Insights from outside BJOG

Pre-eclampsia is a leading cause of maternal and perinatal mortality and morbidity. It accounts for a major portion of antenatal surveillance, admissions, in-patient hospital resources, post-natal care and neonatal services Even when signs or symptoms arise, making the diagnosis requires an array of haematological, renal and hepatic tests before management protocols can be instituted. It would be useful to have a biochemical test that would confirm or refute the diagnosis, allowing swifter decisions to be made. One such candidate marker is placental growth factor (PlGF), and levels in maternal plasma have been researched in the clinical setting. To evaluate its application, over 1000 women in the UK who developed signs or symptoms of pre-eclampsia had their PlGF levels measured, then had the results revealed or withheld. The researchers calculated whether PlGF levels made a difference in the time to diagnosis (Duhig et al. Lancet 2019;393:1807–18). When clinicians were informed of the results, the diagnosis of pre-eclampsia took 2 days whereas when the results were withheld it took 4 days. This accelerated diagnostic strategy allowed decisions to be made more expediently protocols to be implemented promptly, and maternal morbidity was significantly reduced. There was no difference in fetal or neonatal outcomes but there were shorter neonatal intensive care stays in the ‘revealed’ group so its practical application is supported by these results. The high sensitivity of PlGF for diagnosing or excluding pre-eclampsia will make a material difference to services. In this trial, a PlGF of less than 100 pg/ml prior to 35 weeks’ gestation had a sensitivity of 95%, specificity of 53%, a positive predictive value of 26% and a negative predictive value of 98%. The fact that in-patient days will be reduced has attracted UK authorities’ attention, with NHS England saying access to the test should be rolled-out with immediate effect. This means that patients can be reassured as appropriate and referrals made as required (Iacobucci BMJ 2019;365:l1543). There are many advantages to using minimally invasive surgical techniques for removing the uterus for benign indications. These include patient comfort, scar aesthetics, duration of hospital stay, less post-operative analgesia, faster return to normal function and financial savings. This is apparent in the increase in the proportion of laparoscopic hysterectomies in the UK in recent years (Madhvani et al. BJOG 2019;126:795–802). There is evidence that removing the indwelling catheter at the end of the procedure offers some advantages to leaving it in situ for some hours (Sandberg et al. BJOG 2019;126:804–13) but there may be merit in filling the bladder then removing the catheter. One of the factors in out-patient hysterectomy duration-of-stay is the time to spontaneous micturition post-operatively, which in turn dictates the time spent in the post-anaesthetic care unit. If the Foley's catheter is removed at the end of the procedure then the woman's bladder must fill spontaneously to micturition levels before she can void and be discharged. Two trials have been published showing advantage in ‘back-filling’ the patient's bladder with 150 ml of saline before removing the catheter (Moawad et al. Am J Obstet Gynecol 2019;220:367e1–7 and Chao and Mansuria Obstet Gynecol 2019;133:879–87). Both studies confirmed shorter voiding intervals and shorter post-operative stays when the bladder was filled, compared with when it was emptied. This counter-intuitive technique is a cost-saver that is readily introducible as standard procedure. Is there a place for bladder filling in other gynaecological or even obstetric operations? A threatened miscarriage occurs in approximately one in four pregnancies. It is defined as bleeding with a closed cervix and 25% of such pregnancies will not survive to viability so the risk to the fetus is substantial. When bleeding occurs there may be an obligation to ‘do something to help’ by care providers but the evidence that anything actually ‘protects’ the pregnancy is not convincing. Advice about supplements, rest and avoidance of coitus or other measures is well meaning but not evidence based. A trial of more than 4000 pregnancies complicated by bleeding in the first trimester was conducted in the UK to test the efficacy of progesterone treatment (Coomarasamy et al. N Engl J Med 2019;380:1815–24). Half were given 400 mg micronised progesterone as a vaginal suppository twice a day until 16 weeks’ gestation and half received a placebo. There was no significant difference (20% versus 22%) in the number of pregnancies that did not result in a live birth beyond 34 weeks’ gestation so the authors believe that expectant management is all that can be offered at present. Population rates of miscarriage vary with reports but are conservatively estimated to be at least 15% for most groups. Commonly associated factors are maternal age and pregnancy history, with data from Norway providing the most precise national