Manchester University NHS Foundation Trust

5. Mrs P is complaining about aspects of her care management from Manchester University NHS Foundation Trust (the Trust) during the delivery of her child on 25 March 2023. She says the Trust:

• failed to spot the placenta was not intact • did not remove all parts of the placenta from the uterine wall • did not do a scan after the surgery to check all the placenta had been removed • failed to prescribe medication on discharge • failed to catheterise Mrs P following the manual placental removal procedure.

6. Mrs P says this resulted in the need for two surgeries. As she did not have the anti-coagulant, she was four times more likely to have gotten a clot. This caused bleeding, breast feeding issues, low mood and stress whilst dealing with a new baby. She says the Trust sent her to another hospital for treatment resulting in travel expenses. Mrs P has pre-existing issues that impact her ability to get pregnant, she is concerned the retained placenta and subsequent procedure have made future children impossible.

7. Mrs P seeks compensation and reimbursement of expenses.

8. What follows is a summary of events. We do not include all details as both the complainant and Trust are aware of these.

9. On 25 March 2023, Mrs P gave birth to her son at the Trust. After Mrs P delivered the placenta, she started to lose blood vaginally.

10. The Trust performed two manual procedures to remove pieces of placenta from the uterine wall.

11. The Trust then discharged Mrs P on 25 March 2023

12. Over the next three months Mrs P’s bleeding continued so the Trust carried out a further examination under anaesthetic.

13. Doctors discovered she still had a four-centimetre piece of placenta attached to the wall of her uterus and Mrs P needed two further procedures, under anaesthetic, to remove it.

18. We follow an open process of reaching an independent and impartial decision in the work that we do. We are unbiased in reaching that view and to do so, when we look at a complaint, we first use relevant standards and guidance to inform us what should happen.

19. We then look at all accounts of events to establish what did happen. We do this by taking the complainants’ account and the organisation account into consideration.

20. Following this, we then look if the care and treatment fell below the relevant standard to be considered a failing. To determine whether an error amounts to maladministration or service failure we need to make a judgement about how serious it was.

21. As not every error will be maladministration or service failure, it is very important that we make clear when something has fallen below the standard and when something has fallen so far below the standard to be maladministration or service failure. In order to differentiate between the two, we may refer to errors which fall below the standard as ‘mistakes’, ‘shortcomings’, or referring to ‘what went wrong’. For those which fall so far below the standard, we use the terms maladministration and service failure, along with ‘failings’ and ‘fault’.

22. When we identify a failing, we next go onto consider the claimed injustice experienced and if we can link this to the failing and the impact stated. We must be able to say the injustice and impact ‘flows’ from the maladministration. Where we identify an injustice and impact that we can link, we next consider what the organisation has done to put matters right. We often refer to this as the ‘remedy’. We use our Principles for Remedy to help determine our approach to securing remedy.

23. We do have regard to the outcome the complainant is seeking when determining the remedy. However, it is for the Ombudsman to decide on a remedy that is appropriate and proportionate to the injustice sustained and if we think more could be done by the organisation, we may make a range of recommendations.

Failed to spot the placenta was not intact

24. Mrs P complains that the Trust failed to notice that her placenta was not intact during a placental examination immediately after birth. She told us once she had delivered her placenta a midwife then placed it in a bowl and left suddenly to assist with an emergency in another room.

25. Once this emergency was over, Mrs P explains a midwife took the placenta away and disposed of it. Mrs P told us she does not believe the midwife carried out an examination of the placenta. We recognise Mrs P’s clear recollection of the events in question, specifically that her placenta was still in the room around an hour and a half after the placenta delivery was recorded. We also recognise that she has no memory of the placenta being taken out of the room for an examination at a point before it was taken away and disposed of.

26. As the placenta was not complete, Mrs P experienced bleeding, infection and complications with her milk production. She told us how difficult it was to experience these symptoms, particularly at a time that should have been happy. We are sorry that it caused her distress and impacted on activities that would have otherwise been routine following birth.

