In December NICE published their guidance on ectopic pregnancy and miscarriage. A summary of these was also published in the British Medical Journal It is fair to say that they were disappointing on many levels. It is worth quoting the view of the patient group the ectopic pregnancy trust (www.ectopic.org.uk) on aspects of what NICE have produced: “The EPT have additional concerns and cannot support some significant and specific parts of the guidance.
- In our view the guidelines restrict choice for women who suffer a miscarriage. NICE state that all women with a miscarriage should be offered expectant (watch and wait) or medical treatment. These can be offered as an outpatient. 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 to all women who want it.
- The EPT has major 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. No consideration is given to adopting a watch and wait approach with monitoring. 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 potential for 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 would like to see further detail and clarification on its suggested use.
We welcome the interest NICE has taken in early pregnancy care. However, we are disappointed to see the fact of what we see as an erosion of choice in the care of women with early pregnancy problems. There was an opportunity to say something about the need to make the care of early pregnancy problems a ‘Specialist field’ in Gynaecology, to promote training and to encourage commissioners to support the use of computerised reporting in early pregnancy utits to facilitate audit, better knowledge of outcome and drive up standards. Unfortunately they have failed to do this.”
The miscarriage association has also voiced concerns: “ We cannot, however, endorse the following recommendations/exclusions:
- Expectant management (letting nature take its course, as against medical or surgical management) as the first-line response in confirmed miscarriage
- This removes patient choice – a crucial component of the patient-centred care which the guideline generally recommends
- Previous research indicates that most women have a definite preference for one management method or another
- Enforced waiting once miscarriage is confirmed can be extremely distressing for the woman and her partner
We believe that as long as the woman is clinically stable, offering informed choice of all available and clinically appropriate management options should be the first-line strategy in confirmed diagnosis of non-viable pregnancy.
The exclusion of molar (hydatidiform mole) pregnancy from the guideline.
- This form of pregnancy loss is most often diagnosed after surgical management of miscarriage and we believe the guideline should include a general statement regarding recommended means of contact, information and referral.”
Clearly there are issues with the guidance which has been summarised in the British Medical Journal (BMJ) http://www.ncbi.nlm.nih.gov/pubmed/23236034. The ectopic pregnancy trust has also corresponded with the BMJ on this issue outlining their worries. There is a general view that this is a “rationing” of care and that NICE have not listened to women nor considered their psychological well being. Further major concerns relate to NICE recommending that Methotrexate (drug) treatment be the first line treatment of ectopic pregnancy in any relatively small ectopic pregnancies. This invites major problems when this drug is given and the location of the pregnancy has been misdiagnosed. In the States there have been such concerns over this that a consensus conference was held to develop protocols to avoid exactly the scenario NICE are promoting.
NICE also missed an opportunity to discuss training and audit – two of the main ways standards can be driven up. Such are concern amongst senior doctors in early pregnancy care that many have written to the BMJ outlining their concerns – particularly over the methotrexate issue. These include the Professor of Radiology at Harvard and the President elect of the American Institute of Ultrasound in Medicine. NICE needs to listen to these people and the women they are supposedly promoting excellence for.