1.Consent and refusal
7. Consent in laboring patients
Joanna M. Davies
Sarah is a 32-year-old, gravida 1, para 0 in active labor at 4 cm cervical dilatation. She is experiencing considerable pain and requests an epidural for analgesia. However, as the anesthesiologist arrives, the patient’s husband, Tom, is telling the nurse that, prior to labor, his wife specifically told him that she did not want an epidural for pain, even if she begged for one, and he should not let her change her mind. This information is also written in her birth plan. Sarah is now screaming with each contraction and, despite receiving a total of 150 mcg of intravenous fentanyl, is adamant that she wants an epidural “now.”
Principle-based medical ethics focuses on the four concepts of autonomy, beneficence, nonmaleficence and justice. Over time, there has been movement from the beneficence driven paternalism of “doctor knows best” towards increasing patient autonomy. Authentic patient autonomy requires that the patients make their own decisions after they have received all of the relevant information pertinent to their situation and are therefore fully informed. Informed consent requires several elements: (1) capacity of the patient to make a decision, (2) freedom or voluntariness of the patient in decision-making, (3) disclosure of adequate information to the patient, (4) understanding of that information by the patient, and (5) consent by the patient to the procedure. Ensuring that these elements have been addressed and obtaining consent for procedures in laboring patients can be extremely challenging.
Can informed consent be obtained during the pain of labor?
There are conflicting views on whether informed consent is even possible during active labor. Black and Cyna, analyzed responses from 291 anesthesiologists surveyed about the risks they discussed with laboring patients, and whether it was possible to gain fully informed consent from them.1 Seventy percent considered active labor a barrier to the ability of a woman to give consent. However, a Society of Obstetric Anesthesia and Perinatology Anesthesiologists (SOAP) survey, published the same year (2006), found that 68% of 448 anesthesiologists thought that women in active labor are able to give informed consent.2 Scott has gone so far as to say “the only time when consent to an epidural to relieve the pain of labor is truly informed is in labor itself … when the person concerned knows what the pain is like.”3
Several studies of the patient’s perspective of informed consent during labor show that the pain of labor does not appear to interfere with the patient’s ability to hear and comprehend the information relevant to consent.4 Furthermore, a woman’s ability to understand epidural risks does not correlate with level of labor pain, anxiety, duration of pain, opioid medication, previous epidural experience or the desire for an epidural.5 In fact, the ability to recall the risks has been found to be similar in both laboring and nonlaboring, nonobstetric patients.6 Ideally, written or visual information about labor analgesia should be provided or at least available during prenatal visits to the obstetrician’s office in the antenatal period or during early labor allowing time for consideration of the available options and any questions.
Is Sarah’s consent impeded by the fentanyl she has received? In general the answer is poorly addressed in the literature. There are no US legal precedents regarding this issue and most institutions have inconsistent policies. Anesthesiologists can and do routinely make judgments about a patient’s capacity for informed consent based on the elements described above. There is normally no need to contact a psychiatrist or obtain legal advice. Sarah must have the mental capacity to comprehend and participate in the consent process and analgesia may allow her to do this. Withholding appropriate analgesia, particularly if there is a delay in the anesthesiologist obtaining consent, may in itself put the anesthesiologist in an unsupportable ethical position.
At this stage in her care, the literature supports that Sarah, despite being in severe pain and having received fentanyl, should be able to provide fully informed consent for epidural placement. However, an additional ethical dilemma has developed. Sarah’s husband, Tom, is insistent that Sarah does not really want an epidural and produces a written birthing plan which includes a statement that Sarah does not want to be permitted to deviate from this plan or her wishes concerning an epidural. Such a document is known as a “Ulysses directive” and brings into conflict the anesthesiologist’s beneficent desire to provide Sarah with analgesia, and the wish to respect Sarah’s autonomous decision to have a “natural” delivery.
