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NCT Number: NCT02646423

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 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sutter Health, California Pacific Medical Center, St. Luke's Campus, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prior CD Decision App

Behavioral

The Prior CD Decision App begins with an explanation that its goal is to help the user better understand the two approaches to delivery she is eligible for (trial of labor after cesarean (TOLAC) and elective repeat cesarean delivery (ERCD)), and that its goal is to help her engage with her provide in making an informed, shared decision regarding which approach to undergo. It includes four sections: a calculator to estimate the likelihood of having a vaginal delivery if she undergoes TOLAC, a series of information pages that include graphical presentations of the chances of various potential outcomes of the two options, a series of values clarification exercises to help the user think through what's important to her, and a summary print out for her to keep.

Primary outcomes

  1. Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery

    Time frame: 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 outcomes

  1. Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC)

    Time frame: 0 to 8 weeks after delivery

    Number of participants who underwent vaginal birth after cesarean (VBAC), as noted in the medical record.

  2. Knowledge About TOLAC and ERCD

    Time frame: 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.

  3. Decisional Conflict

    Time frame: 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.

  4. Shared Decision Making

    Time frame: 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.

  5. Decision Self-Efficacy

    Time frame: 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).

  6. Decision Satisfaction

    Time frame: 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.

  7. Maternal Major Morbidity

    Time frame: 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.

  8. Maternal Minor Morbidity

    Time frame: 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.

  9. 3rd or 4th Degree Lacerations

    Time frame: Collected 0 to 8 weeks after delivery.

    3rd or 4th degree lacerations, as noted in the medical record for her delivery.

  10. Perinatal Death or Hypoxic-ischemic Encephalopathy

    Time frame: 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.

  11. Neonatal Respiratory Morbidity

    Time frame: Collected 0 to 8 weeks after delivery.

    Respiratory morbidity requiring CPAP or intubation, as noted in the medical record for her delivery.

  12. Neonatal Intensive Care Unit (NICU) Admission

    Time frame: Collected 0 to 8 weeks after delivery.

    Neonatal intensive care unit (NICU) admission, as noted in the medical record for her delivery.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Marin Community Clinics
  • Massachusetts General Hospital
  • Northwestern Memorial Hospital
  • Sutter Health

Registry information

Official study title

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

Acronym: PROCEED

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 5, 2016
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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