It was very pleasing to see a paper reporting a pilot study of Primary care endometrial sampling1as this was something I have been involved with over the last 25 years, although I was a little disappointed that there was no reference to some of the previous work on this subject in primary care2. I published two papers on the subject in 1998, The first considered the end of the operation Dilatation and Curettage (D & C) which until the 1990s had been the investigation of choice for abnormal uterine bleeding and the emergence of new techniques such as Pipelle sampling3. The second paper I published was entitled Endometrial sampling in general practice and was a case series of 38 women investigated for unexpected vaginal bleeding4. I had introduced the procedure to the Honiton Practice in 1993; having held the qualification for intrauterine techniques for many years and having acquired further training from the local gynaecology department and taken advice from the relevant defence unions. It was not part of General Medical Services then and under new general practice arrangements it was recognized as ‘provision of secondary care within primary care’ and remunerated. It is also important to realize that the current 2 week wait referral procedure did not exist and sometimes women with abnormal bleeding could w...
It was very pleasing to see a paper reporting a pilot study of Primary care endometrial sampling1as this was something I have been involved with over the last 25 years, although I was a little disappointed that there was no reference to some of the previous work on this subject in primary care2. I published two papers on the subject in 1998, The first considered the end of the operation Dilatation and Curettage (D & C) which until the 1990s had been the investigation of choice for abnormal uterine bleeding and the emergence of new techniques such as Pipelle sampling3. The second paper I published was entitled Endometrial sampling in general practice and was a case series of 38 women investigated for unexpected vaginal bleeding4. I had introduced the procedure to the Honiton Practice in 1993; having held the qualification for intrauterine techniques for many years and having acquired further training from the local gynaecology department and taken advice from the relevant defence unions. It was not part of General Medical Services then and under new general practice arrangements it was recognized as ‘provision of secondary care within primary care’ and remunerated. It is also important to realize that the current 2 week wait referral procedure did not exist and sometimes women with abnormal bleeding could wait quite a while for further investigation. One woman in this study was actually diagnosed with endometrial cancer from the primary care sample. The published study was awarded a local audit prize and I also received a research award from the BMA for it.
I tried to help other practices introduce the procedure with limited success. As further reorganizations of the NHS and primary care happened this important service was rarely recognized and eventually funding ceased although within the practice we continued to provide the service. I hope that this paper1 would encourage a renewed interest in undertaking this procedure in primary care.
1.Dickson JM, Delaney B, Connor ME. Primary care endometrial sampling for abnormal uterine bleeding: a pilot study. J Fam Pann Reprod Health Care 2017;43:296-301
2.Shapley M, Redman CWE. Endometrial sampling and general practice. Br J Gen Pract 1997;47:387-392
3.Seamark CJ. The demise of the D&C. J Roy Soc Med 1998;91:76-79
4.Seamark CJ. Endometrial sampling in general practice. Br J Gen Pract 1998;48:1597-1598
Jonathan Lord, Lesley Regan and colleagues make a strong case for allowing home use of misoprostol in early medical abortion. Indeed it has been obvious for some years ever since the WHO reviewed research trials in various countries. Isn't this really the time to make both abortifacients, mifepristone and misoprostol, available off prescription?
They are safe, reliable and easy to use. Complications requiring further medical attention after self-administration are only marginally more common than when supervised by medical staff. Dire results are rare. Is this the time to recognise that the present, medically supervised, regulated system has been outflanked by pharmaceutical technology?
In fact abortion has become so easy that many women obviously prefer it to contraception. In 2017 approximately 74 000 abortions in England & Wales (39% of the total) were for women who had had at least one before. Whether or not repeated abortion by medical means in early pregnancy is undesirable or even harmful does not seem to have been established.
Pills over the counter would be a popular innovation because it would enable a pregnant woman to achieve a termination more quickly and with greater privacy than now. She would, for example, not need to run the gauntlet of abortion protesters outside clinics.
Of course there are snags and difficulties. It could not be done without a change in the laws which currently forbid self-induction of abortion and r...
Jonathan Lord, Lesley Regan and colleagues make a strong case for allowing home use of misoprostol in early medical abortion. Indeed it has been obvious for some years ever since the WHO reviewed research trials in various countries. Isn't this really the time to make both abortifacients, mifepristone and misoprostol, available off prescription?
They are safe, reliable and easy to use. Complications requiring further medical attention after self-administration are only marginally more common than when supervised by medical staff. Dire results are rare. Is this the time to recognise that the present, medically supervised, regulated system has been outflanked by pharmaceutical technology?
