Foetal scalp monitoring
23. Miss E complains she did not consent to foetal scalp monitoring.
24. She explains staff said they needed to take foetal blood samples, and she needed to lie on her left side to do it. Staff were monitoring her baby using a CTG monitor at this time. She tells us this would not stay on so staff said they would have to use FSE monitoring instead.
25. Miss E says staff did not tell her the FSE was optional. She explains her birth plan said unless it was completely medically necessary, she did not want foetal scalp monitoring. She tells us she did not consent, and she said she was crying and shaking her head during the monitoring.
26. In the Trust’s complaint response, it explained when women are in labour, the baby is monitored using a CTG to ensure any concerns related to the baby are actioned appropriately. It said as it identified concerns with Miss E’s CTG, it used the FSE as this can ensure the baby’s heartbeat is recorded accurately. It said the midwife apologised if they did not clearly explain the reason for the foetal scalp monitoring at the time, and it reassured Miss E this was appropriate to ensure the safety of her baby.
27. The Trust’s own policy ‘Intrapartum Care Guideline for all birth settings’ (14 May 2021) says clinicians should ask permission before all procedures and observations.
28. The RCOG guidance on ‘Obtaining Valid Consent’ (January 2015) is also relevant here. Section 4.1 of this guidance says:
‘When consent has to be obtained from a woman during painful labour, such as to perform a vaginal examination, episiotomy, operative delivery or to site an epidural, information should be given between contractions. If appropriate, upon admission in labour or for induction of labour, consideration should be given to the provision of summarised information concerning possible procedures and interventions. Women should be encouraged to express their views on such procedures so that their carers are aware of the choices made by the women and act accordingly.’
29. Our adviser said staff should document the reason for needing to use an FSE, they have discussed this with the patient, and sought consent for its use. They told us if Miss E rolled over and put her leg into the stirrup then this may imply she was consenting to the monitoring.
30. Miss E’s medical records show a registrar applied an FSE at 6.15pm, after being called to the room due to concerns with the CTG results. They also note a midwife assisted Miss E into the left lateral position around this time.
31. There is nothing within the records to show staff discussed the need for foetal scalp monitoring with Miss E or took her consent.
32. We consider the Trust should have got Miss E’s consent to go ahead with the foetal scalp monitoring, and it should have explained to Miss E what this involved and why it wanted to do this.
33. Our considerations about what happened are difficult here, as we were not present during Miss E’s labour. Having considered the evidence we have seen, we cannot be assured the Trust followed either its own Intrapartum Care Guideline for all birth settings policy or the above RCOG relating to consent. We consider this is a failing.
34. We have considered what our adviser said about the midwife assisting Miss E into the left lateral position potentially implying her consent. As Miss E explains she showed her lack of consent by crying and shaking her head, we cannot be satisfied this implied Miss E’s consent on this occasion.
35. We have considered the impact the failing had on Miss E later in this report.
Additional foetal blood samples
36. Miss E complains she did not consent to further attempts to obtain foetal blood samples, after a first attempt.
37. She says she consented to the first sample, and they did it three times. After that, she says she begged staff to get off her, and they turned her on to her side as she was crying and begging. She says her notes say two attempts but it was three.
38. She explains she did not want the samples as she was in a lot of pain and did not want them messing around ‘down there’. She says she just wanted them to leave her alone.
39. In the Trust’s response, it said the registrar involved advised he sought consent from Miss E for the procedure to take place and explained what was happening. He said if she had asked him to stop the procedure at any time, he would have done so.
40. The above RCOG guidance on ‘Obtaining Valid Consent’ is relevant here.
41. NICE clinical guideline 190: ‘Intrapartum care for healthy women and babies’ (3 December 2014) also applies here. This says when considering foetal blood sampling, the clinician should take into account the woman's preferences and the whole clinical picture.’
42. Our adviser said a doctor would usually explain the reason for taking foetal blood samples, explain what will happen, and gain verbal consent from the patient. They would then usually write a brief reason for the foetal blood samples, and document they had explained this to the patient and taken consent for this to happen.
43. They said they would expect there to be documentation to support the need for further samples given the processing issues the Trust had. They also said they would not expect separate consent for each sample, but once staff processed them and realised they needed to repeat the procedure it would be common to reconfirm consent.
44. The records show staff took foetal blood samples, and due to issues processing the samples, they took further samples. The registrar involved provided a statement as part of the complaint investigation, which supports this.
45. This statement also says the first samples were rejected and this led to them needing repeat samples. He said he apologised for this and again asked for consent to carry out the further samples.
46. There is no documentation to show staff explained the need to complete any of the foetal blood samples, or to show they took explicit consent from Miss E.
