Mismanagement of Assisted Vaginal Birth

The application of forceps or vacuum during the second stage of labour is intended to expedite spontaneous vaginal birth. Performed by trained, skilled, and experienced practitioners under controlled, appropriate conditions, such instruments can be safely employed to manage challenging deliveries. However, harm can also result from their use. Recent studies and editorials questioned if the goal of reducing caesarean delivery rates comes at a too high cost to pregnant persons, and noted “startling” high rates of severe perineal trauma (Ng, 2018) (Balayla, Lasry, Badeghiesh, Volodarsky-Perel, & Gil, 2022). Hospitals and health regions may become involved in malpractice claims associated with vacuum-assisted vaginal birth (VAVB) and forceps-assisted vaginal birth (FAVB) as a function of their oversight accountabilities for physicians credentialing, privileges and performance management. Hospitals and health regions may also be implicated in VAVB and FAVB malpractice claims as a result of resource challenges, including the absence of contingency plans that may be required during the course of obstetrical emergencies.

Expected Outcomes

Develop and implement evidence-based protocol to include (but not limited to) the following:
o        Systematic and coordinated care approach for all assisted vaginal births (AVBs);
o        Timely and complete communication and documentation of care pre-, peri-, and post-AVBs;
o        Scheduled preventive maintenance checks on all AVB equipment and supplies.

Ensure all individuals involved in the care process are:
o        Adequately trained, certified, and deemed competent;
o        Supported by formal strategies to enhance the team’s clinical knowledge, skills (technical and non-technical), and practical experience surrounding the AVBs;
o        Equipped with scheduled interprofessional and cross-department team training and education.

Organizational efforts to monitor and measure standardized quality indicators for AVBs that incorporate internal and external learnings into local protocols as well as staff and client education and training.

Definitions and Acronyms

• AVB – assisted vaginal birth
• Client – includes all persons who receive healthcare and related services including patients, residents and persons in-care
• FAVB – forceps assisted vaginal birth
• OR – operating room
• MRP – most responsible practitioner, often a midwife, nurse practitioner or physician
• VAVB – vacuum assisted vaginal birth
• Sequential assisted vaginal birth – the sequential or serial use of vacuums and forceps e.g., failed trial of a vacuum birth followed by forceps
• 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

Common Claims Themes and Contributing Factors

Organizational

• Limited opportunities for physicians and teams to acquire and maintain skills and experience in AVB.
• Inconsistent definition and interpretation of a vacuum-related pop off (versus release of pressure during contraction and / or pulls) leading to record discrepancies between nurses and attending physicians.
• VAVB and FAVB privileges granted and renewed without demonstrated evidence of skill (refer to Inappropriate Credentialing, Reappointment, and Performance Management Risk Reference Sheet for further details). 
• Lack of systematic approach to pregnant / postpartum person and neonatal quality of care reviews involving the use of forceps, vacuums, or both.
• Culture of normalizing of mild to severe trauma associated with AVBs e.g., known complications versus looking at organization, team, and practitioner safety learnings.
• Delayed caesareans following failed AVB (refer to Delayed Decision to Delivery Time for Caesareans Risk Reference Sheets for further details).
• Physicians resorting to an AVB (last resort) due to the inability to access primary or ORs or surgical team members for urgent or emergent caesareans.

Knowledge and Judgement

• Chaotic or inadequately implemented AVB:
  • Delays in abandoning ineffective AVB resulting sequential assisted births, delayed caesareans, and significant trauma;
  • Lack of team and practitioner situational awareness;
  • Failure to call for assistance when supports are needed;
  • Failure to have resuscitation equipment prepared and accessible; 
  • Failure to develop, confirm, or communicate the contingency plan (including resources and staffing) in preparation for a potential failed AVB. 
• AVBs, including sequential assisted vaginal births, performed in the absence of clinical indication (no documented justification).
• High risk AVB and trials undertaken outside of the OR.
• Lack of familiarity or compliance with recommended interventions for FAVB and VAVB.
• Lack of competency and misapplied forceps and vacuums (i.e., judgement and user error).
• Inappropriate client selection for AVB.

