Insights from outside BJOG

There is an increased risk of breast cancer with hormonal contraceptive use according to research carried out 2 or 3 decades ago. Studies found a small relative risk of 1.20 for current hormonal contraceptive users – mainly oral contraceptives – compared with never users. Since then, hormone sophistication and modes of delivery have advanced, as have data collection methods, so a report from Denmark with up-to-date information is helpful (Mørch et al. NEJM 2017;377:2228–39). ‘Big data’ are available since the Danish can link national prescription fulfilment to breast cancer diagnoses and integrate personal information to take into account many previously confounding variables. They monitored all the women of their country of reproductive age and were able to calculate the risk of breast cancer developing in relation to hormone use of current contraceptive products. After following nearly 2 million women for 10 years they found a relative risk of breast cancer of 1.20 (CI: 0.96–1.23) for women using hormonal contraception compared with never users. This risk increased with duration of use and remained elevated for 5 years post cessation although this lingering risk depended on how long the contraceptive was used. Types of oral contraceptives varied within a narrow range and the increase for progestin-only intrauterine devices was similar (RR 1.21 CI: 1.11–1.33). These relative risks translate into small absolute risks being an increase of 13 per 100 000 person-years or 1 extra breast cancer case for 7 800 women using hormonal contraception for 1 year. The interpretation of these outcomes are put into perspective in an editorial by Hunter (NEJM 2017;377:2276–7) as follows: Firstly, there is a high probability of these findings being accurate given the completeness and volume of the data, the prospective collection and its consistency. Secondly, the data included women aged between 40 and 50 years when the risk of breast cancer rises, when in fact for women under the age of 35 years the absolute increased risk is only 2 per 100 000 women years. Most of the diagnoses of breast cancer in the study were in women over the age of 40 years. Thirdly, hormonal contraceptives have a wide range of advantages which need to be weighed against the small increase in breast cancer risk. These are effective contraception, decreased dysmenorrhoea, menorrhagia, anaemia, acne and other malignancies in later life such as substantial reductions in the risk of ovarian, endometrial and colo-rectal cancers. The probability is that there is a net decrease in overall cancer risk associated with using hormonal contraceptives for 5 years. Two papers recently published suggest links between folate supplementation in pregnancy and the risk of autism spectrum disorders (ASD) in offspring. The first is an observational cohort study of Israeli children born about 10 years ago and followed-up for the diagnosis of ASD and relating it to folate supplementation by their mothers (Levine et al. JAMA 2018. https://doi.org/10.1001/jamapsychiatry.2017.4050). 1.3% of the children had ASD and the researchers showed that mothers who took folate and/or multivitamins were statistically significantly less likely to have a child with ASD compared with those not taking such supplements. Their risk ratios for prepregnancy supplementation were 0.39 (CI: 0.30–0.50) and for supplementation during the pregnancy 0.27 (CI: 0.22–0.33). There were over 45 000 children in the study and the convincing results of maternal consumption before and during pregnancy for the prevention of ASD have important public health implications if corroborated. The second study is from Norway and concerns the use of folate in epileptic women taking anti-epileptic drugs (AED) in pregnancy (Bjørk et al. JAMA 2017. https://doi.org/10.1001/jamaneurol.2017.3897). It is established that women on AEDs have a greater risk of giving birth to children with ASD than the general population (including women with epilepsy not on medication) but it is not known whether folate supplementation reduces such risk. The researchers tracked over 100 000 children and found that they were less likely to suffer from ASD if their epileptic mothers had taken folate as well as AEDs compared with epileptic mothers taking AEDs but not folate. The risk ratio at 1.5 years was 5.9 (CI: 2.2–15.8) and at 3 years was 7.9 (CI: 2.5–24.9). The degree of autistic trait ‘protection’ was positively associated with maternal plasma folate levels at 18 weeks of gestation. Women without epilepsy (and those with epilepsy but not taking AED) also had lowered risks of having children with ASD if they took folate before and during their pregnancy. These results together with the