In fact abortion has become so easy that many women obviously prefer it to contraception. In 2017 approximately 74 000 abortions in England & Wales (39% of the total) were for women who had had at least one before. Whether or not repeated abortion by medical means in early pregnancy is undesirable or even harmful does not seem to have been established.
Pills over the counter would be a popular innovation because it would enable a pregnant woman to achieve a termination more quickly and with greater privacy than now. She would, for example, not need to run the gauntlet of abortion protesters outside clinics.
Of course there are snags and difficulties. It could not be done without a change in the laws which currently forbid self-induction of abortion and require each to be approved by two doctors. The control and supervision of this procedure by medical staff would be greatly reduced. Identifying other medical conditions would also be less frequent. A few women might use the drugs in late pregnancy, when the foetus was already viable, but they can do this already. Statisticians, without a medical certificate for every abortion, would have to make estimates.
Making such a radical change in the present parliament would not be easy but it might help British society catch up with the reality that these pills are available fairly cheaply, world-wide, right now. If most women could manage the whole process themselves it would be a further step towards equality with men.
Reference
1 Lord J, Regan L, Kasliwal A, et al. Early medical abortion: best practice now lawful in Scotland and Wales but not available to women in England. BMJ Sex Reprod Health 2018;44:155–158.
Regarding the Scottish decision on home abortion of 26th October 2017, Lord J, Regan L, Kasliwal A, et al. claim that "Home use of misoprostol in Scotland is relatively new. The larger abortion services in Scotland report widescale uptake of home use of misoprostol among women and that it is highly appreciated with no negative impact on services." The Scottish “abortion services” consulted are not named and the reference for the bold claim that home use of misoprostol is “highly appreciated” is “S Cameron [co-author], personal communication 2018”. Such statements do not inspire confidence.
In response to some other claims made in the article: women having better control over timing in practice will mean less precision in timing, since medical supervision is supposed to guarantee ‘correct’ time between drugs and a ‘correct’ route of administration, whether sublingual, buccal or vaginal. If these are departed from, the effectiveness goes down, and the complications go up. This is well-known.
As regards travel and onset of bleeding, the Creinin paper [1] referred to by the authors had a bleeding onset median time of 2 hours for the standard (misoprostol taken 24 hours after mifepristone), and 3.7 hours when mifepristone and misoprostol were taken together. Others state that the onset of bleeding with the standard regimen was after 2 hours and meant light to moderate spotting at 4 hours after misoprostol [2]. Depending on the travel time, there m...
Regarding the Scottish decision on home abortion of 26th October 2017, Lord J, Regan L, Kasliwal A, et al. claim that "Home use of misoprostol in Scotland is relatively new. The larger abortion services in Scotland report widescale uptake of home use of misoprostol among women and that it is highly appreciated with no negative impact on services." The Scottish “abortion services” consulted are not named and the reference for the bold claim that home use of misoprostol is “highly appreciated” is “S Cameron [co-author], personal communication 2018”. Such statements do not inspire confidence.
In response to some other claims made in the article: women having better control over timing in practice will mean less precision in timing, since medical supervision is supposed to guarantee ‘correct’ time between drugs and a ‘correct’ route of administration, whether sublingual, buccal or vaginal. If these are departed from, the effectiveness goes down, and the complications go up. This is well-known.
As regards travel and onset of bleeding, the Creinin paper [1] referred to by the authors had a bleeding onset median time of 2 hours for the standard (misoprostol taken 24 hours after mifepristone), and 3.7 hours when mifepristone and misoprostol were taken together. Others state that the onset of bleeding with the standard regimen was after 2 hours and meant light to moderate spotting at 4 hours after misoprostol [2]. Depending on the travel time, there may be some women who would begin bleeding on the way home from a clinic. However, 30-40% of women will begin bleeding after mifepristone and before misoprostol in any case, and the chance that the abortion would occur on the way home would normally be slim.
If travel time is greater than a couple of hours, it is surely in any case risky to offer a woman misoprostol to take at home because by the same token she would presumably have difficulty accessing emergency care. Rural women without easy access to emergency care are not candidates for medical abortion. This is so whatever our views about whether abortion more generally is in fact ‘care’ or ‘treatment’ for the woman [3], given that her pregnancy is not a disease. We should also bear in mind that ambivalence in women about the abortion decision is common [4] and associated with regret [5]. Indeed, some women having medical abortions refuse to take misoprostol after mifepristone, whereupon the foetus may be found to be still alive, and born without adverse effects [6].
Nor is it clear as to why there should be better emotional support for a woman who takes misoprostol at home rather than at a clinic. Either way, the abortion will happen at home, and if, for example, a partner or family are going to provide emotional support at all to the woman as she loses the baby, there are multiple ways that they can do so. If misoprostol is taken at home, we must face the fact that not only will some women get no support at all but the ‘support’ they will get may be pressure to abort (bearing in mind the strong link between abortion and intimate partner violence ) [7].
