Active or Passive Third Stage of Labour

Introduction

This dissertation is primarily concerned with the arguments that are currently active in relation to the benefits and disadvantages of having either an active or passive third stage of labour. We shall examine this issue from several angles including the currently accepted medical opinions as expressed in the peer reviewed press, the perspective of various opinions expressed by women in labour and theevidence base to support these opinions.

It is a generally accepted truism that if there is controversy surrounding a subject, then this implies that there is not a sufficiently strong evidence base to settle the argument one way or the other. (De Martino B et al. 2006). In the case of this particular subject, this is possibly not true, as the evidence base is quite robust (and we shall examine this in due course).

Midwifery deals with situations that are steeped in layers of strongly felt emotion, and this has a great tendency to colour rational argument. Blind belief in one area often appears to stem from total disbelief in another (Baines D. 2001) and in consideration of some of the literature in this area this would certainly appear to be true.

Let us try to examine the basic facts of the arguments together with the evidence base that supports them.

In the civilised world it is estimated that approximately 515,000 currently die annually from problems directly related to pregnancy. (extrapolated from Hill K et al. 2001). The largest single category of such deaths occur within 4 hrs. of delivery, most commonly from post partum haemorrhage and its complications (AbouZahr C 1998), the most common factor in such cases being uterine atony. (Ripley D L 1999). Depending on the area of the world (as this tends to determine the standard of care and resources available), post partum haemorrhage deaths constitutes between 10-60% of all maternal deaths (AbouZahr C 1998). Statistically, the majority of such maternal deaths occur in the developing countries where women may receive inappropriate, unskilled or inadequate care during labour or the post partum period. (PATH 2001). In developed countries the vast majority of these deaths could be (and largely are) avoided with effective obstetric intervention. (WHO 1994). One of the central arguments that we shall deploy in favour of the active management of the third stage of labour is the fact that relying on the identification of risk factors for women at risk of haemorrhage does not appear to decrease the overall figures for post partum haemorrhage morbidity or mortality as more than 70% of such cases of post partum haemorrhage occur in women with no identifiable risk factors. (Atkins S 1994).

Prendiville, in his recently published Cochrane review (Prendiville W J et al. 2000) states that:

where maternal mortality from haemorrhage is high, evidence-based practices that reduce haemorrhage incidence, such as active management of the third stage of labour, should always be followed

It is hard to rationally counter such an argument, particularly in view of the strength of the evidence base presented in the review, although we shall finish this dissertation with a discussion of a paper by Stevenson which attempts to provide a rational counter argument in this area.

It could be argued that the management of the third stage of labour, as far as formal teaching and published literature is concerned, is eclipsed by the other two stages (Baskett T F 1999). Cunningham agrees with this viewpoint with the observation that a current standard textbook of obstetrics (unnamed) devotes only 4 of its 1,500 pages to the third stage of labour but a huge amount more to the complications that can arise directly after the delivery of the baby (Cunningham, 2001). Donald makes the comment "This indeed is the unforgiving stage of labour, and in it there lurks more unheralded treachery than in both the other stages combined. The normal case can, within a minute, become abnormal and successful delivery can turn swiftly to disaster." (Donald, 1979).

Chapter 1: Define Third Stage of Labour

The definition of the third stage of labour varies between authorities in terms of wording, but in functional terms there is general agreement that it is the part of labour that starts directly after the birth of the baby and concludes with the successful delivery of the placenta and the foetal membranes.

Functionally, it is during the third stage of labour that the myometrium contracts dramatically and causes the placenta to separate from the uterine wall and then subsequently expelled from the uterine cavity. This stage can be managed actively or observed passively. Practically, it is the speed with which this stage is accomplished which effectively dictates the volume of blood that is eventually lost. It follows that if anything interferes with this process then the risk of increased blood loss gets greater. If the uterus becomes atonic, the placenta does not separate efficiently and the blood vessels that had formally supplied it are not actively constricted. (Chamberlain G et al. 1999). We shall discuss this process in greater detail shortly.

Proponents of passive management of the third stage of labour rely on the normal physiological processes to shut down the bleeding from the placental site and to expel the placenta. Those who favour active management use three elements of management. One is the use of an ecbolic drug given in the minute after delivery of the baby and before the placenta is delivered. The second element is early clamping and cutting of the cord and the third is the use of controlled cord traction to facilitate the delivery of the placenta. We shall discuss each of these elements in greater detail in due course. The rationale behind active management of the third stage of labour is basically that by speeding up the natural delivery of the placenta, one can allow the uterus to contract more efficiently thereby reducing the total blood loss and minimising the risk of post partum haemorrhage. (O'Driscoll K 1994)

Discuss Optimal Practice

Let us start our consideration of optimal practice with a critical analysis of the paper by Cherine (Cherine M et al. 2004) which takes a collective overview of the literature on the subject. The authors point to the fact that there have been a number of large scale randomised controlled studies which have compared the outcomes of labours which have been either actively or passively managed. One of the biggest difficulties that they experienced was the inconsistency of terminology on the subject, as a number of healthcare professionals had reported management as passive when there had been elements of active management such as controlled cord traction and early cord clamping.

As an overview, they were able to conclude that actively managed women had a lower prevalence of post partum haemorrhage, a shorter third stage of labour, reduced post partum anaemia, less need for blood transfusion or therapeutic oxytocics (Prendiville W J et al. 2001). Other factors derived from the paper include the observation that the administration of oxytocin before delivery of the placenta (rather than afterwards), was shown to decrease the overall incidence of post partum haemorrhage, the overall amount of blood loss, the need for additional uterotonic drugs, the need for blood transfusions when compared to deliveries with similar duration of the third stage of labour as a control. In addition to all of this they noted that there was no increased incidence of the condition of retained placenta. (Elbourne D R et al. 2001). The evidence base for these comments is both robust and strong. On the face of it, there seems therefore little to recommend the adoption of passive management of the third stage of labour.

Earlier we noted the difficulties in definition of active management of the third stage of labour. In consideration of any individual paper where interpretation of the figures are required, great care must therefore be taken in assessing exactly what is being measured and compared. Cherine points to the fact that some respondents categorised their management as passive management of the third stage of labour when, in reality they had used some aspect of active management. They may not have used ecbolic drugs (this was found to be the case in 19% of the deliveries considered). This point is worth considering further as oxytocin was given to 98% of the 148 women in the trial who received ecbolic. In terms of optimum management 34% received the ecbolic at the appropriate time (as specified in the management protocols as being before the delivery of the placenta and within one minute of the delivery of the baby). For the remaining 66%, it was given incorrectly, either after the delivery of the placenta or, in one case, later than one minute after the delivery of the baby.