47. We have two differing accounts about what happened from Miss E and the registrar. The available evidence we have supports Miss E’s account as there is no record she consented to the further foetal blood samples. We are not assured the Trust followed either its own Intrapartum Care Guideline for all birth settings policy or the above RCOG guidance relating to consent. We are also not satisfied the Trust considered Miss E’s preference in line with NICE clinical guideline 190. We consider this is a failing.
48. We have considered the impact the failing we have found had on Miss E later in this report.
Episiotomy
49. Miss E complains she did not consent to an unnecessary episiotomy. She says staff put her in position in stirrups whilst she was pushing, and she remembers being fine up to that point. She tells us the doctor said he was going to cut her to make it easier so she shouted ‘no’ at him. She says he continued anyway, and she was screaming in pain.
50. She explains she did not consent because she did not think an episiotomy was necessary as she was pushing, and the baby was coming out fine.
51. In the complaint response, the Trust explained in the later stages of labour the CTG monitoring deteriorated. As the reading was pathological, immediate intervention was required to ensure Miss E’s baby was delivered safely and quickly. The Trust said it reviewed the care and the episiotomy was appropriate. It explained an episiotomy is only performed in emergency situations, such as Miss E’s, and without intervention to help deliver the baby, there was a risk of hypoxia. Hypoxia is when the foetus does not have enough oxygen.
52. The registrar’s statement for the complaint investigation said the baby’s head was visible, and they recall explaining to Miss E the seriousness of the situation and the best course of action would be to perform an episiotomy.
53. They said they told Miss E why an episiotomy would be required, as well as risks and benefits of having the episiotomy and they believed Miss E provided verbal consent to continue with the episiotomy.
54. We will first consider whether the episiotomy was appropriate.
55. The records show following five foetal blood samples, the result was 7.21. This was a borderline pH result according to NICE clinical guideline 190: ‘Intrapartum care for healthy women and babies’ (3 December 2014). This guideline also says:
‘Perform an episiotomy if there is a clinical need, such as instrumental birth or suspected foetal compromise.’
56. Miss E’s CTG result was suspicious. A CTG result can be categorised as normal, suspicious or pathological depending on the findings.
57. Our adviser reviewed these results, and said they show there was no acute compromise of the baby, which means the baby was not severely distressed. Foetal distress is a sign the baby is not well. It happens when the baby is not receiving enough oxygen through the placenta.
58. Following the foetal blood samples, the records show a registrar completed a vaginal examination, which confirmed Miss E was fully dilated, and she had commenced active pushing and was advancing well. Following this, the registrar performed an episiotomy.
59. We cannot say from the records whether the delivery of Miss E’s baby was imminent or not.
60. However, our adviser explained it was not wrong to suggest an episiotomy in the circumstances as there were risk factors involved, as the CTG result was suspicious and the foetal blood sample results showed a low borderline pH result. This means there are high amounts of acid levels in an unborn baby's blood. The Trust also tested Miss E’s placenta after the birth, and these results show they found meconium staining during these tests. This means the baby had passed its first stool before they were born, and it can be a sign the baby is distressed.
61. Having weighed up the available evidence, we are unable to say the episiotomy was unnecessary.
62. That said, an episiotomy should only go ahead if the mother consents to the procedure. We will next consider whether Miss E consented to the episiotomy.
63. The Trust’s own policy ‘Intrapartum Care Guideline for all birth settings’ (14 May 2021) applies here. This says clinicians should ask permission before all procedures and observations.
64. NICE clinical guideline 190: ‘Intrapartum care for healthy women and babies’ (3 December 2014) also says: ‘Talk with the woman and her birth companion(s) about why the birth needs to be expedited and what the options are.’
65. There is a form within the Trust’s birth notes with a tick box to indicate whether an episiotomy took place, and a box to write the reason for an episiotomy. Our adviser said this should be completed with the details of the episiotomy, such as explaining the CTG concerns and foetal blood sample results meant they needed to deliver the baby more rapidly. They said a doctor would then document they had discussed this with the mother, noting they have obtained consent to perform the episiotomy and explained the reason for the delivery.
66. Staff did not complete any of this information on the form other than completing the signature section. Further, the episiotomy notes are very brief. The midwife documents a registrar performed an episiotomy at 7pm, and they checked and repaired this at 7.15pm.
67. The registrar then wrote notes retrospectively at 8.25pm, which reflect the midwife’s earlier notes.
68. Miss E’s birth plan also stated she would like to avoid an episiotomy unless absolutely medically necessary, and her preference was natural tearing.
69. Our adviser said circumstances change, and if the clinician gains consent and explains the reason for the procedure, then it is appropriate to deviate from the patient’s birth plan.
70. There are no notes documenting whether the doctor gained Miss E’s consent, or to show they explained the reason they considered an episiotomy was appropriate.
