27. Before we address the complaints in turn, we would first like to explain what was seen on the scan. We recognise this will be highly distressing for Mr and Mrs B to read and we are very sorry for any upset unintentionally caused. It is very important we explain what was seen, as this will help to better explain what happened, and our views about what happened.
28. Mr and Mrs B attended on 3 October for their very first scan, 12 weeks and 3 days into their pregnancy. The scan very sadly showed major anatomical (structural, bodily) abnormalities with the developing baby. We have reviewed the records carefully, and our adviser confirms the abnormalities seen on the scan were to such an extent they carried a very poor prognosis for the pregnancy proceeding.
29. One concerning feature found on the scan was the nuchal translucency. All babies have a small amount of fluid under the skin, which is seen as a black space at the back of the neck on scan. This is called nuchal translucency. This collection of fluid normally measures less than 3.5mm between 11 and 14 weeks of pregnancy.
30. The scan taken on 3 October reported a nuchal translucency of 6.6mm. As explained on the NHS Knowledge Hub, a nuchal translucency of over 6.5mm at this point in pregnancy carries a 65.5% risk of chromosomal anomaly, a 46.2% risk of major foetal anomaly and a 19% chance of pregnancy loss. These are significant percentage rates of risk.
31. Another concerning finding on the scan was the crown-rump length. This is an ultrasound measurement of the developing baby from the top of their head, the crown, to the bottom of their buttocks, the rump. The scan reported a crown-rump length of 49.7mm. As explained within NHS Scotland data, which our adviser confirms applies in England, this was below the fifth centile. This means the scan showed a very small developing baby for this stage in the pregnancy.
32. We sadly found other concerning findings. The scan reported generalised oedema (swelling caused by an excess build-up of fluid in the body’s tissues) from the nuchal translucency down to the abdomen and pelvis. This is suggestive of cystic hygroma and gut herniation through the cord insertion.
33. Cystic hygroma is an abnormal growth that usually appears on a baby’s head or neck, consisting of one or more fluid-filled cysts. Gut herniation is when the bowel grows outside of the abdomen during gestational development. The scan showed the bowel had grown into the base of the umbilical cord.
34. A second scan was taken when Mr and Mrs B returned on 4 October. We are very sorry to say that this reported the same abnormalities as above, along with some facial development abnormalities and findings of a possible heart abnormality.
35. We recognise these are complicated and distressing medical findings. In lay terms, both scans found a considerable number of anatomical abnormalities. These were unequivocal and suggested a significant raised risk of chromosomal abnormalities in the developing baby. With this understanding, we go on to explain our views on the issues raised in this complaint.
Discussion after scans 36. We know how strongly Mr and Mrs B feel that what was said during discussions after these scans was inappropriate. There is no guidance that specifies what should or should not be discussed in the situation Mr and Mrs B and healthcare practitioners involved found themselves in on these occasions. This is because the circumstances vary so widely. There is some guidance on communication in this circumstance that does apply.
37. NICE 126 guidance gives recommendations on support and information giving. It explains people will react to complications or the loss of a pregnancy in different ways. It advises healthcare practitioners to break bad news sensitively, taking their individual circumstance and emotional response into account.
38. GMC guidance also gives recommendations on communication. It says healthcare practitioners must give patients the information they want or need to know in a way they can understand, whilst being considerate in giving them information and support.
39. Our adviser says it is reasonable that the findings seen on any scan are communicated. This means whether they are findings of a typical and healthy development or whether they are findings of abnormalities, this should be discussed. Our adviser says this includes discussing any indications of potential problems not yet diagnosed.
40. Whilst we recognise it would have been such a shock and incredibly distressing to Mr and Mrs B, we consider it appropriate these discussions informed them of the large number of major anatomical abnormalities seen, and of the likelihood of chromosomal abnormalities. We consider it appropriate for them to have been informed due to these findings at such an early stage, this carried a very poor prognosis for the pregnancy proceeding.
41. We were not there to have witnessed what happened during these discussions, to know how this bad news was broken. We must rely on Mr and Mrs B’s recollection and the recorded notes made by Trust staff at the time.
