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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLund University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Pregnant women aged ≥18 years

Referred for consultation regarding planned cesarean section

Able to provide informed consent (with interpreter support if needed)

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Cesarean Bundle

    Other intervention

    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

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Intervention: Cesarean BundleActive comparator 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

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.

Time frame
Pilot: 12-18 months; Actual study 48 months

Secondary outcomes

1

Cesarean section rates

Using Robson Groups

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.
2

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.

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.
3

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.

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
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lund University

Lead sponsor

Skane University Hospital

Collaborator