Guidelines

Ectopic pregnancy and miscarriage: summary of NICE guidance

BMJ 2012; 345 doi: http://dx.doi.org/10.1136/bmj.e8136 (Published 12 December 2012)
Cite this as: BMJ 2012;345:e8136

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We are grateful to Bourne et al. for their interest in this guideline. We have addressed their specific points below:

1. Access to care: The guideline development group (GDG) discussed the issue of referral to an early pregnancy assessment service at length. They agreed that women are often uncertain about their dates, and so recommended that any woman with a pregnancy of uncertain gestation should be referred to an early pregnancy assessment service, as should all women with symptoms and/or signs of pregnancy complications with a pregnancy of 6 weeks gestation or more and women with pain (regardless of gestation). They also agreed that in women with a pregnancy of less than 6 weeks gestation an ectopic pregnancy could not be excluded in a single consultation, and so specifically recommended that women with continuing or worsening symptoms should return. However, they were concerned that immediately referring every woman with bleeding and no pain in the first 6 weeks of pregnancy would result in a lot of unnecessary ultrasound scans being performed and that mistakes in diagnosis could be made as a result of scans being done too early in the pregnancy to be informative.
The GDG, which included a general practitioner and consultant nurses as well as lay members and consultants in gynaecology, emergency medicine, and psychiatry, felt that for the majority of women, seeing another healthcare professional before referral to an early pregnancy assessment service was appropriate. They were aware that some services have a high proportion of women self-referring and that this was often due to a desire for reassurance and/or for a scan early in a pregnancy that is progressing normally. While understandable, they felt that this was not an appropriate use of early pregnancy assessment service resources and could lead to the service being overwhelmed. The aim of the recommendations about referral was not to restrict access, but rather to ensure that resources are targeted to maximise the quality of care for women with early pregnancy complications.

2. Pregnancy of unknown location (PUL): The GDG agreed that the majority of women with a pregnancy of unknown location would be receiving care in an early pregnancy assessment service, but the recommendation was worded to incorporate the situation in which a woman had been assessed and scanned in a non-dedicated service (for example a gynaecology ward) due to the dedicated service being unavailable. The use of hCG ratios to triage women was based on evidence from a systematic review which demonstrated that women with a decrease in serum hCG of more than 50% or an increase of more than 63% were at lower risk of ectopic pregnancy; therefore, the developers concluded that the more intense surveillance should be focused on women with serum hCG changes between these thresholds. However, the GDG agreed that promptly locating the pregnancy was important for women with rapidly increasing hCG and therefore recommended that these women should receive a repeat scan. They also emphasised in their recommendations that clinical symptoms should take precedence over biochemical tests, with women being given written information about what to do if they experience any new or worsening symptoms. The GDG felt confident that this combination of approaches would minimise the risk of an ectopic pregnancy being missed.

3. Miscarriage: Health economic analysis is an integral part of the NICE guideline development process, in order to ensure that the limited resources of the health service are allocated most appropriately. Therefore, in addition to data on clinical outcomes on the management of miscarriage, the GDG considered the results of a recent economic evaluation based on a trial conducted in the UK, which clearly demonstrated that expectant management was the most cost-effective option. They agreed that expectant management was not appropriate for all women and therefore, they made specific recommendations about when other treatment options should be offered. However, the use of expectant management has the added benefits of negating the risk of intervening and terminating a viable pregnancy, and avoiding exposing women to the risks associated with surgery and other interventions. Given this, and the general fear of intervention that was reported in the qualitative literature, they felt that for most women, expectant management for a defined period would be an acceptable or even preferable option. However, it should be noted that if further treatment is required, the recommendation is that all options should be discussed and offered.

4. Ectopic pregnancy: Methotrexate is only recommended as a first line management strategy under very specific and clearly-stated circumstances, one of which is that there must be no intrauterine pregnancy as confirmed on an ultrasound scan. The guideline also recommends that all scans “be performed and reviewed by someone with training in, and experience of, diagnosing ectopic pregnancies”, in order to minimise the chance of methotrexate being mistakenly administered to a woman with a viable intrauterine pregnancy. The GDG’s experience was that ultrasound-confirmed ectopic pregnancies would only be managed expectantly in rare circumstances and by experienced clinicians based on an assessment of the woman’s individual clinical situation. It was their view that only a small minority of centres in England and Wales had the capacity to safely manage ectopic pregnancies expectantly, and given the large quantity of other important topics in the area of early pregnancy care it was not considered a priority area for the scope.

