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Selected Investigations Completed October 1999 - March 2000 > Part II, Case no. E.2135/98-99
Complaint against: East Yorkshire Hospitals NHS Trust
Complaint as put by Mr and Mrs B
1. On the evening of 30 June 1998 Mrs B, who was pregnant and experiencing contraction pains, attended a labour ward of Castle Hill Hospital (the hospital), which is managed by the Trust. She was connected to a cardio-tocography machine and was monitored by a midwife. (Cardio-tocography - CTG - is a commonly used technique for monitoring a baby's heart rate in relation to uterine contractions - contractions of the womb.) At around 11.00 pm, Mrs B was examined by a doctor. A more senior doctor was consulted, and when Mrs B informed him she was having sharp pains he decided to induce labour. At 2.10 am on 1 July Mrs B was having pain every two minutes and CTG monitoring was resumed. At 2.33 am the baby was having early decelerations of her heart (dips in her heart rate). Mrs B remained in pain and was given an epidural at 3.55 am. CTG monitoring continued through the night. She was put on syntocinon (a drug used to augment uterine contractions) at 8.10 am. The baby's heart rate subsequently began to drop more dramatically. Mr and Mrs B called a midwife on three occasions, but each time the midwife reassured them that all was well. Mrs B entered the second stage of labour at 12.30 pm and her baby was born at 1.50 pm. Mr and Mrs B were concerned because she was not breathing. After an unsuccessful attempt to clear her airways the baby was taken to the resuscitation room. A paediatrician told Mr and Mrs B that the baby had suffered a cardiac arrest at birth and was deeply unconscious due to severe brain damage. The baby was transferred to the Special Care Baby Unit and died 26 hours later.
2. On 17 September 1998 the acting head of women's services wrote to Mr and Mrs B setting out recommendations she had made after investigating events prior to the baby's birth. On 28 November Mr B wrote to the Trust's chief executive (the chief executive) complaining that their concerns had not been investigated adequately and that they had not had a formal response. The chief executive replied on 8 December stating that the Trust believed that Mr and Mrs B had wanted their complaint to be dealt with informally. (Note: Mrs B was a nurse employed by the Trust.)
3. The complaint investigated was that Mrs B's care during labour was inadequate.
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4. The statement of complaint for the investigation was issued on 8 July 1999. Comments were obtained from the Trust and relevant papers, including Mrs B's clinical records, were examined. The Ombudsman's investigators took evidence from Trust staff. Two independent professional assessors, a consultant obstetrician and gynaecologist and a head of midwifery and supervisor of midwives, were appointed to advise on the clinical aspects of the case. Their report is set out in full following paragraph 12 of this report.
Background information
5. Much of this report is concerned with the importance of observing and acting on possible signs of fetal distress indicated by CTG. Fetal distress, which is not a clearly defined term, may have a number of causes, of which the most common is hypoxia (oxygen deprivation). Marked changes in the fetal heart rate can be an indication of distress. The use of CTG allows monitoring of the fetal heart rate and the relationship between changes in the fetal heart rate and uterine contractions. CTG produces two traces. The upper trace represents the fetal heart rate. Minor variations in the fetal heart rate register as small fluctuations on the trace. There are normally minor variations in the fetal heart rate - referred to as baseline variability - of about 10 beats per minute within a range of about 110 to 150 beats per minute. Decelerations i.e significant lowering of the fetal heart rate, are associated with uterine contractions. Such decelerations are classified as 'early' (also sometimes referred to as type 1) which coincide with a contraction, or 'late' (or type 2), where, the lowest point of the deceleration occurs after the peak of the contraction. Generally, late contractions and reduced baseline variability are possible indications of fetal distress (although reduced variability associated with 'sleep phases' of no more than around 40 minutes duration is not, in itself, cause for concern). In practice variations in fetal heart rate may be complex and difficult to interpret and offer an important, but not the sole indicator of fetal distress.
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Evidence of Mr and Mrs B
6. In putting their complaint to the Ombudsman Mr and Mrs B emphasised, that there were issues at the time of the original investigation into the baby's death, of which they had been unaware and uninformed. Mrs B wrote:
'...our additional concerns stem from the incorrect use of Syntocinon. A review of my medical notes has enabled me to determine that there is no prescription card for this drug; I was given twice the maternity unit's usual recommended maximum rate of the drug: the drug was administered to me, even though the CTG monitor had for approximately 10 hours shown signs of foetal distress. Even when, after receiving this drug for approximately one hour, the baby's heart rate began to fluctuate dramatically (towards the end of my labour down to 30 beats per minute) this drug was not stopped. In fact it was turned up from 3-48mls per hour during this time.
