Issue no. 15 (July, 2017)

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Click on title link to view Minor updates to NICE clinical guideline on antenatal and postnatal mental health (CG192) New footnotes to recommendations 1.4.17 and 1.9.9 advise that the UK Drugs in Lactation Advisory is available as an additional resource when seeking advice about specific drugs. Further footnotes link to the MHRA toolkit on the risks of valproate medicines in female patients.

SAFETY ALERT Epilim (sodium valproate) risk management material: Poster warning of use of valproate in girls/women. Sanofi UK Summary: This poster, to be displayed in dispensaries of pharmacies warns that valproate should only be used in girls, women of child bearing age and those who are pregnant or planning pregnancy, when other treatments are ineffective or not tolerated. Click to view NIHR SIGNAL Treating subclinical thyroid dysfunction in pregnancy probably has no benefit Summary: Expert commentary is provided for 2 trials which found that levothyroxine treatment during pregnancy had no significant effect on child IQ. This study helps reassure, however did not include treatment in very early pregnancy where benefits remain unknown. Click to view Drug reduces deaths from bleeding after childbirth Summary: Expert commentary is provided for an RCT (20,600 women with post-partum haemorrhage) which found that IV tranexamic acid reduced the risk of death from bleeding vs placebo. The challenge is to promptly implement the early use of tranexamic acid into best practice. Click to view Using mesh does not improve results in vaginal prolapse surgery Summary: Synthetic mesh or biological tissue graft is no better than standard surgical repair, without use of these materials, in women with vaginal wall prolapse. Some women had problems from the mesh. Click to view Induction of labour may be considered in pregnant women with a large baby Induction of labour does not increase the risk of caesarean delivery in pregnant women with a larger than average baby. This is based on a review of four trials of 1190 women with a suspected large baby who were allocated either to have labour induced from 38 weeks or to watchful waiting. Click to view BAYER HEALTHCARE Summary: Bayer has announced that the CE Mark Certification for the product has not been approved, and therefore, marketing of the product in the EU has been suspended for up to 90 days, pending completion of enquiries. The device has been linked to complications, including hysterectomies. Click to view Read UKMi comment ROYAL COLLEGE OF OBSTETRICIANS AND GYNAECOLOGISTS Each Baby counts: 2015 Summary report Summary: This report looked at 1,136 stillbirths, neonatal deaths and brain injuries that occurred on UK maternity units during 2015. It recommends, amongst other points that all low-risk women are assessed on admission in labour to see what foetal monitoring is needed. Click to view

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Coasting (withholding gonadotrophins) for preventing ovarian hyperstimulation syndrome Low-quality evidence suggests coasting reduces rates of moderate/severe OHSS more than no coasting, but no evidence to suggest it is more beneficial than other interventions; one small study (very low quality evidence) suggested another intervention (FSH co-trigger) may be better Interconception care for women with a history of gestational diabetes for improving maternal and infant outcomes Online Publication Date: August 2017 Authors' conclusions: The role of interconception care for women with a history of GDM remains unclear. Randomised controlled trials are required evaluating different forms and protocols of interconception care for these women on perinatal and long-term maternal and infant health outcomes, acceptability of such interventions and cost-effectiveness. Different strategies for diagnosing gestational diabetes to improve maternal and infant health. Online Publication Date: August 2017 Authors' conclusions: There is insufficient evidence to suggest which strategy is best for diagnosing GDM. Large randomised trials are required to establish the best strategy for correctly identifying women with GDM. Antenatal and intrapartum interventions for preventing cerebral palsy: an overview of Cochrane systematic reviews Online Publication Date: August 2017 Authors' conclusions: This overview summarises evidence from Cochrane reviews on the effects of antenatal and intrapartum interventions on cerebral palsy, and can be used by researchers, funding bodies, policy makers, clinicians and consumers to aid decision-making and evidence translation. We recommend that readers consult the included Cochrane reviews to formally assess other benefits or harms of included interventions, including impacts on risk factors for cerebral palsy (such as the reduction in intraventricular haemorrhage for preterm babies following exposure to antenatal corticosteroids). Cytology versus HPV testing for cervical cancer screening in the general population Online PDate: August 2017 Authors' conclusions: Whilst HPV tests are less likely to miss cases of CIN 2+ and CIN 3+, these tests do lead to more unnecessary referrals. However, a negative HPV test is more reassuring than a negative cytological test, as the cytological test has a greater chance of being falsely negative, which could lead to delays in receiving the appropriate treatment. Evidence from prospective longitudinal studies is needed to establish the relative clinical implications of these tests.

