Trial · NCT02646423
Effect of a Patient-Centered Decision App on TOLAC
NCT02646423, Not applicable, Completed, University of California, San Francisco; results first posted 2021-02-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of a Patient-Centered Decision App on TOLAC. Trials, record NCT02646423. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02646423
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of a Patient-Centered Decision App on TOLAC
- NCT number
- NCT02646423
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,485 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Pregnancy, Repeat Cesarean Section, Vaginal Births After Cesarean
- Interventions
- Prior CD Decision App
- First posted
- 2016-01-05
- Last updated
- 2021-02-02
- Results first posted
- 2021-02-02
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery | 0-8 weeks after delivery | Prior CD Decision App (PCDDA): no data available for N=8 participants who delivered at outside institution and no chart or outside questionnaire obtained.~Usual Care - No App: no data available for N=3 participants who delivered at outside institution and no chart or outside questionnaire obtained. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC) | 0 to 8 weeks after delivery | Prior CD Decision App (PCDDA): no data available for N=8 participants who delivered at outside institution and no chart or outside questionnaire obtained.~Usual Care - No App: no data available for N=3 participants who delivered at outside institution and no chart or outside questionnaire obtained. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Knowledge About TOLAC and ERCD | Approx 34-37 weeks gestation | Prior CD Decision App (PCDDA): 676 Follow-up telephone interviews obtained, 31 Could not be reached for follow-up, 26 Delivered prior to follow-up interview, 2 Had pregnancy loss ≥22 wk.~Usual Care - No App: 681 Follow-up telephone interviews obtained, 31 Could not be reached for follow-up, 23 Delivered prior to follow-up interview. | score on a scale | MEAN |
| SECONDARY | Decisional Conflict | Approx 34-37 weeks gestation | Prior CD Decision App (PCDDA): 676 Follow-up telephone interviews obtained. Responses on the Decisional Conflict Scale missing for 5 participants with PCDAA.~Usual Care-No App: 681 Follow-up interviews obtained. Responses on the Decisional Conflict Scale missing for 6 participants with usual care. | score on a scale | MEAN |
| SECONDARY | Shared Decision Making | Approx 34-37 weeks gestation | Prior CD Decision App (PCDDA): 676 Follow-up telephone interviews obtained. Responses on the Shared Decision Making Scale missing for 12 participants with PCDAA.~Usual Care-No App: 681 Follow-up interviews obtained. Responses on the Shared Decision Making Scale missing for 9 participants with usual care. | score on a scale | MEAN |
| SECONDARY | Decision Self-Efficacy | Approx 34-37 weeks gestation | Prior CD Decision App (PCDDA): 676 Follow-up telephone interviews obtained. Responses on the Decisional Self-Efficacy Scale missing for 6 participants with PCDAA.~Usual Care-No App: 681 Follow-up interviews obtained. Responses on the Decisional Self-Efficacy Scale missing for 9 participants with PCDAA. | score on a scale | MEAN |
| SECONDARY | Decision Satisfaction | Approx 34-37 weeks gestation | Prior CD Decision App (PCDDA): 676 Follow-up telephone interviews obtained. Responses on the Decisional Satisfaction Scale missing for 1 participant with PCDAA.~Usual Care-No App: 681 Follow-up interviews obtained. Responses on the Decisional Satisfaction Scale missing for 2 participants with PCDAA. | score on a scale | MEAN |
| SECONDARY | Maternal Major Morbidity | Collected 0 to 8 weeks after delivery. | PCDDA: 15 delivered at outside institution and outcome for maternal major morbidity was not obtained.~Usual Care- No app: 12 delivered at outside institution and outcome for maternal major morbidity was not obtained. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maternal Minor Morbidity | Collected 0 to 8 weeks after delivery. | PCDDA: 15 Delivered at outside institution and maternal minor morbidity outcome not collected during chart review. 1 additional without complete chart review information.~No App: 12 Delivered at outside institution and maternal minor morbidity outcome not collected during chart review. 1 additional without complete chart review information. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 3rd or 4th Degree Lacerations | Collected 0 to 8 weeks after delivery. | PCDDA: 15 delivered at outside institution and outcome for 3rd or 4th degree lacerations was not obtained.~Usual Care- No app: 12 delivered at outside institution and outcome for 3rd or 4th degree lacerations was not obtained. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery | Prior CD Decision App (PCDDA) | 315 | Participants | ||
| Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery | Usual Care - No App | 338 | Participants | ||
| Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC) | Prior CD Decision App (PCDDA) | 231 | Participants | ||
| Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC) | Usual Care - No App | 233 | Participants | ||
| Knowledge About TOLAC and ERCD | Prior CD Decision App (PCDDA) | 5.0 | Standard Deviation 1.8 | score on a scale | |
| Knowledge About TOLAC and ERCD | Usual Care - No App | 5.0 | Standard Deviation 1.7 | score on a scale | |
| Decisional Conflict | Prior CD Decision App (PCDDA) | 17.2 | Standard Deviation 12.9 | score on a scale | |
| Decisional Conflict | Usual Care - No App | 17.5 | Standard Deviation 13.9 | score on a scale | |
| Shared Decision Making | Prior CD Decision App (PCDDA) | 74.4 | Standard Deviation 14.9 | score on a scale | |
| Shared Decision Making | Usual Care - No App | 74.8 | Standard Deviation 15.9 | score on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prior CD Decision App (PCDDA) | 742 | |
| Overall Study | STARTED | Usual Care - No App | 743 | |
| Overall Study | COMPLETED | Prior CD Decision App (PCDDA) | 735 | |
| Overall Study | COMPLETED | Usual Care - No App | 735 | |
| Overall Study | NOT COMPLETED | Prior CD Decision App (PCDDA) | 7 | |
| Overall Study | NOT COMPLETED | Usual Care - No App | 8 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prior CD Decision App (PCDDA) | 0 | 727 |
| Total, all-cause mortality | Usual Care - No App | 0 | 732 |
| Total, other adverse events | Prior CD Decision App (PCDDA) | 0 | 727 |
| Total, other adverse events | Usual Care - No App | 0 | 732 |
| Total, serious adverse events | Prior CD Decision App (PCDDA) | 0 | 727 |
| Total, serious adverse events | Usual Care - No App | 0 | 732 |
Source ClinicalTrials.gov
Papers15
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD078748 | Effect of a patient-centered decision app on TOLAC: An RCT | KUPPERMANN, MIRIAM | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2014 to 2018 |
Source NIH RePORTER
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prior CD Decision App (PCDDA) vs Usual Care - No App: 3rd or 4th Degree Lacerations | Trial comparisons |
| Prior CD Decision App (PCDDA) vs Usual Care - No App: Maternal Major Morbidity | Trial comparisons |
| Prior CD Decision App (PCDDA) vs Usual Care - No App: Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery | Trial comparisons |
| Prior CD Decision App (PCDDA) vs Usual Care - No App: Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC) | Trial comparisons |
| Prior CD Decision App (PCDDA) vs Usual Care - No App: deaths from any cause | Trial comparisons |
| Prior CD Decision App (PCDDA) vs Usual Care - No App: Neonatal Respiratory Morbidity | Trial comparisons |
| Prior CD Decision App (PCDDA) vs Usual Care - No App: Maternal Minor Morbidity | Trial comparisons |
| Prior CD Decision App (PCDDA) vs Usual Care - No App: Neonatal Intensive Care Unit (NICU) Admission | Trial comparisons |
| Prior CD Decision App (PCDDA) vs Usual Care - No App: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02646423
GET https://conductscience.org/api/trials/v1/NCT02646423/results?page=2