'I have since had time to visit the local health library and have reviewed the 1993-1997 CESDI [confidential enquiry into stillbirths and deaths in infancy] reports, current research papers, the Royal College of Obstetricians (1998) 'guidelines for the induction of labour' and the 'Novartis' drug formulary. All clearly identify:
'a) Syntocinon should not be prescribed in cases where foetal distress is suspected - as I had already been told at 23.00hrs that my baby was very quiet and the CTG had shown 'reduced variability', 'no variability', 'early decelerations', 'variable decelerations', and 'late decelerations' throughout the night - I feel my baby was clearly showing signs of foetal distress. This view is compounded by the fact that the doctor placed a clip on the baby's head to aid monitoring. I had once required oxygen therapy and twice had my position changed to attempt to improve the CTG trace. Though not recorded in my medical records, the doctors had also 'starved' me and told me I may need a caesarean section. Also, the doctor told us at this time that he would come and take a blood sample from the baby's head - however he never did so. I was later able to find out from my own enquiries that this procedure is used to determine if a baby is becoming hypoxic [suffering from diminished amounts of oxygen in the tissues].
'b) Mothers should be monitored very closely and if decelarations of a baby's heart rate are seen (especially the 'Type 2' decelerations that [the baby] experienced for almost 5 hours), the Syntocinon should be turned off immediately and immediate action taken to reverse the effects of this drug and expedite delivery of the baby.
'c) Parents should be given enough information about the uses and complications/side effects of the drug to enable them to make an informed choice about their care. Again, no information was given to my husband and I to allow us to make such a choice.
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'The day after the baby's funeral we went to see our consultant... We were told that, in the five hours leading up to the baby's birth, she was clearly distressed and immediate action should have been taken to deliver her. We were told that the midwives had incorrectly read the CTG and therefore failed to identify the 'late decelerations'. My husband and I asked 'what could have caused the distress?' and were told that these things happen, often for no apparent reason.
'Though we did not at this time feel able to begin writing lengthy letters, we did stress our view that as the baby's death amounted to a lack of care, a full and formal enquiry should be carried out. We were reassured that this would be so. We were also reassured that we would be given feed-back on all the issues raised.
'However, we feel very let down and misled. The formal enquiry failed to identify any issue relating to the use of Syntocinon. Because of this I spent almost 5 months blaming myself and my body for sending the baby into distress. Constantly questioning 'could I have done things differently to prevent this?' ...All these issues have affected our grieving and have caused us a great deal of additional stress and suffering. Feelings which could have easily been avoided with more open, honest and truthful answers to our many questions.
'It has also caused us to question the rigour of the Trust's 'formal enquiry'. This view is compounded by the fact that the risk and complaints manager for the Trust was not informed of any of the events which led up to [the baby's] death. Neither was my GP.'
(Note: I have seen that hospital staff wrote to Mrs B's GP, providing information about the circumstances of the baby's delivery and death, on 7 July and 17 August 1998.)
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Trust's investigation
7. On 10 September 1998 the Trust's acting head of women's services produced a report following her investigation of the events surrounding the baby's delivery. That report is reproduced in full as the Annex to this report. On 17 September 1998 the acting head of women's services wrote to Mr and Mrs B enclosing the recommendations made in her report and stating:
'The aim of making these recommendations is to learn from any mistakes made and to try to prevent such a tragedy happening to anyone else. I am, therefore, very pleased to report that apart from the last recommendation, which still requires further discussion with the management team, all the other recommendations have been accepted and the majority have been implemented...'.
Trust's response to the Ombudsman
8. In his formal response to the statement of complaint the chief executive of the Trust wrote:
'The circumstances surrounding the death of the baby were discussed in detail with [Mr and Mrs B] and they were offered an honest account of the events leading to this tragic outcome. An error of judgment was made by a midwife when reviewing the CTG trace. Signs of fetal distress could be detected on the CTG trace and therefore the baby's death could possibly have been prevented if a caesarean section had been performed. [Mr and Mrs B] are fully aware of this and have been informed of the action taken by the Trust to avoid a repetition of these tragic circumstances...
