The association between miscarriage, ectopic pregnancy and PTSD

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This week we published a pilot study on the psychological impact of miscarriage and ectopic pregnancy. We expected a high level of anxiety and depression in the women in the study – however we found that 38% of women in the study fullfilled the screening criteria for PTSD three months after the event. It is surprising that there are very few studies in this area – with thge previous largest study including later pregnancy events, making it hard to interpret the level of PTSD in early pregnancy.

The findings are potentially important, as PTSD if untreated has such a serious impact on so many aspects of life. Furthermore the treatment is specific and the condition is unlikely to be helped by general “counselling”. We believe that the answer will be to screen women for PTSD three months after a miscarriage or ectopic pregnancy to see if they have evidence of PTSD so they can be reviewed by a clinical psychologist. We are just finishing a much larger study on almost 800 women examining the same issue. From this we hope to identify the risk factors for developing PTSD so we can identify women ahead of time that are most likely to suffer from the condition – and so intervene early.

The paper can be read here as an open access publication with BMJ Open: http://bmjopen.bmj.com/content/6/11/e011864.full

Professor Tom Bourne

Professor Tom Bourne is Adjunct Professor at Imperial College London, and Consultant Gynaecologist at Queen Charlotte's and Chelsea Hospital. He is also visiting Professor at KU Leuven, Belgium. He has extensive clinical and research experience in early pregnancy care as well as gynaecological ultrasound. He has published over 300 academic papers with an H-index of 63. He advises NICE, is trustee of the ectopic pregnancy trust, President of the UK association of early pregnancy units (AEPU) and on the board of ISUOG. He has a private practice at The Women's Ultrasound Centres at 86 Harley Street and Parkside Hospital in Wimbledon.

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Can we really reduce the number of miscarriage by up to 25% ?

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A study was published in the British Journal of Obstetrics and Gynaecology yesterday that led to headlines in many of the national newspapers. The message was that perhaps up to 25% of miscarriages could be avoided. The reference for the paper is: Risk factors for miscarriage from a prevention perspective: a nationwide follow-up study. Feodor Nilsson S, Andersen P, Strandberg-Larsen K, Nybo Andersen AM. BJOG. 2014 Feb 19. doi: 10.1111/1471-0528.12694.

This study from Denmark was based on telephone interviews, and at first glance seems huge with over 91,000 patients included and so appears to offer convincing evidence. The authors identified associations between the following risk factors and an increased miscarriage risk: age of 30 years or more at conception, being underweight, and obesity prior to pregnancy. During pregnancy the modifiable risk factors were: alcohol consumption, lifting of >20 kg daily, and night work. Maternal age at conception and alcohol consumption were the most important risk factors. The authors hypothesise that  25.2% of the miscarriages in their study might have been prevented by reduction of all the risk factors to low risk levels.

Now much of this is not new. We know that increased age is a risk factor for miscarriage, and it is no surprise that alcohol may be linked to an increased risk of miscarriage. The same authors have also published before on a possible association between working habits and lifting with miscarriage risk.

However before anyone becomes alarmed it is important to be clear that this study does not establish a causal relationship between the risk factors it has identified and miscarriage. The study identifies potential candidate risk factors that may be associated with miscarriages, it does not demonstrate causation, and does not show any intervention or alteration in behaviour actually reduces the number of miscarriages.

When looking at this study two issues jump out. First is the issue of association rather than causation. As the authors note, “we cannot tell from this observational study whether the associations are causal”. The second issue is that the results may be sensitive to recall bias (because  participants were interviewed after their pregnancy ended in a miscarriage). A final potential problem with the study is that the majority of their participants were recruited “after the gestational age where miscarriage is most common”. It is difficult to know how this might impact on results.

So what are we supposed to think? Well – first thing is someone needs to carry out a prospective study looking at these risk factors in pregnancy. I imagine the Danish group may well already be doing this. There is a great deal of discussion already in society about age and pregnancy outcome as well as fertility. Most couples know this is an issue and this information will probably add anxiety rather than tell people anything they do not already know. The majority of women in my experience stop drinking as soon as they know they are pregnant – but inevitably many or indeed most do not know they are pregnant until after they have missed a period. This information will make people more cautious if they are planning a pregnancy about alcohol intake in the later stage of their cycle. Being very under or over weight is another high profile societal issue. Again this information will add to the argument that either end of the spectrum is not healthy.