A Scottish trial in 2010 surveyed women’s responses and experience of returning home immediately after the administration of misoprostol to abort. 100 out of 145 women answered the survey (making one wonder why 45 did not respond). 12 of the 100 responded that they were extremely upset by the experience. 8 out of 100 were home alone at the time of the abortion [8].
Removing a second visit to take misoprostol, with an increase in complications and side effects, could have a significant impact on resources because of the severity of some of the complications.
It is somewhat ironic that the authors refer to the paper by Lohr et al , which highlights the increased risk of complications when women take mifepristone and misoprostol simultaneously. Lord et al. [9]claim that because 85% of women choose to take misoprostol and mifepristone at the same time at the clinic, this demonstrates “how much of a barrier access is for many women.” Instead, we think it shows two different things. First, that BPAS is prepared to offer a less effective and more risky regimen that they know significantly increases harm to women (perhaps as a wedge to use in campaigning for home abortions?) And second, rather than choosing simultaneous drug taking because of access barriers, we think it just as likely that women choose simultaneous use because all they want is for the horrible process to be over sooner.
The experience is clearly unpleasant with high percentages of women experiencing a lot of pain, excess bleeding, cramps, chills, vomiting, diarrhoea, nausea, dizziness, weakness, fever, and headache. Some figures for these from the three key US trials are as follows: listed as very common (>10%) by the manufacturer of Mifegymiso (mifepristone plus misoprostol) include nausea (30.7 - 69.2%), vomiting (22.3 - 34.1%), diarrhea (31.8 - 58.6%), pain (91.6%), fever (21.3 – 44.3%), chills (36.5 – 44.3%), headache (12.3 – 42%), dizziness 13.1 – 45.5%), and weakness (19.2 – 56.6%). We wonder how many women undergoing this ordeal, many of whom would have been emotionally conflicted about the abortion, were offered help at any stage to have their baby.
I am grateful to Dr Greg Pike for the use of his research materials.
[1] Creinin M et al. (2007) Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion. A randomized controlled trial. Obstet. Gynecol. 109(4):885-894.
[2] Sitruk-Ware R (2006) Mifepristone and misoprostol sequential regimen side effects, complications and safety. Contraception 74:48-55.
[3] McCarthy A (2018). Abortion Matters. Philos Educational Publications.
[4] Kero A, Högberg U, Jacobsson L & Lalos A (2001) Legal abortion: a painful necessity. Social Science and Medicine 53:1481-1490.
[5] Kero A, Högberg U & Lalos A (2004); Wellbeing and mental growth – long-term effects of legal abortion. Social Science and Medicine 58:2559- 2569.
[6] Delgado G et al. (2018) A case series detailing the successful reversal of the effects of mifepristone using progesterone. Issues in Law & Medicine.33(1): 1-12.
[7] Pallitto CC, García-Moreno C, Jansen HAFM, Heise L, Ellsberg M & Watts C (2013) Intimate partner violence, abortion, and unintended pregnancy: results from the WHO Multi-country Study on Women’s Health and Domestic Violence. Int J Gynecology Obstetrics 120:3-9.
[8] Cameron S et al. (2010) Women’s experiences of the final stage of early medical abortion at home: results of a pilot survey. J Fam Plann Reprod Health Care 36(4): 213–216.
[9] Lohr PA, Wade J, Riley, et al. Women’s opinions on the home management of early medical abortion in the UK. J Fam Plann Reprod Health Care 2010; 36:21-5.
As a general practitioner and intrauterine device (IUD) fitter for
over 13 years now I applaud looking at new ways to reduce the pain of IUD
insertion as described in Vincent and Sewell's letter in the October 2012
issue of the Journal,[1] and recently I have also looked into the
possibility of getting some Entonox in our practice for IUD fitting. For
most women the experience of having an IUD fitted is unpleasant and cr...
As a general practitioner and intrauterine device (IUD) fitter for
over 13 years now I applaud looking at new ways to reduce the pain of IUD
insertion as described in Vincent and Sewell's letter in the October 2012
issue of the Journal,[1] and recently I have also looked into the
possibility of getting some Entonox in our practice for IUD fitting. For
most women the experience of having an IUD fitted is unpleasant and crampy
but tolerable. For some women, however, the procedure is excruciatingly
painful. The reasons for the variation are many but are usually fairly
unpredictable, and so in my opinion pain relief of some sort should be
given routinely to everyone being fitted with an IUD.
