Les nouvelles grossesses

Collection questions – Presses Universitaires de France

Pr Jean-Claude PONS, 1998

Sujets :
– Grossesse à haut risque
– Procréation médicalement assistée
– Grossesse
– Techniques reproduction
– Législation médicale — France
– Bioéthique — France
– bioéthique — désir d’enfant — foetus — grossesse
– Aspect physiologique
– Aspect psychologique
– Femme enceinte
– Hygiène
– Santé

Le Distilbène DES, en savoir plus

Valproate should have a restricted licence for prescribing only by nominated prescribers and on a named patient basis

Weighing the risks of valproate in women who could become pregnant

A baby in utero looking out and seeing his/her mother taking valproate is a scenario not to be contemplated. It could be equated to someone being forced to take poison against their will. The result is almost certainly organ damage including brain damage. Beautiful healthy babies forced to ingest poison against their will and ending up with lifelong disability. In cold stark terms this is what is being discussed. A class action by such affected individuals once born and once endowed with human rights and protection, would certainly sober up the situation and rein in any distracted prescribing practices.

This graphic way of reasoning does not take into account the mother’s illness and need for safe treatment, nor the prescribing doctor’s dilemma with imperfect treatments and unpredictable risks to the mother either from epilepsy or bipolar illness. However it is outrageous that thousands of women in Europe and USA are inadvertently taking valproate without knowing what the risks are. A “named patient only” regime by designated prescribers only, may be a safer way to go.
Large court settlements have been awarded to “valproate babies” and it is a sad day for mother and child to have to come to this end, instead of what should and maybe could have been a much happier day (healthy baby and mother). Inevitably due to human error accidents will happen, but what is truly insupportable is that young women and their babies wake up to a sad situation and say “but no body told us.

Babies in utero are human beings, and at present in most jurisdictions their human rights are put on hold until they reach their majority – birth. How would anyone feel about being disabled for life because they were helplessly poisoned while awaiting their inheritance? The same could be said of foetal alcohol people who were poisoned in utero. A class action by those negligently harmed by valproate or any toxin in utero would focus medical and pharmacological opinion on what safeguards need to be in place. Valproate should have a restricted licence for prescribing only by nominated prescribers and on a named patient basis.

Eugene G Breen‘s response to : “Despite international consensus on the harmful effects of valproate during pregnancy, women should not be denied the human right to make their own decisions after fully informed discussion, say Heather Angus-Leppan and Rebecca Liu
Physician/Psychiatrist
62/63 Eccles St Dublin 7, Ireland

Parents’ Preconception Well-Being Affects Child’s Future Health

A series of three articles, published online April 16 in the Lancet, shine a light on this critical period

Medscape Medical News reviewed emerging evidence showing that preconception health of the mother- and father-to-be — especially their diet and weight — affects fertilization, embryo development, and even their child’s risk of future cardiometabolic disease.

Health and nutrition of both men and women before conception is important not only for pregnancy outcomes but also for the lifelong health of their children and even the next generation. The preconception period can be seen in three different ways: from a biological standpoint as the days and weeks before embryo development; from the individual perspective as the time of wanting to conceive; and through a population lens as any time a women is of childbearing age. This Series of three papers highlights the importance and summarises the evidence of preconception health for future health and suggests context-specific interventions. It also calls for a social movement to achieve political engagement for health in this particular phase in life.

Before the beginning : nutrition and lifestyle in the preconception period and its importance for future health

Summary

A woman who is healthy at the time of conception is more likely to have a successful pregnancy and a healthy child. We reviewed published evidence and present new data from low-income, middle-income, and high-income countries on the timing and importance of preconception health for subsequent maternal and child health. We describe the extent to which pregnancy is planned, and whether planning is linked to preconception health behaviours. Observational studies show strong links between health before pregnancy and maternal and child health outcomes, with consequences that can extend across generations, but awareness of these links is not widespread. Poor nutrition and obesity are rife among women of reproductive age, and differences between high-income and low-income countries have become less distinct, with typical diets falling far short of nutritional recommendations in both settings and especially among adolescents. Several studies show that micronutrient supplementation starting in pregnancy can correct important maternal nutrient deficiencies, but effects on child health outcomes are disappointing. Other interventions to improve diet during pregnancy have had little effect on maternal and newborn health outcomes. Comparatively few interventions have been made for preconception diet and lifestyle. Improvements in the measurement of pregnancy planning have quantified the degree of pregnancy planning and suggest that it is more common than previously recognised. Planning for pregnancy is associated with a mixed pattern of health behaviours before conception. We propose novel definitions of the preconception period relating to embryo development and actions at individual or population level. A sharper focus on intervention before conception is needed to improve maternal and child health and reduce the growing burden of non-communicable diseases. Alongside continued efforts to reduce smoking, alcohol consumption, and obesity in the population, we call for heightened awareness of preconception health, particularly regarding diet and nutrition. Importantly, health professionals should be alerted to ways of identifying women who are planning a pregnancy.

