Mismanagement of Trial of Labour After Caesarean (TOLAC)

Antenatal and intrapartum care for the pregnant person choosing trial of labour after caesarean (TOLAC) requires that the pregnant person is fully informed of the risks, benefits, and alternatives given their evolving clinical circumstances. In instances of negative outcomes associated with TOLAC, shared decision making (informed choice-informed consent), the planning and delivery of care, and responses to the obstetrical emergency are examined. In the absence of good documentation, it is challenging to understand what was considered and to confirm whether the pregnant person was fully informed of the risks, in particular the risks to the fetus / future child. Additionally, the failure to detect signs and symptoms of a uterine rupture and respond promptly is a significant exposure for healthcare providers and organizations. 

Expected Outcomes

Implement a standardized evidence-based protocol for the management of TOLAC.

Adopt a standardized, interdisciplinary, collaborative and evidence-based protocol for conducting quality of care reviews involving TOLAC resulting in client harm or death. 

Adopt standardized quality indicators for TOLAC. 

Definitions and Acronyms

• Client – includes all persons who receive healthcare and related services including patients, residents and persons in-care
• Community birth settings – births occurring in the community versus in a hospital 
• EFM – electronic fetal monitoring
• ERC – elective repeat caesarean
• IA – intermittent auscultation
• IV – intravenous 
• MRP – most responsible practitioner, often a midwife, nurse practitioner or physician
• NICU – neonatal intensive care unit
• OR – operating room
• Situational awareness – deliberate and active scanning and assessing of the situation to maintain a holistic understanding of the environment in which the team is functioning
• TOLAC - trial of labour after caesarean also known as vaginal birth after caesarean or VBAC

Common Claims Themes and Contributing Factors

Shared Decision Making (Informed Choice - Informed Consent)

• Assumption that shared decision making (informed choice - informed consent) discussions are not required based on the assumption that the discussions undertook by other practitioners are transferable to the attending practitioners. 
• Lack of communication between providers about the details of the consent discussion(s) and clarifying responsibilities for obtaining informed consent.
• Inconsistent and confusing practices for use of consent forms (where utilized).
• Minimizing the risks or withholding pertinent details related to the risks (in particular risks to the fetus) to influence the pregnant person’s choice for either an ERC or TOLAC.
• Failure to describe risks to the fetus and pregnant person in language that can be understood by the pregnant person.
• Perceived and actual delegation of the shared decision making (informed choice-informed consent) and completion of consent forms to nurses.
• Perceived and actual organizational pressures to reduce rates of ERC (e.g., alleged coercion or minimizing risks to impact pregnant person decision making). 

Induction and Augmentation of Labour

• Normalizing oxytocin induction or augmentation without recognition of increased risk of uterine rupture. 
• Failure to obtain or reconfirm informed consent to IV oxytocin augmentation prior to infusion. 

Knowledge and Judgement

• Failure to recognize or respond to warning signs of an impending uterine rupture resulting in delayed medical and surgical interventions.
• Failure to identify and respond to signs of fetal deterioration in a timely manner.

Documentation 

• Inadequate documentation to demonstrate the risks, benefits, and alternatives (including the risks and benefits associated with the alternatives) was understood by the pregnant person, in particular the risks to the fetus / future child, including options such as:
  • TOLAC and ERCs;
  • Continuous EFM versus IA;
  • Oxytocin induction or augmentation.
• Inadequate documentation of the discussions associated with the current availability and access to specialists (e.g., obstetricians) and resources (e.g., OR for an emergency caesarean) in the planned and actual birth location.
• Failure to confirm pregnant person’s choices during consultation or transfer of care. 

Mitigation Strategies

Care Processes

• Adopt a standardized evidence-based protocol for the management of TOLAC (Guerby, Bujold, & Chaillet, 2022) (Dy, DeMeester, Lipworth, & Barrett, 2019).

Shared Decision Making (Informed Choice - Informed Consent)

• Implement an evidence-based TOLAC pregnant person handout / resource to supplement the shared decision making (informed choice-informed consent) conversations between the MRP and the pregnant person (Association of Ontario Midwives, 2021a) (Miazga, et al., 2020) (Provincial Council for Maternal and Child Health & Health Quality Ontario, 2018).
• Ensure the TOLAC client handout / resources (and related shared decision making (informed choice-informed consent) conversations) use clear, explicit, and unbiased language when describing the risks, benefits, alternatives, and related evidence associated with TOLAC and ERC (Dy, DeMeester, Lipworth, & Barrett, 2019) (Gure, MacDonald, & Minichiello, 2021).
• Implement strategies to enable access to interpreter services during shared decision making (informed choice-informed consent) conversations.