The method of pain relief I use - and which I'm sure is fairly
standard in most clinics - is simply lidocaine gel local anaesthetic (an
unlicensed use, I believe). For many years I believed that this was barely
significant in its effects other than as a lubricant and the placebo
effect of telling the patient I was using local anaesthetic jelly. It
didn't seem to have much of an effect and I wondered if there was much
point in using it at all.
The trouble is, in our ever increasingly busy clinics, we pop the
jelly in and perhaps think we have waited long enough for it to work, and
as time is pressured we get on and insert the IUD. I am fairly sure this a
commonplace practice, and it's certainly how I was taught.
Now I have started to wait a full (timed) 3 minutes after insertion
of the jelly into the canal and on the surface of the cervix before
attempting to fit the IUD, and I believe this has made a big difference to
the amount of pain experienced by my patients. [NB. We use lidocaine 2 g
in a pre-filled 6 ml syringe with a quill so we can be sure of reaching
into the canal.]
After the jelly is introduced and the clock is started we say "We are
going to wait a full 3 minutes for the local anaesthetic to work so you
can just relax for now", and then we all chat about something or other,
usually the patient's toenail colour or their escape from childcare or
whether they have a day off, and so on. It's amazing the range of
conversations you can have in 3 minutes and it's also surprising how long
3 minutes really is when you are timing it!
I believe that this is time well spent. Who knows whether it's the
effects of the lidocaine or whether it's the conversation and subsequent
relaxation of the patient immediately prior to IUD insertion? But I do
know that since I have adopted this much more precise practice I have
hardly had anyone feel faint, and had no one jumping off the bed in agony.
I will still consider using Entonox because there are always a few women
whose pain will not be tolerable with lidocaine gel alone; but for those
clinicians using this method, do make sure you time a full 3 minutes
before sounding the canal. I am convinced that if we all did this then IUD
fitting generally would be a lot less painful for the patient.
Reference
1. Vincent LC, Sewell E. Entonox analgesia for IUD insertions and
removals. J Fam Plann Reprod Health Care 2012;38:270.
Sexual abuse in children is a problem that often goes unnoticed by parents. Sometimes it is really difficult for parents to be aware of it. Children should not only receive sex education but should also be alerted to the possibility of assault by
strangers, teachers, superiors in offices/workplaces, etc. Special counselling is required, and a great deal of psychological reassurance and
support by their elders may also be n...
Sexual abuse in children is a problem that often goes unnoticed by parents. Sometimes it is really difficult for parents to be aware of it. Children should not only receive sex education but should also be alerted to the possibility of assault by
strangers, teachers, superiors in offices/workplaces, etc. Special counselling is required, and a great deal of psychological reassurance and
support by their elders may also be needed. In spite of such measures, some children are inevitably going to suffer abuse, and consequently there is a great need for psychologist services.
I read with interest the letter by Webb et al.[1] about the pitfalls
of adapting the Clinical Effectiveness Unit's guidance on emergency
contraception.[2] Their letter discusses, in relation to maximising the
pharmacodynamic attributes of ulipristal acetate (UA), the significant
inaccuracies inherent in the calculation of the timing of ovulation based
on the menstrual history. However, we frequently rely on such a
calcu...
I read with interest the letter by Webb et al.[1] about the pitfalls
of adapting the Clinical Effectiveness Unit's guidance on emergency
contraception.[2] Their letter discusses, in relation to maximising the
pharmacodynamic attributes of ulipristal acetate (UA), the significant
inaccuracies inherent in the calculation of the timing of ovulation based
on the menstrual history. However, we frequently rely on such a
calculation when deciding whether an intrauterine device (IUD) can be
fitted as an emergency contraceptive. Maybe in light of the evidence
supplied in their letter this practice should be reviewed? If we accept
that menstrual history can be used to guide the timing of ovulation in
relation to emergency contraception, then recognising the significant cost
differential between UA and levonorgestrel and UA's proposed superior
ability to delay/inhibit ovulation, maybe there is an opportunity to use
UA 'smarter' around the proposed time of ovulation when an IUD is
declined.
References
1. Webb A, McGough P, Melvin, L. Pitfalls of adapting emergency
contraception CEU guidance. J Fam Plan Reprod Health Care 2012;38:270.
2. Faculty of Sexual and Reproductive Healthcare. Emergency Contraception.
2011. http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf
[accessed 16 October 2012].
I have read with interest in this Journal, since my retirement, the
continuing debate over nurse training and accreditation by the Faculty of
Sexual and Reproductive Healthcare (FSRH) and am saddened that there is
still no resolution. Indeed, the October 2012 issue of the Journal
included three letters on this very topic [1-3].
Nurse and midwifery training is validated through universities at
diploma or graduat...