However, autonomous decision-making brings with it the privilege for a woman to change her mind, especially if she has never experienced the pain of childbirth before. One might argue that Sarah’s directive be considered invalid because it was made at a time when the she was not fully informed. Antenatally, she may have been determined not to have an epidural. However, she may not have received appropriate information regarding the risks and benefits of epidurals, nor had she experienced labor pain previously. Information and valid experience are critical prerequisites for autonomous decision-making. While Scott considers it unethical “to withhold pain relief from a greatly distressed woman … solely because of a statement written in her birth plan..”, Thornton and Moore have argued that this “… does not respect her long-term preferences”, and hence her autonomy.”7 Other authors have even postulated that the duty of beneficence (in this case to relieve pain) may allow an intervention to proceed in the absence of informed consent until evidence of patient refusal is forthcoming.8 In this instance there is no unequivocal ethical ground upon which to stand and it has been suggested that the anesthesiologist be guided by the circumstances.9
Sarah is a primiparous woman at 4 cm cervical dilatation and is likely to be in labor for many more hours. Placing an epidural for analgesia is certainly an ethically defensible decision in this case. Interestingly, frequently it is the legal ramifications rather than the ethical debate that cause anesthesiologists the most concern. As a woman with capacity, Sarah can legally overrule her birth plan at any point. However, there is a risk after delivery, when the pain is long gone, that Sarah might feel she somehow “failed” during the birthing process by agreeing to have an epidural and see the anesthesiologist as an accomplice in this failure. This could result in an accusation of assault, or unconsented touching of the patient.
The anesthesiologist should be encouraged to see the patient and her family postpartum. At that time the anesthesiologist can discuss the events and reassure the patient that her decision was the correct one for the circumstances in which she found herself. It may help to inform the patient that relief of pain and stress during labor has benefits for the fetus and the course of labor. It is also wise to document the decision-making process that occurred. An example chart note might read:
After an appropriate consent process, the patient has decided to withdraw her previous refusal of epidural analgesia for labor. I will proceed based on her currently stated request for epidural analgesia.
In this particular case the ethical tension was resolved when the anesthesiologist conducted a patient and lengthy discussion with both Tom and Sarah. They agreed that they may not have appreciated how painful the labor would be, that an epidural would allow Sarah to enjoy the birth more, and that perhaps they had been naïve in her inexperience to completely refuse to consider all of her analgesic options.
How much information is enough?
How much information is too much and how long a discussion is too long during the throws of active labor? The amount of information given to Sarah regarding the risks and benefits of an epidural needs to be balanced against her level of pain and urgency to proceed. If possible, discussions should be held between contractions when the woman can focus on what she is being told. It is prudent to have this conversation with the patient’s support person present. Tom, in this case, will be able to ask questions and witness that the information has been provided. Every anesthesiologist has their own routine when providing information to a patient during the consent process. Brooks and Sullivan have aided the practitioner by developing a list of recommended issues that should be discussed with the patient.10 This list includes:
(1) benefits of the epidural to the mother, i.e., excellent pain relief;
(2) potential beneficial effects of an epidural on the baby and labor;
(3) risks of epidurals, such as epidural failure, side effects, and rare but serious risks;
(4) information relevant to the individual patient, e.g., the effect of an epidural on preexisting medical conditions she may already have, e.g., chronic back pain or neurological disease;
(5) alternatives for analgesia and any further information requested by the patient.
Which risks should be disclosed?
As is frequently the case, Sarah does not wish to hear a lot of details about the procedure and urges the anesthesiologist to “just get on with it.” While being flexible in the approach to providing information under these conditions, it is imperative that the anesthesiologist cover the risks of the procedure. There is no universal standard of care when disclosing risks associated with an epidural to obtain informed consent, although different rules have been proposed. Several studies have found that the majority of women want to hear all the risks associated with regional anesthesia, particularly those that occur commonly but are less severe, and those which are rare but could be serious or life-threatening.11
Should informed consent be written or verbal?
There is no consensus about whether it is better to have patients sign consents or, simply verbally consent: both are ethically and legally acceptable in many states. Documentation of this discussion can include either a separate anesthesia consent form signed by the patient or a detailed note in the patient’s chart verifying verbal consent.
Is informed consent during labor a liability issue?
Knapp examined three legal cases that addressed the issue of adequacy of informed consent during labor. In every instance the cases were found in favor of the defending anesthesiologist because the courts felt there was not only evidence of “reasonable” information having been provided to the patients but also, the patients had not objected to, and in fact, had actively cooperated with the procedure.12
Case 2: Refusal to consent to treatment
Fatima is a non-English speaking, 19-year-old, gravida 2, para 1, Somalian Muslim married to 40-year-old Mohammed. It is 3:00 am. Because of the hour there is no formal Somali interpreter available so Mohammed has been providing interpretation. Fatima has been in labor for more than 20 hours with slow progress. She is at 9 cm cervical dilatation and the fetus is showing signs of distress with severe variable heart rate decelerations into the 60s. The obstetricians want to perform an urgent cesarean section but Mohammed is refusing, despite being told that the baby could die if surgery is delayed. In spite of his refusal for surgery Fatima continues to say that she wants her baby to be delivered safely. There is concern that Mohammed is not giving his wife the correct information or providing the practitioners with an adequate representation of Fatima’s wishes.
