Re: Ectopic pregnancy and miscarriage: summary of NICE guidance
13 December 2012
British Medical Journal
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.