I have read with interest in this Journal, since my retirement, the
continuing debate over nurse training and accreditation by the Faculty of
Sexual and Reproductive Healthcare (FSRH) and am saddened that there is
still no resolution. Indeed, the October 2012 issue of the Journal
included three letters on this very topic [1-3].
Nurse and midwifery training is validated through universities at
diploma or graduate level and is regulated professionally through the
Nursing and Midwifery Council (NMC). Registration is maintained by
demonstrating compulsory continuing professional development, usually in
the area of practice, to remain on the Nursing Midwifery Register.
Reproductive and sexual health courses are competency based and
acquire accreditation points that will go towards a degree or go towards
upgrading from diploma to graduate and postgraduate level; these points
are transferable from one academic institution to another.
That being the case, there is no reason why some university across
the four countries would not consider the content of the Diploma of the
Faculty of Sexual and Reproductive Healthcare (DFSRH) for nursing and
award it accreditation points, particularly since the course is organised
and quality assured through a highly accredited medical faculty. If this
could be achieved, criteria must be set for post-registration experience
for nurses before embarking on the course.
The award title 'DFSRH' may not be appropriate for nurses because of
pre-registration academic differences in medical and nurse training;
currently it takes 3 years pre-registration training for a nurse to
receive a diploma.
Rebadging the course for nurses to a Statement of Competence,
'CFSRH', may be acceptable to an institution that could consider
accrediting the course along with the Faculty. It would be recognisable
nationally and differentiate between a medical and nursing qualification.
It would meet the criteria for continuous professional development in the
area of practice, which is a requirement for nurses working in the
speciality.
I fail to understand why 'CFSRH' could not be progressed and the
successful recipient negotiate with an institution of choice, accrued
points to go towards a degree at higher level if required.
There is a body of evidence to suggest that there is a requirement
for a standardised recognisable competency award for nursing, in
reproductive and sexual health, that our medical colleagues will
understand and acknowledge. The range of existing and newly planned
courses at different levels across the four countries leads to confusion
for service leads who are responsible from employing nursing staff.
This area of health care has pioneered modernisation and integration:
keep it going by taking forward CFSRH!
Although retired, I maintain a keen interest in the Faculty, and wish
it every success with this important initiative.
References
1. Ward M. An innovative training for nurses in sexual and reproductive
health. J Fam Plann Reprod Health Care2012;38:272.
2. Hunt S, Onslow D. Innovative training for nurses in SRH. J Fam Plann
Reprod Health Care2012;38:273.
3. Beddard S. Training for nurses working in SRH. J Fam Plann Reprod
Health Care2012;38:272-273.
We write in response to the article in the July 2012 issue of this
Journal by Shelley Mehigan and Janice Burnett entitled 'An innovative
training for nurses in sexual health'[1]. We agree wholeheartedly that a
nationally recognised, standardised training for nurses in sexual and
reproductive health is needed and that the best way forward may be for the
Faculty of Sexual and Reproductive Healthcare (FSRH) to accredit nurse...
We write in response to the article in the July 2012 issue of this
Journal by Shelley Mehigan and Janice Burnett entitled 'An innovative
training for nurses in sexual health'[1]. We agree wholeheartedly that a
nationally recognised, standardised training for nurses in sexual and
reproductive health is needed and that the best way forward may be for the
Faculty of Sexual and Reproductive Healthcare (FSRH) to accredit nurses or
to open up the Faculty Diploma (DFSRH) to nurses. Mehigan and Burnett warn
of the dangers of reinventing lots of different wheels. In Hull this is
exactly what we have done.
Previous training initiatives to increase the numbers of long-active
reversible contraception (LARC) providers within primary care proved
unsuccessful due to low numbers of nurses with the prerequisite
qualifications (i.e. a family planning qualification) necessary to access
LARC training. In addition, a training needs assessment demonstrated lack
of interest in undertaking a lengthy academic pathway to achieve family
planning status. To overcome these problems we worked in partnership with
commissioners and York St John University to develop a fast-track
contraceptive course with 30 credits at degree level to enable nurses to
counsel clients about all methods of contraception and to fit and remove
subdermal implants.
We do, however, disagree with Mehigan and Burnett about the value of
working with a university to ensure that the programme has academic
accreditation. Even if the Faculty does eventually accredit nurses and we
have a nationally recognised qualification thus standardising training
across the UK this will not help nurses with their career pathway in the
way that transferable academic credit can do. Nursing is now a degree and
masters level profession and any training and education needs to reflect I
the academic level of the knowledge and skills development involved.