Strategies for Midwives and Physicians

• Ensure complete and timely documentation of the shared decision making (informed choice-informed consent) discussions surrounding TOLAC in the health record (Dy, DeMeester, Lipworth, & Barrett, 2019) (Gure, MacDonald, & Minichiello, 2021); if an informed consent / decline form is used, ensure it is accompanied by complete and timely documentation in the health record.

Additional Considerations

Example of elements to discuss and document surrounding the TOLAC shared decision making:

• The pregnant person’s overall and evolving clinical scenario;
• Risks to the pregnant person and fetus;
• Availability of hospital staff (e.g., anesthesiologist, respiratory therapists, obstetricians, midwives, OR nurses) and resources (e.g., caesarean ready rooms, NICU) needed to respond to obstetrical emergencies;  
• Potential consequences of a uterine rupture for both the pregnant person and fetal / neonatal clients;
• Benefits, risks, and alternatives of IV oxytocin augmentation (where utilized);
• Discussion of national, provincial (where in place), and local clinical practice guidelines particularly where the pregnant person declines fetal monitoring, vaginal exams, or continuous EFM where indicated. 

• For planned and actual community births, ensure the record of the informed choice discussion include (but is not limited to):
  • Emergency measures available / not available in the community birth setting as well local or privileging hospital;
  • Availability of continuous EFM for labour surveillance;
  • Distance from the community birth location to hospital with caesarean capability;
  • Transport plan;
  • Evidence that the pregnant person met the criteria supporting the informed choice for a community TOLAC (e.g., criteria outlined in the Association of Ontario Midwives’ TOLAC clinical practice guidelines);
  • A review of the evidence surrounding community-based TOLAC births including (but not limited to) midwifery clinical practice guidelines (e.g., Association of Ontario Midwives) and any other pertinent clinical practice guidelines (e.g., Society of Obstetricians and Gynecologist of Canada and Ontario’s Provincial Council for Maternal and Child Health).
• Obtain / revisit (and document) the pregnant person’s informed consent to TOLAC:
  • Upon admission to hospital or midwife-led birth centre;
  • Prior to pharmaceutical induction or augmentation of labour (Dy, DeMeester, Lipworth, & Barrett, 2019) (Provincial Council for Maternal and Child Health, 2020) (Gure, MacDonald, & Minichiello, 2021);
  • Upon acceptance of an interprofessional or intraprofessional transfer of care (Canadian Medical Protective Association, 2021).
• Develop detailed antenatal and labour / birth care management plans for the pregnant persons choosing a TOLAC; ensure the care plan is readily accessible by team members; include all attempts to obtain the prior operative reports from prior caesareans as well as the actions take to assess the person’s clinical eligibility in the absence of the reports.

Additional Considerations

Examples of elements to include in the TOLAC antenatal and labour / birth care management plans:

• The pregnant person overall and evolving clinical scenario (i.e., a holistic understanding);
• The pregnant person’s risk factors, predictive factors, and contraindications; 
• Plans for possible post-dates pregnancy;
• Plans for possible labour dystocia;
• Local privileging hospital’s resources (e.g., scheduling an induction of labour, scheduling an elective caesarean and performing an emergency caesarean, physician, nursing, anesthesiology, and pediatric and / or neonatology availability);
• For planned and actual community births:
  • Community birth resources;
  • Transfer plan;
• Antenatal consults (where conducted).

Team Training and Education 

• Implement formal strategies to support and enhance the team’s clinical knowledge, skills (technical and non-technical), and practical experience surrounding the prevention, recognition, and response to uterine rupture including (but not limited to) scheduled interprofessional and cross-department skill drills and simulations (Agency for Healthcare Research and Quality, 2017).
• Ensure the scheduled interprofessional and cross-department team training and education strategies consider or involve: 
  • Knowledge, skills, and practical experience required for both hospital and community birth and postpartum locations (Association of Ontario Midwives, 2021b);
  • Transfers from the community birth setting;
  • Team and practitioner situational awareness (‘helicopter view’) and human factors; 
  • Program areas or sites with limited practical experience with obstetrical emergencies such as low birth volume sites, midwifery led birth centres, emergency departments, laboratory services, and blood bank;
  • Unregulated care providers (where utilized), locums, travel, agency, contracted care providers in addition to regulated health professionals.

Monitoring and Measurement

• Adopt a standardized, interdisciplinary, collaborative, and evidence-based protocol for conducting quality of care reviews involving TOLAC resulting in client harm or death; incorporate system thinking and human factors concepts into the review process (Delpero, Tannenbaum, & Thomas, 2020) (Society of Obstetricians and Gynaecologists of Canada , 2021) (Ray, et al., 2018) (Canadian Institute for Health Information & Canadian Patient Safety Institute, 2021) (Machen, 2023).
• Adopt standardized quality indicators for:
  • TOLAC and uterine rupture (Agency for Healthcare Research and Quality, 2019) (Better Outcomes Registry & Network, 2021) (Provincial Council for Maternal and Child Health & Health Quality Ontario, 2018);
  • Response to uterine rupture.
• Incorporate learning from local, provincial, and national perinatal safety reviews and data related to TOLAC into local protocols as well as staff and client education and training.  