71. We have two different accounts from Miss E and the registrar, and no evidence in the records showing what happened. In this case, we must weigh up what is most likely to have happened. Based on the evidence we have, we are not satisfied the Trust followed the consent process in its own Intrapartum Care Guideline for all birth settings policy, or NICE guidance on discussing this with Miss E. We consider this is a failing.
72. We have considered the impact the failing had on Miss E below.
The impact
73. Miss E has provided us with a detailed description of the emotional impact the failings had on her. She says what happened has caused her PTSD symptoms, anxiety and depression. She has intrusive thoughts, and she disassociates regularly. Discussing her labour or birth causes her extreme distress and emotion. She gets flashbacks, has difficulty sleeping and has constant nightmares. This has also affected her intimacy with her partner, due to the emotional impact this has had on her.
74. We are sorry to learn this was Miss E’s experience, and what she has been through.
75. We recognise the failings we have identified have had an emotional impact on Miss E and have impacted her in the way she has described. We recognise how difficult Miss E’s experience of labour was, and the lasting impact this has had on her.
76. We also reviewed Miss E’s GP records, which support what she has told us. Her GP has recorded she reported feeling traumatised by the birth due to her not consenting to procedures around a month after her son was born, and she was not sleeping because of this.
77. We can also see Miss E’s GP referred her urgently to the perinatal community mental health team for support with how she was feeling.
78. Miss E says she now has a fear of and lack of trust in medical professionals, which has impacted her seeking healthcare.
79. We acknowledge Miss E not consenting to procedures of such an intimate nature has made her fear and lack trust in medical professionals. We acknowledge this has affected her seeking healthcare.
80. Miss E also tells us she experiences ongoing pain from the episiotomy. We have considered the difference it would have made to Miss E’s outcome if staff had gained her consent.
81. There is relevant clinical research available to help us understand the impact on Miss E. ‘The Birth Memories and Recall Questionnaire (BirthMARQ): development and evaluation’ research shows there is a link between poor birth experiences and women reporting more pain.
82. As above, we have recognised Miss E’s experience of birth was poor, as we have found the Trust did not act in line with guidance by explaining the need to do foetal scalp monitoring, additional foetal blood samples due to issues with processing the samples, and an episiotomy. We have found no evidence to show Miss E consented to these procedures. The above research supports there being a link between this poor experience and the pain Miss E has described.
83. The NHS website has information about ‘Episiotomy and perineal tears’. This says it is common to feel some pain after an episiotomy. It also says it is ‘unusual for pain after an episiotomy to last longer than 2 to 3 weeks. If the pain lasts longer than this, speak to a doctor, health visitor, or another health professional’.
84. Our adviser said ongoing pain is a potential risk of an episiotomy and a small number of women will have ongoing problems.
85. Having weighed this up, we have decided on the balance of probabilities, Miss E has ongoing pain which she would have not experienced if the Trust had taken account of her choices, as the episiotomy would not have gone ahead.
86. Miss E also tells us the episiotomy caused damage which she needs further surgery to repair.
87. We have not seen any evidence within Miss E’s hospital records about Miss E needing further surgery to repair damage from her episiotomy.
88. Our adviser said Miss E would need to get an examination and an opinion from a medical professional about whether the episiotomy caused damaged which has resulted in ongoing pain and requires further surgery.
89. Based on the evidence we have available, we are unable to say Miss E needs further surgery because of what happened.
90. To summarise, we have decided we can link some of the impact Miss E describes to the failings we have found.
91. We have thought about what the Trust has done already to put things right. The Trust has made efforts to put things right by documenting learning points in its complaint file after investigating the complaint. It has documented the following learning points:
• To ensure the interventions are discussed with women and revisited during the debrief so they can understand what has happened and why • Ensure women are informed of the interventions and the options available • Need to discuss the indications for interventions for the baby and record consent for the intervention, including the discussion in the notes • Any interventions with women must be discussed with women and record in the documentation, and gain consent.
92. It has taken steps to put this learning in place by producing a newsletter, a safety brief, and discussing this with the doctors and midwives. We asked the Trust to provide evidence of this and it sent us a safety brief dated 20 February 2023, and a newsletter from January 2023. The safety brief says:
‘Please ensure consent is sought prior to any procedure and is documented within the notes.’
93. The newsletter says ‘an examination of any kind must be supported with justification for it and this needs to be documented on the maternity record’.
94. Whilst it is evident the Trust has learnt from Miss E’s complaint as it has reminded staff about what they should document and the need to gain consent prior to any procedure, we are not satisfied it has done enough to prevent the failings we have identified happening again. We are not assured it has done enough to put things right. This is because it has not acknowledged the failings we have found to Miss E, and it has not apologised for these or the injustice to Miss E.
95. Overall, we uphold this complaint.