27. In the response of 30 October 2023, and comments provided, the Trust explained the midwife documented that Mrs P’s placenta appeared complete following an examination which took place. It also explained that examinations can be limited in their accuracy and that the completeness of the placenta or membrane is not always obvious during examination. Section 2.4.8 of the Trust’s ‘retained placenta’ guidelines also explain that even if the placenta looks complete there is always the risk factor of additional lobe and fragments of tissue remaining.

28. A retained placenta occurs when some of the placenta does not spontaneously deliver within a designated period. Factually, we note that a retained placenta occurs in around one to three percent of deliveries according to a study published in the International Journal of Women’s Health, 2019 (Retained placenta after vaginal delivery: risk factors and management - PMC).

29. From our gynaecology and midwifery advice, we understand there are limitations to accuracy of placental examinations and that the process does involve a margin for error. Our gynaecology adviser explained it is well known that a visual examination of the placenta does not rule out retained pieces.

30. As there are accepted limitations to a visual placental examination, we do not consider that missing an incomplete placenta represents a failing in and of itself, that this is a risk of examination. Rather, our consideration is of whether the Trust acted in line with guidance when examining the placenta for completeness as an action occurring postpartum.

31. Our midwifery adviser referred specifically to NICE CG190 on intrapartum care as the relevant guidance for this. This was in place at the time of the events in question but has been replaced by NICE NG235 in September 2023.

32. Section 1.16.1 of NICE CG190 explains clinicians should examine the placenta and membranes. This is to assess their condition, structure, cord vessels and completeness. The Trust’s ‘Care in Labour’ policy also outlines this requirement.

33. We have reviewed the available evidence relating to this issue. This includes Mrs P’s detailed recollection of her birth. As outlined above, she specifically told us that a midwife placed her placenta in a bowl and left it whilst then having to deal with an emergency elsewhere on the unit.

34. She told us she remembers the bowl containing her placenta still being on the ward at around 9.50am, approximately one and a half hours after the Trust record her delivering her placenta. She says she did not see the midwife take her placenta into a separate room to examine it or examine it in the delivery room.

35. We have also reviewed the relevant medical records taken at the time of events which form a contemporaneous legal and medical account of activities occurring during and after birth. The records document that the Trust carried out an assessment of the placenta at 8.21 on 25 March. The record of the assessment includes completed mandatory fields regarding observation of placenta, membrane and cord condition as well as the number of cord vessels. We understand these are all details that would usually be documented.

36. The records do not document any information regarding the presence of an offensive odour or the specific presence of the amnion and chorion as part of the placental membrane (which are also checks performed). From our advice we understand it is important for midwives to have the facility to document information on these concerns, usually through a free-text option.

37. In response, the Trust demonstrated to us that its system allowed for clinicians to add any additional findings in a free text comment box. It explained the clinicians involved in Mrs P’s care had not done so because there were no significant findings to document, and no additional comments were therefore required. Taking our advice, and the specifics of the Trust’s system into account, we consider this is a reasonable approach to adopt.

38. In a situation such as this, where we have evidence indicating that something did and did not happen, our approach is to make a balance of probabilities judgement. This allows us to say that something is more likely than not to have happened. To do this we place emphasis or weight onto one piece of evidence that shows likely ‘on a balance’ there is a situation where something is more likely than not to have occurred.

39. Medical records and clinical notes are legal documents, and the Nursing and Midwifery Council’s code explains clinicians should ‘keep clear and accurate records’, as outlined above, the notes do document an examination taking place.

40. On the other hand, we have considered Mrs P’s detailed recollection as well as the fact that the placenta was documented as complete despite not being so. We accept it should generally be possible to confirm completeness through an examination. However, it is also feasible that an examination could be carried out sufficiently and still not spot that a placenta was incomplete due to the limitations we have already explained.

41. We also acknowledge the argument Mrs P made in response to our provisional views regarding the placenta being recorded as complete too soon after delivery for a full examination to have been carried out. She told us the placenta was recorded as complete at 8.21am, which she says is six minutes after the recorded delivery.

42. We have reviewed the records and sought further evidence from the Trust’s IT team to help with this query. The records do specify a time of 8.21am on the placental form. However, this is recorded as the time of delivery and would fit with the timeline of an injection being given at 8.15am to speed up the delivery of the placenta.

