PregnancyPROCEEDNCT02646423
Effect of a Patient-Centered Decision App on TOLAC
A study testing Prior CD Decision App in people with Pregnancy and Repeat Cesarean Section, run by University of California, San Francisco at 5 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Repeat Cesarean Section, Vaginal Births After Cesarean
- What is being tested?
- Prior CD Decision App
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,485 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindications to vaginal delivery (e.g., placenta previa, prior classical cesarean, previous uterine rupture).
- Prior VBAC.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Sutter Health, California Pacific Medical Center, St. Luke's Campus
San Francisco, California, 94110
UCSF
San Francisco, California, 94143
Marin Community Clinic
San Rafael, California, 94901
About this study
Official title: Effect of a Patient-Centered Decision App on TOLAC: An RCT
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.
- Being tested
- Prior CD Decision App
- Keywords
- Trial of labor after cesarean, Elective repeat cesarean delivery, Decision tool, Shared decision making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prior CD Decision AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prior CD Decision App (PCDDA) | Experimental | 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. Receives: Behavioral: Prior CD Decision App |
| Usual Care - No App | No intervention | Women randomized to the Usual Care - No App group will simply continue with usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-8 weeks after delivery
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Collected 0 to 8 weeks after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,485 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern Memorial Hospital, Massachusetts General Hospital, Marin Community Clinics, Sutter Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Miriam Kupperman, PhD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646423
- Sponsor's protocol ID
- 1R01HD078748
- Other IDs
- 1R01HD078748
- Acronym
- PROCEED
- Status last verified
- Jan 2021
- First submitted
- 15 Dec 2015
- Last updated
- 2 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bernstein SN, Matalon-Grazi S, Rosenn BM. Trial of labor versus repeat cesarean: are patients making an informed decision? Am J Obstet Gynecol. 2012 Sep;207(3):204.e1-6. doi: 10.1016/j.ajog.2012.06.057. Epub 2012 Jul 4.
PubMed 22939727Farnworth A, Robson SC, Thomson RG, Watson DB, Murtagh MJ. Decision support for women choosing mode of delivery after a previous caesarean section: a developmental study. Patient Educ Couns. 2008 Apr;71(1):116-24. doi: 10.1016/j.pec.2007.11.020. Epub 2008 Feb 6.
PubMed 18255248O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
PubMed 7898294Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
PubMed 19879711Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114.
PubMed 8717600Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2012. Natl Vital Stat Rep. 2013 Sep;62(3):1-20.
PubMed 24321416Guise JM, Eden K, Emeis C, Denman MA, Marshall N, Fu RR, Janik R, Nygren P, Walker M, McDonagh M. Vaginal birth after cesarean: new insights. Evid Rep Technol Assess (Full Rep). 2010 Mar;(191):1-397.
PubMed 20629481Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Kirmeyer S, Mathews TJ, Wilson EC. Births: final data for 2009. Natl Vital Stat Rep. 2011 Nov 3;60(1):1-70.
PubMed 22670489Grobman WA, Lai Y, Landon MB, Spong CY, Rouse DJ, Varner MW, Caritis SN, Harper M, Wapner RJ, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. The change in the rate of vaginal birth after caesarean section. Paediatr Perinat Epidemiol. 2011 Jan;25(1):37-43. doi: 10.1111/j.1365-3016.2010.01169.x. Epub 2010 Oct 25.
PubMed 21133967Landon MB, Hauth JC, Leveno KJ, Spong CY, Leindecker S, Varner MW, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM, Gabbe SG; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal and perinatal outcomes associated with a trial of labor after prior cesarean delivery. N Engl J Med. 2004 Dec 16;351(25):2581-9. doi: 10.1056/NEJMoa040405. Epub 2004 Dec 14.
PubMed 15598960Macones GA, Peipert J, Nelson DB, Odibo A, Stevens EJ, Stamilio DM, Pare E, Elovitz M, Sciscione A, Sammel MD, Ratcliffe SJ. Maternal complications with vaginal birth after cesarean delivery: a multicenter study. Am J Obstet Gynecol. 2005 Nov;193(5):1656-62. doi: 10.1016/j.ajog.2005.04.002.
PubMed 16260206Lavin JP, Stephens RJ, Miodovnik M, Barden TP. Vaginal delivery in patients with a prior cesarean section. Obstet Gynecol. 1982 Feb;59(2):135-48.
PubMed 7078857Silver RM. Delivery after previous cesarean: long-term maternal outcomes. Semin Perinatol. 2010 Aug;34(4):258-66. doi: 10.1053/j.semperi.2010.03.006.
PubMed 20654776Lydon-Rochelle M, Holt VL, Martin DP, Easterling TR. Association between method of delivery and maternal rehospitalization. JAMA. 2000 May 10;283(18):2411-6. doi: 10.1001/jama.283.18.2411.
PubMed 10815084Kuppermann M, Kaimal AJ, Blat C, Gonzalez J, Thiet MP, Bermingham Y, Altshuler AL, Bryant AS, Bacchetti P, Grobman WA. Effect of a Patient-Centered Decision Support Tool on Rates of Trial of Labor After Previous Cesarean Delivery: The PROCEED Randomized Clinical Trial. JAMA. 2020 Jun 2;323(21):2151-2159. doi: 10.1001/jama.2020.5952.
