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

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

Treatments tested in this trial

  • Cesarean Bundle

Treatment groups

260 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Lund University

Lead sponsor

Skane University Hospital

Collaborator