'In summary, the issues set out in the statement of complaint forwarded with your letter are entirely accepted. I would like to reiterate my sincere apologies to [Mr and Mrs B] for the failure to provide appropriate care and to offer my condolences for the sad loss of their daughter...'.
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Further Trust evidence
9. A consultant obstetrician (the consultant) told the Ombudsman's investigator that he had been on duty on 1 July 1998 and saw Mrs B at 8.40 am. At that time Mrs B had recently been started on syntocinon. He was satisfied that that was appropriate and wrote in her notes that it should continue. Having reviewed the notes, he did not consider that there had been any clear indications to stop syntocinon later in the morning. Mrs B had mostly been contracting at around 4-5:10 (four or five contractions in ten minutes) which was in the normal range. However, with hindsight, doctors should have been called in towards the end of the morning because there were persistent variable decelerations in fetal heart rate which should have rung alarm bells. He did not know why doctors had not been called. It was possible that midwives had been falsely reassured by his own comments at 8.40 am. He did not consider staff shortages had been an issue. Nor had there ever been any concerns about midwives feeling unable or unwilling to contact doctors.
10. The acting head of women's services, who is now substantive in that post, told the Ombudsman's investigator that in her view, while CTG monitoring was a useful tool it could not always be exclusively relied on alone: it is only one part of an assessment of the clinical situation. Sometimes there were problems in establishing and recognising the baseline positions; and resolving exactly what the traces meant was not always easy. Fetal blood sampling (FBS) was very useful in that the results were an additional indicator to determine the health of a baby. If FBS revealed that a baby was in danger, then irrespective of apparently sound CTG traces, a caesarean section might be performed. Conversely, in a case of questionable CTG traces, FBS could reveal that a caesarean was not necessary. In Mrs B's case FBS would have been very helpful but it was not performed. In her opinion the situation in this case had arisen for a number of reasons: the midwives had not spotted significant changes as the morning progressed - mainly that the decelerations were not within acceptable limits. They had not compared the later traces with earlier traces; if they had, the comparison would have revealed changes in the baselines and the CTG traces. The baselines represent the heart rate of the baby. Also the midwives had been reassured about the labour because the consultant had reviewed Mrs B and had not been concerned. In the light of these events the acting head of women's services had made a number of recommendations for improvements in training, particularly in relation to CTGs (see Annex). Those recommendations had been implemented, both in respect of midwives and medical staff.
11. The acting head of women's services said that the unit had a protocol for the dosage and administration of syntocinon. This provided for administration in saline solution at the rate of 10 units of syntocinon in 500mls of solution. The starting dosage was 3mls per hr (equating to 0.006mgs of syntocinon) and the maximum dosage was 96mls per hour. Mrs B never reached that level. (Note: the last increase in syntocinon dosage shown in Mrs B's records was at 11.00am to 48mls/hr.)
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Assessors' report
12. I now reproduce the complete text of the report of the assessors appointed to advise the Ombudsman on Mr and Mrs B's complaint.
Report by the Independent Professional Assessors
1.1 Baby B was born, by spontaneous vaginal delivery, on 1 July 1998 at the hospital. She was born in very poor condition and died the following day. There was an informal inquiry at the hospital, which produced some recommendations. In November 1998, Mr B complained to the Trust that their complaints had not been considered formally through the NHS complaints procedure.
1.2 This report is based on the case notes, and other documents provided by the Health Service Ombudsman.
Background
2.1 Mrs B was a 32 year old primigravida (a woman who is pregnant for the first time) with no relevant past medical history. She booked at the hospital in early pregnancy, and was given an estimated date of delivery of 24 June 1998; this was confirmed by ultrasound. She was a non-smoker. Also she worked as a ward sister at the hospital. Her mother had had toxaemia (a condition where there is raised blood pressure, associated with protein in the urine and oedema - fluid in the tissues) and a stillbirth. Mrs B had routine antenatal care, and no problems were noted.
2.2 On 25 June 1998, Mrs B was admitted to the hospital with possible ruptured membranes. A CTG was reassuring. She had mild tightening only, and had not ruptured her membranes; she was therefore allowed home. She was seen for the second time on 29 June possibly in labour. Again a CTG was reassuring; she was not in established labour, and was allowed home.
