Clinical trial NCT02646423: Effect of a Patient-Centered Decision App on TOLAC
Official title: Effect of a Patient-Centered Decision App on TOLAC: An RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Repeat Cesarean Section
Vaginal Births After Cesarean
Keywords: Trial of labor after cesarean
Elective repeat cesarean delivery
Decision tool
Shared decision making
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Northwestern Memorial Hospital
name: Massachusetts General Hospital
name: Marin Community Clinics
name: Sutter Health
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-01-05
Enrollment: 1485
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery
timeFrame: 0-8 weeks after delivery
Secondary outcomes:
measure: Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC)
timeFrame: 0 to 8 weeks after delivery
measure: Knowledge About TOLAC and ERCD
timeFrame: Approx 34-37 weeks gestation
measure: Decisional Conflict
timeFrame: Approx 34-37 weeks gestation
measure: Shared Decision Making
timeFrame: Approx 34-37 weeks gestation
measure: Decision Self-Efficacy
timeFrame: Approx 34-37 weeks gestation
measure: Decision Satisfaction
timeFrame: Approx 34-37 weeks gestation
measure: Maternal Major Morbidity
timeFrame: Collected 0 to 8 weeks after delivery.
measure: Maternal Minor Morbidity
timeFrame: Collected 0 to 8 weeks after delivery.
measure: 3rd or 4th Degree Lacerations
timeFrame: Collected 0 to 8 weeks after delivery.
measure: Perinatal Death or Hypoxic-ischemic Encephalopathy
timeFrame: Collected 0 to 8 weeks after delivery.
measure: Neonatal Respiratory Morbidity
timeFrame: Collected 0 to 8 weeks after delivery.
measure: Neonatal Intensive Care Unit (NICU) Admission
timeFrame: Collected 0 to 8 weeks after delivery.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Sutter Health, California Pacific Medical Center, St. Luke's Campus
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: San Rafael
country: United States
facility: Marin Community Clinic
state: California
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: University of California, San Francisco
name: Miriam Kupperman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Kuppermann M, Kaimal AJ, Blat C, Gonzalez J, Thiet MP, Bermingham Y, Altshuler AL, Bryant AS, Bacchetti P, Grobman WA. Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial. JAMA. 2020 Jun 2;323(21):2151-2159. doi: 10.1001/jama.2020.5952.