42. Notes of the discussion on 3 October suggest appropriate information was shared with them, of the findings from the scan and the likely risk of chromosomal abnormality. Our adviser says it would have been appropriate had healthcare practitioners advised them the outlook for their pregnancy was poor.
43. Notes of the discussion on 4 October also suggest appropriate information was shared with Mr and Mrs B about the scan findings. We find it appropriate that options for chromosomal testing are documented as having been discussed. The options were explained along with their differences, their accuracy rates and percentage risks.
44. Notes made by the obstetrician on 4 October confirm that they explained the findings were suggestive of major chromosomal or genetic abnormalities. This aligns with the clinical evidence and was appropriate information to share with Mr and Mrs B at that time.
45. Mr and Mrs B say staff repeatedly suggested termination despite them making clear they did not want to discuss this option. They say the midwife said she was ‘99.9% sure’ blood tests would confirm a genetic disorder without knowing the results. The recorded notes do not include reference to termination, or of staff being ‘99.9% sure’ of chromosomal abnormality. We are left with opposing evidence about what was said.
46. We consider any reference to the strong likelihood of a chromosomal disorder at the first discussion would have been appropriate. As we have explained, the considerable number of clear anatomical abnormalities carried a significant raised risk of chromosomal abnormalities.
47. Whilst there was not a known clinical risk of ‘99.9%’, had this figure been vocalised as Mr and Mrs B say it was, we think it was used as a turn of phrase as opposed to a mathematically calculated clinical risk factor. Whilst perhaps an unwise choice of language, we are not critical of the intention behind it, or the suggestion it presented.
48. Even in the absence of any test result confirmation, the clinical evidence indicated a clear suggestion of chromosomal abnormalities which we consider was appropriate knowledge to have shared openly with Mr and Mrs B at that time.
49. We know Mr and Mrs B raise this concern in part because they say later results showed their son did not have the conditions suggested. We do not find this to have been the case, and we take this opportunity to give a more detailed explanation of this matter here.
50. Mr and Mrs B were offered two types of test, non-invasive prenatal testing (NIPT) or chorionic villus sampling and amniocentesis (CVS/amnio). Both tests will only consider the three most common conditions involving chromosomal abnormalities: Down’s syndrome, Edwards’ syndrome and Patau’s syndrome.
51. NIPT involves taking a blood sample from the pregnant person and testing it. This test is completely safe and carries no risk of harm to the person or their baby. It is a screening test, which means it will give a reliable indicator as a result. No screening test is 100% accurate and therefore cannot give a result with 100% certainty.
52. CVS/amnio involves removing and testing a small sample of cells from the placenta. This test is diagnostic, meaning it gives a result with 100% certainty. It does however carry a risk of miscarriage.
53. After the options were explained along with their differences, their accuracy rates and percentage risks, Mr and Mrs B preferred NIPT. The NIPT results later reported a lower chance result for these three main conditions.
54. After delivery, a placental sample was sent for further testing however unfortunately a result could not be achieved. Whether there was any chromosomal abnormality was therefore never confirmed.
55. It remains possible that their son did have one of those three main conditions. We acknowledge NIPT results reported a lower chance, however a lower chance result does not mean no chance at all. We must also remember that NIPT testing screens for the three main conditions only. It is possible he may have had another type of chromosomal abnormality.
56. We acknowledge, of course, it is possible their son had no chromosomal abnormality. However, the scanning suggested such significant anatomical abnormalities at such an early stage in the pregnancy, that these alone – even in the absence of chromosomal abnormality – indicated a poor prognosis for the baby.
57. We do not consider it inappropriate for the strong likelihood of this – significant chromosomal abnormality, or severe anatomical abnormalities likely incompatible with survival – to have been expressed by healthcare practitioners during these discussions.
58. We move on to the concern about discussing termination. We do not consider it would have been appropriate for termination to have been spontaneously raised or advised by staff at the first discussion, at this very early stage before further discussions could take place and as Mr and Mrs B were not expecting any poor outcome from their first scan.
