试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Patient-Reported Trust in the Care Team
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women aged ≥18 years
- •Referred for consultation regarding planned cesarean section
- •Able to provide informed consent (with interpreter support if needed)
排除标准
- •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)
研究组 & 干预措施
Intervention: Cesarean Bundle
Cesarean Bundle (structured discussion guide, mandatory second/team opinion, and regular team reviews/audits)
干预措施: Cesarean Bundle (Other)
Control Arm
Standard care (usual clinical practice without structured tools)
结局指标
主要结局
Patient-Reported Trust in the Care Team
时间窗: 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.
次要结局
- Cesarean section rates(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(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(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(Pilot 12-18 months. Actual study 48-54 months)