5. Training: We agree that training and competencies are very important issues; however, NICE guidelines generally do not provide recommendations on these subjects which are the responsibility of the Royal Colleges and professional organisations. As a result, training did not form part of the scope for this guideline. However, the GDG were aware of the variation in scanning ability that exists among clinicians, and made recommendations to minimise the risk of misdiagnosis, including recommending a second opinion and/or a repeat scan. We fully support the call for more comprehensive training in ultrasound for early pregnancy and the consideration being given to this issue by the RCOG.

6. Extension of cover: The GDG discussed the extension of cover for early pregnancy care to 7 days a week and did not believe it would be associated with a large increase in costs. They did not anticipate it being a 24 hour service and felt it reasonable that multiple units could co-organise their service to provide some level of cover for every day of the week. In many units it is possible that minimal reorganisation could lead to a gynaecologist with experience in scanning being available on a daily basis. The systematic review on the model of service organisation and delivery specifically looked for evidence on staffing, including whether input from doctors was linked to improved outcomes; however, surprisingly, no evidence was available and therefore a research recommendation was made in order to address this paucity of data. We are hopeful that more early pregnancy assessment services will choose to evaluate their model of care and provide data to inform future work.

7. Service provision: The guideline’s recommendations were designed to ensure that women would have access to an early pregnancy assessment service 7 days a week. We do not agree that the recommendations imply that a unit providing a 5 day service would be closed. Rather they indicate that a system should be in place to ensure that women can access another facility when the unit is not open. The GDG felt that this was an important recommendation, because they were aware of how frightening and upsetting it can be for women who are unable to access care at the weekend.

Further details on many of these issues, including a more detailed discussion of the process of moving from evidence to recommendations, can be found in the full version of the guideline which is available from the NICE website (http://guidance.nice.org.uk/CG154/Guidance).

Competing interests: None declared

Dr Roz Ullman, Senior research fellow and clinical lead

Prof. Mary Ann Lumsden, Emma Newbatt, Zosia Beckles, on behalf of the guideline development group

National Collaborating Centre for Women's and Children's Health, King's Court, 2-16 Goodge Street, London, W1T 2QA.

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As Newbatt and colleagues identity, women from minority ethnic groups account for half of maternal deaths from ectopic pregnancy in the UK. Most if not all of these deaths are avoidable. More difficult to quantify is the significant number of women who suffer severe maternal morbidity and emotional distress as a result of ectopic pregnancy and other complications in early pregnancy. Tailoring maternity and primary care systems to address the needs of minority ethnic groups, including women of refugee backgrounds, is critical to saving mothers lives and ‘closing the gap’ in maternal health outcomes.

Two challenges identified by Newbatt and colleagues are women accessing care late, and communication difficulties between families and care providers. We are currently undertaking research with Afghan families (both women and men) of refugee background living in Melbourne, Australia exploring their experiences of having a baby in new country. Afghan men and women consistently identify lack of information in an easily understandable and accessible format as a barrier to help seeking and decision-making. Reasons for late attendance at antenatal care include not being aware of available services, and being unfamiliar with the concept and purpose of pregnancy care. Poor literacy in their own language and limited health literacy have multi-faceted impacts on knowing what to expect in pregnancy, what to expect from care, and when and how to access help. Most Afghan women and men reported accessing health information from family and friends, even if this meant contacting family members that remained overseas.

Very few Afghan women had interpreting support in pregnancy with reliance on husbands as interpreters. Afghan men traditionally play little part in their partner’s pregnancy care. However, in the absence of female relatives to accompany women to appointments, the likelihood that their English is a little better than that of their wives, and often as the providers of transport, men often attended antenatal care appointments. Whilst there were also reports of positive encounters with professional interpreters, women reported a reluctance to trust interpreters who spoke a different dialect to their own, were male, or likely to be known within the community. Confidentiality and the maintenance of dignity are important to all women, but especially important in the context of the refugee experience. What women want is for care providers to show interest in them and their family, including their cultural and religious practices; to be given information in a format that they can understand; and encouragement and opportunity to ask questions.