59. Our adviser explains that people vary significantly, whether to good or to bad news, in terms of what they want to know, what they ask, or what they are open to discussing. We see no reason to disbelieve Mr and Mrs B’s recollection. We accept it is entirely possible that termination could have been referenced, had these discussions involved questions or comments about how to proceed if, for instance, further testing suggested an abnormality incompatible with survival.
60. We therefore acknowledge that due to what was appropriately discussed, it is entirely possible termination was referenced. It would not necessarily have been inappropriate, depending upon the context of it being raised. It would not have been appropriate to have been repeatedly pressed, had Mr and Mrs B made clear they did not wish to discuss this option at that time.
61. In response to the complaint, the Trust acknowledged there may have been ‘an overzealous approach’ from staff when giving information around the options available. It said Mr and Mrs B should have been given an opportunity to digest the information they were given before having conversations about available options. The Trust said it will always give all information available to enable patients to make the choices best for them and at times this will mean asking and going over the options more than once.
62. The Trust said the staff involved have since reflected on their approach and adjusted their practice to ensure this does not happen again. It said the intention was to give Mr and Mrs B the best opportunity to have the best care and make the decisions right for them based on all the information presented. It said it was sincerely sorry it did not get this right for Mr and Mrs B at that time.
63. It is clear Mr and Mrs B left both appointments feeling very upset with the way staff spoke with them. This must have been incredibly distressing, during what were already highly upsetting discussions.
64. We do not consider strong reference to the high likelihood of chromosomal conditions was inappropriate, and depending upon the context reference to termination may also have not been inappropriately raised. The recorded evidence suggests to us that NICE 126 guidance and GMC guidance was followed. It remains we will never be able to independently know what exact wording was used, in what manner it was said, or how it was delivered.
65. We are pleased to see the Trust has taken Mr and Mrs B’s complaint seriously. It explained its best intentions during the discussion whilst recognising the delivery of this messaging left them distressed. The Trust acknowledged Mr and Mrs B found the manner of these conversations inappropriate.
66. The Trust has sincerely apologised to Mr and Mrs B, and the staff involved have completed a reflective learning exercise to improve their communication in future. This demonstrates an open, honest and transparent reflection on what happened. This is the action we would expect, to put this right.
67. We are reassured the Trust has acted in line with NHS Complaints Standards and we consider the actions already taken sufficient to resolve this concern.
Antibiotics 68. The Trust took a urine sample from Mrs B on 3 October. These results were reviewed on 5 October and confirmed a positive result for E. coli. Records note Mrs B was asymptomatic and the Trust requested a repeat sample.
69. Mrs B provided this without delay. The second sample results were reviewed on 10 October, again confirming a positive result for E. coli. An entry on 10 October notes Mrs B was now symptomatic and the Trust then emailed her GP Practice to request antibiotics.
70. NICE 109 guidance says an immediate antibiotic prescription should be offered to a pregnant person with a lower UTI. In line with NICE 109 guidance, the Trust should have acted on the reported positive result known on 5 October to have ensured Mrs B could receive antibiotic treatment without delay.
71. Mrs B says her community midwife advised her she needed antibiotics on 4 October. We consider it reasonable the Trust performed a test and waited for the results of this before acting. That said, we think the Trust should have acted once those first positive results were known, on 5 October.
72. In response to the complaint, the Trust said its policy does not recommend starting treatment at that stage, instead advising a second sample is sent for testing to confirm. This does not align with national NICE 109 guidance. Repeating the test simply delayed the decision to treat. Whether Mrs B was asymptomatic or symptomatic, microbiology results were unequivocal that she had a UTI requiring antibiotic treatment.
73. We are not critical of the Trust’s decision to liaise with the GP to provide antibiotic treatment, only in the timing of it doing so. Appropriate action was reasonably via the GP to prescribe however this should have been done on 5 October.
74. We know how concerned Mr and Mrs B are about the impact of this delayed treatment. They consider their son died as a direct result of the Trust leaving Mrs B’s UTI untreated for so long, allowing the E. coli infection to travel upwards in the body. We very much hope to assure Mr and Mrs B that we see no clinical evidence to show this was case.
