Cesarean BirthCSNCT07759622
The Cesarean Study: Optimizing Cesarean Sections and Improving Patient-Healthcare Provider Trust Using Evidence Informed Recommendations
A study testing Cesarean Bundle in people with Cesarean Birth, run by Lund University at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Birth
- What is being tested?
- Cesarean Bundle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSweden
- Study dates
- 5 May 2026to 31 Dec 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women aged ≥18 years
- Referred for consultation regarding planned cesarean section
- Able to provide informed consent (with interpreter support if needed)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skånes university hospital
Malmö
Mehreen Zaigham, +46 40 33 10 00, mehreen.zaigham@med.lu.se
About this study
Official title: The Cesarean Study
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.
Read more
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.
Read the detailed description
Rising CS rates globally and across Europe pose a growing challenge to maternal-newborn health (1). In some European countries, CS rates have soared to 55%, and in Sweden, almost 20,000 procedures are performed annually, with numbers continuing to rise (2, 3). Strikingly, nearly 40% of these are planned cesareans, highlighting a critical need to change on-going clinical practices, especially for low-risk pregnancies, which are well-known drivers of CS rates (5, 6). These rates also contradict the World Health Organization's (WHOs) recommendations that CS rates above 10-15% are not associated with improved maternal-newborn outcomes (5). The WHO has provided clear guidance for reducing non-essential CS (5, 6), emphasizing evidence-based strategies such as requiring a second clinician's sign-off and fostering multidisciplinary reflection, both of which are key parts of the Cesarean study's intervention.
Qualitative evidence from Kingdon et al. (7,8) has shown that women want their birth preferences acknowledged, value individualized information, and are influenced by how health professionals communicate, making shared decision-making essential. However, studies from Quebec (9) and Spain (10) revealed that there are some persistent barriers to implementing guidelines, such as fragmented care and inconsistent messaging, which reinforce the well-known "know-do gap" where best practices fail to reach routine care. The Cesarean Study responds directly to this need, testing a three-part therapy bundle aligned with WHOs recommendations for maximal impact.
Population Pregnant women remitted to clinicians for planned CS discussion.
Intervention
The "Cesarean Bundle", a three-part, decision-support model, comprising of:
- The Cesarean Discussion Guide, which is a structured clinical tool designed to facilitate personalized, evidence-based conversations between clinicians and patients considering planned cesarean birth. It captures key clinical data, patient values, and birth preferences, integrates risk stratification using the Robson Classification (11-13), and presents short- and long-term outcomes of cesarean versus vaginal birth in a clear, visual format. By standardizing counseling and embedding shared decision-making into routine care, the guide supports more equitable, informed, and patient-centered birth planning. The principal investigator (MZ) has developed the guide with support from Ariadne Labs, Boston USA.
II. Mandatory second opinion/team decision from another clinician for all planned cesarean requests; and, III. Regular team audits reviewing decision-making patterns.
Standard care, consisting of usual clinical consultations for discussing and approving planned CS, without structured guidance or required secondary clinician or team review.
Outcomes Primary outcome Patient-reported trust in the care team, measured by the Health Care Relationship Trust Scale-Revised (HCRTS-R) (14)
Secondary outcomes i) Change in planned CS rate before and after intervention, including subdivisions by Robson Groups for risk stratification ii) Composite of severe neonatal outcomes, including perinatal mortality, 5-min Apgar score <6, hypoxic ischemic encephalopathy grade II-III, intracranial hemorrhage, neonatal seizures, neonatal infection, hypoglycemia, respiratory distress, umbilical arterial pH< 7.05 iii) Composite of severe maternal outcomes, including postpartum hemorrhage (>1000ml), ICU admission, postpartum infection iv) Twelve question survey for clinicians and patients reporting experience of usability, acceptability, feasibility of intervention vs standard care v) Qualitative interviews using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) (15) to evaluate the impact and real-world applicability of the Cesarean Bundle across patient, partner, clinician, and system levels vi) Cost-analysis of intervention vs standard care.
- Conditions
- Cesarean Birth
- Being tested
- Cesarean Bundle
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean BundleOther
The Cesarean Bundle is a structured, three-component clinical intervention designed to support evidence-based and shared decision-making for planned cesarean sections:
- 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.