statistics (Magnus et al. BMJ 2019;364:l869). The lowest rates were found in women in their 20s (10%) and highest for those over 45 years (53%). Rates rise rapidly over the age of 35 years. A history of previous miscarriage was also a strong predictive factor (Figure 1). Source: Magnus et al. BMJ 2019;364:l869. Modest increases were associated with previous preterm delivery, stillbirth, caesarean section and gestational diabetes, and a slight increase was found in those who themselves had been born small for gestational age. Scotland has published the outcomes of its human papilloma virus (HPV) immunisation programme for women born in the mid-1990s (Palmer et al. BMJ 2019;365:l1161). The researchers looked at the prevalence of cervical intra-epithelial neoplasia (CIN) in women being screened by cytology at age 20 years. They compared women born in the 1980s before HPV vaccination was available with those born after it was introduced as routine. The Scottish programme details include: The results comparing a pre-vaccination cohort (1980s) with those who were vaccinated (1990s) are given in Table 1. The bivalent vaccine also provided protection against other high-risk HPV types. There was evidence of herd immunity in that non-vaccinated women growing up within a group of mostly vaccinated peers had lower CIN rates than previous generations. Younger age at immunisation (12–13 years) was associated with greater vaccine effectiveness compared with 17 year olds. This is real-world proof that vaccination results in a dramatic reduction in pre-invasive cervical cancer. There is also evidence of herd immunity without rebound effects of other types of HPV replacing the targeted strains or mutations. Also, no serious adverse effects were demonstrably linked to the vaccine. These data will encourage those in low- and middle-income countries to continue to fight for immunisation programmes to be rolled out where the need is greatest. Then, remarkable impacts (Brotherton BMJ 2019;365:l1375) will be celebrated. Anorexia nervosa is a devastating disorder with an array of difficulties, not least of which are the physical disruptions it brings. One such condition is bone loss, which can partially be protected against by the use of oral contraceptives (OCs) according to a study from France (Maïmoun et al. Fertil Steril 2019;111:1020–29.e2). Women with anorexia had less bone loss when using OCs than their contemporaries not using OCs; some hormonal effect was provided that increased with duration of use. Functional hypothalamic amenorrhoea is found in situations of malnutrition, excessive stress or physical activity, and a broad approach is recommended by the Endocrine Society (Gordon et al. J Clin Endocrinol Metab 2017;102:1413–39). Their recommendations are transdermal estradiol along with an oral progestin, together with holistic interventions for this complex pathology. It is presumed that most women know that smoking is detrimental to them and to the health of their fetus during pregnancy. Despite this, 75% of smokers continue to smoke after they conceive, which attests to the addictive nature of cigarettes, but what about e-cigarettes? Nicotine from e-cigarettes is toxic to the development of the fetal brain and lungs (Kapaya et al. MMWR Morb Mortal Wkly Rep 2019;68:189–94) as well as a cause of maternal cardiovascular pathology and fetal growth restriction. In a national survey of American women in their reproductive years, it was found that the use of e-cigarettes was the same amongst pregnant and non-pregnant women (Liu et al. JAMA Pediatr 2019;173:600–2). This suggests that the nicotine addiction is as strong as in conventional smoking or that people perceive a lack of harm from the practice. Clearly the dangers from the habit of inhaling vapours from e-cigarettes have not reached the public. Aimed at Government decision-makers, public health practitioners and partner organisations, the World Health Organization (WHO) has recently published recommendations for digital interventions for health system strengthening. The guideline aims to help ensure evidence-based decisions are made regarding the choice and implementation of digital health interventions to address health system needs. The guideline provides a review of numerous digital health interventions including birth notification via mobile devices, death notification via mobile devices, stock notification and commodity management via mobile devices across all health conditions, targeted client communication via mobile devices (spread across five population groups for sexual, reproductive, maternal, newborn, child and adolescent health), health worker decision support via mobile devices across all health conditions and provision of training to health workers via mobile devices (mLearning) across all health conditions. Chapter 3 assesses the evidence for each intervention and presents recommendations. For each of the digital interventions assessed, the following criteria are used: effectiveness, acceptability, feasibility, resource use and gender