Further analysis of the practices reported that where uterotonic drugs were given, cord traction was not done in 49%, and early cord clamping not done in 7% of the deliveries observed where the optimum active management of the third stage of labour protocols were not followed.

From an analytical point of view, we should cite the evidence base to suggest the degree to which these two practices are associated with morbidity.

Walter P et al. 1999 state that their analysis of their data shows that early cord clamping and controlled cord traction are shown to be associated with a shorter third stage and lower mean blood loss, whereas Mitchelle (G G et al. 2005) found them to be associated with a lower incidence of retained placenta.

Other considerations relating to the practice of early cord clamping are that it reduces the degree of mother to baby blood transfusion. It is clear that giving uterotonic drugs without early clamping will cause the myometrium to contract and physically squeeze the placenta, thereby accelerating the both the speed and the total quantity of the transfusion. This has the effect of upsetting the physiological balance of the blood volume between baby and placenta, and can cause a number of undesirable effects in the baby including an increased tendency to jaundice. (Rogers J et al. 1998)

The major features that are commonly accepted as being characteristic of active management and passive management of the third stage of labour are set out below.

Physiological Versus Active Management

. .	Physiological Management	Active Management
Uterotonic	None or after placenta delivered	With delivery of anterior shoulder or baby
Uterus	Assessment of size and tone	Assessment of size and tone
Cord traction	None	Application of controlled cord traction* when uterus contracted
Cord clamping	Variable	Early

(After Smith J R et al. 1999)

Physiology of Third Stage

The physiology of the third stage can only be realistically considered in relation to some of the elements which occur in the preceding months of pregnancy. The first significant consideration are the changes in haemodynamics as the pregnancy progresses. The maternal blood volume increases by a factor of about 50% (from about 4 litres to about 6litres). (Abouzahr C 1998)

This is due to a disproportionate increase in the plasma volume over the RBC volume which is seen clinically with a physiological fall in both Hb and Heamatocrit values. Supplemental iron can reduce this fall particularly if the woman concerned has poor iron reserves or was anaemic before the pregnancy began. The evolutionary physiology behind this change revolves around the fact that the placenta (or more accurately the utero-placental unit) has low resistance perfusion demands which are better served by a high circulating blood volume and it also provides a buffer for the inevitable blood loss that occurs at the time of delivery. (Dansereau J et al. 1999).

The high progesterone levels encountered in pregnancy are also relevant insofar as they tend to reduce the general vascular tone thereby increase venous pooling. This, in turn, reduces the venous return to the heart and this would (if not compensated for by the increased blood volume) lead to hypotension which would contribute to reductions in levels of foetal oxygenation. (Baskett T F 1999). Coincident and concurrent with these heamodynamic changes are a number of physiological changes in the coagulation system.

There is seen to be a sharp increase in the quantity of most of the clotting factors in the blood and a functional decrease in the fibrinolytic activity. (Carroli G et al. 2002). Platelet levels are observed to fall. This is thought to be due to a combination of factors. Haemodilution is one and a low level increase in platelet utilisation is also thought to be relevant. The overall functioning of the platelet system is rarely affected. All of these changes are mediated by the dramatic increase in the levels of circulating oestrogen. The relevance of these considerations is clear when we consider that one of the main hazards facing the mother during the third stage of labour is that of haemorrhage. (Soltani H et al. 2005) and the changes in the haemodynamics are largely germinal to this fact.

The other major factor in our considerations is the efficiency of the haemostasis produced by the uterine contraction in the third stage of labour. The prime agent in the immediate control of blood loss after separation of the placenta, is uterine contraction which can exert a physical pressure on the arterioles to reduce immediate blood loss. Clot formation and the resultant fibrin deposition, although they occur rapidly, only become functional after the coagulation cascade has triggered off and progressed. Once operative however, this secondary mechanism becomes dominant in securing haemostasis in the days following delivery. (Sleep, 1993).

The uterus both grows and enlarges as pregnancy progresses under the primary influence of oestrogen. The organ itself changes from a non-gravid weight of about 70g and cavity volume of about 10 ml. to a fully gravid weight of about 1.1 kg. and a cavity capacity of about 5 litres. This growth, together with the subsequent growth of the feto-placental unit is fed by the increased blood volume and blood flow through the uterus which, at term, is estimated to be about 5-800 ml/min or approximately 10-15% of the total cardiac output (Thilaganathan B et al. 1993). It can therefore be appreciated why haemorrhage is a significant potential danger in the third stage of labour with potentially 15% of the cardiac output being directed towards a raw placental bed.

The physiology of the third stage of labour also involves the mechanism of placental expulsion. After the baby has been delivered, the uterus continues to contract rhythmically and this reduction in size causes a shear line to form at the utero-placental junction. This is thought to be mainly a physical phenomenon as the uterus is capable of contraction, whereas the placenta (being devoid of muscular tissue) is not. We should note the characteristic of the myometrium which is unique in the animal kingdom, and this is the ability of the myometrial fibres to maintain its shortened length after each contraction and then to be able to contract further with subsequent contractions. This characteristic results in a progressive and (normally) fairy rapid reduction in the overall surface area of the placental site. (Sanborn B M et al. 1998)

In the words of Rogers (J et al. 1998), by this mechanism the placenta is undermined, detached, and propelled into the lower uterine segment.

Other physiological mechanisms also come into play in this stage of labour. Placental separation also occurs by virtue of the physical separation engendered by the formation of a sub-placental haematoma. This is brought about by the dual mechanisms of venous occlusion and vascular rupture of the arterioles and capillaries in the placental bed and is secondary to the uterine contractions (Sharma J B et al. 2005). The physiology of the normal control of this phenomenon is both unique and complex. The structure of the uterine side of the placental bed is a latticework of arterioles that spiral around and inbetween the meshwork of interlacing and interlocking myometrial fibrils. As the myometrial fibres progressively shorten, they effectively actively constrict the arterioles by kinking them . Baskett (T F 1999) refers to this action and structure as the living ligatures and physiologic sutures of the uterus.

