Family-Centered Cesarean: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- 11-item Patient Satisfaction Questionnaire
研究概览
简要总结
The purpose of this study is to determine if patient birthing experiences differ between the family-centered and traditional cesarean methods. We hypothesize that the family-centered cesarean method will lead to more unique and personalized cesarean birthing experiences without increasing the risks of adverse neonatal and maternal outcomes from those documented with the traditional cesarean.
详细描述
Patients will be consented and randomized to one of two delivery methods by the research coordinator, resident physician, charge nurse or nurse on the day of their planned cesarean section. Several variables of interest will be collected via the electronic medical record and within the OR. Additionally, assessment of patient satisfaction will be conducted following delivery. Questions from an 11-item questionnaire will be asked of the patient by the study coordinator, resident physician, nurse or charge nurses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 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
- •Women ≥18 years of age
- •Women with planned cesarean section
- •≥38 weeks of gestation
- •Singleton fetus
- •Reassuring fetal status (status of scheduled, green and some yellow
排除标准
- •Women with an urgent or emergency clinical situation in which the medical staff caring for the patient determines that obtaining consent would interfere with the patient's clinical care
- •Patients that decline to consent to participate (an opt out log including the consenters initials, time of day, and reason is kept)
- •Patients with anticipated heavy intraoperative bleeding (bleeding disorders, placenta previa, suspected placenta abruption, etc.)
- •Known maternal co-morbidities that could impact neonatal well-being (e.g., uncontrolled diabetes, etc.)
- •Chorioamnionitis or prolonged rupture of membranes (≥18 hours in duration)
- •Known fetal anomalies
- •BMI ≥45 kg/m2
- •Estimated fetal weight <2000 grams
研究组 & 干预措施
Method 1 by Preference 1
Delivery through the Family-Centered Cesarean for patients with known Family-Centered preference.
干预措施: Family-Centered Cesarean (Procedure)
Method 1 by Preference 2
Delivery through the Family-Centered Cesarean for patients with known Traditional Cesarean preference.
干预措施: Family-Centered Cesarean (Procedure)
Method 2 by Preference 1
Delivery through the Traditional Cesarean for patients with known Family-Centered preference.
干预措施: Traditional Cesarean (Procedure)
Method 2 by Preference 2
Delivery through the Traditional Cesarean for patients with known Traditional Cesarean preference.
干预措施: Traditional Cesarean (Procedure)
结局指标
主要结局
11-item Patient Satisfaction Questionnaire
时间窗: Assessed at time of discharge from the hospital (typically 3-5 days post-delivery)
The primary objective of this study was to compare satisfaction with birthing experiences between women who underwent either a family-centered or traditional cesarean delivery, using a modified Likert scale, ranging from 1 (lowest) to 5 (highest).
次要结局
- Timing of Initiation of Family Bond Following Delivery(Assessed in Operating Room)
- Number (Percent) of Patients Planning to Breastfeeding After Discharge(Assessed at time of discharge from the hospital (typically 3-5 days post-delivery))