equity and human rights. These are presented alongside implementation considerations such as legislation, policy and compliance, services and applications, workforce, infrastructure and justifications for each recommendation. In terms of birth and death notification via mobile devices, the guideline specifically focuses on gathering evidence regarding the added value that notification via mobile devices presents over existing civil registration and vital statistics systems, and two key recommendations are set out. In terms of targeted client communication via mobile devices for sexual, reproductive, maternal, newborn, child and adolescent health, one key recommendation is provided along with information regarding links to related WHO recommendations. Chapter 4 provides information on linking recommendations across the health system and Chapter 5 highlights research gaps and considerations for the design of future evaluations. Annex 5 presents a very useful set of evidence maps and illustrative research questions and web supplement 1 reports the evidence-to-decision framework for each recommendation. This Morbidity and Mortality Weekly Report from the US Centres for Disease Control and Prevention presents data on the risk factors for mother-to-child transmission of congenital syphilis from Suzhou, China, 2011–2014. The report states that it is estimated that 930 000 maternal syphilis infections caused 350 000 adverse pregnancy outcomes worldwide in 2012 and that mother-to-child transmission of syphilis continues to be a global health issue despite elimination of congenital syphilis being one of the WHO millennium development goals. The report is based on a cohort of pregnant women recruited in July 2011–July 2014 in Suzhou, eastern China, who had received a new syphilis diagnosis. For each of the women's newborn infants, clinical, laboratory and treatment data were recorded, and the infants were followed up at 3, 6, 9, 12, 15 and 18 months of age. The study found that late diagnosis of syphilis during pregnancy was a significant risk factor for congenital syphilis, and every ‘twofold increase of maternal nontreponemal or treponemal antibody titres doubled the odds of delivering an infected infant’. Table 1 presents data on the characteristics of mothers with syphilis and infants’ biological fathers associated with congenital syphilis (univariate analysis) from Suzhou, China, 2011–2014. Table 2 contains data on the risk factors associated with congenital syphilis among 155 women with syphilis (multivariable analysis). Published by the WHO, this handbook has been developed to support programme managers in conducting an adolescent health services barriers assessment (AHSBA) to identify sub-populations of young people who do not currently have effective access to health services, with the eventual aim of addressing the barriers to care that they are experiencing. The handbook is based on the five dimensions of the Tanahashi Framework for effective health service coverage: availability, accessibility, acceptability, contact/use and effective coverage. With the aim of building in-country capacity, the handbook consists of seven training modules covering assessment preparation, national key informant interviews, literature review, quantitative data mining, sub-national qualitative research, reporting of findings and potential actions, national stakeholder workshop to review findings and plan actions. The modules include clear objectives, examples, questions and decision points, templates and a list of outputs. Appendix 1 includes a generic plan for a national adolescent health services barriers assessment including a timeline, terms of reference and budget; Appendix 7 provides an overview of evidence-based adolescent health interventions; and Appendix 4 includes a very useful list of online quantitative databases for potential mining. This high-impact practice brief, developed by the Family Planning High Impact Practices programme at Johns Hopkins University, aims to provide up-to-date advice and resources for health professionals providing post-abortion family planning services to women. The briefing states that post-abortion family planning has been identified by an international technical advisory group as one of several key high-impact practices in the effective provision of a comprehensive family planning services. The briefing specifically considers two key questions of importance to post-abortion care (PAC): what challenges can post-abortion family planning help countries to address and what is the evidence that post-abortion family planning is high impact? Section 4 provides practical tips based on previous implementation experiences including addressing stigma, and social and community barriers, offering PAC at primary care facilities and allowing nurses and midwives to provide care to expand access and reduce costs, investing in quality, addressing the needs of PAC clients facing gender-based violence, making contraception free or bundling it with the cost of post-abortion treatment