These dramatic effects are triggered and mediated by a number of mechanisms. The actual definitive trigger for labour is still a matter of active debate, but we can observe that the myometrium becomes significantly more sensitive to oxytocin towards the end of the pregnancy and the amounts of oxytocin produced by the posterior pituitary glad increase dramatically just before the onset of labour. (Gülmezoglu A M et al. 2001)

It is known that the F-series, and some other) prostaglandins are equally active and may have a role to play in the genesis of labour. (Gulmezoglu A M et al. 2004)

From an interventional point of view, we note that a number of synthetic ergot alkaloids are also capable of causing sustained uterine contractions. (Elbourne D R et al. 2002)

Chapter 2: Discuss Active Management, Criteria, Implications for Mother and Fetus

This dissertation is asking us to consider the essential differences between active management and passive management of the third stage of labour. In this segment we shall discuss the principles of active management and contrast them with the principles of passive management.

Those clinicians who practice the passive management of the third stage of labour put forward arguments that mothers have been giving birth without the assistance of the trained healthcare professionals for millennia and, to a degree, the human body is the product of evolutionary forces which have focussed upon the perpetuation of the species as their prime driving force. Whilst accepting that both of these concepts are manifestly true, such arguments do not take account of the natural wastage that drives such evolutionary adaptations. In human terms such natural wastage is simply not ethically or morally acceptable in modern society. (Sugarman J et al. 2001)

There may be some validity in the arguments that natural processes will achieve normal separation and delivery of the placenta and may lead to fewer complications and if the patient should suffer from post partum haemorrhage then there are techniques, medications and equipment that can be utilised to contain and control the clinical situation. Additional arguments are invoked that controlled cord traction can increase the risk of uterine inversion and ecbolic drugs can increase the risks of other complications such as retained placenta and difficulties in delivering an undiagnosed twin. (El-Refaey H et al. 2003)

The proponents of active management counter these arguments by suggesting that the use of ecbolic agents reduces the risks of post partum haemorrhage, faster separation of the placenta, reduction of maternal blood loss. Inversion of the uterus can be avoided by using only gentle controlled cord traction when the uterus is well contracted together with the controlling of the uterus by the Brandt-Andrews manoeuvre.

The arguments relating to the undiagnosed second twin are loosing ground as this eventuality is becoming progressively more rare. The advent of ultrasound together with the advent of protocols which call for the mandatory examination of the uterus after the birth and before the administration of the ecbolic agent effectively minimise this possibility. (Prendiville, 2002).

If we consider the works of Prendiville (referred to above) we note the meta-analyses done of the various trials on the comparison of active management against the passive management of the third stage of labour and find that active management consistently leads to several benefits when compared to passive management. The most significant of which are set out below.

Benefits of Active Management Versus Physiological Management

Outcome	Control Rate, %	Relative Risk	95% CI*	NNT	95% CI
PPH >500 mL	14	0.38	0.32-0.46	12	10-14
PPH >1000 mL	2.6	0.33	0.21-0.51	55	42-91
Hemoglobin <9 g/dL	6.1	0.4	0.29-0.55	27	20-40
Blood transfusion	2.3	0.44	0.22-0.53	67	48-111
Therapeutic uterotonics	17	0.2	0.17-0.25	7	6-8

*95% confidence interval Number needed to treat

(After Prendiville, 2002).

The statistics obtained make interesting consideration. In these figures we can deduce that for every 12 patients receiving active management (rather than passive management) one post partum haemorrhage is avoided and further extrapolation suggests that for every 67 patients managed actively one blood transfusion is avoided.

With regard to the assertions relating to problems with a retained placenta, there was no evidence to support it, indeed the figures showed that there was no increase in the incidence of retained placenta. Equally it was noted that the third stage of labour was significantly shorter in the actively managed group.

In terms of significance for the mother there were negative findings in relation to active management and these included a higher incidence of raised blood pressure post delivery (the criteria used being > 100 mm Hg). Higher incidences of reported nausea and vomiting were also found although these were apparently related to the use of ergot ecbolic and not with oxytocin. This is possibly a reflection of the fact that ergot acts on all smooth muscle (including the gut) whereas the oxytocin derivatives act only on uterine muscle. (Dansereau, 1999).

None of the trials included in the meta-analysis reported and incidence of either uterine inversions or undiagnosed second twins. Critical analysis of these findings would have to consider that one would have to envisage truly enormous study cohorts in order to obtain statistical significance with these very rare events. (Concato, J et al. 2000)

With specific regard to the mother and baby we note some authors recommend the use of early suckling as nipple stimulation is thought to increase uterine contractions and thereby reduce the likelihood of post partum haemorrhage. Studies have shown that this does not appear to be the case (Bullough, 1989), although the authors suggest that it should still be recommended as it promotes both bonding and breastfeeding.

The most important element of active management of the third stage of labour is the administration of an ecbolic agent directly after the delivery of the anterior shoulder or within a minute of the complete delivery of the baby. The significance of the anterior shoulder delivery is that if the ecbolic is given prior to delivery of the anterior shoulder then there is a significantly increased risk of shoulder dystocia which, with a strongly contracting uterus, can be technically very difficult to reduce and will have significant detrimental effects on the baby by reducing its oxygen supply from the placenta still further. The fundal height should be assessed immediately after delivery to exclude the possibility of an undiagnosed second twin. (Sandler L C et al. 2000)

There are a number of different (but widely accepted) protocols for ecbolic administration. Commonly, 10 IU of oxytocin is given intramuscularly or occasionally a 5 IU IV bolus. Ergot compounds should be avoided in patients who have raised blood pressure, migraine and Raynaud's phenomenon. (Pierre, 1992).

The issue of early clamping of the cord is complex and, of the three components of the active management of the third stage of labour this, arguably, gives rise to the least demonstrable benefits in terms of the evidence base in the literature.