Reference

Origins of lifetime health around the time of conception: causes and consequences

Summary

Parental environmental factors, including diet, body composition, metabolism, and stress, affect the health and chronic disease risk of people throughout their lives, as captured in the Developmental Origins of Health and Disease concept. Research across the epidemiological, clinical, and basic science fields has identified the period around conception as being crucial for the processes mediating parental influences on the health of the next generation. During this time, from the maturation of gametes through to early embryonic development, parental lifestyle can adversely influence long-term risks of offspring cardiovascular, metabolic, immune, and neurological morbidities, often termed developmental programming. We review periconceptional induction of disease risk from four broad exposures: maternal overnutrition and obesity; maternal undernutrition; related paternal factors; and the use of assisted reproductive treatment. Studies in both humans and animal models have demonstrated the underlying biological mechanisms, including epigenetic, cellular, physiological, and metabolic processes. We also present a meta-analysis of mouse paternal and maternal protein undernutrition that suggests distinct parental periconceptional contributions to postnatal outcomes. We propose that the evidence for periconceptional effects on lifetime health is now so compelling that it calls for new guidance on parental preparation for pregnancy, beginning before conception, to protect the health of offspring.

Reference

Intervention strategies to improve nutrition and health behaviours before conception

Summary

The nutritional status of both women and men before conception has profound implications for the growth, development, and long-term health of their offspring. Evidence of the effectiveness of preconception interventions for improving outcomes for mothers and babies is scarce. However, given the large potential health return, and relatively low costs and risk of harm, research into potential interventions is warranted. We identified three promising strategies for intervention that are likely to be scalable and have positive effects on a range of health outcomes: supplementation and fortification; cash transfers and incentives; and behaviour change interventions. On the basis of these strategies, we suggest a model specifying pathways to effect. Pathways are incorporated into a life-course framework using individual motivation and receptiveness at different preconception action phases, to guide design and targeting of preconception interventions. Interventions for individuals not planning immediate pregnancy take advantage of settings and implementation platforms outside the maternal and child health arena, since this group is unlikely to be engaged with maternal health services. Interventions to improve women’s nutritional status and health behaviours at all preconception action phases should consider social and environmental determinants, to avoid exacerbating health and gender inequalities, and be underpinned by a social movement that touches the whole population. We propose a dual strategy that targets specific groups actively planning a pregnancy, while improving the health of the population more broadly. Modern marketing techniques could be used to promote a social movement based on an emotional and symbolic connection between improved preconception maternal health and nutrition, and offspring health. We suggest that speedy and scalable benefits to public health might be achieved through strategic engagement with the private sector. Political theory supports the development of an advocacy coalition of groups interested in preconception health, to harness the political will and leadership necessary to turn high-level policy into effective coordinated action.

Reference

Glyphosate exposure associated significantly with shortened pregnancy lengths

Glyphosate exposure in pregnancy and shortened gestational length: a prospective Indiana birth cohort study

2018 Study Abstract

Background
Glyphosate (GLY) is the most heavily used herbicide worldwide but the extent of exposure in human pregnancy remains unknown. Its residues are found in the environment, major crops, and food items that humans, including pregnant women, consume daily. Since GLY exposure in pregnancy may also increase fetal exposure risk, we designed a birth-cohort study to determine exposure frequency, potential exposure pathways, and associations with fetal growth indicators and pregnancy length.

Method
Urine and residential drinking water samples were obtained from 71 women with singleton pregnancies living in Central Indiana while they received routine prenatal care. GLY measurements were performed using liquid chromatography-tandem mass spectrometry. Demographic and survey information relating to food and water consumption, stress, and residence were obtained by questionnaire. Maternal risk factors and neonatal outcomes were abstracted from medical records. Correlation analyses were used to assess relationships of urine GLY levels with fetal growth indicators and gestational length.