The NICE guidance on the management of early pregnancy loss is but a first step in tackling health inequalities. Listening and learning from the experiences of marginalised women and their families, those who rarely have a voice in the health system, is the next. Acting to overcome the specific barriers to supporting women through pregnancy care requires a skilled, culturally competent work force together with a health system that has capacity to address the specific support and information needs of culturally and linguistically diverse communities. Unless care is responsive to culture, communication challenges and social complexity, pregnancy outcomes for women from minority ethnic groups will see little improvement.

Dr Jane Yelland
Research Fellow
Healthy Mothers Healthy Families Research Group
Murdoch Childrens Research Institute
Victoria, Australia

Dr Elisha Riggs
Senior Research Officer
Healthy Mothers Healthy Families Research Group
Murdoch Childrens Research Institute
Victoria, Australia

Mr Josef Szwarc
Manager
Research & Policy
Victorian Foundation for Survivors of Torture
Victoria, Australia

Ms Fatema Fouladi
Bicultural Community Researcher
Healthy Mothers Healthy Families Research Group
Murdoch Childrens Research Institute
Victoria, Australia

A/Prof Stephanie Brown
Group Leader & Principal Research Fellow
Healthy Mothers Healthy Families Research Group
Murdoch Childrens Research Institute
Victoria, Australia

Competing interests: None declared

Jane S Yelland, Research Fellow

Elisha Riggs, Josef Szwarc, Fatema Fouladi, Stephanie Brown

Murdoch Childrens Research Institute, Royal Children's Hospital, Flemington Road, Parkville 3052 Victoria, Australia

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18th December 2012

The Editor
British Medical Journal
BMA House
Tavistock Square
London
WC1H 9JP

Dear Sir,

I read with interest the summary of the recently published National Institute for Health and Clinical Excellence (NICE) guidance for the diagnosis and initial management of ectopic pregnancy and miscarriage.

I am pleased to see a focus on the psychological and emotional care of women and couples who have suffered early pregnancy loss, including the training in communicating sensitively and breaking bad news for clinical and non-clinical staff at early pregnancy assessment units and at specialist gynaecological units. However, whilst specialist services receive training in sensitive communication, the generic services that are expected to diagnose initial problems (e.g. GPs and A&E staff) are not explicitly included in this recommendation. Sensitive communication should be ensured across the clinical pathway, and, arguably, especially at the point of diagnosis and in medical emergencies.

Similarly, the recommendations for providing information about what to expect during and after a pregnancy loss is likely to be beneficial for the emotional well-being of women and couples, making the early pregnancy loss more predictable and potentially less traumatic. The recommendation includes providing information of the degree of pain and bleeding. I believe that this should also include written and verbal instructions of what to do with the foetal remains tailored to the clinical presentation.

Providing women and couples with Information of how to access support organisations and counselling is welcomed, however, the extent of this support seems poorly defined and limited in scope. A smaller proportion of women may require specialist psychological care for depression, anxiety disorders or even PTSD after their early pregnancy loss and further consideration and research need to investigate how to best i) identify these women and ii) provide effective psychological treatment to these women. Developing referral links to existing health psychology departments or local Improving Access to Psychological Treatment (IAPT) services would be of importance. Additionally, women should be provided with verbal and written information of what emotional symptoms to be aware of and when to contact specialist psychological services.

The guidelines propose medical management of ectopic pregnancy and expectant management if miscarriage for all women as the first treatment of choice. Whilst this may make financial and often even clinical sense, the psychological impact of these procedures is currently not known. In the lack of any such evidence, informed patient choice of treatment method is likely to be more beneficial in promoting psychological well-being.

Finally, the full guidelines highlight certain groups as being at greater risk or psychological morbidity after early pregnancy loss, including women who are recent immigrants or who do not readily read or speak English. Whilst these groups are most vulnerable to emotional distress, they are also the least likely to benefit from web-based support groups and counselling. Local consultations and needs assessments may help determine how to best provide emotional support for these groups.

