An interventional study of Prior CD Decision App in Pregnancy, Repeat Cesarean Section and Vaginal Births After Cesarean, sponsored by University of California, San Francisco. Completed at 5 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Health services research
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.
University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Prior CD Decision App
Women randomized to the Usual Care - No App group will simply continue with usual care.
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.
Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery
Number of participants who underwent a trial of labor after cesarean (TOLAC) delivery, as noted in the medical record.
Time frame: 0-8 weeks after delivery
Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC)
Number of participants who underwent vaginal birth after cesarean (VBAC), as noted in the medical record.
Time frame: 0 to 8 weeks after delivery
Knowledge About TOLAC and ERCD
8-item knowledge scale, administered during telephone interview. Scores ranged from 0 to 8 with higher scored indicating greater knowledge.
Time frame: Approx 34-37 weeks gestation
Decisional Conflict
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.
Time frame: Approx 34-37 weeks gestation
Shared Decision Making
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.
Time frame: Approx 34-37 weeks gestation
Decision Self-Efficacy
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).
Time frame: Approx 34-37 weeks gestation
Decision Satisfaction
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.
Time frame: Approx 34-37 weeks gestation
Maternal Major Morbidity
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.
Time frame: Collected 0 to 8 weeks after delivery.
Maternal Minor Morbidity
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.
Time frame: Collected 0 to 8 weeks after delivery.
3rd or 4th Degree Lacerations
3rd or 4th degree lacerations, as noted in the medical record for her delivery.
Time frame: Collected 0 to 8 weeks after delivery.
Perinatal Death or Hypoxic-ischemic Encephalopathy
Stillbirth/fetal demise (antepartum or intrapartum), neonatal death, HIE, as noted in the medical record for her delivery.
Time frame: Collected 0 to 8 weeks after delivery.
Neonatal Respiratory Morbidity
Respiratory morbidity requiring CPAP or intubation, as noted in the medical record for her delivery.
Time frame: Collected 0 to 8 weeks after delivery.
Neonatal Intensive Care Unit (NICU) Admission
Neonatal intensive care unit (NICU) admission, as noted in the medical record for her delivery.
Time frame: Collected 0 to 8 weeks after delivery.
| Milestone | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Started | 742 | 743 |
| Completed | 735 | 735 |
| Not completed | 7 | 8 |
| Withdrew: Adverse event | 5 | 7 |
| Withdrew: Ineligible | 2 | 1 |
Number of participants who underwent a trial of labor after cesarean (TOLAC) delivery, as noted in the medical record.
| Participants | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery | 315 | 338 |
Number of participants who underwent vaginal birth after cesarean (VBAC), as noted in the medical record.
| Participants | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC) | 231 | 233 |
8-item knowledge scale, administered during telephone interview. Scores ranged from 0 to 8 with higher scored indicating greater knowledge.
| score on a scale | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Knowledge About TOLAC and ERCD | 5.0 ± 1.8 | 5.0 ± 1.7 |
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.
| score on a scale | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Decisional Conflict | 17.2 ± 12.9 | 17.5 ± 13.9 |
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.
| score on a scale | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Shared Decision Making | 74.4 ± 14.9 | 74.8 ± 15.9 |
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).
| score on a scale | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Decision Self-Efficacy | 90.7 ± 12.3 | 90.3 ± 12.2 |
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.
| score on a scale | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Decision Satisfaction | 4.62 ± 0.59 | 4.65 ± 0.54 |
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.
| Participants | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Maternal Major Morbidity | 19 | 23 |
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.
| Participants | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Maternal Minor Morbidity | 36 | 36 |
3rd or 4th degree lacerations, as noted in the medical record for her delivery.
| Participants | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| 3rd or 4th Degree Lacerations | 16 | 12 |
Stillbirth/fetal demise (antepartum or intrapartum), neonatal death, HIE, as noted in the medical record for her delivery.
| participants | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Neonatal death | 2 | 0 |
| Intrauterine fetal demised | 4 | 0 |
| Hypoxic-ischemic encephalopathy | 2 | 4 |
Respiratory morbidity requiring CPAP or intubation, as noted in the medical record for her delivery.
| Participants | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Neonatal Respiratory Morbidity | 67 | 68 |
Neonatal intensive care unit (NICU) admission, as noted in the medical record for her delivery.
| Participants | Prior CD Decision App (PCDDA) | Usual Care - No App |
|---|---|---|
| Neonatal Intensive Care Unit (NICU) Admission | 98 | 87 |
Collected over Data collection stared on January 2016 and concluded on July 2019. Adverse event data was collected over the entire study time period (3 years, 6 months). Participants were enrolled between 12 to 24 weeks gestation and followed until after delivery. Adverse event data for participants were collected from the date of enrollment until they completed the study at delivery (approximately 1 year).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Prior CD Decision App (PCDDA) | 0/727 (0%) | 0/727 (0%) | 0/727 (0%) |
| Usual Care - No App | 0/732 (0%) | 0/732 (0%) | 0/732 (0%) |
| Age, Continuous(years) | Prior CD Decision App (PCDDA) | Usual Care - No App | Total |
|---|---|---|---|
| Mean | 34.1 ± 4.6 | 34.0 ± 4.5 | 34.0 ± 4.5 |
| Sex: Female, Male(Participants) | Prior CD Decision App (PCDDA) | Usual Care - No App | Total |
|---|---|---|---|
| Female | 735 | 735 | 1470 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Prior CD Decision App (PCDDA) | Usual Care - No App | Total |
|---|---|---|---|
| Race or ethnic group — White | 394 | 411 | 805 |
| Race or ethnic group — Latina | 124 | 124 | 248 |
| Race or ethnic group — Asian or Pacific Islander | 110 | 106 | 216 |
| Race or ethnic group — Black | 64 | 52 | 116 |
| Race or ethnic group — Biracial or multiracial/multiethnic | 23 | 25 | 48 |
| Race or ethnic group — Other | 20 | 17 | 37 |
| Region of Enrollment(Participants) | Prior CD Decision App (PCDDA) | Usual Care - No App | Total |
|---|---|---|---|
| United States — University of California, San Francisco | 192 | 193 | 385 |
| United States — Marin Community Clinic, San Rafael, California | 26 | 25 | 51 |
| United States — St Luke's Women's Clinic, San Francisco | 18 | 18 | 36 |
| United States — Massachusetts General Hospital, Boston | 274 | 278 | 552 |
| United States — Northwestern University Medical Center, Chicago | 225 | 221 | 446 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Francisco