protection offered by folate in reducing the risks of neural tube defects and other congenital abnormalities (Viswanathan et al. JAMA 2017;317:190–203), should encourage all women likely to, or wishing to conceive to supplement their diet with folate and/or multivitamins containing folate. The debate concerning the use of hormone therapy as a preventative measure postmenopausally is likely to be ongoing. Its use in the long term (greater than 7 years) to prevent chronic conditions is not supported by current data nor is it recommended by authoritative organisations, and so its use is presently confined to the relief of climacteric symptoms. However, there is evidence that if estrogen therapy is initiated perimenopausally it may reduce cardiovascular risks and possibly breast cancer likelihood if used exclusively in hysterectomised women. These possibilities raise the issue of ‘preventative perimenopausal’ use and research continues to be published which validates or refutes the harm/benefit ratios. Another aspect of the menopause transition and the early postmenopause is the effect of variations in estrogen levels on a woman's mental status. Fluctuations in circulating estrogens are associated with vasomotor and sleep disturbances. These symptoms may be responsible for mood disorders or depressive episodes may be caused by estrogen lack directly. Whatever the mechanism, hormonal therapy could have a protective effect on the development of depressive symptoms at this vulnerable time. To test this hypothesis researchers conducted a placebo-controlled trial on a group of perimenopausal women and measured the effect on their mental health (Gordon et al. JAMA Psychiatry 2018;75:149–57). They used transdermal estradiol continuously with intermittent micronised progesterone for 1 year and observed the women's depressive symptoms. The results were positive in that fewer women developed clinically significant depression but there were more side effects, particularly vaginal bleeding. On balance the authors recommend its use to prevent mood disorders but an editorial (Joffe and Hickey JAMA Psychiatry 2018;75:125–6) calls for high quality evidence before moving towards considering depression prevention as an indication for hormone therapy. They describe the study as interesting and provocative and the outcomes will certainly be noted. It appears that there is an association between air pollution and a woman's risk of having a preterm delivery. A study of over 1.3 million births in China showed that pregnancies exposed to air polluted by very small particulate matter were at increased risk of having a spontaneous preterm birth (Wang et al. JAMA Pediatr 2018. https://doi.org/10.1001/jamapediatrics.2017.4872). The overall preterm rate was 8% but there appeared to be a ‘dose-related’ effect. Air pollution exposure was associated with an overall preterm birth rate of 1.09 (CI: 1.09–1.10). Very preterm birth rate ratios (less than 32 weeks) rose to 1.20 (CI: 1.18–1.23) and extremely preterm birth rates (below 28 weeks) were 1.29 (CI: 1.25–1.34). They also showed the risk was greater for vulnerable women; those who were older, overweight or from rural areas (Figure 1). A second study, this time from London, assessed air quality and birthweight in relation to pollution and noise (Smith et al. BMJ 2017;395:j5299). There were changes from the lowest to the highest quartiles from 2% to 6% for low birthweight and from 1% to 3% for small-for-gestational-age births. Noise was not correlated to either measure. The authors estimate that 3% of low birthweight births are attributable to the particulate and chemical atmosphere. Another effect air quality has on babies is the length of their telomeres. Infants born to mothers breathing polluted air have shorter telomeres – which are the sequence of base pairs at the end of each chromosome. Each time a cell divides (ages) the length of the telomeres decrease and it is suggested that telomere length can predict the longevity of that cell and hence the organism. A study from Belgium (Martens et al. JAMA Pediatr. 2017;171:1160–7) has demonstrated shorter telomeres in infants whose mothers were exposed to greater pollution compared to those whose mothers breathed clean air during their pregnancy. This is an example of an epigenetic effect where the infant inherits its potential not only from her or his parents but from the environment – in this case the intrauterine milieu. There is little pregnant women can do if they find themselves in a polluted environment and it may be counterproductive to ‘warn’ her of the consequences but these studies add an obstetric impetus to public health motivations for clean air policies. This comparative effectiveness review, produced by the U.S. Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program, aims to assess current treatment effectiveness for fibroids, risk of harms including the risk of leiomyosarcoma in women with fibroids and the extent to which individual or fibroid characteristics has any influence on outcomes. The review focuses on addressing four key questions covering (1) effectiveness of treatments for fibroids; (2) influence of patient/fibroid characteristics on effectiveness; (3) risk of leiomyosarcoma when mass thought to be a fibroid; (4) factors affecting leiomyosarcoma survival. Treatments assessed in this review include: contraceptives; non-steroidal anti-inflammatory agents; gonadotropin-releasing hormone agonists (GnRH); progesterone receptor agents; estrogen receptor agents; antifibrinolytics; combined hormonal replacement treatment (HRT); uterine artery occlusion; uterine artery embolisation; high intensity focused ultrasound; radiofrequency ablation; endometrial ablation; hysterectomy; myomectomy. The review discusses limitations identified in the evidence base for the management of fibroids and sets out some research recommendations. In terms of the key findings the review report includes summary tables for each intervention including the strength of the evidence and a summary and key points are also provided for each of the four review questions. Available online at www.effectivehealthcare.ahrq.gov This High Impact Practices in Family Planning Brief, produced by the U.S. Agency for International Development, focuses on the use of digital technologies to support health care systems and family planning service delivery. The brief reports on the experiences and evidence for the most commonly used digital health technologies including mobile phones and SMS. It reports on use to reduce contraceptive stock-outs, health management information systems for programme monitoring and evaluation, health workforce information solutions for managing the health workforce, the use of mobile money to improve efficiency and transparency of financial transactions and digital applications to help with improving clinician knowledge and to aid client-provider interactions. The briefing outlines a number of tips for implementing digital health technologies to help strengthen family planning systems and provides links to useful tools and resources. Key messages include: family planning indicators should be incorporated into new and existing digital health and logistics management information systems; more research is needed about when and how digital applications for provider support are most effective, efficient, and scalable; mobile money and electronic financial transactions have the potential to provide efficiency and transparency of health care financing and transactions. Available online at www.fphighimpactpractices.org In response to the conclusions drawn from the WOMAN Trial which investigated the effectiveness of tranexamic acid for the treatment of women with postpartum haemorrhage and which was conducted in almost 200 hospitals located in high, middle and low-income countries, the World Health Organization has conducted a technical consultation and published updated guideline recommendations. The updated recommendations relate to the early (within 3 hours of birth) use of intravenous tranexamic acid in addition to usual care for women who gave birth either vaginally or by caesarean section and who have been clinically diagnosed with postpartum haemorrhage. The recommendation report comprehensively sets out the evidence behind the updated recommendation, outlines a number of future research implications and discusses dissemination, implementation and applicability issues. Available online at www.who.int Developed by K4Health, Pathfinder International and Evidence to Action (E2A), this toolkit aims to support programme development and implementation. The toolkit focuses on the sexual and reproductive health needs of first-time parents and young married women and addresses topics specifically relevant to this group including healthy timing and spacing of pregnancies, contraception, maternal and newborn health, gender equality, couples’ communication and healthy relationships, HIV prevention, gender-based violence and general life skills. The toolkit provides links to resources on essential knowledge and evidence and implementation experiences. Links to training resources and curricula developed for health service providers, community health workers and other audiences are also listed and numerous tools and job aids are included to guide health professionals working with first-time parents and young married women. Society of Obstetricians and Gynaecologists of Canada (SOGC) The following guideline