Mismanagement of Induction and Augmentation of Labour

Misoprostol and oxytocin are a widely available pharmaceutical agents commonly used for the induction and / or augmentation of labour. The use of oxytocin to augment labour is often associated with significant harm incidents if not managed appropriately. Due to this heightened risk for pregnant persons and for the fetuses, the Institute for Safe Medication Practices classified oxytocin as “high-alert medication” (ISMP, 2018). The initiation of intravenous (IV) oxytocin or its timely discontinuation in the presence of contraindicated clinical circumstances are frequent findings in oxytocin-related Canadian pregnant person and newborn related claims.

Expected Outcomes

Implement standardized current evidence-based induction and augmentation of labour management protocol to facilitate a systematic and coordinated approach, including (but not limited to):
o        Adopting an induction and augmentation of labour safety checklist;
o        Strategies to supports the respectful questioning and challenging of cervical ripening, and induction and augmentation orders.

Most responsible practitioners (MRPs) undertake (and document) shared decision making (informed choice-informed consent) discussions with the pregnant persons regarding cervical ripening, and induction and augmentation of labour. 

Adopt best practices to support psychological safety in the perinatal care settings.

Definitions and Abbreviations

• ARM – artificial rupture of membranes
• BMI – body mass index
• Cervical ripening - the use of pharmacologic or mechanical means to soften, efface, and dilate the cervix prior to induction of labour (IOL) to increase the likelihood of a successful vaginal birth (Robinson, et al., 2023b)
• Client – includes all persons who receive healthcare and related services including patients, residents and persons in-care
• EFM – electronic fetal monitoring 
• FHS – fetal health surveillance
• HIE - hypoxic ischemic encephalopathy
• IV – intravenous 
• Medical directives - an indirect order that gives authorization to a care provider or group of care providers (e.g., emergency department (ED) nurses) to implement the order (e.g., ED chest pain for adults) with a predefined client population (e.g. ED clients presenting with symptoms suggestive of cardiac ischemia or cardiovascular symptoms such as discomfort jaw to umbilicus, upper limb discomfort without known injury, chest trauma…)
• MRP – most responsible practitioner, often a midwife, nurse practitioner or physician
• NICU – neonatal intensive care unit
• OR – operating room

Common Claims Themes and Contributing Factors

Organizational

• Perceived and / or actual tolerance of:
  • Unprofessional practitioner and team behaviours;
  • Unsafe practices surrounding induction and augmentation of labour (including tolerance of verbal orders and informal consultations for induction and augmentation).
• Lack of, unrealistic, or ambiguous:
  • Escalation and chain of command processes;
  • Obstetrical emergency response and codes.
• Inappropriate use of medical directives delegating the decision to induce or augment to nurses.
• Induction and augmentation booked and commenced without appropriate availability of resources (e.g., timely access to an OR and surgical team).
• Lack of standardized and current induction and augmentation protocols including protocols lacking guidance surrounding assessment and monitoring expectations.
• Inconsistent practice expectations surrounding shared decision making (informed choice-informed consent) surrounding the pharmaceutical induction and augmentation of labour.

Knowledge and Judgment

• Gaps in FHS negatively impacting clinical understanding of pregnant person and fetal well-being prior to and during the induction or augmentation.
• Lack of appropriate clinical indication for the induction or augmentation.
• Normalizing and decreased vigilance towards pharmaceutical induction or augmentation. 
• Ordering, implementing, continuing, increasing, or resuming oxytocin infusion in the presence of contraindications.
• Accepting or not questioning orders despite concerns about their clinical appropriateness.
• Lack of awareness or compliance with hospital or health region induction and augmentation of labour guidelines.

Communication 

• Inadequate communication during healthcare provider handoffs and handovers.
• Hesitancy to escalate concerns about unsafe practitioners and practices, including practitioners in leadership roles, due to work culture and resources challenges.
• Delayed physician notification and consultation in the presence of any pregnant person or fetal contraindications and / or signs of decompensation.

Shared Decision Making (informed choice - informed consent)

• Inappropriate pharmaceutical induction and / or augmentation of labour based on the assumption that a valid consent had been obtained by another physician or midwife during the antenatal or intrapartum period.
• No / inadequate documentation to demonstrate:
  • The prescribing physician and / or MRP undertook a share decision making (informed choice - informed consent) discussion with the pregnant person including:
    • Risk and benefits to the fetus / neonate;
    • Alternatives and their associated risks and benefits;
    • The pregnant person was informed of evolving risk factors impacting the initial and ongoing safe administration of the pharmaceutical induction or augmentation; 
    • The pregnant person was informed of the evolving availability and access to local specialists (e.g., obstetrician) and resources (e.g., OR for emergency caesarean) in case of an obstetrical emergency such as uterine rupture.
• Inappropriate delegation to and reliance on nurses to obtain and / or validate if a share decision making (informed choice - informed consent) discussion took place between the ordering practitioner and pregnant person.