and ensuring equitable access to post-abortion contraception. A list of appropriate contraceptive methods is provided, highlighting those that can be started immediately following an abortion and those that require a delay before starting. Tools and resources for obtaining further information are also listed including a link to an e-learning course. International Federation of Gynecology and Obstetrics (FIGO) The following guideline is now available at www.figo.org Initiative on Pre-eclampsia: A Pragmatic Guide for First-Trimester Screening and Prevention Society of Obstetricians and Gynaecologists of Canada (SOGC) The following guidelines are now available at www.jogc.com No. 381-Assisted Vaginal Birth No. 380-Investigation and Management of Prenatally Identified Microcephaly American College of Obstetricians and Gynecologists (ACOG) The following guidelines are now available at www.acog.org Management of Acute Obstructive Uterovaginal Anomalies. (Committee Opinion), No. 779, June 2019 Diagnosis and Management of Hymenal Variants. (Committee Opinion), No. 780, May 2019 Infertility Workup for the Women's Health Specialist. (Committee Opinion), No. 781, May 2019 Prevention of Group B Streptococcal Early-Onset Disease in Newborns. (Committee Opinion), No. 782, June 2019 Royal College of Obstetricians and Gynaecologists (RCOG) The following guideline is now available at www.rcog.org.uk Care of Women Presenting with Suspected Preterm Prelabour Rupture of Membranes from 24+0 Weeks of Gestation (Green-top Guideline No. 73) US2019117443 (A1) Flexible cone-shaped intra-vaginal support device. This patent application relates to the invention of a flexible and non-absorbent vaginal insert device for the treatment of pelvic organ prolapse and urinary incontinence. The device has been designed to ensure that it can be easily and comfortably inserted and removed by the patient. The present patent application claims priority to previously filed US Provisional Patent Application Ser. No. 62/283,092, filed 20 August 2015. Conti A. 25 April 2019. WO2019078577 (A1) Methods and systems for assessing ovarian parameters from ultrasound images. This patent application relates to methods and systems using both two-dimensional (2D) and three-dimensional (3D) ultrasound images of an ovary to quantify ovarian parameters in order to diagnose disorders of the female reproductive tract such as the causes of infertility or diseases such as ovarian cancer. Narra RT, Sivanandan S, Kudavelly SR, Subbarao NN, Singhal N. 25 April 2019. US2019122581 (A1) Laparoscopic training system. This patent application relates to a training device and testing protocols developed to simulate a gynaecological surgical environment to allow trainee surgeons to practise laparoscopic surgery and become proficient in manipulating the laparoscopic instruments within the body using the endoscope video feed as guidance. This application claims priority to US Provisional Patent Application 62/575,263 filed 20 October 2017. Munro M, Messerschmidt J, Anderson T, Hudgens J. 25 April 2019. EP3473729 (A1) MMP1 gene transcript for use as a marker for diagnosis of ovarian cancer prognosis, and test method. This patent application relates to the identification of a marker for detecting, from within a group of patients with ovarian cancer, those who have a poorer prognosis. Specifically, the authors state that this involves measuring the expression level of matrix metalloprotease (MMP) 1 gene transcription product in ascites and exosomes recovered from ascites, or in ovarian cancer tissue samples from a patient. The expression level can be used to predict ovarian cancer prognosis. Ochiya T, Yokoi A, Kato T. 24 April 2019. The US state of Indiana has reportedly become the first state in the USA to pass legislation criminalising health professionals who, amongst other activities, use their own sperm during fertility treatment without the knowledge and consent of the couple undergoing treatment. The new law states that ‘misrepresentation relating to a medical procedure, device or drug and human reproductive material’ is unlawful. Under the new law offenders will, reportedly, receive a penalty for fertility fraud and those lodging a complaint can receive compensation of up to $10,000. Source: www.bionews.org.uk The Eighth District Court of Appeals in Cleveland, Ohio, USA, has recently ruled that embryos lost when a freezer failed at a fertility clinic were not ‘living persons’. The couple who brought the case to court argued that life began at conception and, therefore, the stored embryos should be treated as people and not as property. However, the judges concluded that ‘an embryo that has not been implanted into the uterus of a woman does not constitute a “distinct human entity” and is therefore not entitled to the rights and protections of a person’. Source: www.bionews.org.uk Clinicians keen to keep up-to-date regarding clinical studies that are currently recruiting may find the following informative.

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