Results
The mean age of participants was 29 years, and the majority were Caucasian. Ninety three percent of the pregnant women had GLY levels above the limit of detection (0.1 ng/mL). Mean urinary GLY was 3.40 ng/mL (range 0.5–7.20 ng/mL). Higher GLY levels were found in women who lived in rural areas (p = 0.02), and in those who consumed > 24 oz. of caffeinated beverages per day (p = 0.004). None of the drinking water samples had detectable GLY levels. We observed no correlations with fetal growth indicators such as birth weight percentile and head circumference. However, higher GLY urine levels were significantly correlated with shortened gestational lengths (r = − 0.28, p = 0.02).

Conclusions
This is the first study of GLY exposure in US pregnant women using urine specimens as a direct measure of exposure. We found that > 90% of pregnant women had detectable GLY levels and that these levels correlated significantly with shortened pregnancy lengths. Although our study cohort was small and regional and had limited racial/ethnic diversity, it provides direct evidence of maternal GLY exposure and a significant correlation with shortened pregnancy. Further investigations in a more geographically and racially diverse cohort would be necessary before these findings could be generalized.

Medicines and Medical Devices Safety Review : Joan Ryan MP Comments

Many critical issues still, despite a step in the right direction

In the Commons, Joan Ryan MP reacted to the UK Government announcing a Review into Primodos, Sodium Valproate, Vaginal Mesh.

During a Ministerial Statement on ‘Medicines and Medical Devices Safety Review‘, Joan Ryan MP raised concerns about the hormone pregnancy test Primodos, following new evidence that has shown that the drug does have the potential to deform embryos.

House of Commons and House of Lords Debates

There have been growing calls for a public inquiry into the “Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests” scandal, after MPs debated the Primodos drug’s legacy.

Severals MPs have joined the Primodos campaigners to say that the Expert Working Group review was a complete whitewash.

2018

  • House of Lords’ talks ref “Medicines and Medical Devices Safety Review“, 22 February 2018 – 11:48:58 parliamentlive.tv.
  • House of Commons’ talks ref “Medicines and Medical Devices Safety Review“, 21 February 2018 – 12:48:42 parliamentlive.tv.

2017

  • House of Lords’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 17:53:45 parliamentlive.tv.
  • House of Commons’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 10:40:26 parliamentlive.tv.
  • House of Commons’ talks ref “Hormone pregnancy tests“, 14 December 2017 – 15:20:54 parliamentlive.tv.

2016

  • House of Commons’ talks ref “Hormone pregnancy tests“, 13 October 2016 – 15:05:52 parliamentlive.tv.
  • House of Lords’ talks ref “Hormone pregnancy tests“, 21 January 2016 – 11:06:20 parliamentlive.tv.

More About Primodos

 

Medicines and Medical Devices Safety Review : Yasmin Qureshi MP Comments

Is putting three health scandals into one review a good thing ?

In the Commons, Yasmin Qureshi MP reacted to the UK Government announcing a Review into Primodos, Sodium Valproate, Vaginal Mesh.

Setting up another review is not enough, victims deserve better. Asked @Jeremy_Hunt to look at the new scientific evidence together with evidence of regulatory failings that show there was a cover-up. Its time that this was finally exposed and families given answers #Primodos

Yasmin Qureshi Tweets

House of Commons and House of Lords Debates

There have been growing calls for a public inquiry into the “Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests” scandal, after MPs debated the Primodos drug’s legacy.

Severals MPs have joined the Primodos campaigners to say that the Expert Working Group review was a complete whitewash.

2018

  • House of Lords’ talks ref “Medicines and Medical Devices Safety Review“, 22 February 2018 – 11:48:58 parliamentlive.tv.
  • House of Commons’ talks ref “Medicines and Medical Devices Safety Review“, 21 February 2018 – 12:48:42 parliamentlive.tv.

2017

  • House of Lords’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 17:53:45 parliamentlive.tv.
  • House of Commons’ talks ref “Hormone pregnancy tests“, 16 November 2017 – 10:40:26 parliamentlive.tv.
  • House of Commons’ talks ref “Hormone pregnancy tests“, 14 December 2017 – 15:20:54 parliamentlive.tv.

2016

  • House of Commons’ talks ref “Hormone pregnancy tests“, 13 October 2016 – 15:05:52 parliamentlive.tv.
  • House of Lords’ talks ref “Hormone pregnancy tests“, 21 January 2016 – 11:06:20 parliamentlive.tv.

More About Primodos

 

 

Hormone Pregnancy Test Drug Primodos : Here is Gaynor’s Story

“Made In Birmingham” Interview, 21 Feb 2018

Gaynor Cotterill was born without a left arm after her mother took Primodos. This is her story.