Yours faithfully

Dr Maria Jalmbrant
Clinical Psychologist

Competing interests: None declared

Maria Jalmbrant, Clinical Psychologist

South London & Maudsley NHS Foundation Trust, Lewisham ASD & ADHD Service, Ladywell Unit, Lewisham University Hospital, Lewisham High Street, London, SE13 6LH

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Sincere apologies, the second reference in my earlier letter titled “Anti-D immunoglobulin administration often overlooked” [1] should have read “Baker PN, Kenny LC (eds), 2011, Obstetrics by Ten Teachers, 19th edition, Hodder-Arnold, London, page 105.” The previous reference pointed one to an incorrect page.

Reference

[1] Masukume G. Anti-D immunoglobulin administration often overlooked. [http://www.bmj.com/content/345/bmj.e8136/rr/620404] webcite. BMJ, 2012.

Competing interests: None declared

Gwinyai Masukume, Doctor

Mpilo Central Hospital, Bulawayo, Zimbabwe, PO BOX 2096

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Your article, ‘Ectopic Pregnancy and Miscarriage: summary of NICE guidance’, 15th December 2012(1), fails to mention the intrauterine device as a risk or suspect factor in diagnosis of ectopic pregnancy.

Prof. Martin Vessey and colleagues in their cohort study(2), showed how ‘I.U.D.s are far less effective at preventing ectopic pregnancies than they are at preventing intrauterine pregnancies’. In a letter to the BMJ(3) Vessey mentions the increase in risk of ectopic compared with intrauterine pregnancy in women who became pregnant with an intrauterine device in place, as 10.6 fold. They add ‘failure to appreciate this fact could have disastrous consequences under some circumstances’.

Sadly, in my work in developing countries, I have seen such tragedies. One woman was admitted moribund; the diagnosis of ruptured ectopic was quickly made – collapsed, haemoperitoneum, firm closed cervix. Immediate resuscitative measures, I.V. fluids, ventilation, cardiac massage were provided to no avail. We were informed that she had attended the institution where her device had been fitted, on the two days before she came to us, because ‘she was feeling unwell’.

Clinicians who have experience of working in both the Developed and Developing World soon recognise that a woman with an I.U.D. in situ and possible features of haemoperitoneum must be considered to have an ectopic pregnancy till proved otherwise. It is also more common in the Developing World to have an ‘acute’ rather than ‘chronic’ ectopic pregnancy, and autotransfusion is also more commonly practised (and life-saving) in the Developing World.

John Kelly
Retired O. & G., still functioning in Developing World

1. Newbatt E, Beckles Z, Ullman R, Lumsden MA. Ectopic pregnancy and miscarriage: summary of NICE guidance. BMJ 2012;345:e8136.

2. Vessey MP, Doll R, Johnson B, Peto R. Outcome of pregnancy in women using an intrauterine device. Lancet 1974;1:495-498.

3. Vessey MP. Intrauterine devices and ectopic pregnancy. BMJ 2009;339:710.

Competing interests: None declared

John Kelly, Retired Consultant O. & G.

The University of Birmingham, Edgbaston, Birmingham B15 2TT

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There does not seem to be any mention of referral for contraceptive care, either as a short term measure (if the pregnancy was planned and a repeat attempt is wanted) or long term (if another pregnancy is not wanted). This is a missed opportunity, women who have had an ectopic pregnancy constitute a high-risk group who should receive expert contraceptive advice.

Competing interests: None declared

Lesley E Bacon, consultant in SRH

Lewisham healthcare NHS Trust, Lewisham High Street SE13 6LH

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Congratulations to Newbatt and colleagues on their excellent guideline on ectopic pregnancy and miscarriage [1]. I draw attention to the fact that both ectopic pregnancy and miscarriage are potential sensitizing events for Rhesus disease [2]. Rhesus negativity prevalence in the United Kingdom can be about 15% in some significant populations [2]. Use of anti-D immunoglobulin for Rhesus negative women who are not sensitized is an important aspect of management in patients with ectopic pregnancy and miscarriage [3].