The real areas of controversy relate to night work and lifting which are rather out of left field in terms of miscarriage risk – and clearly if causation were proven – could have a significant impact on policy and the workplace. We would then have to ask at what stage of pregnancy these factors may play a role. If very early – any women trying to conceive could argue that night shifts or lifting are putting them at risk. For the moment the study does not put forward sufficient evidence to know one way or the other. However it is clear that work needs to be carried out in this specific area to know if causation exists.

 

Professor Tom Bourne

Professor Tom Bourne is Adjunct Professor at Imperial College London, and Consultant Gynaecologist at Queen Charlotte's and Chelsea Hospital. He is also visiting Professor at KU Leuven, Belgium. He has extensive clinical and research experience in early pregnancy care as well as gynaecological ultrasound. He has published over 300 academic papers with an H-index of 63. He advises NICE, is trustee of the ectopic pregnancy trust, President of the UK association of early pregnancy units (AEPU) and on the board of ISUOG. He has a private practice at The Women's Ultrasound Centres at 86 Harley Street and Parkside Hospital in Wimbledon.

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Is it possible to personalise the risk of miscarriage

Screen Shot 2013-08-27 at 19.00.23Many women unfortunately have pain or bleeding in pregnancy – or attend for an ultrasound scan or assessment because they are anxious about their pregnancy. Often a scan is not conclusive – which naturally leads to even more anxiety. It is also known that early pregnancy problems can be associated with psychological morbidity. Being able to give an indication about the likely outcome is useful as this may prepare women for the most likely outcome when a scan is repeated at an interval.

In a recent paper in Human Reproduction Guha et al have shown that a mathematical model or simple scoring system can give a very good indication of what will happen to a pregnancy. The prediction is made on the basis if simple ultrasound parameters, the amount of bleeding, and the gestational age of the pregnancy.

Nobody wants to be in the uncertain situation where the health of an early pregnancy is uncertain – but at least this model can give clinicians an approach to counselling women about the likely outcome of a pregnancy. For women it must be hoped that this approach will help deal with the relative uncertainty associated with waiting for repeat scans before having a definitive diagnosis.

Professor Tom Bourne

Professor Tom Bourne is Adjunct Professor at Imperial College London, and Consultant Gynaecologist at Queen Charlotte's and Chelsea Hospital. He is also visiting Professor at KU Leuven, Belgium. He has extensive clinical and research experience in early pregnancy care as well as gynaecological ultrasound. He has published over 300 academic papers with an H-index of 63. He advises NICE, is trustee of the ectopic pregnancy trust, President of the UK association of early pregnancy units (AEPU) and on the board of ISUOG. He has a private practice at The Women's Ultrasound Centres at 86 Harley Street and Parkside Hospital in Wimbledon.

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Does working increase the risk of miscarriage?

Women often ask whether they should change what they do at work once they are pregnant. Is it OK to lift, carry on with shift work or work nights? On 12th December a Scandanavian journal published an interesting study on the impact of workload, lifting, standing, working hours and shift work on the likelihood of miscarriage – using meta-analysis and on the basis of a systematic review http://www.ncbi.nlm.nih.gov/pubmed/23235838. Effectively pooling the data of 30 previous studies they found that working fixed nights was associated with a moderately increased risk of miscarriage (pooled relative risk 1.51 [95% confidence interval (95% CI) 1.27-1.78, N=5). Working in 3-shift schedules, working 40 to 52 hours per week, lifting more than 100 kg/day, standing for  between 6 and 8 hours/day and physical workload were associated with only very small possible increases in the risk with a pooled relative risk of just 1.12, interesting in this review the impact of hours and standing became less evident the better the quality of the studies.  

The conclusion was that the findings were reassuring and did not provide a strong arguement to advise restrictions in the working practices of women in the first trimester of pregnancy. On the other hand it does prove that in individual pregnancies exposure to long hours, standing cannot have an impact. On balence my interpetation is that in general terms women should not feel they have to restrict their working patterns – but in higher risk cases it may be prudent to do so – which mirrors the views expressed by the authors of the paper.