2.3 Mrs B was admitted for the final time on 30 June at 8.00pm when she was 40 weeks and 6 days pregnant. She complained of irregular contractions. However, at around 10.10pm the CTG was sub-optimal (see paragraph 3.2), and she was reviewed by the registrar, at 11.15pm who recommended induction of labour. The registrar also noted that Mrs B complained of reduced fetal movements. He therefore inserted 2mg prostin gel vaginally to start labour. Mrs B was cared for during the night by a midwife (the first midwife). On 1 July at 2.10am, Mrs B began to contract more regularly and a vaginal examination (VE) at 3.10am showed that she was 3-4 cms dilated. An epidural was sited at 3.55am, and the first midwife commenced Mrs B on the partogram at 4.30am. (A partogram is a graphical representation of the progress of labour which is used for noting key observations and actions. Its use indicates that the first midwife thought that Mrs B was in established labour at this time.) At 5.00am the first midwife performed an artificial rupture of the membranes (ARM) with some difficulty and noted blood stained liquor. At 6.30am Mrs B was reviewed by the Senior House Officer (the SHO), as the midwife was concerned about the CTG; the SHO did not write in the notes, but the first midwife wrote 'continue monitoring'. A deceleration was noted at 7.02am with good recovery, and Mrs B was sleeping.
2.4 Another midwife (the second midwife) took over Mrs B's care at 7.15am and performed a VE. She found that Mrs B was 5 cms dilated, turned her onto her right side as there was a deceleration and informed the registrar. The registrar reviewed her at 7.45am; he noted reduced baseline variability in areas and occasional early decelerations. He commented that she needed syntocinon augmentation and 'If decelerations persist for FBS [fetal blood sample]'. The syntocinon was commenced at 8.10am at 3 mls/hour. Mrs B was reviewed by an on-call consultant, at 8.40am; he noted that the CTG was 'now OK. Liquor clear. Has started syntocinon. Plan: continue.' At 8.45am Mrs B's temperature was 37.7°. The second midwife left Mrs B to scrub for a Caesarean section on another patient at 9.30am, and at 10.00am her care was taken over by another midwife (the third midwife), who was doing a bank shift (that is, she is an employee of the hospital working on a shift by shift basis as required), but who was also one of the unit's G grade ward sisters.
2.5 The third midwife documented at 10.00am that the contractions were 4-5:10 strong, and that there were early decelerations with good recovery. Her next comment is at 11.00am when she noted that Mrs B was contracting 3-4:10, and that there were early decelerations with good recovery, and that the syntocinon was increased to 48 mls/hour. There is a blood pressure measurement on the partogram for 10.30am but otherwise no observations were documented between 10.00am and 11.00am. The second midwife took over Mrs B's care again at 11.30am. She performed a VE at 11.40am and found that the cervix was fully dilated with the head at the level of the ischial spines (the lower part of the pelvis). She noted 'Type One decelerations recovering well'. At 12 midday the second midwife wrote 'head seen in the distance', and the second midwife waited for further descent prior to commencing pushing. She noted 'Type One decelerations recovering quickly'. At 12.15pm Mrs B's temperature was 37.8. At 12.30pm the baby's head was visible and active pushing was commenced. At 12.40pm decelerations were noted but recovering in between the contractions. At 1.40pm the baby's heartbeat could not be picked up through the monitor, and the second midwife commented 'listening in by attaching wire to FSE [fetal scalp electrode]'. At 1.45pm Mrs B was noted to be 'becoming distressed' and Mr B was asked by the midwife to buzz for help.
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2.6 The baby's head was delivered at 1.50pm and meconium was noted. (Meconium is the name for the fluid material that collects in a baby's bowels before it is born. A sign of a baby's distress can be evacuation of the meconium from the bowels.) A nursing auxiliary arrived to assist and the second midwife requested a paediatrician in view of the meconium. The second midwife tried to clear the baby's airways but the wall suction appeared not to work. The cord was loose around the baby's neck, and was presumably slipped over the head. The third midwife arrived as the baby's body was being delivered; the cord was clamped and cut, and the baby taken to the resuscitaire (resuscitation trolley) by the third midwife. The third midwife noted 'baby pale, very poor tone, no heart rate felt, meconium ++'. The paediatrician was crash bleeped. Another doctor arrived immediately as the second midwife was sucking out the baby under direct vision. A consultant paediatrician (the consultant paediatrician) reviewed the baby at approximately 30 minutes of age, and counselled the parents about the extremely poor prognosis and transferred the baby to the Special Care Baby Unit. The consultant paediatrician found that the baby was in a very poor condition, and after discussion with the parents, withdrew intensive care. The baby died the following day, 2 July aged 26 hours.