PubMed 32484533
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Patient-Centered Decision App on TOLAC: An RCT
- ClinicalTrials.gov ID
- NCT02646423
- Acronym / sponsor ID
- PROCEED / 1R01HD078748
- Keywords
- Trial of labor after cesarean, Elective repeat cesarean delivery, Decision tool, Shared decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,485 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Northwestern Memorial Hospital, Massachusetts General Hospital, Marin Community Clinics, Sutter Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 5 Jan 2016 (estimated)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prior CD Decision App (PCDDA) | Experimental | Behavioral: Prior CD Decision AppWomen 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. |
| Usual Care - No App | No intervention | –Women randomized to the Usual Care - No App group will simply continue with usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindications to vaginal delivery (e.g., placenta previa, prior classical cesarean, previous uterine rupture).
- Prior VBAC.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prior CD Decision AppThe 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. | Behavioural | Prior CD Decision App (PCDDA) |
Primary outcome
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.
12 secondary outcomes
Number of Participants Who Underwent Vaginal Birth After Cesarean (VBAC)
Time frame: 0 to 8 weeks after delivery
Knowledge About TOLAC and ERCD
Time frame: Approx 34-37 weeks gestation
Decisional Conflict
Time frame: Approx 34-37 weeks gestation
Shared Decision Making
Time frame: Approx 34-37 weeks gestation
Decision Self-Efficacy
Time frame: Approx 34-37 weeks gestation
Decision Satisfaction
Time frame: Approx 34-37 weeks gestation
Maternal Major Morbidity
Time frame: Collected 0 to 8 weeks after delivery.
Maternal Minor Morbidity
Time frame: Collected 0 to 8 weeks after delivery.
3rd or 4th Degree Lacerations
Time frame: Collected 0 to 8 weeks after delivery.
Perinatal Death or Hypoxic-ischemic Encephalopathy
Time frame: Collected 0 to 8 weeks after delivery.
Neonatal Respiratory Morbidity
Time frame: Collected 0 to 8 weeks after delivery.
Neonatal Intensive Care Unit (NICU) Admission
Time frame: Collected 0 to 8 weeks after delivery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22939727Bernstein SN, Matalon-Grazi S, Rosenn BM. Trial of labor versus repeat cesarean: are patients making an informed decision? Am J Obstet Gynecol. 2012 Sep;207(3):204.e1-6. doi: 10.1016/j.ajog.2012.06.057. Epub 2012 Jul 4.
- Background: PubMed 18255248Farnworth A, Robson SC, Thomson RG, Watson DB, Murtagh MJ. Decision support for women choosing mode of delivery after a previous caesarean section: a developmental study. Patient Educ Couns. 2008 Apr;71(1):116-24. doi: 10.1016/j.pec.2007.11.020. Epub 2008 Feb 6.
- Background: PubMed 7898294O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
- Background: PubMed 19879711Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30.
- Background: PubMed 8717600Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML, Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the satisfaction with decision scale. Med Decis Making. 1996 Jan-Mar;16(1):58-64. doi: 10.1177/0272989X9601600114.
- Background: PubMed 24321416Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2012. Natl Vital Stat Rep. 2013 Sep;62(3):1-20.
- Background: PubMed 20629481Guise JM, Eden K, Emeis C, Denman MA, Marshall N, Fu RR, Janik R, Nygren P, Walker M, McDonagh M. Vaginal birth after cesarean: new insights. Evid Rep Technol Assess (Full Rep). 2010 Mar;(191):1-397.
- Background: PubMed 22670489Martin JA, Hamilton BE, Ventura SJ, Osterman MJ, Kirmeyer S, Mathews TJ, Wilson EC. Births: final data for 2009. Natl Vital Stat Rep. 2011 Nov 3;60(1):1-70.
- Background: PubMed 21133967Grobman WA, Lai Y, Landon MB, Spong CY, Rouse DJ, Varner MW, Caritis SN, Harper M, Wapner RJ, Sorokin Y; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. The change in the rate of vaginal birth after caesarean section. Paediatr Perinat Epidemiol. 2011 Jan;25(1):37-43. doi: 10.1111/j.1365-3016.2010.01169.x. Epub 2010 Oct 25.
- Background: PubMed 15598960Landon MB, Hauth JC, Leveno KJ, Spong CY, Leindecker S, Varner MW, Moawad AH, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai B, Langer O, Thorp JM, Ramin SM, Mercer BM, Gabbe SG; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Maternal and perinatal outcomes associated with a trial of labor after prior cesarean delivery. N Engl J Med. 2004 Dec 16;351(25):2581-9. doi: 10.1056/NEJMoa040405. Epub 2004 Dec 14.
- Background: PubMed 16260206Macones GA, Peipert J, Nelson DB, Odibo A, Stevens EJ, Stamilio DM, Pare E, Elovitz M, Sciscione A, Sammel MD, Ratcliffe SJ. Maternal complications with vaginal birth after cesarean delivery: a multicenter study. Am J Obstet Gynecol. 2005 Nov;193(5):1656-62. doi: 10.1016/j.ajog.2005.04.002.
- Background: PubMed 7078857Lavin JP, Stephens RJ, Miodovnik M, Barden TP. Vaginal delivery in patients with a prior cesarean section. Obstet Gynecol. 1982 Feb;59(2):135-48.
- Decisional Conflict ScaleLink provided by the sponsor.
- Decision Self-Efficacy ScaleLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Kupperman, PhD, MPH principal investigator
University of California, San Francisco
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prior CD Decision App in people with Pregnancy and Repeat Cesarean Section, run by University of California, San Francisco at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Underwent a Trial of Labor After Cesarean (TOLAC) Delivery (time frame: 0-8 weeks after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02646423, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.