Professor Tom Bourne

Professor Tom Bourne is Adjunct Professor at Imperial College London, and Consultant Gynaecologist at Queen Charlotte's and Chelsea Hospital. He is also visiting Professor at KU Leuven, Belgium. He has extensive clinical and research experience in early pregnancy care as well as gynaecological ultrasound. He has published over 300 academic papers with an H-index of 63. He advises NICE, is trustee of the ectopic pregnancy trust, President of the UK association of early pregnancy units (AEPU) and on the board of ISUOG. He has a private practice at The Women's Ultrasound Centres at 86 Harley Street and Parkside Hospital in Wimbledon.

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NICE guidance on ectopic pregnancy and miscarriage are a serious concern

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.

  1. 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.
  2.  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.

Professor Tom Bourne

Professor Tom Bourne is Adjunct Professor at Imperial College London, and Consultant Gynaecologist at Queen Charlotte's and Chelsea Hospital. He is also visiting Professor at KU Leuven, Belgium. He has extensive clinical and research experience in early pregnancy care as well as gynaecological ultrasound. He has published over 300 academic papers with an H-index of 63. He advises NICE, is trustee of the ectopic pregnancy trust, President of the UK association of early pregnancy units (AEPU) and on the board of ISUOG. He has a private practice at The Women's Ultrasound Centres at 86 Harley Street and Parkside Hospital in Wimbledon.

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The ovulation-implantation interval is fundamental to understanding fetal size

A recent paper has been published in the international journal Ultrasound in Obstetrics and Gynecology. The authors concluded that early implantation leads to a larger CRL and late implantation to a smaller CRL at 10–14 weeks, independent of CRL growth rate. The conclusion is that Implantation timing is a major determinant of fetal size at 10 – 14 weeks and largely explains the variation in estimates of GA in the first trimester derived from embryonic or fetal CRL. The major finding of the study was that  fetal size at 10 – 14 weeks’ gestation is mainly a composite of ovulation and implantation timing. This may prove to be a fundamental biological insight. Previously variations in size of the first trimester embryo were though to reflect the time from conception. This new study shows that the ovulation to implantation interval is a significant contributor. This work ties in with publications from Professor Jan Brosens group in Warwick. Brosens takes the view that defects in decidualisation leading to an abnormal implantation interval is a precursor to recurrent miscarriage. What is clear is that these events in early pregnancy are of real interest and will become the focus of research efforts in the next few years.

Professor Tom Bourne

Professor Tom Bourne is Adjunct Professor at Imperial College London, and Consultant Gynaecologist at Queen Charlotte's and Chelsea Hospital. He is also visiting Professor at KU Leuven, Belgium. He has extensive clinical and research experience in early pregnancy care as well as gynaecological ultrasound. He has published over 300 academic papers with an H-index of 63. He advises NICE, is trustee of the ectopic pregnancy trust, President of the UK association of early pregnancy units (AEPU) and on the board of ISUOG. He has a private practice at The Women's Ultrasound Centres at 86 Harley Street and Parkside Hospital in Wimbledon.

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Hyperemesis Gravidarum (HG) – in the news…..

No doubt there will be a lot of press coverage relating to “morning sickness” in the next week or so. Interestingly in 2006 we published a case control study matching 286 women with HG with the same number of controls without the condition (http://www.ncbi.nlm.nih.gov/pubmed/16720621) . There was no increase in the number of multiple pregnancies or molar disease. Interestingly when a women had HG she was less likely to miscarry. Our conclusion was that we did not need to scan women with this condition as they were not at risk. This data was in contrast to the old “textbook” teaching – but in our view reflects the reality of what is happening with this disorder.

Many women have nausea in early pregnancy and it is mild and generally self-limiting. Women are usually advised to avoid spicy or fried food and eat “little and often” – trying to keep down dry foods. Ginger has often been said to be helpful and certainly there is no harm in trying this. There is also some evidence to suggest acupuncture may have an impact in some cases. Hydration is important. It is usual to check the urine for ketones and to take blood to check for liver disease – but this is unusual.

