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

Condition(s) studied

Investigational drug(s) / intervention(s)

Cesarean Bundle: 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

Study 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.

Eligibility

Primary outcome measure(s)

• Patient-Reported Trust in the Care Team — 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.

Trial sites (1)

More Lund University trials in Sweden