Communication

• Failure to escalate care concerns or care disagreements in a timely way, or at all.
• Informed consent not obtained prior to AVB (e.g., procedure explained but not the risks).
• Failure to provide adequate time or information (i.e., risks) for an informed consent for AVB.
• Misunderstanding between the referring midwife or physician and the consulting or delivering physician as to who is responsible to obtain informed consent to an AVB.

Documentation

• Conflicting documentation of AVB interventions (e.g., between the nurse and delivering physician(s)).
• Inadequate documentation related to assisted vaginal deliveries including:
  • Informed consent;
  • Indications for VAVB, FAVB, and sequential AVB;
  • Fetal position and status prior to and during AVB;
  • Number of attempts;
  • Rationale for performing higher risk and trials of AVB outside the OR;
  • Management of shoulder dystocia (where applicable).

Mitigation Strategies

Reliable Care Process

• Adopt an evidence-based protocol to ensure a systematic and coordinated approach for all:
  • AVBs (Mendoza, Hobson, Windrim, Kindom, & Rojas-Gauldon, 2022) (Hobson, Cassell, Windrim, & Cargill, 2019);
  • Third and four-degree perineal tears (Harvey & Pierce, 2015) (Royal College of Obstetricians and Gynaecologists, 2015).

Additional Considerations

Examples of elements to address within the evidence-based AVB protocol:

• Criteria for vacuum and forceps delivery;
• Team-based back up / contingency plan / exit strategy to facilitate the effective coordination and communication for potential failed AVB;
• Who needs to be present (e.g., personnel skilled in neonatal resuscitation);
• Shared care decision making requirements;
• Location for the birth (e.g., trials in the OR); 
• Need to alert the OR if not occurring in the OR and related staff.

Safety Culture

• Implement formal strategies to develop and maintain a work environment which supports and expects:
  • Assertive and respectful questioning and challenging of care decisions (in order to obtain clarity and / or to advance client safety concerns);
  • Zero tolerance of intra- and inter-disciplinary bullying and intimidation.
• Adopt a standardized and formalized chain of command (‘escalation’) protocol for the rapid escalation of unresolved care disagreements related to concerns about questionable client conditions, orders, or care delivery (Canadian Medical Protective Association, 2021) (Canadian Patient Safety Institute, 2020) (Provincial Council for Maternal and Child Health, 2022); for smaller organizations, consider the need to include successively higher level of authority (e.g., the Chief of Staff, administration on call or other executive leaders) to ensure a satisfactory resolution is achieved.

Shared Decision Making (Informed Choice-Informed Consent)

• Ensure the AVB client handout / resources (and related shared decision making conversations) use clear, explicit, and unbiased language when describing the risks, benefits, alternatives, and related evidence associated with AVB and alternatives.
• Implement strategies to enable access to interpreter services during shared decision making (informed choice-informed consent) conversations.

Strategies for Physicians 

• Ensure the timely and complete documentation of the AVB related shared decision making (informed choice-informed consent) discussions with the pregnant person, in particular related to (but not limited to) sequential assisted births; if an informed consent / decline form is used, ensure it is accompanied by complete and timely documentation in the health record (Hobson, Cassell, Windrim, & Cargill, 2019) (Muraca, et al., 2021) (Baskett, 2019) (Murphy, Strachan, & Bahl, 2020).

Additional Considerations

Examples of elements to discuss (and document) during shared decision making (informed choice-informed consent) surrounding AVBs:

• The pregnant person’s overall and evolving clinical status and risk factors;
• The likelihood the forceps or vacuum assisted birth will be successful;
• Potential, known, and foreseeable risks to the pregnant person and fetus / neonate associated with the forceps, vacuum, or sequential assisted vaginal delivery (where considered);
• Local hospital’s resources to launch a timely caesarean for potential failed AVB;
• Alternatives to an AVB (including the alternatives’ risks and benefits to the pregnant person and fetus).