Nurses within our service in Hull have undergone much training, which has
equipped them well in providing safe and effective care for their clients
but has left them short on academic qualifications and the credibility
which this brings. Working in true collaboration with a local university
to achieve academic accreditation has enabled us to maintain ownership of
our essentially practical skills-based course, but also given us access to
the expertise of educationalists in a higher educational institution to
ensure that our assessment processes are rigorous and appropriate. The
university, always needing to update its own practices, has benefitted
from the opportunity to work with practitioners who are at the forefront
of service enhancement. Without accreditation we would not have obtained
funding and approval from commissioners to provide this training, which we
anticipate will make a real difference to the high unplanned pregnancy
rates in our local area and demonstrate a tangible return on investment
for all stakeholders.
We are more than willing to work with Mehigan and Burnett or indeed
anyone else out there who is trying to reinvent wheels, but to do this
effectively we believe that it is important to share practice with
academic colleagues and avoid working in silos.
Reference
1. Mehigan S, Burnett J. An innovative training for nurses in sexual
health. J Fam Plann Reprod Health Care 2012;38:194-195.
May I congratulate the authors of the commentary describing
contraceptive options for women with systemic lupus erythematosis
(SLE).[1] This was a comprehensive summary and I was interested in their
views regarding the suitability of progestogen-only methods in women with
antiphospholipid antibodies. The authors felt these methods were unsafe in
such women (World Health Organization Medical Eligibility Criteria for
Contr...
May I congratulate the authors of the commentary describing
contraceptive options for women with systemic lupus erythematosis
(SLE).[1] This was a comprehensive summary and I was interested in their
views regarding the suitability of progestogen-only methods in women with
antiphospholipid antibodies. The authors felt these methods were unsafe in
such women (World Health Organization Medical Eligibility Criteria for
Contraceptive Use Category 3 - generally risks outweigh the benefits of
use). As up to 42% of women with SLE will be positive for these
antibodies[2] the authors are reducing contraceptive choice to barrier
methods, copper intrauterine devices or sterilisation.
About one-third of women with antiphospholipid antibodies develop a
venous thromboembolism (VTE) in their lifetime and this risk is further
increased in pregnancy and the puerperium.[2] Maternal mortality in women
suffering from SLE is thought to be 2-3%.[3] We now have good evidence
that progestogen-only contraceptive methods such as the levonorgestrel-
releasing intrauterine system and desogestrel pill do not increase the
risk of VTE in the general population.[4] A recent study also suggested
that oral pregnane progestogen contraceptives appear to have little effect
on the development of VTE in women with SLE (where 29.4% of 187 women had
detectable antiphospholipid antibodies).[5]
Perhaps the authors would like to provide an additional comment?
References
1 Culwell KR, Curtis KM. Contraception for women with systemic lupus
erythematosus. J Fam Plann Reprod Health Care 2013; 39:9-11.
2 Al-Homood IA. Thrombosis in systemic lupus erythematosus: a review
article. ISRN Rheumatol 2012;2012:428269. Epub 2012 Jul 30.
3 Iozza I, Cianci S, Di Natale A, Garofalo G, Giacobbe AM, Giorgio E,
De Oronzo MA, Politi S. Update on systemic lupus erythematosus pregnancy.
J Prenat Med 2010; 4(4):67-73.
4 Lidegaard O, Lokkegaard E, Svendsen AL, Agger C. Hormonal
contraception and risk of venous thromboembolism: national follow-up
study. BMJ 2009 Aug 13;339:b2890. doi: 10.1136/bmj.b2890.
5 Chabbert-Buffet N, Amoura Z, Scarabin PY, Frances C, Levy DP,
Galicier L, Wechsler B, Bletry O, Piette JC, Gompel A. Pregnane progestin
contraception in systemic lupus erythematosus: a longitudinal study of 187
patients. Contraception 2011;83:229-237.
Conflict of Interest:
The author has received financial support to attend pharmaceutical advisory board meetings, undertake research studies, speak at educational meetings and conferences along with travel grants from Astellas, Bayer, Consilient Healthcare, HRA Pharma, Merck, Pfizer and Vifor Pharma.
We thank Dr Mansour for her interest in our article[1] and for her
provocative questioning of the recommendations for use of progestogen-only
contraceptives by women with systemic lupus erythematosus (SLE) who test
positive for anti-phospholipid antibodies.[2] We are sensitive to any
reductions in choice of contraceptive methods, particularly for women in
whom pregnancy has significant health consequences, such as women w...
We thank Dr Mansour for her interest in our article[1] and for her
provocative questioning of the recommendations for use of progestogen-only
contraceptives by women with systemic lupus erythematosus (SLE) who test
positive for anti-phospholipid antibodies.[2] We are sensitive to any
reductions in choice of contraceptive methods, particularly for women in
whom pregnancy has significant health consequences, such as women with
SLE. As mentioned in our article, any considerations of contraceptive use
in women with SLE must be weighed against the alternative of pregnancy,
which brings many risks, particularly in women with active disease or
those with positive anti-phospholipid antibodies.