The cardiotocographs
3.1 The CTGs during the first two admissions on 25 and 29 June 1998 were entirely normal and reassuring.
3.2 During Mrs B's third admission, the CTG that started on 30 June at 8.57pm initially showed a baseline of 140-150 with good baseline variability and accelerations. The trace is reassuring until 10.10pm when there is a possible small early deceleration followed by reduced baseline variability (which may be indicative that the baby was in a sleep phase). Prostin gel was given at 11.15pm; there is a gap in monitoring between 10.50pm and 11.16pm. There is a further period with reduced baseline variability between 11.40pm and 12.15am - again, compatible with a sleep period. The CTG is then reassuring until 12.38am when monitoring was discontinued whilst Mrs B had a shower.
3.3 The CTG recommenced at 2.05am; the CTG is reassuring with good baseline variability and accelerations until 2.33am when there is a shallow early deceleration down to 80, but the trace is reassuring again until 3.12am. There is then no recording until 3.58am (Mrs B had a VE at this time). There may be some recording prior to 3.58am but this is obscured. At 3.58am, during the epidural insertion, the baseline is approximately 140 with reduced variability. There is a late deceleration (the first late one) at 4.18am, and a further significant late deceleration at 4.41am. An ARM was performed at 5.00am and a fetal scalp electrode applied. Following the ARM, the trace is difficult to interpret until there is a prolonged deceleration at 5.13am for 5 minutes. The CTG then improves until 5.30am, following which there is a period of reduced baseline variability until 6.16am when there was a shallow late deceleration. The CTG is then rather difficult to interpret, but there are probably late decelerations until 6.30am when the SHO reviewed Mrs B. The CTG again improves; there is an early deceleration at 6.45am, and a small late deceleration at 6.55am. There is then a prolonged late deceleration at 7.02am, followed by a further late deceleration at 7.14am. The registrar reviewed her at 7.45am and noted that she should have a fetal blood sampling test if there were persistent decelerations. Immediately after this there were 3 early decelerations before 7.56am. At this stage Mrs B was contracting 4:10.
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3.4 Immediately after starting the syntocinon, there were 4 late decelerations by 8.25am. The syntocinon was increased. There is then a period of reduced variability from 8.30am, and the on-call consultant reviewed her at 8.40am. There are some shallow late decelerations at 9.15am. By 9.40am Mrs B is contracting 5:10 with persistent variable decelerations until 11.00am. At 11.00am, she was contracting 5-6:10 with persistent variable decelerations; the syntocinon was increased.
3.5 At 11.40am, when Mrs B was found to be fully dilated, the baseline dropped to approximately 110 with persistent late decelerations. At 12.20pm she is contracting 6:10 and the recovery phase between the decelerations becomes shorter. After the commencement of pushing at 12.30pm, the fetal heart drops to a baseline of approximately 100. There is complete loss of baseline variability at 1.18pm at which time Mrs B is contracting 8:10, and virtually no recording after 1.32pm.
The record keeping
4.1 Documentation was of a good standard antenatally.
4.2 During the labour, documentation was not of an acceptable standard. Numerous pages were without the patient's name and were not dated. There was little documentation around direct patient care. The partogram was very poorly filled in, without patient identification. There is no observation recorded after 11.00am. There was minimal notation about the syntocinon.
The syntocinon infusion
5.1 It was not unreasonable to start the syntocinon infusion at 8.10am; there was no meconium, and although the CTG was suspicious, the registrar had reviewed Mrs B and recommended a fetal blood sample if decelerations persisted. The registrar would therefore have expected to be contacted if there were further decelerations.
5.2 The syntocinon does not appear to have been prescribed.
5.3 The syntocinon appears to have been increased despite a clearly abnormal fetal heart tracing. Furthermore, the syntocinon was increased despite there having been frequent uterine activity. There is clear evidence of hyperstimulation (contractions at a rate of more than four per ten minutes) from approximately 11.00am onwards. All professionals involved in caring for women in labour should know to stop a syntocinon infusion in the presence of any suspected fetal distress.