- 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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| Intervention: Cesarean Bundle | Active comparator | Cesarean Bundle (structured discussion guide, mandatory second/team opinion, and regular team reviews/audits) Receives: Other: Cesarean Bundle |
| Control Arm | No intervention | Standard care (usual clinical practice without structured tools) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pilot: 12-18 months; Actual study 48 months
Secondary outcomes (4)
Cesarean section rates
Using Robson Groups
Measured: 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
This is a composite of whether any of the following maternal outcomes was found (Y/N): postpartum hemorrhage (> or = 1000 ml), admission to intensive care unit (ICU) admission, and postpartum infection needing antiobiotics.
Measured: 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
This is a composite of whether any of the following neonatal outcomes was present (Y/N): perinatal mortality, 5-minute Apgar score less than 7, hypoxic-ischemic encephalopathy (grade I-III), intracranial hemorrhage, neonatal seizures, infection, hypoglycemia, respiratory distress, and umbilical artery pH <7.05.
Measured: 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
This is a survey that uses a 12-item questionnaire assessing acceptability, usability, and feasibility of the intervention. Total score 0-12 where 12 is the highest number and indicated best reported experience.
Measured: Pilot 12-18 months. Actual study 48-54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start5 May 2026
- Primary completion15 May 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Cesarean BirthStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Skane University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759622
- Sponsor's protocol ID
- 2025-05909-01
- Other IDs
- 2025
- Acronym
- CS
- Status last verified
- May 2026
- First submitted
- 26 Jun 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be shared, including demographic variables (e.g., age, parity, BMI), clinical characteristics (e.g., pregnancy and delivery data, indication for cesarean section), intervention exposure, and outcome measures (e.g., planned cesarean rates, maternal and neonatal outcomes, and patient-reported trust scores). Survey responses (e.g., HCRTS-R and acceptability/feasibility questionnaires) and relevant implementation metrics may also be included. All data will be pseudonymized, with direct identifiers removed, in accordance with GDPR and applicable data protection regulations.
Publications
15) RE-AIM. Reach Effectiveness Adoption Implementation Maintenance [Internet]. Available from: https://re-aim.org
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.
PubMed 16977644Zaigham 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.
PubMed 3831990112) Robson MS. Classification of caesarean sections. Fetal and Maternal Medicine Review 2001;12(1):23-39.
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.
PubMed 39705988Bermudez-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.
PubMed 28851394Chaillet 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.
PubMed 18038061Kingdon 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.
PubMed 30559163Kingdon 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.
PubMed 30041661Opiyo 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.
PubMed 31902964WHO Recommendations Non-Clinical Interventions to Reduce Unnecessary Caesarean Sections. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK532672/
PubMed 30398818Caesarean 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/
PubMed 35675476Velebil 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.
PubMed 403280502) Socialstyrelsen (National Board of Health and Welfare). Graviditeter, förlossningar och nyfödda barn: statistik 2023 [Internet].
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.
PubMed 34130991
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cesarean Study
- ClinicalTrials.gov ID
- NCT07759622
- Acronym / sponsor ID
- CS / 2025-05909-01
- Conditions
- Cesarean Birth
- Keywords
- Cesarean Section, Planned Cesarean, Cesarean Bundle, Decision Support Tool, Shared Decision-Making, Patient-Clinician Communication, Patient Trust, Maternal Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Skane University Hospital
- Study start
- 5 May 2026 (actual)
- Primary completion
- 15 May 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rising CS rates globally and across Europe pose a growing challenge to maternal-newborn health (1). In some European countries, CS rates have soared to 55%, and in Sweden, almost 20,000 procedures are performed annually, with numbers continuing to rise (2, 3). Strikingly, nearly 40% of these are planned cesareans, highlighting a critical need to change on-going clinical practices, especially for low-risk pregnancies, which are well-known drivers of CS rates (5, 6). These rates also contradict the World Health Organization's (WHOs) recommendations that CS rates above 10-15% are not associated with improved maternal-newborn outcomes (5). The WHO has provided clear guidance for reducing non-essential CS (5, 6), emphasizing evidence-based strategies such as requiring a second clinician's sign-off and fostering multidisciplinary reflection, both of which are key parts of the Cesarean study's intervention.
Qualitative evidence from Kingdon et al. (7,8) has shown that women want their birth preferences acknowledged, value individualized information, and are influenced by how health professionals communicate, making shared decision-making essential. However, studies from Quebec (9) and Spain (10) revealed that there are some persistent barriers to implementing guidelines, such as fragmented care and inconsistent messaging, which reinforce the well-known "know-do gap" where best practices fail to reach routine care. The Cesarean Study responds directly to this need, testing a three-part therapy bundle aligned with WHOs recommendations for maximal impact.