We have already discussed the increased incidence of postnatal jaundice in the newborn infant if cord clamping is delayed but this has to be offset against both the occasional need for the invoking of prompt resuscitation measures (i.e. cord around the neck) or the reduction in the incidence of childhood anaemia and higher iron stores (Gupta, 2002). In a very recent paper, Mercer also points to the lower rates of neonatal intraventricular haemorrhage although it has to be said that the evidence base is less secure in this area. (Mercer J S et al. 2006)

Other foetal issues are seldom encountered in this regard except for the comparatively rare occurrence when some form of dystocia occurs and the infant had to be manipulated and represented (viz. the Zavanelli procedure). If the cord has already been divided then this effectively deprives the infant of any possibility of placental support while the manoeuvre is being carried out with consequences that clearly could be fatal. (Thornton J G et al. 1999)

In the recent past, the emergence of the practice of harvesting foetal stem cells from the cord blood may also have an influence on the timing of the clamping but this should not interfere with issues relating to the clinical management of the third stage. (Lavender T et al. 2006)

There are some references in the literature to the practice of allowing the placenta to exsanguinate after clamping of the distal portion as some authorities suggest that this may aid in both separation (Soltani H et al. 2005) and delivery (Sharma J P et al. 2005). of the placenta. It has to be noted that such references are limited in their value to the evidence base and perhaps it would be wiser to consider this point unproven.

We have searched the literature for trials that consider the effect of controlled cord traction without the administration of embolic drugs. The only published trial on the issue suggested that controlled cord traction, when used alone to deliver the placenta, had no positive effect on the incidence of post partum haemorrhage (Jackson, 2001). The same author also considered the results of the administration of ecbolic agents directly after placental delivery and found that the results (in terms of post partum haemorrhage at least), were similar to those obtained with ecbolics given with the anterior shoulder delivery, although an earlier trial (Zamora, 1999) showed that active management (as above) did result in a statistically significant reduction in the incidence of post partum haemorrhage when compared to controlled cord traction and ecbolics at the time of placental delivery.

In this segment we should also consider the situation where the atonic uterus (in passive management of the third stage of labour) can result in the placenta becoming detached but remaining at the level of the internal os. This can be clinically manifest by a lengthening of the cord but no subsequent delivery of the placenta. In these circumstances the placental site can continue to bleed and the uterus can fill with blood, which distends the uterus and thereby increases the tendency for the placental site to bleed further. This clearly has very significant implications for the mother. (Neilson J et al. 2003)

There are other issues which impact on the foetal and maternal wellbeing in this stage of the delivery but these are generally not a feature issues relating to the active or passive management of the third stage of labour and therefore will not be considered further.

There are a number of other factors which can influence the progress of the third stage of labour and these can be iatrogenic. Concurrent administration of some drugs can affect the physiology of the body in such a way as to change the way it responds to normal physiological processes. On a first principles basis, one could suggest that, from what we have already discussed, any agent that causes relaxation of the myometrium or a reduction in uterine tone could potentially interfere with the efficient contraction of the uterine musculature in the third stage and thereby potentially increase the incidence of post partum haemorrhage.

Beta-agonists (the sympathomimetic group) work by relaxing smooth muscle via the beta-2 pathway. The commonest of these is salbutamol. When given in its usual form of an inhaler for asthma, the blood levels are very small indeed and therefore scarcely clinically significant but higher doses may well exert a negative effect in this respect. (Steer P et al. 1999)

The NSAIA group have two potential modes of action that can interfere with the third stage. Firstly they have an action on the platelet function and can impair the clotting process which potentially could interfere with the body's ability to achieve haemostasis after placental delivery. (Li D-K et al. 2003)

Secondly their main mode of therapeutic action is via the prostaglandin pathway (inhibitory action) and, as such they are often used for the treatment of both uterine cramping, dysmenorrhoea and post delivery afterpains. (Nielsen G L et al. 2001)

They achieve their effect by reducing the ability of the myometrium to contract and, as such, clearly are contraindicated when strong uterine contractions are required, both in the immediate post partum period and if any degree of post partum haemorrhage has occurred.

Other commonly used medications can also interfere with the ability of the myometrium to contract. The calcium antagonist group (e.g. nifedipine) are able to do this (Pittrof R et al. 1996) and therefore are changed for an alternative medication if their cardiovascular effects need to be maintained. (Khan R K et al. 1998)

We should also note that some anaesthetic agents can inhibit myometrium contractility. Although they are usually of rapid onset of action, and therefore rapid elimination from the body, they may still be clinically significant if given at the time of childbirth for some form of operative vaginal delivery. (Gülmezoglu A et al. 2003)

Relevant legal and ethical issues related to topic and midwife

Many of the legal and ethical issues in this area revolve around issues of consent, which we shall discuss in detail shortly, and competence.

Professional competence is an area which is difficult to define and is evolving as the status of the midwife, together with the technical expectations expected of her, increase with the advance of technology.

In general terms the areas of professional competence are defined in both legal and ethical terms. These two areas commonly overlap but they do differ in a number of ways.

The ethical duty of non-malificence is essentially an obligation not to do harm to the patient. The legal consideration of this point is rather broader insofar as the law requires that not only do you (as a midwife) have to ensure that you do no harm to the patient but that you also have a duty to ensure that no harm comes to the patient by other means. This essentially means that the healthcare professionals concerned must speak out if they are aware of the possibility of potential harm to the patient. (Halpern S D 2005)

In the context of this dissertation we could cite the hypothetical example of an obstetrician who was practicing passive management of the third stage of labour in direct conflict with the evidence base in the area. This would require a professional midwife to voice her concerns on the matter and she would be held legally liable if she simply acquiesced in silence. (Dimond. B. 2001). Another example (and supported by legal precedent would be the liability of a midwife who did not speak as the patient's advocate if the obstetrician was incapacitated by illness or (for example) alcohol. (Re C 1994)

In broad terms, the issues enshrined in the area of professional competence are encapsulated in the Bolam Principle. (Hunt T 1994). This states that a healthcare professional should not be held as negligent if he or she acts in accordance with the practice accepted at the time by a reasonable body of medical opinion. in effect, this principle is saying that it is neither reasonable nor practical to expect every professional to achieve expert status in every field of their clinical practice. When acting in a clinical sphere, the healthcare professional should effectively go to lengths that another reasonable practitioner would go to then they would not be considered negligent. (Clarke J E et al 1997). This principle effectively allows common sense to prevail. It is of particular importance in the next section where we shall consider issues of informed consent. A balance must be drawn between what is possible and what is necessary. There is no merit in covering one's self by explaining all possible eventualities to a patient if the net result is that the patient is going to be unrealistically terrified of the potential hazards of a procedure. We shall discuss this in detail shortly.