5.4 The hospital protocol for induction and acceleration of labour with epidural in use in 1998 stated that the syntocinon should be decreased if there was hyperstimulation or fetal distress. This was clearly ignored by the midwives.
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Midwifery staffing
6.1 It appears as if there were too few midwives to provide continuous 1:1 care for this patient with an abnormal CTG and an epidural.
6.2 There was only one midwife (the second midwife) and a nursing auxiliary at the delivery; the second midwife had to summon aid.
Other points
7.1 Mrs B's pyrexia (high temperature) appears to have triggered no further investigation.
7.2 The registrar specifically noted that there should be a fetal blood sample if the decelerations persisted; this was not acted upon.
7.3 It is absolutely critical that syntocinon is not administered in the presence of suspected fetal distress, and that contractions need to be carefully monitored.
7.4 The internal investigation of the case after the tragic death was apparently conducted in an exemplary manner with the support of the Local Supervising Authority's Midwifery Officer. In particular, we applaud the non-punitive approach. However, this was an extremely serious incident, and in future such events should trigger detailed formal investigation through a clinical governance scheme.
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Assessors' opinion
8.1 The care given to Mrs B during her labour was sub-standard. The decision to induce labour was appropriate; she was then carefully monitored by the first midwife during the night. That midwife noted abnormalities in the fetal heart rate, correctly performed an ARM to exclude meconium and summoned medical advice. The registrar appropriately reviewed Mrs B at 7.45am, and correctly noted that there should be a fetal blood sample if the decelerations persisted. There was then a failure by the midwives caring for her during the morning to summon medical assistance in view of the persistent decelerations. A fetal blood sample should have been attempted. Furthermore, there was a serious failure to appreciate the abnormalities in the fetal heart and the hyperstimulation in the presence of syntocinon.
8.2 In our opinion, it was inappropriate not to have 1:1 midwifery care. Not only was Mrs B being induced because of reduced fetal movements and a suspicious CTG, but she had an epidural and an ongoing suspicious CTG.
8.3 The protocol for induction/ acceleration of labour current in 1998 failed to state how many contractions should be aimed for. It does, however, state that the syntocinon should be decreased if hyperstimulation or fetal distress occurs. In the current protocol for induction of labour, the aim is for 3-4 contractions in 10 minutes with continuous fetal monitoring.
8.4 It is not possible to state at which time of delivering the baby might have escaped irreversible brain damage. However, this baby may have been compromised at the beginning of labour (witness reduced fetal movements and a sub-optimal CTG); this would have been compounded by the prolonged hyperstimulation which occurred for two and a half hours prior to delivery.
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Recommendations
9.1 In the light of the Audit Commission's recommendations of 1.15 midwives per women in labour, the hospital should be working towards this level. The Delivery Suite rotas should reflect the appropriate skill mix so there are midwives who can undertake the care of women with epidurals in situ. The hospital should consider carefully whether an epidural should be administered to a woman in labour if it is not possible to provide 1:1 midwifery care. The Trust should ensure that midwifery staffing is based on a ratio of the very minimum of 1 midwife to 35 deliveries per year and we understand that currently the ratio is one midwife per 33 deliveries. The aim should be to have 2 midwives at each delivery, and this practice should be auditable. Best practice is for 2 midwives to be present at delivery and staffing levels should reflect this standard. However, it is recognised that this may be one midwife and one student midwife or in extreme situations 1 midwife and 1 Healthcare Support Worker. This should be auditable. If the workload does not permit this a strategy of calling in extra midwifery staff should be developed to cope with such peaks.
9.2 We applaud the recommendation that all staff should undergo training in interpretation of CTG tracings and that annual updating should be mandatory for all staff.
9.3 There should be clear care plans documented in the notes if a doctor has been called to see a woman in labour. However, if the doctor has reassured the midwife, the doctor should not necessarily review the woman, who may have then returned to a 'low risk' category.
9.4 In the current protocol for induction of labour, we feel that there should be greater emphasis on stopping the syntocinon infusion if there is any suspicion of fetal distress or hyperstimulation.
