The Optimize Trial: Optimizing Timing of Cesarean Delivery Consent on Labor and Delivery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Patient Perception of Informed Consent Process
研究概览
简要总结
Nationally, 32.1% of pregnant patients deliver via cesarean delivery, including both patients who undergo a planned cesarean delivery and patients who intend to undergo vaginal delivery and are recommended to deliver via cesarean delivery. The investigators aim to understand how to optimize the patient experience for patients who present to the hospital intending to deliver vaginally but are recommended to deliver via cesarean delivery (an unplanned cesarean delivery). Practices regarding timing of informed consent for possible cesarean delivery vary widely across hospitals in the United States; some institutions will consent every patient on admission to the hospital for possible cesarean delivery, whereas some institutions consent patients for possible cesarean delivery only if a patient's clinical course suggests cesarean delivery may be indicated.
This study aims to determine optimal timing for consent for possible cesarean delivery by randomizing patients to either be consented for possible cesarean delivery on admission to the hospital or if it appears to be clinically indicated. This study will only assess altered timing of a surgical consent process and will not impact the clinical care participants receive. After delivery, participants will share their experiences with the consent process and with their overall childbirth experience.
详细描述
This study is a randomized-controlled trial in which patients presenting to Labor and Delivery for their scheduled induction of labor will be randomized to either be consented for possible cesarean delivery on admission to Labor and Delivery or be consented for possible cesarean delivery if it appears to be clinically indicated (as is current standard of care). The purpose of this study is to understand whether earlier cesarean delivery consent could be one strategy to improve the delivery experience of patients recommended to undergo unplanned cesarean delivery and enhance education for all birthing patients. The proposed study will fill this gap in the literature by determining whether early informed surgical consent reduces negative patient delivery experiences and address concerns about the mechanism of obtaining informed consent for cesarean delivery.
Duke Perinatal Durham or Duke Women's Health Associates patients will be approached to be consented for the research study between 34-41 weeks of pregnancy. Those who agree to participate will be randomized to either an early surgical consent for possible cesarean delivery at the time of admission to Labor and Delivery or, as per our current standard of care, will be surgically consented for cesarean delivery if it is clinically indicated. On postpartum day 1, patients will be texted a link to a survey about their experience with the surgical consent process and their overall childbirth experience. The investigators will collect additional patient information via chart review, including a patient's medical history and information about their labor, delivery, and postpartum courses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •18 years of age or older
- •Receiving prenatal care at Duke Perinatal Durham or Duke Women's Health Associates
- •Between 34 weeks 0 days and 41 weeks 0 days of gestation
- •Scheduled for induction of labor OR are eligible/intend to be scheduled for an induction of labor
排除标准
- •Trial of labor after cesarean delivery
- •Multiple gestation
- •Major fetal anomalies
- •Presenting for induction of labor as a transfer from the antepartum inpatient service
- •Non-English speaking
- •Those who do not intend to labor
- •Patients who are ineligible for vaginal delivery for other reasons, including fetal malpresentation or abnormal placentation
研究组 & 干预措施
Early Consent for Possible Cesarean Delivery
Patients randomized to this arm of the study will undergo surgical consent for possible cesarean delivery upon arrival to labor and delivery for the start of their induction of labor.
干预措施: Early Surgical Consent (Other)
Indicated Consent for Possible Cesarean Delivery
Patients randomized to this arm of the study will undergo surgical consent for possible cesarean delivery only if it appears to be clinically indicated throughout their induction of labor.
干预措施: Surgical Consent if Clinically Indicated (Other)
结局指标
主要结局
Patient Perception of Informed Consent Process
时间窗: From day 1 postpartum to 6 weeks postpartum
As measured by survey.
次要结局
- Patient Childbirth Experience(From day 1 postpartum to 6 weeks postpartum)