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NCT02646423 · ClinicalTrials.gov registry record · NA
Effect of a Patient-Centered Decision App on TOLAC
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 1,485
- Enrollment target
NCT02646423 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 1,485 participants.
The verdict
NCT02646423, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,485 participants
- Enrollment target
Study Summary
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 pr
Interventions
- BEHAVIORAL Prior CD Decision App
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,485 participants |
| Start Date | 2016-01 |
| Est. Completion | 2019-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02646423
The ClinicalTrials.gov registry entry for NCT02646423 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,485 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Prior CD Decision App is the first listed.
NCT02646423 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02646423 about?
NCT02646423 is a clinical study titled "Effect of a Patient-Centered Decision App on TOLAC". 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 increa...
What is the current status of trial NCT02646423?
This trial is currently completed. It is a NA study. The enrollment target is 1,485 participants. The study started on 2016-01. Estimated completion is 2019-06.
What interventions are being tested in trial NCT02646423?
The interventions under investigation include: Prior CD Decision App (BEHAVIORAL).
Who is sponsoring clinical trial NCT02646423?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
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