Continuing mortality [4] from ectopic pregnancy prompted this guideline [1], however, long term mortality and morbidity for example from lack of administering anti-D immunoglobulin should also be considered.

References

[1] Newbatt E, Beckles Z, Ullman R, Lumsden MA. Ectopic pregnancy and miscarriage: summary of NICE guidance. BMJ, 2012 345:e8136.

[2] Baker PN, Kenny LC (eds), 2011, Obstetrics by Ten Teachers, 19th editon, Hodder-Arnold, London, page 251.

[3] Walker JJ. Ectopic pregnancy. Clin Obstet Gynecol. 2007 50(1):89-99.

[4] Masukume G. Nausea, vomiting, and deaths from ectopic pregnancy. BMJ, 2011 343:d4389

Competing interests: None declared

Gwinyai Masukume, Doctor

Mpilo Central Hospital, Bulawayo, Zimbabwe, PO BOX 2096

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15th December 2012

The Editor
British Medical Journal
BMA House
Tavistock Square
London
WC1H 9JP

Dear Sir,

Re: Ectopic pregnancy and miscarriage: summary of NICE guidance

We read with interest the summary of the recently published National Institute for Health and Clinical Excellence (NICE) guidance for the diagnosis and initial management of ectopic pregnancy and miscarriage (1). We note this is based on systematic reviews and economic analyses carried out by NICE – although unfortunately the methodology is not included in the article.

We welcome the wider use and increased availability of urinary pregnancy tests in primary care and the focus given to considering ectopic pregnancy in women of reproductive age. However we have concerns about several of the recommendations that in our view restrict access to care, limit choice and in some circumstances are unsafe in clinical practice. Specifically we wish to make the following observations:

1.Restriction of access: We do not believe women at risk of ectopic pregnancy should have access to prompt care restricted on the basis of gestational age or the presence or absence of any one symptom. Although the likelihood of an inconclusive scan is gestation dependent, it is not possible to exclude the presence of an EP when symptomatic women present at < 6 weeks gestation (2). Furthermore many women do not have accurate knowledge of their dates (3,4). NICE stipulates that most women with pain and bleeding should see another health care professional before accessing an early pregnancy assessment unit (EPAU). This is illogical and will impede access. Without ultrasonography no useful assessment can be made in such women and this recommendation will only act as a hurdle to appropriate care. It will also be poor use of clinical staff time who will not be in a position to give women useful information, and is likely to lead to duplication of intimate examinations for no good reason.

2.Pregnancy of unknown location (PUL): The guidance suggests women with a PUL with a change in serum hCG levels over 48 hours between -50% and +63% should be referred for assessment in an EPAU. This recommendation is puzzling. For a pregnancy to be classified as a PUL the women must have undergone ultrasonography, which should occur in an EPAU. Perhaps the authors are discussing apportioning risk to PUL based on a serum hCG value 48 hours after initial presentation and ultrasonography. Classifying PUL as high risk using this approach could lead to approximately 20% of ectopic pregnancies being classified as low risk with a consequent failure to refer for further ultrasound. Unfortunately, using this algorithm, the false negative results will often be ectopic pregnancies with relatively high hCG ratios, which arguably may be the most dangerous subgroup. (5).

3.Miscarriage: NICE recommends the preferred management of women with a miscarriage is a conservative “watch and wait” approach with no planned intervention. We agree expectant management for at least one week should be offered to most women, but feel strongly they must be aware of all approaches including medical management and surgery which should be discussed and be available at the time of diagnosis. A woman’s choice of how her pregnancy loss is managed should not be rationed.