75. Lower UTI infection can travel upwards, becoming what is termed an upper UTI. As outlined in NICE 109 guidance, a known possible complication of this is that an ascending UTI can cause preterm labour in pregnancy.
76. Mrs B did not have preterm labour. Very sadly, this was an intrauterine death of the developing baby. The scan on 12 October found no foetal heartbeat, and this incredibly tragic outcome was explained by the findings from the scans taken on 3 and 4 October. Our adviser explains the findings of such a small grown baby, with the number of anatomical abnormalities found and high associated risk of chromosomal abnormality very sadly explain why their son did not survive. This was the case, even in the absence of a UTI.
77. Our adviser is not aware of any standard, guidance, or evidence-base providing any suggestion that a complication of lower UTI, whether treated or untreated, can lead to first trimester pregnancy loss. The only clinical impact from the delay in Mrs B receiving antibiotics would have been a possible lengthening of the time and severity of any UTI-related symptoms she experienced. This would have been for a relatively short period, considering she did receive antibiotics, just some days later than was reasonable.
78. Whilst any clinical impact was minor and soon resolved, we consider this has caused Mr and Mrs B a more significant personal impact, leaving them with concerns about whether the impact was greater than we find it to have been. They are also left without the assurance that the Trust will act differently in future, in line with national guidance. For these reasons, we set recommendations.
Notes referring to a coil 79. From the time of the scan on 12 October, Mrs B’s records include the abbreviation IUD. In this context, IUD stands for intrauterine death, a medical term used to describe a pregnancy loss in the way Mr and Mrs B tragically experienced here.
80. The abbreviation IUD is more commonly known in a different context, to stand for intrauterine device, such as a contraceptive coil.
81. Mrs B says when she arrived at the early pregnancy unit on 10 November for a scan due to her heavy bleeding, a healthcare assistant asked why she was there, as their information said she was to have a coil fitted.
82. We understand why Mrs B is concerned that her records were wrong. We can assure her we do not find anything incorrectly documented. We think it most likely the healthcare assistant read the abbreviation in Mrs B’s records and first thought of the more common usage of this referring to a contraceptive coil, rather than intrauterine death.
83. We recognise the confusion and upset this caused Mrs B at the time. We do not underestimate this. We consider the comment an unfortunate result of staff mistaking the context of the abbreviation rather than the result of any service failure.
Retained placenta 84. We cannot imagine how incredibly difficult it was for Mr and Mrs B, to have to experience labour to deliver their son in these devastating circumstances. We recognise that having been advised the placenta had also been delivered, it was the cause of more distress for Mrs B in particular, to have the experience of RPOC on two further occasions.
85. Our adviser explains there is always the chance of RPOC with any management of intrauterine death, whether medical management or surgical management. This is a known possibility and considered a risk of the process. When this occurs, it does not mean or even imply that something has gone wrong with the previous procedures.
86. NICE 126 guidance says the healthcare provider should inform people receiving any management following intrauterine death about what to expect throughout the process and potential side effects.
87. Mr and Mrs B opted for medical management at the initial delivery. Before this proceeded, records show Mrs B was consented. The consent form, which Mrs B signed, lists ‘retained placenta’ under the heading of ‘serious or frequently occurring risks’.
88. On the second occasion when Mrs B attended on 10 November, records note her options were explained. Records included discussion about the risks, and it is documented: ‘She understands there is a 10-20% failure rate with this’, referring to a potential failure to remove all retained products.
89. Records of the third occasion note this attendance was due to a previous failure to remove all retained products. We know Mrs B says the Trust was very reluctant and she had to insist to obtain this further appointment. We are saddened to hear this was her experience. We cannot see any independent evidence to support this resistance, and in any event find the appointment proceeded, at which time Mrs B opted for surgical management. A later follow-up scan confirmed no further retained products.
90. We are assured by the evidence, that NICE 126 guidance was appropriately followed, both in terms of the procedures undertaken and that Mrs B was clearly informed of the potential for RPOC. It remains Mr and Mrs B suffered the emotional and physical distress of this experience, which we in no way underestimate. Our adviser reiterates that no method is free from this potential problem, and we do not find it occurred due to any apparent service failure.