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Findings
13. In their letter to the Ombudsman (paragraph 6) Mr and Mrs B explained that a few days after their baby's death their consultant told them that in the five hours leading up to her birth she was clearly distressed; that immediate action should have been taken to deliver her; and that the midwives had incorrectly read the CTG and therefore failed to identify late decelerations. Mr and Mrs B said that they had continued to pursue their complaint because they had doubts about the rigour of the Trust's enquiry. They were particularly concerned that it had failed to identify any issue relating to the use of the drug syntocinon. The chief executive of the Trust said in his response to the Ombudsman (paragraph 8) that Mr and Mrs B had been offered an honest account of events and had been informed of the actions taken to avoid a repetition. He accepted that Mrs B's care during labour was inadequate and reiterated his sincere apologies for that.
14. I am satisfied that the reasons for the sad outcome of Mrs B's labour on 1 July 1998 were essentially as explained to her and her husband shortly after their baby's death. The Trust's own enquiry into the events (see Annex) identified that there was a failure to undertake fetal blood sampling despite persisting decelerations in fetal heart rate; and that midwives did not interpret the CTG tracing as a whole labour event. The Ombudsman's assessors have additionally expressed concerns about the continued administration of syntocinon in the face of clear signs of fetal distress. I am concerned that there is no record that this drug was in fact properly prescribed. The Ombudsman's assessors (paragraphs 7.4 and 9.2 of their report) have commended the way the Trust investigated the case and the steps taken as a result of it. The assessors have made some further suggestions (paragraphs 9.1 - 9.4 of their report) and I recommend that the Trust consider those suggestions as part of a comprehensive review of the effectiveness of the measures taken to prevent a repetition of these circumstances. I uphold this complaint.
Conclusions
15. I have set out my findings in paragraphs 13-14. The Trust have agreed to implement my recommendation in paragraph 14 and have asked me to reiterate - as I do through my report - their apologies for the shortcomings identified.
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Annex to E.2135/98-99
Report prepared by the Trust's acting head of women's services on the events surrounding baby B's delivery
AN INVESTIGATION FOLLOWING BIRTH OF UNEXPECTED SERIOUSLY ILL BABY, RESULTING IN A NEONATAL DEATH AT 26 HOURS OF AGE
This report has been produced as part of the routine investigation following the birth of an unexpected seriously ill baby on 1 July 1998. A copy of this report will also be sent to [the local supervising authority's midwifery officer] to inform her of the recommendations made and any Supervisory action taken.
Procedure
Labour ward manager gave a verbal account of the incident.
The supervisor of midwives supported the staff concerned.
Statements requested from the three midwives who had provided care to the mother during labour.
Case notes reviewed and medical opinion sought from [the consultant obstetrician] who was on labour ward session and had reviewed the patient during labour and the patient's own consultant.
Details regarding workload, staffing levels, and any mitigating circumstances collected.
Multidisciplinary discussion held at the perinatal mortality meeting on 11 September and recommendations included in this report.
Back to top Findings
The records are well documented and signed.
06.30 [The first midwife] working during the night had called in the SHO regarding her concerns about the CTG tracing showing both early and late decelerations. She was advised to continue with the monitoring.
07.45 [The second midwife] called in [the registrar] in view of concern re the CTG tracing. His records documented the need for syntocinon augmentation but, despite being reminded by [the second midwife], this is not written up on an Intravenous drug chart. The I.V. infusion of syntocinon was commenced and increased as per the unit protocol.
[The registrar] had documented that if decelerations persisted fetal blood sampling should be undertaken. This was not done despite decelerations persisting.
The doctor taking over from [the registrar] at 08.30 did not assess the patient in labour, however at 08.40 the patient was reviewed by [the on-call consultant], who advised to continue.
There were three midwives working on Labour & Delivery Suite ; a G grade midwife [the first midwife] who was in charge for the duration of the early shift; an E grade midwife [the second midwife] who was allocated this patient, and a midwife [the third midwife], who was doing a bank shift but is one of the unit's own experienced G grade labour ward sisters. The midwife in charge, had allocated herself some patients to care for therefore she was not able to be supernumerary. The Labour & Delivery Suite Manager was on duty, but was doing paperwork in her office. She was not called to assist until after the incident happened.
[The second midwife] had several years experience but had been employed at this hospital for just over 2 months. She had been preceptored for one month and had spent all of her time on the Labour & Delivery Suite. There were no concerns about her abilities as a midwife. She had been in the habit of asking other midwives to check the CTG tracings if she was concerned but on this occasion she did not as the consultant and another midwife had seen the patient and, at the time, had agreed with her findings.
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A planned caesarean section was undertaken with [the second midwife] having to leave her patient in the care of [the third midwife] whilst she went to scrub in theatre. The middle grade doctor was also in theatre for this case.