The effects of cash transfers and vouchers on the use and quality of maternity care services: A systematic review. Conclusions: Future research should use multiple intervention arms to compare cost-effectiveness with similar investment in public services, and should look beyond short- to medium-term service utilisation by examining programme costs, longer-term effects on service utilisation and health outcomes, and the equity of those effects.

Interventions to provide culturally-appropriate maternity care services: factors affecting implementation. Conclusions: Several important factors should be considered and addressed when implementing interventions to provide culturally-appropriate care. These factors reflect more general goals on the international agenda of improving access to skilled maternity care; providing high-quality, respectful care; and community participation. A systematic mixed-methods review of interventions, outcomes and experiences for midwives and student midwives in work-related psychological distress.

Conclusions: There is a lack of evidence based interventions available to support both midwives and student midwives in work-related psychological distress. Available studies reported positive outcomes and experiences for the majority of

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participants. However, future intervention studies will need to ensure that they are flexible enough for midwives and student midwives to engage with. Future intervention research has the opportunity to progress towards more rigorous studies, particularly ones which include midwives and student midwives as solitary population samples. The effect of senior obstetric presence on maternal and neonatal outcomes in UK NHS maternity units: a systematic review and meta-analysis. Conclusions: Increased consultant presence has some effect on mode of delivery, but no evidence for a benefit for adverse outcomes was found.

What are the effects of breastfeeding support in healthy mothers with healthy term babies? Click to view answer How does planned delivery compare with expectant management in pregnant women with hypertensive disorders? Click to view answer What are the effects of home uterine monitoring of pregnant women to detect preterm labor? Click to view answer

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Topics: Weight loss medications for obesity in adults phentermine/topiramate extended-release may reduce incident diabetes in adults with overweight or obesity (Diabetes Care 2017 Jul) Topics: Prediabetes phentermine/topiramate extended-release may reduce incident diabetes in adults with overweight or obesity (Diabetes Care 2017 Jul)

WHAT’S NEW IN OBSTETRICS & GYNAECOLOGY (Click on titles to view) OpenAthens Login required offside

OBSTETRICS

Increased nuchal translucency and Noonan syndrome (August 2017) Increased nuchal translucency on first trimester ultrasound screening has been associated with over 100 developmental and genetic syndromes. In a retrospective study in which a Noonan syndrome gene sequencing panel was obtained in 39 euploid fetuses with nuchal translucency ≥3.0 mm (median thickness 4.0 mm), 10 percent had variants consistent with Noonan syndrome [1]. It may be reasonable to offer screening for genetic mutations associated with Noonan syndrome

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in euploid fetuses with nuchal translucency ≥3.0 mm, but prospective studies are still needed to validate this result. (See "Cystic hygroma and increased nuchal translucency", section on 'Targeted genetic studies'.)

REPRODUCTIVE ENDOCRINOLOGY Gene editing in human embryos to prevent disease (August 2017) In vitro fertilization with preimplantation genetic diagnosis (IVF/PGD) is an established strategy for avoiding implantation of embryos with specific pathogenic gene mutations. In a landmark study of the correction of a pathogenic gene mutation, a mutant paternal allele in human embryos was repaired using the homologous wild-type maternal gene instead of a synthetic DNA template [49]. The embryos were not transferred or allowed to mature beyond the blastocyst stage. This technology is experimental and the efficacy, safety, and clinical utility of gene editing remain unknown. (See "In vitro fertilization", section on 'Other uses'.)

UROGYNECOLOGY Electroacupuncture for stress urinary incontinence in women (August 2017) Treatment options for stress urinary incontinence (SUI) in women include lifestyle modifications, bladder training, medications, devices, and surgery. The use of electroacupuncture for SUI has been reported in a multicenter randomized trial in China [53]. Compared with sham treatments, electroacupuncture reduced the volume of urine leaked and number of leakage episodes. Availability of this therapy may limit this option. Additionally, confirmation of these results in other trial settings is needed before its general use can be widely recommended. (See "Treatment of urinary incontinence in women", section on 'Stress incontinence'.)