References

• Agency for Healthcare Research and Quality. (2017). Agency for Healthcare Research and Quality. Retrieved from Sample scenario for severe abdominal pain/VBAC in situ simulation: https://www.ahrq.gov/hai/tools/perinatal-care/modules/situ/simulation-vbac-ab-pain.html
• Agency for Healthcare Research and Quality. (2019). Retrieved from Inpatient quality indicator 22 (IQI 22) vaginal birth after cesarean (VBAC) delivery rate, uncomplicated: https://qualityindicators.ahrq.gov/Downloads/Modules/IQI/V2019/TechSpecs/IQI_22_Vaginal_Birth_After_Cesarean_(VBAC)_Delivery_Rate_Uncomplicated.pdf
• Association of Ontario Midwives. (2021a). Deciding how to give birth after a caesarean section. Retrieved from Association of Ontario Midwives: https://www.ontariomidwives.ca/sites/default/files/2021-06/Deciding-how-to-give-birth-after-caesarean-section-English.pdf
• Association of Ontario Midwives. (2021b). Retrieved from Emergency Skills Workshop Manual. 7th Edition: https://www.ontariomidwives.ca/esw
• Better Outcomes Registry & Network. (2021). VBAC quality standard report. 
• Canadian Institute for Health Information & Canadian Patient Safety Institute. (2021). Sepsis. 
• Canadian Medical Protective Association. (2021). Consent: A guide for Canadian physicians. Retrieved from https://www.cmpa-acpm.ca/en/advice-publications/handbooks/consent-a-guide-for-canadian-physicians
• Delpero, E., Tannenbaum, E., & Thomas, J. (2020). Labour Management in Trial of Labour After Cesarean Delivery (TOLAC): A Gap Analysis and Quality Improvement Initiative. J Obstet Gynaecol Can, 43(8), 967-972. doi:10.1016/j.jogc.2020.10.023
• Dy, J., DeMeester, S., Lipworth, H., & Barrett, J. (2019). No. 382-Trial of Labour After Caesarean. J Obstet Gynaecol Can, 41(7), 992–1011. doi:10.1016/j.jogc.2018.11.008
• Guerby, P., Bujold, E., & Chaillet, N. (2022). Impact of Third-Trimester Measurement of Low Uterine Segment Thickness and Estimated Fetal Weight on Perinatal Morbidity in Women With Prior Cesarean Delivery. J Obstet Gynaecol Can, 44(3), 261-271.e4. doi:10.1016/j.jogc.2021.09.021
• Gure, F., MacDonald, T., & Minichiello, A. (2021). Management of vaginal birth after previous low-segment Caesarean section. Retrieved from https://www.ontariomidwives.ca/sites/default/files/2022-01/CPG-Vaginal-birth-after-caesaean-section-2021-PUB-.pdf
• Machen, S. (2023, 5). Thematic reviews of patient safety incidents as a tool for systems thinking: a quality improvement report. BMJ Open Quality, 12(2), e002020.
• Miazga, E., Reed, C., Tunde-Byass, M., Cipolla, A., Shapiro, J., & Shore, E. M. (2020). Decreasing Cesarean Delivery Rates Using a Trial of Labour After Cesarean (TOLAC) Bundle. J Obstet Gynaecol Can, 42(9), 1111-1115. doi:10.1016/j.jogc.2020.02.113
• Provincial Council for Maternal and Child Health & Health Quality Ontario. (2018). Vaginal birth after Caesarean: Care for people who have had a Caesarean birth and are planning their next birth. Retrieved from https://www.hqontario.ca/portals/0/documents/evidence/quality-standards/qs-vaginal-birth-after-caesarean-patient-guide-en.pdf
• Provincial Council for Maternal and Child Health. (2020). Retrieved from Vaginal birth after Caesarean: Education toolkit: https://www.pcmch.on.ca/wp-content/uploads/2022/02/EducationToolkit2020V5-OCT2020.pdf
• Ray, J., Park, A., Dzakpasu, S., Dayan, N., Deb-Rinker, P., Luo, W., & Joseph, K. (2018, 11). Prevalence of Severe Maternal Morbidity and Factors Associated With Maternal Mortality in Ontario, Canada. JAMA Network Open, 1(7), e184571.
• Society of Obstetricians and Gynaecologists of Canada . (2021). Prevention of maternal mortality in Canada. Retrieved from https://sogc.org/en/en/content/about/Prevention_of_Maternal_Mortality_in_Canada.aspx