4.Treatment of ectopic pregnancy: NICE recommends that with some exceptions the first line approach to the management of an ectopic pregnancy is Methotrexate. This suggestion seems arbitrary. No consideration is given to adopting a “watch and wait” approach with monitoring of serum hCG levels (6). To date the evidence based optimal management strategy for an unruptured ectopic pregnancy has not been determined and such a recommendation may lead to unnecessary use of methotrexate, which has inherent morbidity. A further problem with Methotrexate is the possibility for its administration when the location and viability of a pregnancy has been misdiagnosed. Giving Methotrexate when a pregnancy is intrauterine will result in either miscarriage of a potentially viable pregnancy or probable serious abnormalities in the baby if it survives (7,8). There is a distinct possibility that the recommendations by NICE could result in systemic methotrexate being used in a patient with a normal pregnancy. There are numerous cases in which this exact error has occurred (9). Avoiding this situation is dependent upon the quality of ultrasonography in a unit and appropriate interpretation of serum biochemistry prior to treatment. In the United States, concerns about these errors recently led to a conference held by the Society of Radiologists in Ultrasound (SRU) to reach consensus on how to reduce the likelihood of methotrexate being used inappropriately.

5.Training: We would argue that training in ultrasonography is a major problem. As evidenced by the Health Service Executive enquiry into misdiagnosis of miscarriage (10) and the last triennial report into maternal deaths (11), poor training and clinician’s lack of insight of their ultrasound skills can have lethal consequences. Core training for junior doctors is of a basic level. Trainees are familiar with ultrasound in early pregnancy but are not trained to practice independently. Learning to carry out a safe ultrasound examination takes time and this is currently not provided outside the context of clinical fellowships and some special interest modules. In our view, one of the biggest problems in early pregnancy care lies not with guidance, but with competency and appropriate supervision. The provision of reporting software and digital image archiving to facilitate audit would also transform the performance of many units.

6.Extension of cover: We feel providing seven-day cover for early pregnancy care is going to have significant financial implications. We would argue that the best units have daily hands on input from consultants with a special interest in early pregnancy care. If NICE are serious about this issue it needs to be serious about the level of staffing and training required to deliver such services to a high standard. Arguing for extending cover without explicitly discussing training is ducking the issue.

7.Rationalising units: In large cities rationalizing units to provide high quality cover at weekends makes sense. However the main problem will be out of the main conurbations where such arrangements will not be possible and women will have to travel large distances to access care. Ultimately this may be acceptable, but the concern is that failure to offer weekend cover may lead to closure of units that currently provide a good service to the local community, but can only function 5 days a week. Again this might be reasonable, but needs to be an explicit aim to ensure the process is transparent.

We welcome the interest NICE has taken in early pregnancy care. However we are concerned to see an erosion of choice for women with early pregnancy problems and the recommendation of potentially unsafe practice. We urge NICE to reconsider aspects of this guidance and to remove the restrictions to choice for women that will inevitably result.

Professor Tom Bourne
Consultant Gynaecologist
Queen Charlotte's and Chelsea Hospital
Imperial College, London, W12 0HS, UK
and Department of Development and Regeneration
University Hospitals, KU Leuven. Belgium

Professor Kurt Barnhart
Professor of Obstetrics and Gynecology and Epidemiology
The Perelman School of Medicine at the University of Pennsylvania
Philadelphia PA 19104, USA

Professor Carol B. Benson
Director of Ultrasound and Co-Director of High-Risk Obstetrical Ultrasound, Brigham and Women's Hospital
Professor of Radiology, Harvard Medical School, USA

Professor Jan Brosens
Professor of Obstetrics & Gynaecology
Head, Division of Reproductive Health, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK

Professor Ben Van Calster
Professor in Medical Statistics
Department of Development and Regeneration
KU Leuven, Belgium

Professor George Condous
Associate Professor of Gynaecology
University of Sydney
Director of OMNI Gynaecological Care
Ground Floor 207 Pacific Highway
St Leonards NSW 2065, Australia

Professor Arri Coomerasamy
Professor of Gynaecology
School of Clinical and Experimental Medicine
University of Birmingham, UK

Professor Peter M. Doubilet
Senior Vice Chair of Radiology, Brigham and Women's Hospital
Professor of Radiology, Harvard Medical School, USA

Professor Steven R. Goldstein MD
President Elect of the American Institute of Ultrasound in Medicine.
Professor of Obstetrics and Gynecology, Director of Gynecological Ultrasound,
New York University Medical Center, USA

Ms Deborah Gould
Consultant Obstetrician and Gynaecologist
Chief of Service and clinical lead for Emergency Gynaecology
St Mary’s Hospital, Imperial College NHS Trust, London, UK