Population Pregnant women remitted to clinicians for planned CS discussion.
Intervention
The "Cesarean Bundle", a three-part, decision-support model, comprising of:
- The Cesarean Discussion Guide, which is a structured clinical tool designed to facilitate personalized, evidence-based conversations between clinicians and patients considering planned cesarean birth. It captures key clinical data, patient values, and birth preferences, integrates risk stratification using the Robson Classification (11-13), and presents short- and long-term outcomes of cesarean versus vaginal birth in a clear, visual format. By standardizing counseling and embedding shared decision-making into routine care, the guide supports more equitable, informed, and patient-centered birth planning. The principal investigator (MZ) has developed the guide with support from Ariadne Labs, Boston USA.
II. Mandatory second opinion/team decision from another clinician for all planned cesarean requests; and, III. Regular team audits reviewing decision-making patterns.
Standard care, consisting of usual clinical consultations for discussing and approving planned CS, without structured guidance or required secondary clinician or team review.
Outcomes Primary outcome Patient-reported trust in the care team, measured by the Health Care Relationship Trust Scale-Revised (HCRTS-R) (14)
Secondary outcomes i) Change in planned CS rate before and after intervention, including subdivisions by Robson Groups for risk stratification ii) Composite of severe neonatal outcomes, including perinatal mortality, 5-min Apgar score <6, hypoxic ischemic encephalopathy grade II-III, intracranial hemorrhage, neonatal seizures, neonatal infection, hypoglycemia, respiratory distress, umbilical arterial pH< 7.05 iii) Composite of severe maternal outcomes, including postpartum hemorrhage (>1000ml), ICU admission, postpartum infection iv) Twelve question survey for clinicians and patients reporting experience of usability, acceptability, feasibility of intervention vs standard care v) Qualitative interviews using the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) (15) to evaluate the impact and real-world applicability of the Cesarean Bundle across patient, partner, clinician, and system levels vi) Cost-analysis of intervention vs standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Intervention: Cesarean Bundle | Active comparator | Other: Cesarean BundleCesarean Bundle (structured discussion guide, mandatory second/team opinion, and regular team reviews/audits) |
| Control Arm | No intervention | –Standard care (usual clinical practice without structured tools) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women aged ≥18 years
- Referred for consultation regarding planned cesarean section
- Able to provide informed consent (with interpreter support if needed)
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cesarean BundleThe 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 | Other | Intervention: Cesarean Bundle |
Primary outcome
Patient-Reported Trust in the Care Team
Time frame: Pilot: 12-18 months; Actual study 48 months
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.
4 secondary outcomes
Cesarean section rates
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pilot 12-18 months. Actual study 48-54 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background15) RE-AIM. Reach Effectiveness Adoption Implementation Maintenance [Internet]. Available from: https://re-aim.org
- Background: PubMed 16977644Bova 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.
- Background: PubMed 38319901Zaigham 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.
- Background12) Robson MS. Classification of caesarean sections. Fetal and Maternal Medicine Review 2001;12(1):23-39.
- Background: PubMed 39705988El 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.
- Background: PubMed 28851394Bermudez-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.
- Background: PubMed 18038061Chaillet 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.
- Background: PubMed 30559163Kingdon 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.
- Background: PubMed 30041661Kingdon 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.
- Background: PubMed 31902964Opiyo 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.
- Background: PubMed 30398818WHO Recommendations Non-Clinical Interventions to Reduce Unnecessary Caesarean Sections. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK532672/
- Background: PubMed 35675476Caesarean 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/
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be shared, including demographic variables (e.g., age, parity, BMI), clinical characteristics (e.g., pregnancy and delivery data, indication for cesarean section), intervention exposure, and outcome measures (e.g., planned cesarean rates, maternal and neonatal outcomes, and patient-reported trust scores). Survey responses (e.g., HCRTS-R and acceptability/feasibility questionnaires) and relevant implementation metrics may also be included. All data will be pseudonymized, with direct identifiers removed, in accordance with GDPR and applicable data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cesarean Bundle in people with Cesarean Birth, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehreen Zaigham, PhD, MBBS (+46 40 331000, mehreen.zaigham@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Trust in the Care Team (time frame: Pilot: 12-18 months; Actual study 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07759622, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.