UK Government announces a Review into Primodos, Sodium Valproate, Vaginal Mesh

Baroness Cumberlege will lead an examination of the circumstances in all three health cases and consider whether there are grounds for wider inquiries

The UK Prime Minister has ordered a review of public health scandals involving the hormone-based pregnancy test drug Primodos, the use of vaginal mesh implants and the anti-epilepsy drug sodium valproate.

In the Commons, Jeremy Hunt has announced a review into public health scandals caused by failings in the regulation of vaginal mesh implants, anti-epilepsy drug sodium valproate and hormone-based pregnancy test drug Primodos.

On Twitter

Controversial pregnancy test drug shows deformities in zebrafish embryos within hours of exposure

Primodos drug components can cause embryonic damage in a dose and time responsive manner

“This is a great stepping stone. It doesn’t give definitive answers, but it’s a start, so we can finally put to rest whether or not Primodos caused birth defects

Dr Vargesson says.

The components of a controversial drug, allegedly linked to birth defects in the 1960s and ’70s, caused deformations to fish embryos just hours after they received a dose in new studies by researchers at the University of Aberdeen.

Primodos was a hormone pregnancy test used by thousands of women in the UK between 1958 and 1978.

“The first step was to show the drug has caused problems in fish and hopefully that will lead to some funding for tests on mammals and other tissues to show exactly what is going on.”

Dr Vargesson says.

Research at the time suggested the drug could be linked to a higher risk of women giving birth to babies with abnormalities – a claim denied by Primodos’ manufacturer.

Although Primodos is no longer in use, its components (Norethisterone acetate and Ethinyl estradiol) are used in other medications today including treatments for endometriosis and contraceptives.

“This research helps the campaigners because they can see there has been some up-to-date science being done with modern techniques.”

Dr Vargesson says.

In November last year a UK Government expert working group (EWG) study found no ‘causal association’ between the drug and the abnormalities, stating that outdated methods used by scientists in the 1970s was partly responsible for a failure to find a connection.

Now a new study at the University of Aberdeen, published today in the Scientific Reports journal, has revealed more about the effects of Primodos’ components on the embryos of zebrafish

The paper outlines how after the components of Primodos were added to water around zebrafish embryos, their movement slowed down rapidly; developed changes to the heart within four hours; and within 24 hours displayed damage to tissues such as the fins, eyes and spinal cords.

“I would like to think the PM will take this on board and consider there might be an alternative decision to the one the Commission On Human Medicines made in the Westminster report.”

Dr Vargesson says.

More surprisingly, according to the researchers, the study showed that the drug accumulates in the zebrafish embryo over time. They suggest that if this also occurs in a mammalian species that even a seemingly low dose of the drug for the mother could result in much higher levels for the embryo.

This latest study was led by Dr Neil Vargesson from the University of Aberdeen, who has also published extensive research into thalidomide – a drug used in Germany in the 1950s to treat morning sickness but which caused thousands of babies worldwide to be born with malformed limbs.

“At the moment the scientific research into whether or not Primodos caused these birth defects is inconclusive.”

“What this study highlights is that there is a lot still to be learned about Primodos and more widely its components effects on mammals.”

“Our experiments with the zebrafish embryos shows quite clearly the effects the Primodos components have. This does not mean it would do the same in humans of course, we are a long way from saying that but we need to carry out more research into these components because they are still in drugs today and in some cases in much higher doses than those found in Primodos.”

“The assumption by some previously has been that the doses given to mothers was too low to cause any damage but our study shows that the levels of Primodos’ components accumulate in the embryos over time because they don’t have a fully functional liver that can break down the drug. This too is new information and if the same thing happens in mammals, these drugs could build up in the embryo to much higher levels than shown in the mother’s blood.”

Dr Vargesson explains.

More About Primodos

Primodos 2018 Study : Yasmin Qureshi MP Comments

New Primodos study found that pregnancy tests had potential to deform embryos

I was on Sky News earlier to discuss ground breaking new research from Aberdeen University that shows Hormone Pregnancy Test drug Primodos had the potential to deform embryos in the womb, something I have long been campaigning on. Victims and families have been denied answers and justice for over 40 years. The Prime Minister and Health Secretary must take note of this evidence and set up an Independent Inquiry that seeks to put families first.

Yasmin Qureshi MP
13 February 2018 on Facebook.

More About Primodos