Frequently, such dilemmas are resolved by further discussion regarding the risks and benefits of the Cesarean section, understanding the fears of surgery that the patient brings to the table, and gentle persuasion as to the best course of action to gain the consent of the husband to proceed. However, that is not always the result. There are several ethical issues that must be considered in this situation. The first is that of “maternal–fetal conflict,” also discussed in Chapter 8, under “CDMR from the Fetus’s Perspective.”
This case demonstrates how two fundamental ethical principles, autonomy and beneficence, can come into conflict. A competent pregnant woman such as Fatima, has the autonomous right to refuse medical intervention, even if that decision may adversely affect her fetus. This can be distressing to the obstetrician who is advising a cesarean section in accordance with the ethical principle of beneficence to ensure the best outcome for both Fatima and her baby.
Some physicians may feel that the obvious solution in this case would be to obtain a court order to perform the cesarean section and save Fatima’s baby. It has long been debated as to whether the fetus should be considered as a patient, with its own rights, separate from the mother. This stance does consider the fact that the fetus is dependent on the mother for its existence. While delivery of the fetus may respect the right to life of the fetus, it compromises Fatima’s right to autonomy.
There has been much discussion in the literature regarding forced medical intervention and its possible justification in certain situations. The American College of Obstetricians and Gynecologists (ACOG) has provided clear guidance on this, stating that in cases of maternal refusal of treatment for the sake of the fetus, “court-ordered intervention against the wishes of a pregnant woman is rarely, if ever acceptable.”13 The American Medical Association (AMA) considers forced intervention to be counter-productive, stating that “women may withhold information from the physician … Or they may reject medical or prenatal care altogether.”14 A compounding issue is whether the obstetrician’s prognosis regarding the fetal outcome without intervention is correct. There have been cases where the woman has refused emergency cesarean section on religious grounds, only to deliver a healthy baby vaginally.15 When court orders have been sought in the US, different states and judges have come to different judgments in these difficult cases. The risk to the primary patient, the mother, may often decide these cases. Specifically, there is a foreseeable risk for a mother with a complete placenta previa, not just a threat to her undelivered fetus.
Cultural and religious beliefs
Some cultures and religions place constraints on medical care. Physicians must have respect for different belief systems and work with laboring patients to achieve the best outcome for both mother and baby.
In Western culture, Fatima’s autonomy regarding her medical care is paramount and we would expect her to decide whether she is willing to consent to a Cesarean section only after receiving all the pertinent information. According to the Islamic faith, Mohammed has the right to make decisions for his wife. This is seen as a positive, caring aspect of their marriage. Personal autonomy is not considered important. Even if Fatima is asked her decision, there is no guarantee that she has not been influenced by others. In this case, while respecting the cultural and religious basis upon which Mohammed is operating – and thereby potentially manipulating Fatima’s care – we also want Fatima to understand the situation, so that she could at least discuss it with her husband.
There some is concern that critical information is not being conveyed accurately to Fatima. Muslim women are allowed to voice their opinion but, like anyone, they need all the facts before making their decision. The absence of an interpreter is a problem. One solution is to use a telephone interpreter service, to which many hospitals subscribe. Such services provide access to most languages at any time of day. This service was unfortunately not available on that particular night. Interpreter help in urgent situations can also be sought from hospital employees, religious community members, or relatives of the patients who might be reachable by phone.
Ultimately, Mohammed and Fatima stood by their decision, despite prolonged discussions with the obstetricians. Fatima’s baby was still-born several hours later. Although distressed by their loss, they were comforted by their belief that this was Allah’s will. The obstetricians were devastated.
Could this case have been managed differently? Ethically, the obstetricians behaved correctly by respecting Mohammed’s autonomous decision to refuse a cesarean section for Fatima. There will always be concerns that Fatima was not given all the facts about the fetal condition and may have been able to persuade her husband to allow a Cesarean delivery.