Team Training and Education 

• Implement a standardized process to ensure all:
  • Obstetrical trainees receive appropriate and adequate training and are deemed competent in assisted vaginal deliveries prior to independent practice (Mendoza, Hobson, Windrim, Kindom, & Rojas-Gauldon, 2022) (Hobson, Cassell, Windrim, & Cargill, 2019) (Murphy, Strachan, & Bahl, 2020);
  • Physicians granted privileges for VAVB and / or FAVB demonstrate the necessary skills, knowledge, and experience on a continuous basis.
• Implement formal strategies to support and enhance the team’s clinical knowledge, skills (technical and non-technical), and practical experience surrounding the AVBs, including (but not limited to) scheduled interprofessional and cross-department skill drills and simulations (Mendoza, Hobson, Windrim, Kindom, & Rojas-Gauldon, 2022) (Hobson, Cassell, Windrim, & Cargill, 2019) (CMPA, 2021) (Gossett, Gilchrist-Scott, Wayne, & Gerber, 2016)( (Murphy, Strachan, & Bahl, 2020).
• Ensure the scheduled interprofessional and cross-department team training and education strategies consider or involve: 
  • Improving team and practitioner situational awareness (‘helicopter view’) (Hobson, Cassell, Windrim, & Cargill, 2019) (CMPA, 2021) (Walshe, et al., 2021);
  • Program areas or sites with limited practical experience with obstetrical emergencies such as low birth volume sites and rural sites;
  • Unregulated care providers (where employed), locums, travel, agency, contracted care providers in additional to regulated health providers.

Documentation

• Adopt a standardized AVB documentation template (paper and / or electronic) to facilitate timely and reliable documentation by physicians and team members (Murphy, Strachan, & Bahl, 2020).

Additional Considerations

Examples of elements / fields to address within the standardized AVB documentation template:

• Physicians involved or in attendance;
• Location of the delivery;
• Indication for use and evidence that prerequisites fulfilled;
• Estimated fetal weight;
• Anaesthesia type;
• A record of the shared decision making (informed choice-informed consent); 
• The use of translators or interpreters (i.e., name and relationship to the pregnant person), including during the shared decision making (informed choice-informed consent) discussions;
• Manual rotation attempts (where applicable) prior to assisted vaginal birth;
• Position and station of the fetal head;
• Amount of moulding and caput present;
• Assessment of pregnant person’s pelvis and fetal status;
• Number of attempts and ease of application;
• Type of vacuum or forceps used; 
• Number of popoffs (vacuums);
• Complications.

Communication

• Adopt a standardized AVB pamphlet (digital and / or paper) to support AVB shared decision making (informed choice-informed consent). 
• Implement debriefings and offer of supports and counseling for the:
  • Postpartum person and family following AVB, in particular but not limited to those involved in challenging and failed AVB (Hobson, Cassell, Windrim, & Cargill, 2019);
  • Involved staff.

Monitoring and Measurement

• Adopt a standardized, interdisciplinary, collaborative, and evidence-based protocol for conducting quality of care reviews involving AVB resulting in client harm or death (Machen, 2023); incorporate system thinking and human factors concepts into the review process.
• Adopt standardized quality indicators for AVBs (Agency for Healthcare Research and Quality, 2017) (Calder, et al., 2019) (Cook, et al., 2017) (Canadian Institute for Health Information, 2022) (Canadian Institute for Health Information, 2023).
• Incorporate learning from local, provincial, and national pregnant / postpartum person and neonatal morbidity and mortality AVB-related incidents and data into local protocols as well as staff and client education and training (Muraca, et al., 2021). 