Title: Postpartum Weight Loss on the Web Citation: Eleanor Bimla Schwarz, MD, MS. Reviewing Tsai AG and Nicholson WK., JAMA 2017 Jun 20; 317:2375 Summary: Internet-based weight-loss program helps low-income mothers achieve prepregnancy weight. Comment: This Web-based program offers intriguing possibilities for large-scale dissemination. Replication of the findings remains to be done in other populations, but given the long-term health burdens associated with postpartum weight retention — which can result in hypertension, diabetes, and cardiovascular disease — I anticipate that this program will be a cost-effective addition to WIC programs in many clinical settings. Click to view Tiitle: Pharmacologic vs. Physical Approaches to Cervical Ripening in Hypertensive Women Citation: Allison Bryant, MD, MPH. Reviewing Suri V and Sikka P., Lancet 2017 Jun 28; Summary: Women who received oral misoprostol delivered faster than those who received a Foley catheter for cervical ripening. Comment: In this head-to-head trial, cervical ripening with oral misoprostol was superior to transcervical Foley catheter regarding timely achievement of vaginal delivery and, notably, patient-reported satisfaction with the method. As we all seek to improve safety, efficiency, and acceptability of the healthcare we deliver, trials such as this are useful (especially when performed in settings vastly different than our own). Although the misoprostol dosing and Foley catheter volumes in this study differ from those in many U.S. labor units, these results provide good reason to support reaching for prostaglandins to initiate labor induction when time is of the essence. Click to view Title: Bevacizumab for advanced cervical cancer: final overall survival and adverse event analysis of a randomised, controlled, open-label, phase 3 trial (Gynecologic Oncology Group 240) Citation: The Lancet Summary: RCT (n=452) reports chemotherapy + bevacizumab (CB) statistically significantly improves overall survival vs chemotherapy-alone: 16.8 vs 13.3 months respectively (HR 0.77; p=0.007). Fistula (any grade) occurred in 15% of patients in CB group vs 1% of chemotherapy-alone group. UKMi comment: In a related editorial, the author comments that “A key question that arises is how to identify patients who are most likely to derive the greatest survival advantage from antiangiogenic therapy and with least risk? The Moore criteria (based on clinical factors), prospectively validated in the GOG 240 trial, identified that the survival benefit from bevacizumab is greatest in the moderate-risk and high-risk defined subgroups. This finding has the potential to guide oncologists in the decision-making process balancing the merits of addition of bevacizumab with the risks of toxicities, including fistula formation. Fistula incidence is not unsubstantial (15% for all grades; 6% for grade 3) in the bevacizumab group.” Click to view

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Title: Progestogens for Maintenance Tocolysis in Women With a Short Cervix: A Randomized Controlled Trial Citation: Obstet Gynecol. 2017 Jul;130(1):64-70. doi: 10.1097/AOG.0000000000002065. (Original) PMID: 28594783 CONCLUSION: The use of progestogens for maintenance tocolysis in women with a short cervix did not reduce the rate of preterm birth. Click to view Title: Cesarean Delivery as a Pathway to Nonmedical Opioid Use Citation: Anna Wald, MD, MPH reviewing Osmundson SS et al. Obstet Gynecol 2017 Jul . Summary: Are clinicians providing too many pills after cesareans? Comment: These studies show that the quantity of opioids prescribed after cesarean delivery is often excessive. The amount of medication for adequate pain control differs for each woman, so shared decision making seems appropriate. The reasons for this wide spectrum of need for pain control are partly physiologic, but also probably reflect differential social support, understanding of normal postpartum events, and awareness of nonopioid analgesics such as nonsteroidal anti-inflammatory drugs and acetaminophen. Concern about reaching a clinician during off hours and receiving an appropriate evaluation may also contribute, and facilitating follow-up may mitigate these anxieties. Click to view Title: Sleep Disorder Diagnosis During Pregnancy and Risk of Preterm Birth Citation: Obstetrics & Gynecology: September 2017 - Volume 130 - Issue 3 - p 573–581 Authors conclusion: Insomnia and sleep apnea were associated with significantly increased risk of preterm birth. Considering the high prevalence of sleep disorders during pregnancy and availability of evidence-based nonpharmacologic interventions, current findings suggest that screening for severe presentations would be prudent. Click to view Title: Association of previous cesarean with surgical complications after a hysterectomy later in life. Citation: JAMA Surg2017. doi:10.1001/jamasurg.2017.2825 Summary: “The results imply that information on long term associations should be made more readily available to women, clinicians, and policy makers and suggest that decisions on caesarean delivery should take into account not only immediate maternal and neonatal influences but also women’s health in the long term, including an increased risk of reoperation and complications associated with surgery later in life.” Click to view Title: Use of antibiotics during pregnancy and the risk of major congenital malformations: a population based cohort study Source: British Journal of Clinical Pharmacology Summary: The results of this study found in utero exposure to clindamycin, doxycycline, macrolides, quinolones and phenoxymethylpenicillin during the first trimester was associated with a small absolute increased risk of organ-specific major congenital malformations. Click to view Click there to Read UKMi comment Title: Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia Source: New England Journal of Medicine Summary: This RCT (n=1620) reports aspirin reduces risk of pre-term preeclampsia, occurring in 13 participants (1.6%) in the aspirin group, vs 35 (4.3%) in the placebo group (OR 0.38, P=0.004; number needed to treat to avoid one primary outcome=38). UKMi comment: In a related editorial, the authors highlight that on the basis of a 2014 systematic review, the US Preventive Services Task Force currently recommends daily low-dose (81 mg) aspirin therapy beginning at 12 weeks of gestation in patients who are considered to be at “high risk for preeclampsia” according to medical and obstetrical criteria. The findings of this study appear to support the recommendations for the use of prophylactic low-dose aspirin in high-risk women. NICE, in their clinical guideline on the management of hypertension in pregnancy, advises women at high risk of pre-eclampsia to take 75 mg of aspirin daily from 12 weeks until the birth of the baby. Women at high risk are those with any of the following: hypertensive disease during a previous pregnancy, chronic kidney disease, autoimmune disease such as systemic lupus erythematosis or antiphospholipid syndrome, type 1 or type 2 diabetes or chronic hypertension. Click to view

