-54 months depending on when data is available from the patient charts and once the pregnancy has led to birth of the baby

• Patient-Reported Experience

  Pilot 12-18 months. Actual study 48-54 months

Study Arms (2)

Intervention: Cesarean Bundle

ACTIVE COMPARATOR

Cesarean Bundle (structured discussion guide, mandatory second/team opinion, and regular team reviews/audits)

Other: Cesarean Bundle

Control Arm

NO INTERVENTION

Standard care (usual clinical practice without structured tools)

Interventions

Cesarean Bundle OTHER

The Cesarean Bundle is a structured, three-component clinical intervention designed to support evidence-based and shared decision-making for planned cesarean sections: 1. Cesarean Discussion Guide: A standardized decision-support tool used during all consultations for planned cesarean section. It incorporates clinical data, risk stratification (e.g., Robson classification), and clear information on short- and long-term risks and benefits of cesarean versus vaginal birth, while also capturing patient preferences and values. 2. Mandatory Second/team Opinion: All requests for planned cesarean section require review and approval by a second clinician/team before a final decision is made. 3. Regularl Multidisciplinary Team Meetings: Regular team-based reviews of cases and decision-making patterns to promote consistency, reflection, and adherence to evidence-based practice. The intervention is integrated into routine care, with minimal disruption to standard workflows, and is support

Intervention: Cesarean Bundle

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological sex due to pregnancy related condition
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women aged ≥18 years
• Referred for consultation regarding planned cesarean section
• Able to provide informed consent (with interpreter support if needed)

You may not qualify if:

• Women with an absolute medical indication for cesarean section (e.g., placenta previa), where shared decision-making is not applicable
• Women who decline participation in the study components (e.g., surveys/interviews)

Sponsors & Collaborators

• Lund University: lead
• Skane University Hospital: collaborator

Study Sites (1)

Skånes university hospital

Malmö, Sweden

RECRUITING

Related Publications (15)

• 15) RE-AIM. Reach Effectiveness Adoption Implementation Maintenance [Internet]. Available from: https://re-aim.org

  BACKGROUND

• Bova C, Fennie KP, Watrous E, Dieckhaus K, Williams AB. The health care relationship (HCR) trust scale: development and psychometric evaluation. Res Nurs Health. 2006 Oct;29(5):477-88. doi: 10.1002/nur.20158.

  PMID: 16977644 BACKGROUND

• Zaigham M, Varallo J, Thangaratinam S, Nicholson W, H A Visser G. Global disparities in caesarean section rates: Why indication-based metrics are needed. PLOS Glob Public Health. 2024 Feb 6;4(2):e0002877. doi: 10.1371/journal.pgph.0002877. eCollection 2024. No abstract available.

  PMID: 38319901 BACKGROUND

• 12) Robson MS. Classification of caesarean sections. Fetal and Maternal Medicine Review 2001;12(1):23-39.

  BACKGROUND

• El Radaf V, Campos LN, Savona-Ventura C, Mahmood T, Zaigham M. Robson ten group classification system for Caesarean sections across Europe: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2025 Feb;305:178-198. doi: 10.1016/j.ejogrb.2024.11.052. Epub 2024 Dec 4.

  PMID: 39705988 BACKGROUND

• Bermudez-Tamayo C, Fernandez Ruiz E, Pastor Moreno G, Maroto-Navarro G, Garcia-Mochon L, Perez-Ramos FJ, Cano-Aguilar A, Velez MDP. Barriers and enablers in the implementation of a program to reduce cesarean deliveries. Reprod Health. 2017 Aug 29;14(1):106. doi: 10.1186/s12978-017-0369-3.

  PMID: 28851394 BACKGROUND

• Chaillet N, Dube E, Dugas M, Francoeur D, Dube J, Gagnon S, Poitras L, Dumont A. Identifying barriers and facilitators towards implementing guidelines to reduce caesarean section rates in Quebec. Bull World Health Organ. 2007 Oct;85(10):791-7. doi: 10.2471/blt.06.039289.

  PMID: 18038061 BACKGROUND

• Kingdon C, Downe S, Betran AP. Interventions targeted at health professionals to reduce unnecessary caesarean sections: a qualitative evidence synthesis. BMJ Open. 2018 Dec 16;8(12):e025073. doi: 10.1136/bmjopen-2018-025073.

  PMID: 30559163 BACKGROUND

• Kingdon C, Downe S, Betran AP. Women's and communities' views of targeted educational interventions to reduce unnecessary caesarean section: a qualitative evidence synthesis. Reprod Health. 2018 Jul 24;15(1):130. doi: 10.1186/s12978-018-0570-z.

  PMID: 30041661 BACKGROUND

• Opiyo N, Kingdon C, Oladapo OT, Souza JP, Vogel JP, Bonet M, Bucagu M, Portela A, McConville F, Downe S, Gulmezoglu AM, Betran AP. Non-clinical interventions to reduce unnecessary caesarean sections: WHO recommendations. Bull World Health Organ. 2020 Jan 1;98(1):66-68. doi: 10.2471/BLT.19.236729. Epub 2019 Nov 29. No abstract available.

  PMID: 31902964 BACKGROUND

• WHO Recommendations Non-Clinical Interventions to Reduce Unnecessary Caesarean Sections. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK532672/

  PMID: 30398818 BACKGROUND

• Caesarean section on maternal request: A systematic review and assessment of medical, health economic, ethical and social aspects [Internet]. Stockholm: Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU); 2021 Dec 22. Available from http://www.ncbi.nlm.nih.gov/books/NBK580955/

  PMID: 35675476 BACKGROUND

• Velebil P, Savona-Ventura C, Zaigham M, Mahmood T, Wladimiroff J, Louwen F. How to influence rising caesarean section rates in Europe? An invited scientific review by European Board and College of Obstetrics and Gynaecology (EBCOG). Eur J Obstet Gynecol Reprod Biol. 2025 Jul;311:113979. doi: 10.1016/j.ejogrb.2025.113979. Epub 2025 Apr 16.

  PMID: 40328050 BACKGROUND

• 2) Socialstyrelsen (National Board of Health and Welfare). Graviditeter, förlossningar och nyfödda barn: statistik 2023 [Internet].

  BACKGROUND

• Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021 Jun;6(6):e005671. doi: 10.1136/bmjgh-2021-005671.

  PMID: 34130991 BACKGROUND

Central Study Contacts

Mehreen Zaigham, PhD, MBBS

CONTACT

+46 40 331000; mehreen.zaigham@med.lu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional Study Model: Stepped-Wedge Cluster Randomized Trial (Multicenter) with Pilot Pre-Post Phase The study includes an initial pilot phase followed by a national multicenter stepped-wedge cluster design. In the pilot phase, a pre-post design is used at selected sites (Malmö and Lund), where outcomes during a baseline (pre-intervention) period are compared with outcomes after implementation of the Cesarean Bundle. This phase evaluates feasibility, acceptability, and preliminary effects of the intervention. In the main study, participating hospitals (clusters) sequentially transition from standard care to the intervention at different time points according to a predefined schedule (stepped-wedge design). All sites begin in the control phase and cross over to the intervention phase over time, allowing each site to serve as its own control while accounting for temporal trends and ensuring all sites

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: August 12, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): May 15, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: August 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

SE (1)