We would first like to clarify an apparent misunderstanding by Dr
Mansour that we believe that use of progestogen-only methods by women with
SLE and positive anti-phospholipid antibodies is "unsafe". The
recommendations included in our article are those which are in the World
Health Organization (WHO) Medical Eligibility Criteria for Contraceptive
Use (MEC)[3] and subsequent adaptations by the UK and USA. In these
recommendations, progestogen-only contraceptives, including progestogen-
only pills (POPs), injectables, implants and the levonorgestrel-releasing
intrauterine system (LNG IUS) are given a Category 3 rating, meaning the
risks usually outweigh the benefits. However, a Category 3 rating does not
automatically mean that this method should not be used in any
circumstance. The introduction to the 4th edition of the WHO MEC states:
"However, provision of a method to a woman with a condition classified as
Category 3 requires careful clinical judgement and access to clinical
services; for such a woman, the severity of the condition and the
availability, practicality, and acceptability of alternative methods
should be taken into account. For a method/condition classified as
Category 3, use of that method is not usually recommended unless other
more appropriate methods are not available or acceptable. Careful follow-
up will be required". In practice, this means that a woman with SLE and
positive anti-phospholipid antibodies could be offered progestogen-only
methods if more appropriate alternatives, such as a copper intrauterine
device (IUD), are unavailable or unacceptable to her. The decision about
which method is optimal for a particular woman would best be made through
consultation with a specialist, such as a family planning specialist
and/or a rheumatologist after thorough counselling regarding the potential
risks and benefits and careful follow-up. The WHO MEC goes on to say (p.
10): "Where resources for clinical judgement are limited, such as in
community-based services, the four category classification framework can
be simplified into two categories. With this simplification, a
classification of Category 3 indicates that a woman is not medically
eligible to use the method".
While we know that progestogen only methods don't carry the same risk
of thromboembolism as do methods containing estrogen, such as combined
oral contraceptives (COCs), the evidence is insufficient to conclude that
there is no risk of thromboembolism with progestogen-only methods. A
recent meta-analysis of eight observational trials found that evidence on
risk of venous thromboembolism (VTE) with use of progestogen-only methods
was limited but that there appeared to be no increased risk with POPs or
the LNG IUS, while there may be an increased risk with progestogen-only
injectables.[4] In addition, these studies were generally conducted among
healthy women without other risk factors for VTE. The only evidence we
have of use of progestogen-only methods by women with SLE is from the
randomised controlled trial by Sanchez-Guerrero et al., included in our
review, in which women were randomised to COC, POP or copper IUD use.[5]
There were four episodes of thromboembolism in the study, two in the COC
group and two in the POP group, with none in the group assigned to copper
IUD. All four of these patients were reported to have positive anti-
phospholipid antibodies. The incidence of thromboembolism was therefore
4.75/100 woman-years in the COC group and 5.44/100 woman-years in the POP
group. This study was not powered to detect a difference in the outcome of
thromboembolism between the groups.
Based on the best available evidence, we agree with the WHO MEC
recommendations of a Category 3 for use of progestogen-only contraceptives
for women with SLE and positive anti-phospholipid antibodies, but also
would agree that clinical judgment might lead to the use of progestogen-
only methods in these women following adequate counselling regarding the
risks, benefits and alternatives, including the alternative of non-use of
contraception and subsequent pregnancy.
References
1 Culwell KR, Curtis KM. Contraception for women with systemic lupus
erythematosus. J Fam Plann Reprod Health Care 2013;39:9-11.
2 Mansour D. Contraceptive options for women with SLE [Letter]. J Fam
Plann Reprod Health Care 2013; 8 January 2013 [Epub ahead of print].
3 World Health Organization. Medical Eligibility for Contraceptive
Use (4th edn). 2009.
http://whqlibdoc.who.int/publications/2010/9789241563888_eng.pdf [accessed
19 December 2012].
4 Mantha S, Karp R, Raghavan V, et al. Assessing the risk of venous
thromboembolic events in women taking progestin-only contraception: a meta
-analysis. BMJ 2012. 345: e4944.
5 Sanchez-Guerrero J, Uribe AG, Jimenez-Santana L, et al. A trial of
contraceptive methods in women with systemic lupus erythematosus. N Engl J
Med 2005. 353:2539-2549.
Conflict of Interest:
The findings and conclusions in this article are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.
