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Eligibility
for females ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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 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.

Official Title

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

Keywords

Pregnancy Repeat Cesarean Section Vaginal Births After Cesarean Trial of labor after cesarean Elective repeat cesarean delivery Decision tool Shared decision making

Eligibility

You can join if…

Open to females ages 18 years and up

  1. Women with exactly one prior Cesarean Delivery.
  2. Current singleton pregnancy.
  3. Gestational age, 16-24 weeks.
  4. English or Spanish speaker.
  5. Must be receiving prenatal care at one of the participating centers.

You CAN'T join if...

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

Locations

  • Marin Community Clinic accepting new patients
    San Rafael, California, 94901, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
Decisional Conflict Scale
Decision Self-Efficacy Scale
ID
NCT02646423
Lead Scientist
Miriam Kuppermann
Study Type
Interventional
Last Updated
September 12, 2016
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