Documentation

• Inconsistent documentation surrounding:
  • The clinical rationale for ordering, accepting, or implementing an order, and for increasing or continuing the infusion in the presence of satisfactory uterine contractility, uterine tachysystole, or abnormal FHS pattern; 
  • Verbal orders and consultations for induction and augmentation, including orders to continue, increase, or restart oxytocin;
  • Management plan for pregnant persons at higher risk.

Mitigation Strategies

Care Process

• Implement a standardized current evidence-based induction and augmentation of labour management protocol to facilitate a systematic and coordinated approach (Provincial Council for Maternal and Child Health, 2022), including current evidence-based protocols for:
  • Cervical ripening (Robinson, et al., 2023a) (Robinson, et al., 2023b);
  • Induction and augmentation of labour (Robinson, et al., 2023a) (Robinson, et al., 2023c).

Additional Considerations

Examples of elements to address within the evidence-based induction and augmentation of labour protocol:

• Universal definition of labour dystocia and tachysystole (e.g., SOGC definitions); 

• “Hard stop” policies (e.g., department chair or committee approval to schedule induction before 39 weeks without medical indication);

• Requirements before an order for induction or augmentation is implemented (e.g., recent in-person midwife or physician assessment of the pregnant person, a written order and evidence of documented Bishop score, documented indication for the induction and augmentation, and the midwife’s or physician’s documented IV oxytocin informed consent discussion(s) with the pregnant person);

• Requirements for restarting or increasing the rate of infusion in the presence of pregnant person or fetal contraindications; 

• The starting dose and incremental increases, and the defined rate (or range) for resuming oxytocin after discontinuation;

• Standardized ‘pre-oxytocin’ and ‘oxytocin in-use’ safety checklists;

• Standardized IV oxytocin order set; 

• Monitoring requirements before and during infusion;

• Indications for immediate physician notification and / or consult;

• Indications for immediately stopping or reducing the infusion;

• Adopt a current evidence-based induction and augmentation of labour safety checklist (e.g., pre- and in-use oxytocin safety checklist) (Provincial Council for Maternal and Child Health, 2022) (Robinson, et al., 2023c).
• Discontinue the use of induction and augmentation “standing orders” (College of Nurses of Ontario, 2020) and medical directives.
• Adopt a standardized evidence-based induction booking process and triage protocol (Reproductive Care Program of Nova Scotia, 2012).

Additional Considerations

Examples of elements to address within the standardized evidence-based induction booking and triage protocol:

• Agreed-to standards for determination of gestational age, approved medical indications, and degree of urgency, including chain of command and / or escalation protocol for medical review; 
• Requirements for postponing medically indicated inductions (e.g., only postponed when absolutely necessary and accompanied by scheduled or regular fetal and pregnant person assessments) as well as elective inductions;
• The current and foreseeable unit acuity and volumes (including possible transfers from the community labour / birth settings);
• The adequacy of the current and foreseeable staffing levels and mix, and resources to respond to an obstetrical emergency;
• Specific actions to be taken if the unit acuity and volumes change during an induction or augmentation.

Safety Culture

• Implement formal strategies to develop and maintain a work environment which supports and expects:
  • Assertive and respectful questioning and challenging of cervical ripening, induction and augmentation orders (Provincial Council for Maternal and Child Health, 2022) (Agency for Healthcare Research and Quality, 2017).
  • Zero tolerance of intra- and inter-disciplinary bullying and intimidation;
  • Early response to suspected and actual pregnant person and / or fetal deterioration, including seeking assistance from peers and other resources (e.g., rapid response teams where in place).
• Adopt a standardized, formalized, and program-specific chain of command (escalation) protocol for the rapid escalation of unresolved care concerns or disagreements related orders and / or decisions related to cervical ripening, induction, and / or augmentation of labour (Provincial Council for Maternal and Child Health, 2022) (Agency for Healthcare Research and Quality, 2017).

Shared Decision Making (Informed Choice - Informed Consent)

• Implement a current evidence-based handout / resource to supplement the shared decision making (informed choice-informed consent) conversations between the MRP and the pregnant person regarding cervical ripening, and induction and augmentation of labour (ISMP Canada, 2022a) (ISMP Canada, 2022b) (Provincial Council for Maternal and Child Health, 2022).
• Ensure the 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 evidence related to the cervical ripening, induction, and / or augmentation of labour (ACOG Committee on Ethics, 2021); ensure the discussion (and documentation) includes a clear description of the pregnant person and fetus clinical status.
• 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:
  • Cervical ripening and pharmaceutical induction and augmentation of labour (Provincial Council for Maternal and Child Health, 2022) (Robinson, et al., 2023a) (Robinson, et al., 2023c);
  • Continuous electronic fetal monitoring (EFM) where indicated (use of oxytocin or repeated doses of prostaglandin E1 for induction of labour) (Robinson, et al., 2023b) (Robinson, et al., 2023c).

