NCT07759622 The Cesarean Study: Optimizing Cesarean Sections and Improving Patient-Healthcare Provider Trust Using Evidence Informed Recommendations
| NCT ID | NCT07759622 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lund University |
| Condition | Cesarean Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 260 participants |
| Start Date | 2026-05-05 |
| Primary Completion | 2030-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 260 participants in total. It began in 2026-05-05 with a primary completion date of 2030-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Pregnant women aged ≥18 years * Referred for consultation regarding planned cesarean section * Able to provide informed consent (with interpreter support if needed) Exclusion Criteria: * 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07759622 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cesarean Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07759622 currently recruiting?
Yes, NCT07759622 is actively recruiting participants. Contact the research team at mehreen.zaigham@med.lu.se for enrollment information.
Where is the NCT07759622 trial being conducted?
This trial is being conducted at Malmö, Sweden.
Who is sponsoring the NCT07759622 clinical trial?
NCT07759622 is sponsored by Lund University. The trial plans to enroll 260 participants.