Ethical considerations are of primary importance in cases such as these, but there are also legal issues that need to be considered and managed. Whenever a patient refuses medical care, the American College of Obstetricians and Gyencologists suggest that following information should be documented:16
(1) The patient’s refusal to consent to a medical treatment, surgical procedure, or diagnostic test
(2) Confirmation that the need for this treatment, procedure, or test has been explained
(3) The reasons stated by the patient for refusal of treatment
(4) Confirmation that the consequences of the refusal, including possible jeopardy to health or life, have been described to the patient.
• Although many anesthesiologists believe that laboring women may not be able to give informed consent, most studies indicate that laboring women are similarly capable to nonlaboring patients of hearing and remembering the risks involved and consenting to treatment.
• The informed consent process in laboring patients has requirements to disclose risks, benefits, and alternatives to anesthesia care that are similar to that in nonlaboring patients.
• Ulysses directives – advance directives that include irrevocable instructions – are sometimes included in birth plans, but are ethically problematic in laboring women who retain personal autonomy during labor. Women have the right to change plans and may do so in light of valid new experience. It is questionable whether such directives are ethically or legally binding in most cases. Deviation from Ulysses directives requires appropriate discussion and documentation.
• Every labor carries the risk of maternal–fetal conflicts. ACOG and AMA guidelines discourage forced intervention in all but rare cases, and recognize that respect for maternal autonomy is usually the dominant ethical principle to follow.
• Cultural and religious beliefs may complicate care of the laboring patient and require consideration in managing ethical conflicts.
• When a laboring woman refuses critical intervention, all efforts should be made to inform her of the risks and benefits of refusal of treatment, including the use of interpreter services if needed to a conduct careful and complete discussion.
1 Black, J. and Cyna, A.M. (2006). Issues of consent for regional analgesia in labour: a survey of obstetric anaesthetists. Anaesth Intens Care, 34, 254–60.
2 Saunders, T.A., Stein, D.J. and Dilger, J.P. (2006). Informed consent for labor epidurals: a survey of Society for Obstetric Anesthesia and Perinatology anesthesiologists from the United States. IJOA, 15,98–103.
3* Scott, W.E. (1996). Ethics in obstetric anaesthesia. Anaesthesia, 51, 717–18.
4* Pattee, C., Ballantyne, M. and Milne, B. (1997). Epidural analgesia for labour and delivery: informed consent issues. Can J Anaesth, 44, 918–23.
5* Jackson, A., Henry, R., Avery, N., et al. (2000). Informed consent for labour epidurals: what labouring women want to know. Can J Anaesth, 47, 1068–73.
6* Affleck, P.J., Waisel, D.B., Cusick, J.M., et al. (1998). Recall of risks following labor epidural analgesia. J Clin Anesth, 10, 141–4.
7* Brooks, H. and Sullivan, W.J. (2002). The importance of patient autonomy at birth. IJOA, 11, 196–203.
8* Hoehner, P.J. (2003). Ethical aspects of informed consent in obstetric anesthesia – new challenges and solutions. J Clin Anesth, 15, 587–600.
9 Brooks, H. and Sullivan, W.J. (2002). The importance of patient autonomy at birth. IJOA, 11, 196–203.
10 Brooks, H. and Sullivan, W.J. (2002). The importance of patient autonomy at birth. IJOA, 11, 196–203.
11 Jackson, A., Henry, R., Avery, N., et al. (2000). Informed consent for labour epidurals: what labouring women want to know. Can J Anaesth, 47, 1068–73.
12* Knapp, R.M. (1990). Legal view of informed consent for anesthesia during labor. Anesthesiology, 72, 211.
13* Patient choice in the maternal–fetal relationship. In Ethics in Obstetrics and Gynecology. 2nd edn. (2004). Washington, DC: American College of Obstetricians and Gynecologists, pp. 34–6.
14 Hoehner, P.J. (2003). Ethical aspects of informed consent in obstetric anesthesia – new challenges and solutions. J Clin Anesth, 15, 587–600.
15* Weiniger, C.F., Elchalal, U., Sprung, C.L., et al. (2006). Holy consent – a dilemma for medical staff when maternal consent is withheld for emergency caesarean section. IJOA, 15, 145–8.
16* Informed refusal. In Ethics in Obstetrics and Gynecology. 2nd edn. Washington, DC: American College of Obstetricians and Gynecologists, pp. 105–6.
Beauchamp, T.L. and Childress, J.F. (2001). Principles of Biomedical Ethics, 5th edn. Oxford, UK: Oxford University Press Inc.
Walton, S. (2003). Birth plans and fallacy of the Ulysses directive, I5OA, 12, 138–45.