Title: Oral contraceptives, breastfeeding and the risk of developing rheumatoid arthritis: results from the Swedish EIRA study Source: Annals of Rheumatic Diseases

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Summary: This analysis (2578 cases/4129 controls) found women who had ever used oral contraceptives had lower risk of anticitrullinated protein antibodies (ACPA)-positive rheumatoid arthritis (OR 0.84; 95% CI 0.74-0.96); >7 years’ use decreased risk of ANCA-positive and -negative disease. Click to view Click here to Read UKMi comment Title: Are expanding disease definitions unnecessarily labelling women with polycystic ovary syndrome (PCOS)? Source: British Medical Journal Summary: The authors of this analysis say that PCOS may be overdiagnosed and they recommend carefully weighing up the benefits and harms for each individual woman and taking a slower, stepped, or delayed approach to diagnosis to optimise benefits and reduce harm from disease labelling. Click to view Title: Randomized Controlled Trial Testing the Efficacy of Platinum-Free Interval Prolongation in Advanced Ovarian Cancer: The MITO-8, MaNGO, BGOG-Ov1, AGO-Ovar2.16, ENGOT-Ov1, GCIG Study Source: Journal of Clinical Oncology Summary: This RCT (n=215) reports no statistically significant overall survival benefit in the single-agent non platinum-based chemotherapy (PBC) arm vs PBC (median 21.8 v 24.5 months; HR 1.38; 95%CI 0.99-1.94; P=0.06) supporting recommendations that PBC not be delayed in favour NPBC. Click to view

Reports that antibacterials in pregnancy are 'harmful' unfounded . Monday Aug 14 2017 "Warning to pregnant women, don't use antibacterial soap! Chemicals in the products can make children fat and disrupt their development," is the alarming, yet entirely unsupported, headline from the Mail Online...Click to view Vitamin B3 found in Marmite not proven to prevent miscarriage. Thursday Aug 10 2017 "Like it or loathe it, but Marmite could help prevent millions of miscarriages and birth defects around the world," is the overly optimistic headline in The Daily Telegraph. The news is based on research into just four families…Click to view Royal College of Midwives clarifies 'normal births' stance After being the ‘subject of much attention in the press’, the Royal College of Midwives (RCM) has clarified its position on so-called ‘normal births’ – a term it abandoned three years ago.. Click to view NHS Choices assessment: Does paracetamol taken in pregnancy affect masculinity? NHS Choices NHS Choices has published an assessment of press reports which claim that taking paracetamol when pregnant 'makes boys less manly, less aggressive and lowers their sex drive.' These claims are based on research in mice. Click to view

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