In the event of “moderate” HG – more supportive therapy is needed. This takes the form of anti-emetic drug treatment and the use if intravenous fluids to maintain hydration. Both these can usually now be managed on an outpatient basis – with women coming in to a day care facility for intravenous fluids before going home. A variety of anti-emetics may be used as first line treatment – promethazine (25 mg 4 to 6 hourly) and metoclopramide (10 mg four times a day) are the ones generally advised – and they are safe to use in pregnancy. If these do not work then Odansetron (4mg 6 hourly) may be substituted. In terms of intravenous support – an isotonic fluid (essentially salt or similar  solution) should be used, and this should be supplemented by Thiamine and Folic acid. During intravenous treatment blood tests need to be taken to check electrolytes (sodium, potassium levels etc). Finally if there is no response a trial of steroid treatment can be given – as trials have shown that this works. If there is still no response after 4 to 5 days consideration needs to be given to more intrusive supportive management.

Generally the situation will be stabilised as an outpatient – however occasionally the condition is severe enough to merit admission to hospital. This may involve better management of fluids and nursing care – but may if there is no resolution involve feeding using a naso-gastric tube or even enteral nutrition. If an inpatient it is important to be alert to the risk of venous thromboembolism as dehydation, pregnancy and immobility are risk factors. However it must be emphasised that these cases requiring prolonged admission are rare.

There is no doubt that HG is very unpleasant – however in the majority this is a self limiting condition that settles after relatively minor treatment or a short stay in hospital. The emphasis now is very much on outpatient management whereas not that long ago admission was the norm.

 

 

 

Professor Tom Bourne

Professor Tom Bourne is Adjunct Professor at Imperial College London, and Consultant Gynaecologist at Queen Charlotte's and Chelsea Hospital. He is also visiting Professor at KU Leuven, Belgium. He has extensive clinical and research experience in early pregnancy care as well as gynaecological ultrasound. He has published over 300 academic papers with an H-index of 63. He advises NICE, is trustee of the ectopic pregnancy trust, President of the UK association of early pregnancy units (AEPU) and on the board of ISUOG. He has a private practice at The Women's Ultrasound Centres at 86 Harley Street and Parkside Hospital in Wimbledon.

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Uterine Transplantation: Is it really happening?

The research into uterus transplantation (UTn) reached a cresendo during the past 12 months as three human attempts were performed worldwide. In August 2011, a team in Turkey (Professor O Ozkan) performed the second human UTn in history, on a 21 year old recipient with congenital uterovaginal agenesis. This is the longest-lived transplanted human uterus to date, which subsequently achieved menstrual cycles (12 in total). Subsequently, two mother-to-daughter human transplants were perfromed by Prfoessor M Brannstrom in Sweden. It is worth emphasising that actual success will be the delivery of a single healthy fetus from the transplanted uteri.

To date, the teams working on bringing UTn closer to the human setting are represented by a multi-national group of five research teams (two American, one British, one Swedish and one Turkish). In view of what has occurred in the past 12 months with regards to human UTn attempts, presented here are a set of parameters that must be considered in order for UTn to become an acceptable procedure in the human setting.

UTn has been proposed as a potential solution to absolute uterine factor infertility (AUFI). Causes of AUFI include congenital (absence or malformation) or acquired uterine factors (e.g. hysterectomy for uncontrollable haemorrhage) rendering a woman ‘unconditionally infertile’. Current estimates are that inUSA, up to 7 million women, age 15-34 years, with AUFI may be appropriate candidates for UTn. UTn was first performed in humans in 2000 on a 26 year old who had her uterus removed as a result of post-partum haemorrhage. As a result of this first human attempt, investigators have responded with a plethora of publications demonstrating successful UTn attempts including pregnancies, in various autogeneic, syngeneic and allogeneic animal models. These pregnancies along with the second human UTn performed in August 2011 means that UTn is now a recognised feasible procedure.

Before UTn becomes an accepted procedure, it must satisfy defined criteria for any surgical innovation i.e. research background, field strength, and institutional stability. Equally important, UTn must satisfy accepted bioethical principles (respect for autonomy, beneficence, non-maleficence and justice) and their application: informed consent, appropriate assessment of risk and benefit and fair selection of individuals. Whether seen as innovative surgery or a medical study, eventually the early decisions to proceed in any venue should depend on approval by a duly constituted ethics review committee, the participating institution, the local transplant team and most importantly, the patient to whom the transplant will be offered. Furthermore, we believe that a defined number of transplants should not be exceeded worldwide without a successful term delivery to minimize proceeding in futility using current techniques. Towards this end, a registry should be maintained of all recipients and candidates.