We can conclude this section on negligence with the overview that it has been accepted that if a healthcare professional can point to or cite evidence that has been published in a reputable peer reviewed journal with a secure evidence base, then it is unlikely to be successfully challenged. The greater the evidence base for a specific course of action, the less likely it is that it can be disputed. (Hewison, A. 2004)

Informed choice and informed consent

Healthcare professionals in general, and midwives in particular, are constantly confronted with the issue of consent. Some situations are tacitly taken for granted simply because there is a general understanding that if the patient allows contact, such as having their face washed, then there is the implication of consent. At the other end of the clinical spectrum, if a patient needs a LSCS and has arrived in the anaesthetic room, they are not realistically in a position to leave if they so choose. Given these circumstances it is vital that the patient has been in a position to have given informed consent which means that it should have been carefully and considerately explained to them beforehand.

Consent is the difference between therapy and assault (Veitch RM 2002). This comment is essentially at the forefront of our considerations here. Even in antiquity there was general agreement that consent was necessary. There are surviving texts from the days of Hippocrates which suggest that although the healthcare professionals of the day had an obligation to do their best for the patient there was no formal obligation on the part of the patient to have to accept what was advised. In reality, we can reflect on the fact that many of the treatments of those days were clearly gross and the issue of consent would actually have been less of a matter of contention simply by virtue of the fact that the patient would clearly have had to have made up their mind to accept the treatment if they turned up to see the physician at all. (Carrick P 2000).

The realities of today mean that there are a great many more subtleties to consider and we now have the benefit and guidance of the advice given by the Good Practice in Consent Initiative Group which was a direct result of the requirements of the NHS Plan that proper consent must be sought from all NHS patients and research subjects. (DOH 2000). It was set up under the auspices of the National Institute for Clinical Excellence which noted an area of ambiguity in current practice and felt that definitive guidance was needed. (Brechin A et al 2000). Their advice is considered to be perhaps currently the definitive guide on the subject. (Say R E et al 2003).

The group use the term proper consent which is not just casual phrase but does have a very precise definition. We note that the definition however, is different in ethical and legal contexts.

The ethical connotation is that the adult is always considered to be competent to give proper consent unless it is proved to be not the case. (Kuhse & Singer 2001).

The legal connotation was summed up by Lord Donaldson (Donaldson 1993) who ruled that

The test that they should apply is Can this patient understand and weigh up the information needed to make this decision? (DOH 2000). If they can, then the clinician has judged them to be competent and the consent is Proper. In the converse case then clearly it is not.

The whole area of childbirth is one which is invested with a high emotional content. It is therefore incumbent on the midwife (and all healthcare professionals) that they should not let their own personal values influence the decision that the patient eventually makes. (Mason T et al. 2003). If the patient should make a decision that appears to be completely out of character or irrational, one should not immediately assume that they are incompetent. it is actually probably more rational to conclude that they may not have clearly understood the explanations given to them by the professionals and as Mezirow comments, it may also therefore be a consequence of the fact that inadequate opportunity has been given for the patient to reflect, consider and to ask questions. (Mezirow, J 1991).

The issue of competence is complicated further with the recognition of the fact that the legal definition of being competent to give consent is not necessarily universal. Winter (R et al. 1999) gives the example of a patient who can be judged competent to decide whether they have a flu vaccination or nor yet may not be competent to make a complex decision relating to investment strategy. Problems arise not so often in the every-day circumstances of professional practice, but at the margins where situations are encountered which are perhaps not met very often. The midwife may find herself in a situation where the patient cannot, either by virtue of sudden emergency of perhaps being under the influence of sedation or anaesthetic, give competent informed consent. The question then arises as to who is able to give consent for any particular procedure?

It is a common situation for relatives to be present and they may wish to give consent on behalf of their relative. Both the Good Practice in Consent Initiative and the professional guidelines on the subject drawn up by the Royal College of Midwives give unequivocal guidance on the subject. Both these authorities concur with the ruling by Lord Donaldson (Donaldson 1993) who ruled that if a patient is considered incompetent to give consent, for any reason at all, then others cannot give that consent for them. It is entirely appropriate for the clinician to listen to the points of view of all interested parties and may appropriately ask them to sign a form stating that this is their opinion or that they are happy with a proposed procedure, but they cannot give vicarious consent for that procedure on behalf of the patient. In short, the responsibility lies with the clinician involved to make a considered judgement on what they consider the patient would have said when they were competent and the responsibility for that decision is theirs. This is clearly a decision that has to take into consideration issues that have a range and scope that is far wider than simply the clinical issues to be considered. Douglas sums up the situation by commenting that the clinician must try to come to an opinion as to just how it would be thought likely that the patient would have reacted in the circumstances. (Douglas C 2002)

One other area of clinical importance where the law gives clear guidance, is the area where the patient has given instructions or perhaps expressed a wish as to how they wised to be treated in any specific situation even though they may not be able to give that opinion at the time in question and the clinician must abide by these wishes in the absence of any other factors. (Sugarman J & Sulmasy 2001)

The ethical debate about a patient's choice revolves around the issue of autonomy. (Coulter A. 2002). Healthcare professionals have to allow the individual patient the right, Gillon would suggest the responsibility, (Gillon R 1997) of each patient to determine how they wish to advance their own welfare.

The key issue in this regard is enunciated by Dimond (B 1999) who we cite verbatim:

In the context of medical consent, this right and responsibility is exercised by freely and voluntarily consenting or refusing to consent to recommended procedures or treatments when in possession of a sufficient knowledge of the benefits .. and risks involved.

It is this last phrase which encapsulates the difficulty in this area. How does a healthcare professional ensure that a patient has sufficient knowledge to make the decision they are being asked to make without either frightening them inordinately with excesses of information or attempting to sway or influence their decision by making a conscious decision to restrict the amount of information given.

To illustrate this with an example. If a patient decides that they do not want to have ecbolic drugs the healthcare professional is faced with a dilemma. If they know that the evidence base is considerably in favour of the use of such drugs, to what extent should they invade the potential autonomy of the patient in seeking to persuade them to change their mind to what may be seen as a more rational choice?

Yura helps us with an analytical assessment of this point. (Yura H et al. 1998). The authors suggest that the judgement as to whether the patient is making a proper decision should be based on consideration of four criteria, namely:

1) Adequate disclosure of information

2) Patient freedom of choice

3) Patient comprehension of information

4) Patient capacity for decision-making

If these criteria are met then one must assume that the decision is proper and should not seek to change it further.