Jonathan Lord, Lesley Regan and colleagues make a strong case for allowing home use of misoprostol in early medical abortion. Indeed it has been obvious for some years ever since the WHO reviewed research trials in various countries. Isn't this really the time to make both abortifacients, mifepristone and misoprostol, available off prescription?
They are safe, reliable and easy to use. Complications requiring further medical attention after self-administration are only marginally more common than when supervised by medical staff. Dire results are rare. Is this the time to recognise that the present, medically supervised, regulated system has been outflanked by pharmaceutical technology?
In fact abortion has become so easy that many women obviously prefer it to contraception. In 2017 approximately 74 000 abortions in England & Wales (39% of the total) were for women who had had at least one before. Whether or not repeated abortion by medical means in early pregnancy is undesirable or even harmful does not seem to have been established.
Pills over the counter would be a popular innovation because it would enable a pregnant woman to achieve a termination more quickly and with greater privacy than now. She would, for example, not need to run the gauntlet of abortion protesters outside clinics.
Of course there are snags and difficulties. It could not be done without a change in the laws which currently forbid self-induction of abortion and r...
Show MoreRegarding the Scottish decision on home abortion of 26th October 2017, Lord J, Regan L, Kasliwal A, et al. claim that "Home use of misoprostol in Scotland is relatively new. The larger abortion services in Scotland report widescale uptake of home use of misoprostol among women and that it is highly appreciated with no negative impact on services." The Scottish “abortion services” consulted are not named and the reference for the bold claim that home use of misoprostol is “highly appreciated” is “S Cameron [co-author], personal communication 2018”. Such statements do not inspire confidence.
In response to some other claims made in the article: women having better control over timing in practice will mean less precision in timing, since medical supervision is supposed to guarantee ‘correct’ time between drugs and a ‘correct’ route of administration, whether sublingual, buccal or vaginal. If these are departed from, the effectiveness goes down, and the complications go up. This is well-known.
As regards travel and onset of bleeding, the Creinin paper [1] referred to by the authors had a bleeding onset median time of 2 hours for the standard (misoprostol taken 24 hours after mifepristone), and 3.7 hours when mifepristone and misoprostol were taken together. Others state that the onset of bleeding with the standard regimen was after 2 hours and meant light to moderate spotting at 4 hours after misoprostol [2]. Depending on the travel time, there m...
Show MoreAs a general practitioner and intrauterine device (IUD) fitter for over 13 years now I applaud looking at new ways to reduce the pain of IUD insertion as described in Vincent and Sewell's letter in the October 2012 issue of the Journal,[1] and recently I have also looked into the possibility of getting some Entonox in our practice for IUD fitting. For most women the experience of having an IUD fitted is unpleasant and cr...
Sexual abuse in children is a problem that often goes unnoticed by parents. Sometimes it is really difficult for parents to be aware of it. Children should not only receive sex education but should also be alerted to the possibility of assault by strangers, teachers, superiors in offices/workplaces, etc. Special counselling is required, and a great deal of psychological reassurance and support by their elders may also be n...
I read with interest the letter by Webb et al.[1] about the pitfalls of adapting the Clinical Effectiveness Unit's guidance on emergency contraception.[2] Their letter discusses, in relation to maximising the pharmacodynamic attributes of ulipristal acetate (UA), the significant inaccuracies inherent in the calculation of the timing of ovulation based on the menstrual history. However, we frequently rely on such a calcu...
I have read with interest in this Journal, since my retirement, the continuing debate over nurse training and accreditation by the Faculty of Sexual and Reproductive Healthcare (FSRH) and am saddened that there is still no resolution. Indeed, the October 2012 issue of the Journal included three letters on this very topic [1-3].
Nurse and midwifery training is validated through universities at diploma or graduat...
We write in response to the article in the July 2012 issue of this Journal by Shelley Mehigan and Janice Burnett entitled 'An innovative training for nurses in sexual health'[1]. We agree wholeheartedly that a nationally recognised, standardised training for nurses in sexual and reproductive health is needed and that the best way forward may be for the Faculty of Sexual and Reproductive Healthcare (FSRH) to accredit nurse...
May I congratulate the authors of the commentary describing contraceptive options for women with systemic lupus erythematosis (SLE).[1] This was a comprehensive summary and I was interested in their views regarding the suitability of progestogen-only methods in women with antiphospholipid antibodies. The authors felt these methods were unsafe in such women (World Health Organization Medical Eligibility Criteria for Contr...
We thank Dr Mansour for her interest in our article[1] and for her provocative questioning of the recommendations for use of progestogen-only contraceptives by women with systemic lupus erythematosus (SLE) who test positive for anti-phospholipid antibodies.[2] We are sensitive to any reductions in choice of contraceptive methods, particularly for women in whom pregnancy has significant health consequences, such as women w...
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