43. Having sought input from the Trust’s IT team, we understand modifications were made to the placental form at 8.26am and 8.38am. Although the Trust have recorded that the placenta was delivered at 8.21am, it did not document it as being complete until later on. We cannot determine exactly when the entry was given stating that the placenta was complete was made. However, we understand an entry made in records at 8.38am would give sufficient time for a thorough examination to have taken place.

44. Mrs P also told us she remembered her placenta still being in the room at around 9.50am, approximately one and a half hours after the time it was delivered. We understand her concern though in consideration of the detail are not able to say with any robustness this recollection demonstrates a failure to examine.

45. In considering a complaint, we are reliant on the available material evidence. In this case, the medical records which have a recorded entry that an examination did take place. We acknowledge Mrs P’s recollection which opposes this However, we do not consider this outweighs the material evidence.

46. We are therefore satisfied that it is likely a placental examination of the placenta did take place, in line with the guidance identified above. As we have explained, a retained placenta is an accepted risk of the birthing process. There are also limitations to a visual placental examination, which mean it is not always possible to identify when a placenta is incomplete. Failing to spot this does not represent a failure to act in line with guidance.

47. Our consideration has instead focussed on whether or not the Trust acted in line with guidance in carrying out a placental examination, as an attempt to determine whether the placenta is intact. In this regard, we are satisfied it is more likely than not that the Trust carried out a placental examination in line with guidance.

48. We therefore do not consider the Trust failed to act in line with guidance and based on the evidence we have seen, do not uphold this aspect of the complaint.

Did not remove all parts of the placenta from the uterine wall

49. Mrs P complains that the Trust failed to remove all retained pieces of placenta at an early stage. She told us that on 25 March 2023, she had pieces of retained placenta tissue removed. First by the midwife, and then by a doctor, after she started bleeding vaginally. The doctor then took Mrs P into theatre to remove more tissue.

50. Mrs P underwent two further operations, at four and 15 weeks following the birth, to remove more retained placenta. In total the Trust removed five pieces of placenta.

51. We appreciate these procedures have caused Mrs P distress and worry. She told us they have made her anxious about having any further procedures under anaesthetic, and it makes her worried about her future health.

52. The Trust confirm, on 25 March 2023, a midwife and doctor initially removed some placental tissue in the department. The doctor then removed more under anaesthetic in theatre. During this procedure the doctor found a small lobe of placental tissue attached to Mrs P’s uterine wall. The doctor removed this and was unable to find any more during a full examination of Mrs P’s uterus.

53. In its response letter the Trust apologised the doctor did not identify any remaining tissue. It says a clinician is limited during an examination under anaesthetic (EUA) to what can be physically felt.

54. We sought input from our gynaecologist adviser to help inform our decision on this component. Our adviser referred to the Royal College of Obstetricians and Gynaecologists (RCOG) Green-top Guideline No.52 guidance on the Prevention and Management of Postpartum Haemorrhage. This guidance explains that retained placental tissue can lead to bleeding or infection so the threshold for checking for and removing this should be low.

55. They also reviewed the Trust’s ‘manual removal of placenta policy’ which details the considerations and practicalities for carrying out a procedure to remove retained parts of the placenta.

56. From advice sought we understand the decision to conduct an EUA was appropriate given the circumstances and that it appeared the procedure complied with the Trust’s policy. They also accepted it can be difficult to feel small pieces of tissue when they are stuck to the uterus wall, especially soon after birth when the cavity is still quite large.

57. We also understand there are two further relevant considerations. One is that the size of retained pieces of placenta may change over time due to infection or other processes, meaning the pieces may have been small at the time of the initial inspection. The other is that the retained pieces appeared to be ‘abnormally adherent’ to the wall of the uterus, which would make them more difficult to spot.

58. We acknowledge that the Trust’s response notes a situation such as this, where several pieces of tissue were missed, is ‘unusual’. However, from our advice we understand it would be possible for areas of tissue to be overlooked or even missed, even when exploring the cavity immediately after birth, particularly if these were abnormally adherent.