is now available at www.jogc.com No. 355-Physiologic Basis of Pain in Labour and Delivery: An Evidence-Based Approach to its Management, February 2018 U.S. Preventative Services Task Force (USPSTF) The following guideline is now available at www.uspreventiveservicestaskforce.org Final Recommendation Statement: Screening for Ovarian Cancer Faculty of Sexual and Reproductive Healthcare The following guideline is now available at www.fsrh.org FSRH CEU Statement on Contraception for Women using Known Teratogenic Drugs, February 2018 American College of Obstetricians and Gynecologists (ACOG) The following guidelines are now available at www.acog.org Fatigue and Patient Safety (Committee Opinion) No. 730, February 2018 Group Prenatal Care (Committee Opinion), No. 731, March 2018 Practice Advisory: Hepatitis B Prevention Royal College of Obstetricians and Gynaecologists (RCOG) The following guideline is now available at www.rcog.org Esmya (ulipristal acetate) - MHRA safety alert, February 2018 Multiple Pregnancy Following Assisted Reproduction (Scientific Impact Paper No. 22), February 2018 Society for Maternal-Fetal Medicine The following guideline is now available at www.smfm.org SMFM Statement Pharmacological treatment of gestational diabetes The following patents can be found online at http://worldwide.espacenet.com This patent application relates to an assay and kit for identifying the implantation potential of an oocyte before fertilisation to improve the chances of successful implantation in assisted reproduction. Specifically, the authors have discovered variations in the levels of cytokines and growth factors contained in the follicular fluid of the follicle of oocytes obtained following ovarian stimulation, and they suggest that there is a correlation between a high level of granulocyte-colony stimulating factor (G-CSF) in the follicular fluid from an oocyte and a higher implantation potential of an embryo from that oocyte. Lédée N, Piccinni M-P, Lombroso R. 10 January 2018. This patent application outlines the development of a method for the early detection of ovarian cancer based on the collection of cells from a cervical smear or endometrial biopsy and the identification, within those cells, of the presence of a set of mRNA isoforms that are only expressed in ovarian tumour cells. This application claims the benefit of the filing date of U.S. application Ser. No. 62/340,876, filed on May 24, 2016, the disclosure of which is incorporated by reference herein. Barrett C, Carson DA, Frazer K. 30 November 2017. This patent application discusses compositions and methods for treating infertility in women, in particular those with diminished ovarian reserve, natural ageing, premature ovarian ageing and gonadotoxic treatment. Specifically this treatment involves administering an effective dose of anti-Müllerian hormone (AMH) ranging from l00 ng per day to about 44 000 ng per day for around 30 days to about 90 days. This application claims priority to U.S. Provisional Patent Application No. 62/128,127 filed March 4, 2015, the contents of which is incorporated by reference herein in its entirety. Sen A, Gleicher N, Kushnor VA. 10 January 2018. This patent application outlines a method for determining a fertility period for a woman. Specifically, this involves using a device, which is worn during sleep, that contains a noninvasive heart sensor to monitor the heart rate allowing for a calculation of a minimal sleep heart rate (MSHR) which can be compared with values obtained over several nights to determine the probability of ovulation. Buard N, Yang R, Besnard M, Hutchings C. 16 January 2018. Recently, the Irish Parliament Joint Committee on the Eighth Amendment of the Constitution voted to recommend the full repeal of the Eight Amendment of the Irish Constitution which would, if passed, legally allow a woman to request, without requiring a reason, a termination of pregnancy within the first 12 weeks of pregnancy. This recommendation now has to be considered by the Irish government and parliament and following this a constitutional referendum of the electorate will be held later in 2018. Source: www.reproductiverights.org Recently, in San Salvador, the Second Tribunal of Sentence has upheld a ruling where a pregnant woman, who reportedly suffered a stillbirth, was sentenced to 30 years in prison. Currently, in El Salvador termination of pregnancy is illegal in all circumstances and women can be convicted when they suffer pregnancy-related complications and miscarriages. Source: www.reproductiverights.org Clinicians keen to keep up-to-date regarding clinical studies that are currently recruiting may find the following informative.■

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