Additional Considerations

Examples of what should be documented during the share decision making (informed choice-informed consent) discussions surrounding induction of labour:

• The pregnant person’s overall and evolving clinical scenario;
• Why cervical ripening, induction or augmentation is being proposed;
• Benefits and risks associated with the proposed intervention, in particular known, foreseeable, and potential risks and potential consequences to the fetus;
• Alternatives to the proposed cervical ripening, induction, or augmentation, including risks associated with the alternatives;
• Potential, known, and foreseeable risks if the proposed intervention is declined;
• Availability of hospital staff (anesthesiologist, respiratory therapists, obstetricians, midwifery, OR nurses, etc.) and resources (e.g., caesarean ready rooms, NICU) needed to respond to obstetrical emergencies);  
• Why EFM is being recommended during the ripening, induction, or augmentation.

• Ensure complete and timely documentation of the informed decline discussion in the health record where the pregnant person declines the following (but not limited to):
  • EFM before discharge home following prostaglandin E1 or E2 for cervical ripening;
  • EFM during the induction and / or augmentation of labour;
  • Pregnant person and fetal assessments during the ripening, induction, or augmentation.
• If a consent / decline form is used, ensure it is accompanied by complete and timely documentation in the health record. 

Documentation

• Implement formal strategies to monitor, measure, and improve documentation of the interdisciplinary team ordering, implementing, and caring for pharmaceutically induced or augmented pregnant persons (HIROC, 2017).

Additional Considerations

Examples of areas of improvement when monitoring, measuring and improving clinical documentation related to the induction and augmentation of labour:

• FHS assessments and actions taken (where indicated by current evidence based practice);
• Midwives and physician consultations and orders for induction and augmentation (e.g., name of the ordering or consulting physician; date and time the order or consult took place; the fetal status and risk factors relayed at the time of discussion or consultation; the findings and recommendations; changes to the birth or management plan);
• The clinical rationale for accepting an order, continuing or increasing the rate of infusion in the presence of pregnant person or fetal contraindications (‘as per protocol’ or ‘as per orders’ is not appropriate or sufficient).

Monitoring and Measurement    

• Adopt a standardized, interdisciplinary, collaborative, and evidence-based protocol for conducting quality of care reviews involving the induction and / or augmentation of labour resulting in client harm or death (Machen, 2023); incorporate system thinking and human factors concepts into the review process.
• Adopt standardized quality indicators for labour induction and augmentation (Calder, et al., 2019) (Health Quality Ontario, n.d.).
• Incorporate learnings from local, provincial, and national neonatal morbidity and mortality incidents (e.g., coroner reports) and data (e.g., provincial birth registries) into local protocols as well as staff and client education and training.

References

• ACOG Committee on Ethics. (2021). ACOG Committee Opinion No. 819: Informed Consent and Shared Decision Making in Obstetrics and Gynecology. Obstet Gynecol, 137(2), pp. e34-41.
• Agency for Healthcare Research and Quality. (2017). Safe Medication Administration: Oxytocin. Retrieved from https://www.ahrq.gov/hai/tools/perinatal-care/modules/strategies/medication/tool-safe-oxytocin.html
• 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.
• College of Nurses of Ontario. (2020). Directives. Toronto, ON.
• Health Quality Ontario. (n.d.). Vaginal birth after caesarean (VBAC). Retrieved from https://www.hqontario.ca/Evidence-to-Improve-Care/Quality-Standards/View-all-Quality-Standards/Vaginal-Birth-After-Caesarean-VBAC/Quality-Statement-8-Induction-and-Augmentation-of-Labour
• HIROC. (2017). Strategies for improving documentation: Lessons from medical-legal claims. 
• ISMP. (2018). ISMP list of high-alert medications. 
• ISMP Canada. (2022a). Oxytocin to Start or Advance Labour 5 Questions to Ask. Toronto, ON: Institute for Safe Medication Practices Canada.
• ISMP Canada. (2022b). Implementation guide: Oxytocin to start or advance labour 5 questions to ask. Toronto, ON: Institute for Safe Medication Practices Canada.
• 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.
• Provincial Council for Maternal and Child Health. (2022). Safe administration of oxytocin. 
• Reproductive Care Program of Nova Scotia. (2012). Induction of labour in Nova Scotia – Report from the provincial quality assessment review. Halifax, NS.
• Robinson, D., Campbell, K., Hobson, S. R., MacDonald, W. K., Sawchuck, D., & Wagner, B. (2023a). Guideline No. 432a: Cervical Ripening and Induction of Labour – General Information.
• Robinson, D., Campbell, K., Hobson, S. R., MacDonald, W. K., Sawchuck, D., & Wagner, B. (2023b). Guideline No. 432b: Cervical Ripening.
• Robinson, D., Campbell, K., Hobson, S. R., MacDonald, W. K., Sawchuck, D., & Wagner, B. (2023c). Guideline No. 432c: Induction of Labour.