Pregnancy, Repeat Cesarean Section, Vaginal Births After Cesarean
Conditions
Keywords
Trial of labor after cesarean, Elective repeat cesarean delivery, Decision tool, Shared decision making
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.
Interventions
BEHAVIORALPrior CD Decision App
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.
Sponsors
Northwestern Memorial Hospital
Massachusetts General Hospital
Marin Community Clinics
Sutter Health
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prior CD Decision App (PCDDA) 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. | 735 |
| Usual Care - No App Women randomized to the Usual Care - No App group will simply continue with usual care. | 735 |
| Total | 1,470 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 7 |
| Overall Study | Ineligible | 2 | 1 |
Baseline characteristics
| Characteristic | Usual Care - No App | Total | Prior CD Decision App (PCDDA) |
|---|---|---|---|
| Age, Continuous | 34.0 years STANDARD_DEVIATION 4.5 | 34.0 years STANDARD_DEVIATION 4.5 | 34.1 years STANDARD_DEVIATION 4.6 |
| Race/Ethnicity, Customized Race or ethnic group Asian or Pacific Islander | 106 Participants | 216 Participants | 110 Participants |
| Race/Ethnicity, Customized Race or ethnic group Biracial or multiracial/multiethnic | 25 Participants | 48 Participants | 23 Participants |
| Race/Ethnicity, Customized Race or ethnic group Black | 52 Participants | 116 Participants | 64 Participants |
| Race/Ethnicity, Customized Race or ethnic group Latina | 124 Participants | 248 Participants | 124 Participants |
| Race/Ethnicity, Customized Race or ethnic group Other | 17 Participants | 37 Participants | 20 Participants |
| Race/Ethnicity, Customized Race or ethnic group White | 411 Participants | 805 Participants | 394 Participants |
| Region of Enrollment United States Marin Community Clinic, San Rafael, California | 25 Participants | 51 Participants | 26 Participants |
| Region of Enrollment United States Massachusetts General Hospital, Boston | 278 Participants | 552 Participants | 274 Participants |
| Region of Enrollment United States Northwestern University Medical Center, Chicago | 221 Participants | 446 Participants | 225 Participants |
| Region of Enrollment United States St Luke's Women's Clinic, San Francisco | 18 Participants | 36 Participants | 18 Participants |
| Region of Enrollment United States University of California, San Francisco | 193 Participants | 385 Participants | 192 Participants |
| Sex: Female, Male Female | 735 Participants | 1470 Participants | 735 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 727 | 0 / 732 |
| other Total, other adverse events | 0 / 727 | 0 / 732 |
| serious Total, serious adverse events | 0 / 727 | 0 / 732 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prior CD Decision App (PCDDA) | Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery | 315 Participants |
| Usual Care - No App | Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery | 338 Participants |
95% CI: [0.84, 1.05]
Secondary
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.
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prior CD Decision App (PCDDA) | 3rd or 4th Degree Lacerations | 16 Participants |
| Usual Care - No App | 3rd or 4th Degree Lacerations | 12 Participants |
95% CI: [0.64, 2.81]
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prior CD Decision App (PCDDA) | Decisional Conflict | 17.2 score on a scale | Standard Deviation 12.9 |
| Usual Care - No App | Decisional Conflict | 17.5 score on a scale | Standard Deviation 13.9 |
95% CI: [-1.81, 1.05]
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prior CD Decision App (PCDDA) | Decision Satisfaction | 4.62 score on a scale | Standard Deviation 0.59 |
| Usual Care - No App | Decision Satisfaction | 4.65 score on a scale | Standard Deviation 0.54 |
95% CI: [-0.09, 0.03]
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prior CD Decision App (PCDDA) | Decision Self-Efficacy | 90.7 score on a scale | Standard Deviation 12.3 |
| Usual Care - No App | Decision Self-Efficacy | 90.3 score on a scale | Standard Deviation 12.2 |
95% CI: [-0.94, 1.66]
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prior CD Decision App (PCDDA) | Knowledge About TOLAC and ERCD | 5.0 score on a scale | Standard Deviation 1.8 |
| Usual Care - No App | Knowledge About TOLAC and ERCD | 5.0 score on a scale | Standard Deviation 1.7 |
95% CI: [-0.16, 0.19]
Secondary
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.
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prior CD Decision App (PCDDA) | Maternal Major Morbidity | 19 Participants |
| Usual Care - No App | Maternal Major Morbidity | 23 Participants |
95% CI: [0.46, 1.51]
Secondary
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.
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prior CD Decision App (PCDDA) | Maternal Minor Morbidity | 36 Participants |
| Usual Care - No App | Maternal Minor Morbidity | 36 Participants |
95% CI: [0.64, 1.56]
Secondary
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.
Population: Prior CD Decision App (PCDDA): 15 delivered at outside institution and NICU admission was not obtained from chart review.~Usual Care-No app: 12 delivered at outside institution and NICU admission was not obtained from chart review. 1 delivery at institution missing outcome from chart.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prior CD Decision App (PCDDA) | Neonatal Intensive Care Unit (NICU) Admission | 98 Participants |
| Usual Care - No App | Neonatal Intensive Care Unit (NICU) Admission | 87 Participants |
95% CI: [0.86, 1.48]
Secondary
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.
Population: PCDDA: 15 delivered at outside institution and neonatal respiratory morbidity was not obtained from chart review. 1 delivery at institution missing outcome from chart.~No app: 12 delivered at outside institution and neonatal respiratory morbidity was not obtained from chart review. 2 deliveries at institution missing outcome from chart.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prior CD Decision App (PCDDA) | Neonatal Respiratory Morbidity | 67 Participants |
| Usual Care - No App | Neonatal Respiratory Morbidity | 68 Participants |
95% CI: [0.72, 1.35]
Secondary
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
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prior CD Decision App (PCDDA) | Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC) | 231 Participants |
| Usual Care - No App | Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC) | 233 Participants |
95% CI: [0.86, 1.16]
Secondary
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.
Population: PCDDA: 15 delivered at outside institution and outcome for perinatal death or hypoxic-ischemic encephalopathy was not obtained from chart review.~No app: 12 delivered at outside institution and outcome for perinatal death or hypoxic-ischemic encephalopathy was not obtained from chart review. 1 delivery at institution missing outcome from chart.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior CD Decision App (PCDDA) | Perinatal Death or Hypoxic-ischemic Encephalopathy | Neonatal death | 2 participants |
| Prior CD Decision App (PCDDA) | Perinatal Death or Hypoxic-ischemic Encephalopathy | Intrauterine fetal demised | 4 participants |
| Prior CD Decision App (PCDDA) | Perinatal Death or Hypoxic-ischemic Encephalopathy | Hypoxic-ischemic encephalopathy | 2 participants |
| Usual Care - No App | Perinatal Death or Hypoxic-ischemic Encephalopathy | Neonatal death | 0 participants |
| Usual Care - No App | Perinatal Death or Hypoxic-ischemic Encephalopathy | Intrauterine fetal demised | 0 participants |
| Usual Care - No App | Perinatal Death or Hypoxic-ischemic Encephalopathy | Hypoxic-ischemic encephalopathy | 4 participants |
95% CI: [0.6, 6.62]
Secondary
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
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prior CD Decision App (PCDDA) | Shared Decision Making | 74.4 score on a scale | Standard Deviation 14.9 |
| Usual Care - No App | Shared Decision Making | 74.8 score on a scale | Standard Deviation 15.9 |
95% CI: [-1.96, 1.27]