Ms Emma Kirk
Specialist registrar in Obstetrics and Gynaecology
The Whittington Hospital, London, UK

Professor Ben Willem Mol
Professor of Obstetrics and Gynaecology and Clinical Epidemiology,
AMC, Amsterdam, The Netherlands

Mr. Nicholas Raine-Fenning, Clinical Associate Professor & Reader in Reproductive Medicine and Surgery, Faculty of Medicine & Health Sciences, Queen's Medical Centre
,Nottingham
, NG7 2UH
,UK

Ms Catriona Stalder
Consultant in Emergency Gynaecology
Queen Charlottes and Chelsea Hospital
Imperial College NHS Trust, London, W12 0HS, UK

Professor Dirk Timmerman
Professor in Obstetrics and Gynaecology
KU Leuven, Department of Development and Regeneration. Clinical Head Gynaecology, University Hospitals Leuven, Belgium

References

1. Newbatt E, Beckles Z, Ullman R, Lumsden MA; on behalf of the Guideline Development Group.
Ectopic pregnancy and miscarriage: summary of NICE guidance. BMJ. 2012 Dec 12;345:e8136. doi: 10.1136/bmj.e8136.

2. Bottomley C, Van Belle V, Mukri F, Kirk E, Van Huffel S, Timmerman D, Bourne T.
The optimal timing of an ultrasound scan to assess the location and viability of an early pregnancy. Hum Reprod. 2009 Aug; 24(8): 1811-7

3. Savitz DA, Terry JW Jr, Dole N, Thorp JM Jr, Siega-Riz AM, Herring AH. Comparison of pregnancy dating by last menstrual period, ultrasound scanning, and their combination. Am J Obstet Gynecol. 2002 Dec;187(6):1660-6.

4. Mol BW, Hajenius PJ, Engelsbel S, Ankum WM, van der Veen F, Hemrika DJ, Bossuyt PM. Are gestational age and endometrial thickness alternatives for serum human chorionic gonadotropin as criteria for the diagnosis of ectopic pregnancy?
Fertil Steril. 1999 Oct;72(4):643-5.

5. B. Van Calster, Y. Abdallah, S. Guha, E. Kirk, K. Van Hoorde, G. Condous, J. Preisler, W. Hoo, C. Stalder, C. Bottomley,
D. Timmerman, T. Bourne. Rationalizing the management of pregnancies of unknown location: temporal and external validation of a risk prediction model on 1962 pregnancies. Human Reproduction, 2013; doi: 10.1093

6. van Mello NM, Mol F, Verhoeve HR, van Wely M, Adriaanse AH, Boss EA, Dijkman AB, Bayram N, Emanuel MH, Friederich J, van der Leeuw-Harmsen L, Lips JP, Van Kessel MA, Ankum WM, van der Veen F, Mol BW, Hajenius PJ. Methotrexate or expectant management in women with an ectopic pregnancy or pregnancy of unknown location and low serum hCG concentrations? A randomized comparison. Hum Reprod. 2013 Jan; 28(1): 60-7

7. Nurmohamed L, Moretti ME, Schechter T, Einarson A, Johnson D, Lavigne SV, Erebara A, Koren G, Finkelstein Y.Outcome following high-dose methotrexate in pregnancies misdiagnosed as ectopic. Am J Obstet Gynecol. 2011 Dec;205(6):533.e1-3. doi: 10.1016/j.ajog.2011.07.002. Epub 2011 Jul 20.

8. Practice Committee of American Society for Reproductive Medicine. Medical treatment of ectopic pregnancy. Fertil Steril. 2008 Nov;90(5 Suppl):S206-12. doi: 10.1016/j.fertnstert.2008.08.049.

9. Barnhart KT. Early pregnancy failure: beware of the pitfalls of modern management. Fertil Steril. 2012 Nov; 98(5):1061-5.

10. Irish Health Service Executive (HSE). National miscarriage misdiagnosis review. April 2011. Available at: http://www.hse.ie/eng/services/Publications/ services/Hospitals/miscarriagereview.html. Last accessed October 3, 2012.