59. Taking the limitations of the examination, the specifics of the retained placental pieces, and the inherent accepted risk that these can be missed into account, we do not consider the Trust should have identified additional pieces of retained placental tissue. We therefore do not uphold this part of the complaint.

Did not carry out an ultrasound scan after surgery

60. Mrs P complains the Trust discharged her without doing a scan to check for more tissue. She told us that if the Trust had carried out an ultrasound scan it may have identified the remaining placental fragments. It would have therefore been able to remove these sooner and allowed her to avoid complications and further operations to remove them.

61. In its response letter the Trust explained it is not usual clinical practice to offer a follow-up scan after an EUA. It says this is in line with the Trust’s ‘retained placenta’ guidelines as there were no indications Mrs P would need any further intervention.

62. We sought input from our gynaecologist adviser to help inform our decision on this component. Our adviser said there is no specific guidance on carrying out an ultrasound scan to check for pieces of retained placenta, this thus would be clinical judgement.

63. From our advice, we understand it is not usual practice to offer an ultrasound scan after an EUA as the uterine cavity would already have been explored. We also understand an ultrasound scan may not always be reliable for identifying retained placenta tissue as a blood clot often has the same appearance as retained fragments.

64. We have also reviewed the relevant medical records relating to this part of the complaint. We have seen no evidence demonstrating the Trust considered carrying out a scan. From our advice, we also understand this was reasonable as the EUA had already been carried out and there were no indications to carry out an ultrasound scan.

65. Having sought advice we have not identified any guidance which sets out a requirement on the Trust to carry out an ultrasound scan in a situation such as this. We have also seen nothing in the records to indicate one should have been offered. This is particularly because the Trust was working on the premise that there were no pieces of retained placenta present at this point, and we have explained in other sections why we do not consider it a failing to have missed these as this is a risk identified in guidance and procedure. We therefore do not consider it a failing to have relied on the EUA and not carried out an ultrasound scan.

66. Mrs P has told us of the distress this incident has caused her and her family. We are sorry to hear how it severely disrupted the first months with her newborn baby. We hope this information gives Mrs P assurance that her care management on these points were appropriate.

Prescribing appropriate medication on discharge

67. Mrs P complains that the practice failed to prescribe appropriate medication for her on discharge from her admission. Specifically, she complains the Trust didn’t prescribe Fragmin (an anti-coagulant) despite one clinician telling her she needed it. She told us she felt this had put her at increased risk.

68. In the response of 30 October 2023, the Trust acknowledged that it should have prescribed Fragmin to Mrs P for 10 days. This would have been in line with its internal guidance on ‘Venous Thromboembolism Prophylaxis in pregnancy and the Puerperium’.

69. The Trust accepted it had not prescribed this medication and outlined some service improvements for the clinician involved to learn from the events of the complaint.

70. From our advice, we understand the Royal College of Obstetricians and Gynaecologists’ Green-top guideline 37a is relevant to this part of the complaint. This relates to reducing the risk of venous Thromboembolism (blood clots) during pregnancy and the puerperium. Appendix I of this guidance explains low weight heparin (Fragmin) should be administered when any surgical procedure is conducted after delivery, as occurred in this case.

71. As the Trust have accepted this failing, and we consider we are in agreement following advice, we have focussed our consideration on the impact of this on Mrs P. This is a more proportionate and customer-focussed approach.

72. We have reviewed the relevant records from the period in question and also sought input on the impact of this from our gynaecologist adviser.

73. From our advice, and the Trust response, we understand Fragmin is prescribed as an anti-coagulant to reduce the risk of venous thromboembolism (blood clots forming). If this occurs it can lead to complications such as deep-vein thrombosis or pulmonary embolism.

74. From the records and advice sought we have seen no indication that Mrs P experienced a blood clot or any of the associated complications in the months after giving birth. Our adviser also noted that the Trust should have prescribed Fragmin but did not identify that any of the associated impacts of not prescribing this had occurred.

75. Mrs P also told us it was the case that none of the potential complications resulting from not prescribing Fragmin occurred. We acknowledge that not prescribing this medication placed Mrs P at increased risk, and that this would have been worrying for her. However, our approach is to consider whether the failing led to an adverse impact on the complainant that we can link as an impact and injustice flowing.

