A special communication describing an extension to the Consolidated Standards of Reporting Trials (CONSORT) has been published in the Journal of the American Medical Association (JAMA). Led by NPEU CTU Director and Associate Professor Ed Juszczak, the extension aims to provide greater transparency and accuracy in reporting of such trials, to enhance understanding of the methodology and allow readers to accurately assess the conduct of a trial and interpret the results.
This extension to the CONSORT 2010 statement checklist will enhance the reporting of multi-arm trials, and has an important educational role in improving their conduct. It therefore covers the overlapping areas of multi-arm trial methodology and reporting.
Among the recommendations of the extension are that multi-arm trials be identified as such by the authors and that clear objectives and hypotheses referring to all the treatment groups be stated. If periods of recruitment and follow-up are different across groups, these should be explained, along with the statistical implications.
The report shows that the number of women dying as a consequence of complications during or after pregnancy remains low in the UK - fewer than 10 of every 100,000 pregnant women die in pregnancy or around childbirth. However, the report highlights striking inequalities: black women are five times and Asian women two times more likely to die as a result of complications in pregnancy than white women and urgent research and action to understand these disparities is recommended.
A follow-up report will be led by the National Perinatal Epidemiology Unit, which said it hoped to "identify clear ways to reduce the disparity in mortality amongst black and Asian women".
The first study explored mediators of the association between mode of birth and maternal adjustment, and found that unplanned caesarean section and instrumental birth were associated with lower maternal satisfaction with labour, and this association was partly mediated by a number of psychosocial factors. This study highlighted some potential psychosocial support interventions to promote maternal adjustment following delivery. You can read this study, which has been published in BMC Women's Health.
The second study compared two approaches to identifying postnatal depression: a novel single self-reported item versus the standard Edinburgh Postnatal Depression Scale (EPDS). This study found that although agreement between the single item and the EPDS was low at three months postpartum, women identified as having depression by both methods had symptoms indicative of other psychological co-morbidities. The study is published in the Journal of Affective Disorders.
The third study was a systematic review and meta-analysis to assess the impact of parental migration on child and adolescent physical and mental health and nutrition. The study found evidence of more depression, anxiety, suicide ideation and adverse nutritional outcomes among the children and adolescents of migrating parents compared to those of non-migrating parents. This study is published in The Lancet.
Professor Jenny Kurinczuk has been named an Honorary Fellow of the Royal College of Obstetricians and Gynaecologists at the RCOG's January 2019 Members' Admissions Ceremony. The honorary fellowship was awarded in recognition of her contribution to maternal and perinatal health.
Jenny is Professor of Perinatal Epidemiology and Director of the NPEU since 2011. Her research looks into causes, consequences and surgical treatments for congenital anomalies, and surveillance of near-miss maternal morbidity.
Congratulations to Jenny on this prestigious award!
New research has concluded that changes in the sociodemographic characteristics of women who become mothers in Great Britain (GB), and not improvement in breastfeeding practices, may be responsible for the increasing trend in breastfeeding initiation in GB since the 1980s. This is one of few studies globally to examine the relationship between increasing breastfeeding trends and sociodemographic changes in the population that may have resulted from decades of social and health policy reforms. The study used data from the 1985, 1990, 1995, 2000, 2005 and 2010 UK Infant Feeding Surveys, which included population-based samples of 7,000-12,000 women.
The findings showed that while the proportion of mothers who initiated breastfeeding increased from 64% in 1985 to 81% in 2010, there was also a considerable increase in the proportion of first-time mothers who were 30 or older, had higher education and higher-skilled occupations, were cohabiting with a partner, were of BME origin, and did not smoke in pregnancy. In each survey year, these same groups of mothers were significantly more likely to initiate breastfeeding than mothers who were younger, had lower education and lower-skilled occupations, were single, were of white ethnicity, and smoked during pregnancy. The findings suggest that more targeted interventions are necessary to support these latter groups of mothers with unmet needs. The study was conducted by Deon Simpson, and NPEU researchers Maria Quigley, Jenny Kurinczuk and Claire Carson, and can be read in full in PLoS ONE.
‘Doulas’ are trained or experienced lay women who provide social, emotional and practical support to other women during pregnancy and birth. In a qualitative interview study, NPEU researchers Jenny McLeish and Maggie Redshaw have explored the experiences of 19 volunteer doulas and 16 supported mothers at three community doula projects in England.
One paper from the study focuses on volunteer doulas at birth, examining the ways in which their continuous, empowering, woman-focused support sits alongside midwifery. A second paper considers the role of volunteer doulas working with disadvantaged mothers before and after birth. The study found that antenatal and postnatal support from doulas helped the mothers to succeed and flourish by reducing anxiety, unhappiness and stress; increasing self-esteem, self-efficacy, parenting confidence and skills; supporting them to make effective use of maternity services; and enabling them to build social ties in their community.
Studies Within A Trial (SWATs) are smaller studies carried out within a larger clinical trial. Large studies often offer the opportunity to investigate important issues around trial design, methodology and trial processes. Examples include whether sending a letter or telephoning potential participants as a method of follow-up improves recruitment to research, or if there is an optimum time and day to send invitation letter for trials.
Response rates to follow-ups are crucial to the success of a trial and therefore it is very important to maximise response rates in participants. The SIFT study, which aimed to recruit 2800 participants and follow them up at around 2 years, provided an excellent opportunity to monitor and assess response rates. The SIFT study team designed and implemented a SWAT which compared two types of incentive to participants in follow-up - an unconditional incentive (a £15 gift voucher enclosed with the follow-up questionnaire), versus the same value voucher sent to the participant on the return of the completed questionnaire. The SIFT SWAT has been registered with the MRC SWAT Repository Store, set up by Queen's University Belfast, in order to increase transparency in trials and share knowledge on trial methodology and design with other researchers.
Results of the SWAT are currently being written up, and will be submitted for publication very soon.
With no existing evidence to support the use of ursodeoxycholic acid (UDCA) to improve intrahepatic cholestasis of pregnancy (ICP), PITCHES, a Phase III clinical trial proposes to provide definitive evidence to discover if the use of UDCA improves pregnancy outcomes in women with this liver disorder.
For more information, please find the recently published study protocol for the PITCHES trial in the BioMedCentral Trials journal here.