11. Cantwell R, Clutton-Brock T, Cooper G, Dawson A, Drife J, Garrod D, et al. Saving mothers’ lives: reviewing maternal deaths to make motherhood safer: 2006-2008. The eighth reportof the Confidential Enquiries into Maternal Deaths in the United Kingdom. BJOG 2011;118:1-203.

Competing interests: None declared

Tom Bourne, Consultant Gynaecologist

Kurt Barnhart, Carol Benson, Jan Brosens, Ben Van Calster, George Condous, Arri Coomersamy, Peter Doubilet, Steven R. Goldstein, Deborah Gould, Emma Kirk, Ben Willem Mol, Nicholas Raine-Fenning, Catriona Stalder, Dirk Timmerman

Imperial College and KU Leuven, Queen Charlottes and Chelsea Hospital, Du Cane Road, London, W12 0HS

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13 December 2012

The Editor
British Medical Journal
BMA House
Tavistock Square
London
WC1H 9JP

Dear Sir

Re: Newbatt et al BMJ 2012;345:e8136

On behalf of the Ectopic Pregnancy Trust we read with interest the article by Newbatt et al on behalf of the NICE guideline development group that summarises the NICE Guidelines on Ectopic Pregnancy and Miscarriage.

We are pleased to see a focus on early pregnancy complications and welcome many of the proposals. We are in favour of extending the hours of cover for early pregnancy units in order to provide regional cover at weekends. Furthermore the emphasis placed on communication and sensitivity is important. This is something that is highlighted time and again by our service users as being a major concern and we have therefore arranged a series of workshops aimed at medical professionals to assist with training in this important area. We also applaud the recommendation that women are given clear information about their treatment, recovery period and future fertility whilst also ensuring they receive literature and information of other organisations such as the Trust that can be of assistance, both during and after their treatment.

In view of these positive developments it is unfortunate that in our view the guidance suggested by NICE will lead to an erosion of choice for women with early pregnancy loss. NICE state that all women with a miscarriage should be offered expectant or medical treatment. However they state that surgery is not a first line option except for a select group of women. While we applaud the provision of outpatient therapies, some women will prefer surgical treatment and this option should be made available.

Clinically the EPT has particular concerns about the treatment suggested for ectopic pregnancy. NICE suggest that providing certain criteria are met, all women should be offered the drug Methotrexate for treatment. Again patient choice is restricted as no consideration is given to adopting a watch and wait approach. We believe this guidance will lead to a number of women receiving Methotrexate when their ectopic pregnancy would have resolved without intervention. A further problem with Methotrexate arises with the misdiagnosis of a presumed ectopic pregnancy. If the drug is given in error to a pregnancy that is in fact correctly located in the uterus, the result is either miscarriage or the likelihood of serious abnormalities in the baby if it survives. This scenario has been of such concern in the USA that a consensus conference was held recently to try to stem the tide of these cases. We believe in its current form the NICE guidance will lead to similar problems in the UK. Notwithstanding these serious concerns women should be informed of the relative merits of the treatment options available to them and they should be able to opt for expectant management or surgery if it is safe and reasonable to do so.

The EPT is pleased to see ectopic pregnancy and miscarriage brought to the forefront of government thinking. Doubtless this guidance will lead to some improvements to the care of women with this condition. However we do not support what we see as the removal of choice for women with miscarriage and ectopic pregnancy, nor can we recommend the guidance on the treatment of ectopic pregnancy given our concerns about the proposed use of methotrexate.

Much of the guidance summarised in the article by Newbatt et al depends entirely on the quality of ultrasonography and interpretation of serum biomarkers in early pregnancy units. Accordingly we feel to say nothing about support for training and clinical supervision in this area is regrettable. Furthermore improving clinical outcomes requires good information about outcomes and long-term learning. We recommend to NICE that they promote the use of ultrasound reporting databases in early pregnancy units and consider what funding should be earmarked to ensure units are adequately resourced in order that they can audit performance and so improve the care they give to women.

Yours faithfully

Harriette Goldsmith
Executive Director

Competing interests: None declared

Harriette Goldsmith, Executive Director

Ectopic Pregnancy Trust, PO Box 485, Potters Bar, Herts, EN6 9FE

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