Effect of a Patient-Centered Decision App on TOLAC

Not Applicable

Completed

Conditions: Vaginal Births After Cesarean
Repeat Cesarean Section
Pregnancy

Interventions: Behavioral: Prior CD Decision App

Registration Number: NCT02646423

Lead Sponsor: University of California, San Francisco

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 1485

Inclusion Criteria

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.

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prior CD Decision App (PCDDA)	Prior CD Decision App	Women who are randomized to PCDDA will be provided access to a tablet which they can use to view the Prior CD Decision App at their own pace. The research assistant will print a summary of the participant's predicted likelihood of a vaginal delivery (VBAC) if she undergoes a trial of labor (TOLAC), as well as her answers to the values clarification exercises, that she can review and share with whomever she chooses, including her provider.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery	0-8 weeks after delivery	Number of participants who underwent a trial of labor after cesarean (TOLAC) delivery, as noted in the medical record.

Secondary Outcome Measures

Name	Time	Method
Shared Decision Making	Approx 34-37 weeks gestation	9-item Shared Decision Making Scale, administered during telephone interview. Shared decision-making was measured using the 9-item Shared Decision Making Questionnaire (SDM-Q-9), a psychometrically evaluated tool. The core instrument consists of nine statements, which can be rated on a six-point scale from "completely disagree" (0) to "completely agree" (5). The Shared Decision Score can range from 0 to 100, with higher scores indicating more shared decision-making.
Knowledge About TOLAC and ERCD	Approx 34-37 weeks gestation	8-item knowledge scale, administered during telephone interview. Scores ranged from 0 to 8 with higher scored indicating greater knowledge.
Decision Satisfaction	Approx 34-37 weeks gestation	6-item Satisfaction with Decision Scale, administered during telephone interview. Satisfaction With Decision Scale scores range from 0 to 5, with higher scores indicating more satisfaction.
Maternal Major Morbidity	Collected 0 to 8 weeks after delivery.	Defined as any of: uterine rupture, hysterectomy, surgical injury (bowel, bladder/ureter, or other), maternal death, as noted in the medical record for her delivery.
Maternal Minor Morbidity	Collected 0 to 8 weeks after delivery.	Defined as any of: blood transfusion, postpartum febrile morbidity (endometritis, cellulitis, urinary tract infection, or other infection), as noted in the medical record for her delivery.
3rd or 4th Degree Lacerations	Collected 0 to 8 weeks after delivery.	3rd or 4th degree lacerations, as noted in the medical record for her delivery.
Perinatal Death or Hypoxic-ischemic Encephalopathy	Collected 0 to 8 weeks after delivery.	Stillbirth/fetal demise (antepartum or intrapartum), neonatal death, HIE, as noted in the medical record for her delivery.
Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC)	0 to 8 weeks after delivery	Number of participants who underwent vaginal birth after cesarean (VBAC), as noted in the medical record.
Decisional Conflict	Approx 34-37 weeks gestation	16-item Decisional Conflict Scale with 5 response categories, administered during telephone interview. Scoring: total scale-0 (no decisional conflict) to 100 (extreme decisional conflict) lower values indicate lower decisional conflict.
Decision Self-Efficacy	Approx 34-37 weeks gestation	11-item Decisional Self-Efficacy Scale, administered during telephone interview. The total score is calculated by summing the 11 items, dividing by 11 and multiplying by 25. Scores range from 0 (not confident) to 100 (extremely confident).
Neonatal Respiratory Morbidity	Collected 0 to 8 weeks after delivery.	Respiratory morbidity requiring CPAP or intubation, as noted in the medical record for her delivery.
Neonatal Intensive Care Unit (NICU) Admission	Collected 0 to 8 weeks after delivery.	Neonatal intensive care unit (NICU) admission, as noted in the medical record for her delivery.

Trial Locations

Locations (5): Sutter Health, California Pacific Medical Center, St. Luke's Campus
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San Francisco, California, United States
UCSF
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San Francisco, California, United States
Marin Community Clinic
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San Rafael, California, United States
Northwestern Memorial Hospital
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Chicago, Illinois, United States
Massachusetts General Hospital
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Boston, Massachusetts, United States