Between 10.00 and 11.30 care was given by [the third midwife] whilst [the second midwife] was in theatre. On hindsight this midwife now recognises that some of the decelerations she observed were late decelerations but at the time she recorded them as early decelerations. Based on these findings, the Syntocinon was increased from 24 drops to 48 drops per minute as per unit protocols.
The CTG tracing was not interpreted on a 'whole' labour event, merely what was happening at the time.
From 11.40, during the second stage of labour until the delivery at 13.50, [the second midwife] interpreted the CTG tracing as early decelerations with good recovery between the contractions. This tracing is indicative of a baby becoming in severe distress.
[The third midwife] delivered her patient at 13.17, unattended by another professional. [The second midwife] delivered her patient at 13.50 again without anyone else in attendance, until help was requested when meconium stained liquor was seen just prior to delivery of the shoulders. It is customary on this unit to only request a second person/professional at delivery if there are concerns, such as the meconium stained liquor.
[The second midwife] had attempted to use the suction unit to clear the airways but could not get the machine to work properly, however, in response to the requests for help, a senior midwife and a paediatrician were immediately available to resuscitate the baby.
Intubation was undertaken and the baby was taken to the SCBU [special care baby unit] in a very poor condition. A decision was made, with the parents' full agreement, for the machines to be switched off and all treatment was stopped. The baby subsequently died at 26 hours of age.
Back to top The midwives concerned were clearly devastated over this incident because it was so unexpected. They had felt reassured that the CTG was satisfactory as both a registrar and a Consultant Obstetrician had confirmed this to be the case.
The medical staff had not checked on labour progress since 08.40 when the consultant on duty on the labour ward had assessed the situation, nor had they been asked to review the tracing by the midwives.
Medical opinion, sought after the event, expressed a view that similar tracings had been seen which resulted in a healthy live birth.
The updating of knowledge regarding the understanding of CTG tracings is not mandatory for either midwives or doctors.
The recommendations of the 5th Confidential Enquiry into Sudden Deaths in Infancy (CESDI) report has not been implemented.
The midwives have received the support and understanding of their Supervisor of Midwives and an individual action plan has been agreed between [the second midwife] and [the third midwife] has also been supported and debriefed by her Supervisor.
A 'no blame' approach has been adopted and the staff have been supported through a debriefing process.
Back to top Conclusions
This was a totally unexpected event, although earlier concerns about the CTG tracing had been raised with the medical staff.
The interpretation of CTG tracings is a complex and difficult area which is open to misinterpretation, especially during the first stage of labour, however the tracing during the second stage of labour is recognisable as a terminal tracing.
A false sense of security had been felt as a senior doctor and the Consultant Obstetrician had reviewed the tracings earlier. The midwives had been advised to proceed with augmentation and to continue with continuous monitoring of the fetus. Fetal blood sampling as suggested by [the registrar] would have highlighted the depletion of the oxygen to the baby if this procedure had been undertaken.
The labour ward became busy around lunchtime but had been reasonable up to that point and the midwife in charge had not considered the unit to be unsafe otherwise she would have called for assistance from the Labour & Delivery Suite Manager.
With the benefit of hindsight signs of fetal distress could be detected on the CTG trace and therefore the death of this baby could possibly have been prevented if a caesarean section had been performed.
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Recommendations
- The checking of all equipment used on Labour & Delivery Suite to be a daily procedure.
- Medical staff to review progress of women they have been called to see during labour and not wait to be called back.
- Fetal blood sampling to be standard procedure for 'questionable' traces to assist in the decision making process re mode of delivery.
- Training in the interpretation of CTG tracings to be given immediate attention by:-
- Having the CTG tutor installed on all computer terminals for group/individual training
- Reinstatement of weekly case discussion, led by the Consultant Obstetrician
- Annual updating for all midwifery and medical staff to be mandatory
Two professionals to be present during delivery.
- Senior midwife to be supernumerary to be able to support junior midwives.
The Supervisor of Midwives to meet with, support and agree learning objectives with the midwives specifically involved in this case.
All Midwives and Doctors to read the recent CESDI report which is available in all areas.
- Recommendations of the CESDI report should be implemented.
- Consideration to be given to having a midwife based on Labour & Delivery Suite specifically to develop the clinical skills of the midwives.
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