Effect of a Patient-Centered Decision App on TOLAC



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - Any
Updated:9/15/2018
Start Date:January 2016
End Date:July 2019
Contact:Miriam Kuppermann, PhD, MPH
Email:miriam.kuppermann@ucsf.edu
Phone:(415) 502-4089

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

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.


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.
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San Rafael, California 94901
Phone: 415-448-1500
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-643-7407
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Phone: 312-472-4661
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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1635 Divisadero Street
San Francisco, California 94143
Principal Investigator: Miriam Kuppermann, PhD, MPH
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San Francisco, California 94110
Phone: 415-641-6996
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