76. In this case, it is clear the potential adverse impact Mrs P was placed at risk of did not occur. We therefore consider there is no injustice we can identify which flows from the failing of not prescribing an anti-coagulant medication to her on discharge.

77. Our guidance is clear that where we find maladministration or service failure but do not consider an injustice flows from it, our decision should be to partly uphold the case. In Mrs P’s case, as the potential adverse impact has not occurred, we cannot link the claimed impact to the failing we have found. We therefore partly uphold this part of the complaint.

78. As outlined above, the Trust has already apologised and outlined service improvements relating directly to this failing. After seeking clinical input on these, we consider the improvements outlined are reasonable and appropriate. We therefore do not consider it is necessary to make recommendations for the Trust to take further actions in this area.

Failure to catheterise Mrs P

79. Mrs P complains that the Trust failed to catheterise her following her manual placenta removal procedure. She complains that this put her at increased risk of bleeding and urinary retention.

80. In the response of 30 October 2023, the Trust explained there is no guidance stating that a catheter must be inserted for the procedure but that it is common practice for this to be performed. It apologised that this was not done and explained it had carried out a reflective discussion with the clinician involved.

81. We sought input from our gynaecology adviser to help inform our decision on this part of the complaint and the impact. Having done so, we understand, as the Trust stated, there is no specific guidance on catheterisation following a manual placental removal. However, our adviser also stated that it would be usual practice to insert one.

82. Given that the Trust has accepted this, and apologised for not catheterising Mrs P, we have focussed our consideration of this part of the complaint on the potential impact of not doing so, and whether we can link this to the failure to catheterise Mrs P.

83. Our adviser has reviewed the relevant records from the time after the manual placental removal operation and sought advice regarding the potential impact. Having sought advice, we understand not inserting a catheter would increase the risk of further bleeding and urinary retention (inability to empty the bladder).

84. We have seen nothing in the records which demonstrates Mrs P experienced either urinary retention or further bleeding following this procedure. Our adviser also noted that a catheter was inserted at a later stage on the ward and that there was no indication either of the two potential complications above occurred as a consequence of the Trust not inserting a catheter.

85. As we have outlined in the previous complaint component, our approach is to consider whether any failing led to an adverse impact on the complainant that we are able to link. In this case we accept that not catheterising Mrs P would have placed her at increased risk of complications. However, we have seen no indication that these complications occurred and from our advice, understand the clinical impact it placed her at risk of did not occur.

86. Given the above, we consider we are unable to link the Trust’s failure to catheterise Mrs P to a physiological impact on her. As we have outlined in the previous complaint component, this means we are partly upholding her complaint.

87. As we have referred to above, the Trust apologised for this failing in the response of 30 October 2023. It also outlined service improvements which we consider are appropriate, having sought clinical input. We therefore do not consider it is necessary or appropriate for us to recommend the Trust take further action to address these concerns.

88. We thank Mrs P for bringing her complaint to our attention. We recognise she experienced both a physical impact and distress following the events concerned in the complaint and are not intending to diminish this in making our decision. We recognise she will be disappointed with the decision not to fully uphold the complaint but hope the investigation we have conducted provides some reassurance that her complaint has been looked at objectively.

1. We have carefully considered Mrs P’s complaint about the care Manchester University NHS Foundation Trust (the Trust) gave her from 25 March to 13 June 2023. We were sorry to hear about the painful symptoms she explains following her birth, as well as the emotional impact the experience had on her.

2. After reviewing the available evidence, we consider the Trust acted in line with guidance when making efforts to identify the placenta was not intact and removing the retained pieces at an early stage. We also consider the Trust acted in line with guidance when making the decision not to carry out an ultrasound scan.

3. We do not consider we can link the Trust’s failure to prescribe anti-coagulant medication, or failure to catheterise Mrs P after her manual placental removal procedure to a physiological impact on Mrs P.

4. We therefore partly uphold her complaint on the basis that we have identified failings but cannot link these to the claimed impact. We recognise this will come as a disappointment to Mrs P but hope she is reassured we have considered her complaint objectively and thoroughly.