跳至主要内容
临床试验/NCT02646423
NCT02646423已完成不适用

Effect of a Patient-Centered Decision App on TOLAC: An RCT

University of California, San Francisco10 个研究点 分布在 1 个国家目标入组 1,485 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,485
试验地点
10
主要终点
Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery

研究概览

简要总结

Cesarean delivery (CD) is the most common inpatient surgery in the US, accounting for nearly one third of births annually. In the last decade, the CD rate has increased by approximately 50%, with almost 1.3 million procedures performed in 2012 (Hamilton 2013). CDs have been associated with an increase in major maternal morbidity (Silver 2010), with corresponding increases in length of inpatient care following delivery and frequency of hospital readmission (Lydon-Rochelle 2000). Organizations including Healthy People, the American College of Obstetricians and Gynecologists (ACOG), and the American College of Nurse Midwives have targeted reducing the CD rate as an important public health goal for more than a decade; however, identifying interventions to achieve this goal has proven challenging.

Repeat CDs are a significant contributor to the increased cesarean rate, resulting from the combination of a rising rate of primary CD and a decreasing rate of vaginal birth after cesarean (VBAC), which declined from a high of 28.3% in 1996 (Guide 2010) to 9.2% in 2010 (Hamilton 2011). Why the VBAC rate has decreased so dramatically remains a subject of debate; the extent to which these changes are driven by patient preferences is not known. An NIH consensus conference statement noted that "the informed consent process for TOLAC and Elective Repeat Cesarean Delivery (ERCD) should be evidence-based, minimize bias, and incorporate a strong emphasis on the values and preferences of pregnant women," and recommended "interprofessional collaboration to refine, validate, and implement decision-making and risk assessment tools" to accomplish that goal (Cunningham 2010).

Our group recently created a decision tool, which we refer to as the Prior CD App (PCDA), to help English- or Spanish-speaking TOLAC-eligible women delivering at hospitals that offer TOLAC consider individualized risk assessments, incorporate their values and preferences, and participate in a shared decision making process with their providers to make informed decisions about delivery approach. We are now conducting a randomized study of the effect of a Prior CD App on TOLAC and VBAC rates, as well as a number of aspects of decision quality.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women with exactly one prior Cesarean Delivery.
  • Current singleton pregnancy.
  • Gestational age, 12-24 weeks.
  • English or Spanish speaker.
  • Must be receiving prenatal care at one of the participating centers.

排除标准

  • Contraindications to vaginal delivery (e.g., placenta previa, prior classical cesarean, previous uterine rupture).
  • Prior VBAC.

结局指标

主要结局

Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery

时间窗: 0-8 weeks after delivery

Number of participants who underwent a trial of labor after cesarean (TOLAC) delivery, as noted in the medical record.

次要结局

  • Shared Decision Making(Approx 34-37 weeks gestation)
  • Knowledge About TOLAC and ERCD(Approx 34-37 weeks gestation)
  • Decision Satisfaction(Approx 34-37 weeks gestation)
  • Maternal Major Morbidity(Collected 0 to 8 weeks after delivery.)
  • Maternal Minor Morbidity(Collected 0 to 8 weeks after delivery.)
  • 3rd or 4th Degree Lacerations(Collected 0 to 8 weeks after delivery.)
  • Perinatal Death or Hypoxic-ischemic Encephalopathy(Collected 0 to 8 weeks after delivery.)
  • Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC)(0 to 8 weeks after delivery)
  • Decisional Conflict(Approx 34-37 weeks gestation)
  • Decision Self-Efficacy(Approx 34-37 weeks gestation)
  • Neonatal Respiratory Morbidity(Collected 0 to 8 weeks after delivery.)
  • Neonatal Intensive Care Unit (NICU) Admission(Collected 0 to 8 weeks after delivery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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