References

• Agency for Healthcare Research and Quality. (2017). Patient Safety Indicator 18 (PSI 18) Obstetric Trauma Rate – Vaginal Delivery With Instrument. 
• Balayla, J., Lasry, A., Badeghiesh, A., Volodarsky-Perel, A., & Gil, Y. (2022). Mode of delivery is an independent risk factor for maternal mortality: a case-control study. J Matern Fetal Med, 35(10), 1962–1968. doi:10.1080/14767058.2020.1774874
• Baskett, T. F. (2019). Evolution of Operative Obstetric Delivery in Canada. J Obstet Gynaecol Can, 41(S2), S244−S250. doi:10.1016/j.jogc.2019.08.009
• Calder, L. A., Bowman, C. L., Yang, Q., Gondocz, T., Young, C., Zhang, C., . . . G., L. (2019). A quality indicator framework for high-risk areas in obstetrical care. Canadian Medical Protective Association.
• Canadian Institute for Health Information. (2022). Assisted Delivery Rate (Overall) Among Vaginal Deliveries [indicator]. Retrieved April 14, 2023
• Canadian Institute for Health Information. (2023). Assisted Delivery Rate (Overall) Among Vaginal Deliveries [indicator]. Retrieved April 14, 2023
• Canadian Medical Protective Association. (2021). Resolving conflict between healthcare providers. Retrieved from https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2021/resolving-conflict-between-healthcare-providers
• Canadian Patient Safety Institute. (2020). The Safety Competencies: Enhancing Patient Safety Across the Health Professions. 2nd Edition. Edmonton, AL.
• CMPA. (2021). Interprofessional Communication in Obstetrics. Retrieved from https://www.cmpa-acpm.ca/serve/elearning/ob-interprofessional-communication/en/index.html
• Cook, J. L., Janssen, P., Knight, M., Lisonkova, S., Scott, H. T., & Wong, T. (2017). Measuring Maternal Mortality and Morbidity in Canada. J Obstet Gynaecol Can, 39(11), 1028–1037. doi:10.1016/j.jogc.2017.06.021
• 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
• Gossett, D. R., Gilchrist-Scott, D., Wayne, D. B., & Gerber, S. E. (2016). Simulation Training for Forceps-Assisted Vaginal Delivery and Rates of Maternal Perineal Trauma. Obstetrics and gynecology, 128(3), 429–435. doi:10.1097/AOG.0000000000001533
• 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
• Harvey, M., & Pierce, M. (2015, 12). Obstetrical Anal Sphincter Injuries (OASIS):. Retrieved from Society of Obstetricians and Gynaecologists of Canada: https://www.jogc.com/article/S1701-2163(16)30081-0/pdf
• Hobson, S., Cassell, K., Windrim, R., & Cargill, Y. (2019). No. 381-Assisted Vaginal Birth. J Obstet Gynaecol Can, 41(6), P870-882. doi:10.1016/j.jogc.2018.10.020
• 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.
• Mendoza, H. F., Hobson, S., Windrim, R. C., Kindom, J., & Rojas-Gauldon, D. (2022). Identification of Essential Steps in Outlet Forceps-Assisted Vaginal Delivery: A Delphi Study. J Obstet Gynaecol Can, 44(6), P675-682.
• Muraca, G. M., Boutin, A., Cherian, A. M., Razaz, N., John, S., Lisonkova, S., & Joseph, K. S. (2021). Attempted forceps and attempted vacuum delivery: Maternal and neonatal trauma rates by province/territories, tier of obstetric service and hospital, Canada, April 2013 to March 2019. Vancouver: Report of the CIHR Team for Improving Perinatal Health Care Regionalization.
• Murphy, D. J., Strachan, B. K., & Bahl, R. (2020). Assisted Vaginal BIrth. BJOG, 127, e70– e112. Retrieved from Royal College of Obstetricians and Gynaecologists: https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/1471-0528.16092
• Ng, C. (2018). Taking a stand for operative vaginal delivery. Canadian Medical Association Journal, 190(24), E732-E733. doi:10.1503/cmaj.180668
• Provincial Council for Maternal and Child Health. (2022). Safe administration of oxytocin. 
• Royal College of Obstetricians and Gynaecologists. (2015, 6). The Management of Third- and Fourth-Degree Perineal Tears. Retrieved from Roydal College of Obstetricians and Gynaecologists: https://www.rcog.org.uk/media/5jeb5hzu/gtg-29.pdf
• Walshe, N., Ryng, S., Drennan, J., O'Connor, P., O'Brien, S., Crowley, C., & Hegarty, J. (2021). Situation awareness and the mitigation of risk associated with patient deterioration: A meta-narrative review of theories and models and their relevance to nursing practice. International Journal of Nursing Studies, 124(104086). doi:10.1016/j.ijnurstu.2021.104086