Yura then goes on to suggest that if these criteria are all met then one can also say that three further necessary requirements for proper consent are also met.

1) That the individual's decision is voluntary

2) That this decision is made with an appropriate understanding of the circumstances

3) That the patient's choice is deliberate insofar as the patient has carefully considered all of the expected benefits, burdens and risks and reasonable alternatives.

If we look at the current recommendations of the Royal College of Midwives advice on the subject, we can point to the fact that they currently require four specific areas to be addressed. They clearly cannot determine to what depth these areas have to be covered, as this has to be left to the professional judgement of the individual clinician involved. They suggest that if:

1) Diagnosis

2) Nature and purpose of treatment

3) Risks of treatment

4) Treatment alternatives.

(cited in Hogston, R et al 2002).

have all been covered, then the consent process can be considered proper and adequate

These arguments can be encapsulated in a comment by Lewars who, although he was actually writing about consent in the area of radiographic imaging, finds that his comments are equally valid in this respect.

The thrust of this discussion, in essence, revolves around the fact that a consenting competent adult has the right to either agree or disagree with any form of treatment or investigation and that there is no compulsion or necessity for them to justify that decision to anyone else. The problem for the profession is just how to quantify and to educate the patient sufficiently for that consent to be valid. (Lewars M 2004)

Implications for future practice

Putting all of these considerations together, we approached this topic with an open and enquiring mind. It is clearly important, when trying to come to a decision on issues such as these to try to embrace the principles of evidence based practice. In each area of clinical activity, the conscientious practitioner should endeavour to assimilate their own personal evidence base. This should ideally be done by a personal and critical assessment of the available literature. (Taylor. B. J 2000). We note that simply by reading the literature one is not likely to come to a rational conclusion as some papers (particularly the older ones) are little more than an exposition of the personal opinions of experienced clinicians. Although this may have some value, it is graded at Level IV in the scale of evidence

Classification of evidence levels

Ia	Evidence obtained from meta-analysis of randomised controlled trials.
Ib	Evidence obtained from at least one randomised controlled trial.
IIa	Evidence obtained from at least one well-designed controlled study without randomisation.
IIb	Evidence obtained from at least one other type of well-designed quasi-experimental study.
III	Evidence obtained from well-designed non-experimental descriptive studies, such as comparative studies, correlation studies and case studies.
IV	Evidence obtained from expert committee reports or opinions and/or clinical experience of respected authorities.

( After Tanenbaum S. 1999)

Of far greater gravity and legitimate weight are the papers which are categorised as Level I (a + b) which are derived from meta-analyses or properly conducted randomised controlled trials. In researching this discussion we have tried to restrict the papers presented in support of the arguments discussed to be at least Level IIb and above.

This helps to give legitimacy to the arguments put forward.

There appears to be little doubt, from the evidence presented here, that the passive management of the third stage of labour does appear to have a number of rational arguments to support it and there are demonstrable benefits to be obtained from such passive management. We can cite the absence of the side effects of some of the ecbolic drugs as a simple example. If the drugs are not given then the patient will not experience the possible side effects such as nausea, headache and hypertension to name but a few. The corollary of this line of action is that, in sparing the patient such possible side effects it would appear that they are also spared the protective and beneficial aspects of such drugs.

We have set out unassailable evidence that the use of ecbolic drugs reduces the number of post partum haemorrhages and therefore the associated morbidity (and mortality) that goes with it. Proponents of passive management of the third stage point to drawbacks with the use of ecbolics (as indeed do some of the balanced papers that discuss active management of the third stage). There is no doubt that if used unwisely or inappropriately, there are drawbacks to their use.

The issue of the undiagnosed twin is frequently cited as a possible contraindication. In real terms however, in the developed countries, such eventualities are extremely rare, as the advent of commonplace ultrasound investigations of pregnancy has made the diagnosis of multiple pregnancy comparatively easy.

The significance for future practice would appear to be that there is little evidence to support the overall efficacy of passive management of the third stage of labour.

As a concluding comment we will consider the article by Stevenson (Stevenson J 2005) which makes comment on the Bristol third stage trial. It makes interesting reading as a commentary on the presentation of the trial. We have not included it in the main body of discussion as it cannot be considered a balanced argument being essentially the opinions of the writer

Stevenson opens his paper with the comments:

But the trial, based on false premises, is completely misleading, and numerous criteria are mistaken, misunderstood or misinterpreted.

The reason that we have included this in the consideration of the overall issue is his premise about the trial structure in which he comments:

The obvious alternative to active management is passive management, to see whether a woman's body can cope without assistance; that should settle the matter conclusively. Here is a very common blunder in logic: to go from the sublime to the ridiculous, to justify one inordinate extreme by ridiculing the opposite inordinate extreme.

The thrust of Stevenson's logic is clear and he effectively and coherently argues for a middle course of partial management and active intervention only when needed. The difficulty with this course is that it is dependent on both circumstance and individual clinician preference, and as such, it is virtually impossible to construct a protocol for a controlled trial. The corollary of this is that, although Mr Stevenson can freely express his opinions it is unlikely that there will ever be a randomised controlled trial which will allow him to assemble a secure evidence base for his assertions.

Sadly, after a careful and erudite exposition of his argument, Stevenson rather diminishes the validity of his paper by ending with the unflattering comment:

The statistician, nowadays retitled "epidemiologist," without noticing the abysmal flaws in the structure of this trial, has dressed it in jargon, giving it an air of respectability and credibility.

Debate and disagreement is healthy and will promote further research. There is no doubt that further research is needed in this area. Until then we shall content ourselves with the evidence base that is presented thus far.

References

AbouZahr C. 1998 Antepartum and postpartum haemorrhage. In: Murray CJ, AD Lopez, editors. Health dimensions of sex and reproduction. Harvard Univ Press, Boston ; 1998 :172-4.

Akins S. 1994 Postpartum haemorrhage: a 90s approach to an age-old problem. J Nurse Midwifery. 1994 ; 39 : 123S-34S. [Supplement].

Baines D. 2001 A healthy disposition? The use and limitations of the characteristics approach to general practice research. Br J Gen Pract 2001 ; 51 : 749-52.

Baskett T F : 1999 Complications of the third stage of labour. In: Essential Management of Obstetrical Emergencies. 3rd ed. Bristol, UK : Clinical Press ; 1999 : 196-201.