Even if UTn were to become relatively common, we believe that the following research areas should be continuously pursued: 1) Additional pregnancies in a variety of large animal/primate models (to search for unanticipated consequences); 2) Continuous assessment of women diagnosed with AUFI regarding UTn; 3) Continuous assessment using “borrowed” psychological tools from transplant centers, adoption agencies and ART centers of potential recipients; and 4) Continuous careful ethical reflection, assessment and approval. Our group will continue to meet annually to address these areas and other special challenges that will arise. These challenges will require extensive resources from mature institutions experienced in innovations.

Closing on half a century of experience with pregnancy in solid organ recipients, an abundance of data has accumulated indicating satisfactory maternal and neonatal outcomes. Pregnancy after UTn will be challenging, but cannot be unexpected. As we await news of progress from the afore-mentioned three human UTn cases and of any other human attempts, we believe that UTn has become a matter of ‘when next’ rather than ‘if’.

Srdjan Saso

Srdjan Saso qualified from Imperial College, School of Medicine in 2007. He completed basic training in Northwick Park and St. Mary's Hospitals before being appointed to the North West Thames Deanery Obstetrics and Gynaecology programme in 2009. He became a member of the Royal College of Surgeons in March 2011. In October 2010, he deferred his clinical training in order to commence a 3 year PhD programme at Imperial College (Division of Surgery and Cancer, Institute of Reproductive and Developmental Biology, Hammersmith Hospital) under the supervision of Mr Richard Smith, Miss Sadaf Ghaem-Maghami, and Professor David Noakes. His PhD will focus on anatomical, immunological and psychological aspects of uterine transplantation. In addition to his clinical appointments, he held an Honorary Clinical Research Fellowship in the Department of Biosurgery and Surgical Technology at Imperial College under the supervision of Thanos Athanasiou and Lord Ara Darzi. His work focused on the application of statistical methodology to review various aspects of surgical practice.

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IOTA meeting in Leuven

We discussed the IOTA website today in Leuven

Professor Tom Bourne

Professor Tom Bourne is Adjunct Professor at Imperial College London, and Consultant Gynaecologist at Queen Charlotte's and Chelsea Hospital. He is also visiting Professor at KU Leuven, Belgium. He has extensive clinical and research experience in early pregnancy care as well as gynaecological ultrasound. He has published over 300 academic papers with an H-index of 63. He advises NICE, is trustee of the ectopic pregnancy trust, President of the UK association of early pregnancy units (AEPU) and on the board of ISUOG. He has a private practice at The Women's Ultrasound Centres at 86 Harley Street and Parkside Hospital in Wimbledon.

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How long to wait to conceive after a miscarriage..

In a new study published in BMJ Open, researchers at The RAND corporation in the States have reported that if the interval between miscarriage and conception for the next pregnancy is less than 3 months, there is a an increased chance that this next pregnancy will end in a live birth than if the inter pregnancy interval is 6 to 12 months. There was a reduced chance of miscarriage, although the study suggests there may be more complications late in pregnancy. This was a population study on over 10,000 pregnancies in Bangladesh, so the late pregnancy events may relate to the specific health care environment. This paper is interesting as a previous study in the BMJ has suggested greater fertility when “trying” to conceive relatively soon after miscarriage. Certainly the old advice to wait some months before trying to conceive after miscarriage no longer applies.

Professor Tom Bourne

Professor Tom Bourne is Adjunct Professor at Imperial College London, and Consultant Gynaecologist at Queen Charlotte's and Chelsea Hospital. He is also visiting Professor at KU Leuven, Belgium. He has extensive clinical and research experience in early pregnancy care as well as gynaecological ultrasound. He has published over 300 academic papers with an H-index of 63. He advises NICE, is trustee of the ectopic pregnancy trust, President of the UK association of early pregnancy units (AEPU) and on the board of ISUOG. He has a private practice at The Women's Ultrasound Centres at 86 Harley Street and Parkside Hospital in Wimbledon.

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