Brechin A. Brown, H Eby, M 2000 Critical Practice in Health and Social Care Open University, Milton Keynes. 2000

Bullough C H, Msuku R S, Karonde L : 1989 Early suckling and postpartum haemorrhage: controlled trial in deliveries by traditional birth attendants. Lancet 1989 Sep 2 ; 2 (8662) : 522-5

Carrick P 2000 Medical Ethics in the Ancient World Georgetown University press 2000 ISBN : 0878408495

Carroli G, Bergel E : 2002 Umbilical vein injection for management of retained placenta (Cochrane Review). In: The Cochrane Library, Issue 2. Oxford, UK : Macmillian . 2002.

Chamberlain G, and Philip Steer 1999 ABC of labour care : Labour in special circumstances BMJ, Apr 1999 ; 318 : 1124 - 1127

Cherine M, Hassanein K, Sholkamy H, Breebaart M, Elnoury A 2004 Management of the third stage of labor in an Egyptian teaching hospital Int, J Gynaecol Obstet. 2004 October ; 87 (1) : 54-58

Clarke J E & Copcutt L 1997 Management for nurses and Healthcare Professionals. Edinburgh : Churchill Livingstone 1997

Concato, J, Shah, N, Horwitz, RI 2000 Randomised, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000 ; 342, 1887-1892

Coulter A. 2002 The autonomous patient. London: The Nuffield Trust, 2002.

Cunningham F G, Gant N F, Leveno K J, et al : 2001 Conduct of normal labor and delivery. In: Williams Obstetrics. 21st ed. New York, NY : McGraw-Hill ; 2001 : 320-5.

Dansereau J, Joshi A K, Helewa M E, et al : 1999 Double-blind comparison of carbetocin versus oxytocin in prevention of uterine atony after cesarean section. Am J Obstet Gynecol 1999 Mar ; 180 (3 Pt 1) : 670-6

De Martino B , D. Kumaran, B. Seymour, and R. J. Dolan 2006 Frames, Biases, and Rational Decision-Making in the Human Brain. Science 313, 684-687 Dimond. B. 1999. Patient's rights and responsibilities and the nurse. 2nd ed. Salisbury : Quay Books 1999

DOH 2000 Department of Health (2000) The NHS Plan. A Plan for Investment. A Plan for Reform. Cm 4818. London: HMSO 2000

Donald I : 1979 Postpartum haemorrhage. In: Practical Obstetrics Problems. 5th ed. London, UK : Lloyd-Luke ; 1979 : 748-94.

Donaldson L 1993 in Re T (Adult: Refusal of Treatment) 1993 Fam 95 5.

Douglas C 2002 The basics BMJ, Mar 2002 ; 324 : 621 ;

Elbourne D R, Prendiville W J, Carroli G, Wood J, McDonald S. 2001 Prophylactic use of oxytocin in the third stage of labor. Cochrane Database Syst Rev. 2001 ; (4) : CD001808.

Elbourne D R, Prendiville W J, Carroli G, et al: 2002 Prophylactic use of oxytocin in the third stage of labour (Cochrane Review). In: The Cochrane Library, Issue 2. Oxford, UK : Macmillian 2002

El-Refaey H, and Charles Rodeck 2003 Post-partum haemorrhage: definitions, medical and surgical management. A time for change Br. Med. Bull., Dec 2003 ; 67 : 205 - 217.

Gillon. R. 1997. Autonomy London: Blackwell 1997

Gülmezoglu A M, Villar J, Ngoc N T : 2001 WHO multicentre randomised trial of misoprostol in the management of the third stage of labour. Lancet 2001 Sep 1 ; 358 (9283) : 689-95

Gülmezoglu A, J. Villar, N. Ngoc, G. Piaggio, G. Carroli, L. Adetoro, H. Abdel-Aleem, L. Cheng, G. Hofmeyr, P. Lumbiganon 2003 A multicentre randomised trial of the management of the third stage of labour. The Lancet, Volume 358, Issue 9283, Pages 689-695

Gulmezoglu A M, Forna F, Villar J, Hofmeyr G J : 2004 Prostaglandins for prevention of postpartum haemorrhage (Cochrane Review). In: The Cochrane Library, Issue 1. Oxford, UK: Macmillan 2004.

Gupta R, Ramji S: 2002 Effect of delayed cord clamping on iron stores in infants born to anemic mothers: a randomized controlled trial. Indian Pediatr 2002 Feb ; 39 (2) : 130-5

Halpern S D 2005 Towards evidence based bioethics BMJ, Oct 2005 ; 331 : 901 - 903 ;

Hewison, A. 2004 Management for Nurses and Health Professionals: Theory into practice. Blackwell Science : Oxford. 2004

Hill K, AbouZahr C, Wardlaw T. 2001 Estimates of maternal mortality for 1995. Bull World Health Organ. 2001 ; 79 : 182-93.

Hogston, R. Simpson, P. M. 2002 Foundations in nursing practice 2^nd Edition, London: Palgrave & Macmillian. 2002

Hunt T 1994 Ethical issues in Nursing London: Routledge 1994

Jackson K W Jr, Allbert J R, Schemmer G K, et al: 2001 A randomized controlled trial comparing oxytocin administration before and after placental delivery in the prevention of postpartum haemorrhage. Am J Obstet Gynecol 2001 Oct ; 185 (4) : 873-7

Khan R N, SK Smith, and ML Ashford 1998 Contribution of calcium-sensitive potassium channels to NS1619-induced relaxation in human pregnant myometrium Hum. Reprod., Jan 1998 ; 13 : 208 - 213

Kuhse & Singer 2001 A companion to bioethics ISBN: 063123019X Pub Date 05 July 2001

Lavender T, Z. Alfirevic, and S. Walkinshaw 2006 Effect of Different Partogram Action Lines on Birth Outcomes: A Randomized Controlled Trial Obstet. Gynecol., August 1, 2006 ; 108 (2) : 295 - 302.

Lewars M. 2004 Sustainability of medical imaging. To obtain informed consent from everyone is impossible [letter]. BMJ 2004 ; 328 : Pg 24

Li D-K, Liyan Liu, and Roxana Odouli 2003 Exposure to non-steroidal anti-inflammatory drugs during pregnancy and risk of miscarriage: population based cohort study BMJ, Aug 2003 ; 327 : 368 ;

Mason T and Whitehead E 2003 Thinking Nursing. Open University. Maidenhead. 2003

Mercer J S, Vohr B R, McGrath M M : 2006 Delayed cord clamping in very preterm infants reduces the incidence of intraventricular hemorrhage and late-onset sepsis: a randomized, controlled trial. Pediatrics 2006 Apr ; 117 (4) : 1235-42

Mezirow, J 1991 A Critical Theory of Adult Learning and Adult Education. Adult Education 32 (1) : 324.

Mitchelle G G, Elbourne D R. 2005 The Salford Third Stage Trial. Oxytocin plus ergometrine versus oxytocin alone in the active management of the third stage of labour. Online J Curr Clin Trials [Doc. No. 83]. 2005

Nielsen G L , Henrik Toft Sørensen, Helle Larsen, and Lars Pedersen 2001 Risk of adverse birth outcome and miscarriage in pregnant users of non-steroidal anti-inflammatory drugs: population based observational study and case-control study BMJ, Feb 2001 ; 322 : 266 - 270 ;

Neilson J, T Lavender, S Quenby, and S Wray 2003 Obstructed labour: Reducing maternal death and disability during pregnancy Br. Med. Bull., December 1, 2003 ; 67 (1) : 191 - 204.

O'Driscoll K 1994 Active management of labour BMJ, Oct 1994 ; 309 : 1015

PATH 2001 Program for Appropriate Technology in Health (PATH). Preventing postpartum haemorrhage: managing the third stage of labour. Outlook. 2001 ; 19 : 1-8.

Pierre F, Mesnard L, Body G : 1992 For a systematic policy of i.v. oxytocin inducted placenta deliveries in a unit where a fairly active management of third stage of labour is yet applied: results of a controlled trial. Eur J Obstet Gynecol Reprod Biol 1992 Jan 31 ; 43 (2) : 131-5

Pittrof R, C Lees, C Thompson, A Pickles, J F Martin, and S Campbell 1996 Crossover study of glyceryl trinitrate patches for controlling pain in women with severe dysmenorrhoea BMJ, Apr 1996 ; 312 : 884

Prendiville W J, Elbourne D, McDonald S. 2000 Active versus expectant management in the third stage of labor. The Cochrane Library, Issue 4, 2001. Cocrane Database Syst Rev. vol. 3. Oxford Update Software; 2000 : CD000007.

Re C 1994 Re C (Adult: Refusal of Medical Treatment ) 1994 [1994] 1 WLR 290.

Ripley D L. 1999 Uterine emergencies: atony, inversion, and rupture. Obstet Gynecol Clin North Am. 1999 ; 26 : 419-34.

Rogers J, Wood J, McCandlish R, et al: 1998 Active versus expectant management of third stage of labour: the Hinchingbrooke randomised controlled trial. Lancet 1998 Mar 7 ; 351 (9104) : 693-9

Sadler L C, Davidson T, McCowan L M 2000 A randomised controlled trial and meta-analysis of active management of labour. BJOG 2000 ; Jul ; 107 (7) : 909-15

Sanborn B M, C Yue, W Wang, and KL Dodge 1998 G protein signalling pathways in myometrium: affecting the balance between contraction and relaxation Rev. Reprod., Sep 1998 ; 3 : 196 - 205.

Say R E and Thomson R 2003 The importance of patient preferences in treatment decisionschallenges for doctors BMJ, Sep 2003 ; 327 : 542 - 545 ;

Sharma J B, Pundir P, Malhotra M : 2005 Evaluation of placental drainage as a method of placental delivery in vaginal deliveries. Arch Gynecol Obstet 2005 Apr ; 271 (4) : 343-5

Sleep J : 1993 Physiology and management of the third stage of labour. In: Bennett VR, Brown LK, eds. Myles' Textbook for Midwives. 12th ed. London, UK : Churchill Livingstone ; 1993 : 216-29.

Smith J R, Brennan B G 1999 Management of the Third Stage of Labour Obstet Gynecol 1999 Oct-Dec ; 23 (4) : 125-33

Soltani H, Dickinson F, Symonds I : 2005 Placental cord drainage after spontaneous vaginal delivery as part of the management of the third stage of labour. Cochrane Database Syst Rev 2005 ; CD004665

Steer P and Caroline Flint 1999 ABC of labour care: Preterm labour and premature rupture of membranes BMJ, Apr 1999 ; 318 : 1059 - 1062

Stevenson J 2005 The Bristol Third-Stage Trial Midwifery Today Issue 73, Spring 2005

Sugarman J & Sulmasy 2001 Methods in Medical Ethics Georgetown University Press 2001 ISBN : 0878408738

Tanenbaum S. 1999 Evidence and expertise: the challenge of the outcomes movement to medical professionalism. Acad Med 1999 ; 74 : 757-63

Taylor. B. J (2000) Reflective Practice: A Guide for Nurses and Midwives Buckingham : Open University Press. Buckingham 2000

Thilaganathan B, Cutner A, Latimer J, Beard R : 1993 Management of the third stage of labour in women at low risk of postpartum haemorrhage. Eur J Obstet Gynecol Reprod Biol 1993 Jan ; 48 (1) : 19-22

Thornton J G, Lilford R J 1999 Active management of labour: current knowledge and research issues BMJ 1999 ; 309 : 366-9 (6 August)

Veitch R M 2002 Cross-cultural perspectives in medical ethics Jones & Bartlett 2002 ISBN : 0763713325

Walter P, Diana E. 1999 Care during 3rd stage of labor. In: I Enkine, M Enkine, MJNC Keirse, (Eds.), Effective Care in Pregnancy and Childbirth, Oxford Univ Press, Oxford ; 1999 : 114569.

WHO 1994 WHO. Mother-baby package: implementing safe motherhood in Countries. WHO, Geneva ; 1994. WHO/FHE/MSM/94.11 Rev.1.

Winter R & Cohen S 1999 ABC of intensive care: Withdrawal of treatment BMJ, Jul 1999 ; 319 : 306 - 308

Yura H, Walsh M. 1998 The nursing process. Assessing, planning, implementing, evaluating. 5th edition. Norwalk, C T: Appleton & Lange, 1998.

Zamora L A, Philipp J : 1999 A randomised controlled trial of oxytocin administered at the end of the second stage of labour versus oxytocin administered at the end of the third stage of labour in the prevention of postpartum haemorrhage. Philipp J Obstet Gynecol 1999 Oct-Dec ; 23 (4) : 125-33