E-Freeze is a multi-centre randomised controlled trial being conducted in the UK. It compares fresh embryo transfer with frozen thawed embryo transfer for couples undergoing their first, second or third round of fertility treatment.
The main aim of E-Freeze is to understand if having a fresh or thawed embryo transfer makes any difference in the chance of having a healthy baby.
The study protocol for E-Freeze has been published in the BioMedCentral Reproductive Health journal. You can find it here.
Results of the ANODE (prophylactic ANtibiotics for the prevention of infection following Operative DElivery) trial have been published in the Lancet journal. The study found that a single dose of antibiotic after assisted vaginal births can reduce the risk of infection by 56% up to six weeks after delivery, and reduce antibiotic use by 17%.
One in five women experience an infective complication after operative vaginal birth, and according to the senior author of the study, Professor Marian Knight, prophylactic antibiotics can prevent over 7,000 of these infections annually in the UK.
The results of the ANODE trial also have implications for healthcare resources: women who received prophylactic antibiotic were less likely to report visiting a GP, nurse, midwife or hospital outpatient department in relation to concerns about wound healing compared to those who received placebo. According to lead health economist Associate Professor Oliver Rivero-Arias, this resulted in a mean NHS cost saving of £52.60 per woman at six weeks.
You can read more about the findings of the ANODE trial here.
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Manisha is a Senior Epidemiologist and Research Fellow and has established a UK-India collaborative platform for maternal and perinatal health research called MaatHRI and is currently using this platform to conduct large epidemiological studies to improve pregnancy care and outcomes in pregnant women with anaemia.
Her work in India is investigating the risk factors, outcomes and clinical characteristics of heart failure in pregnant women; examining the safety of induction and augmentation of labour in pregnant women with anaemia; examining the difference in coagulation parameters in pregnant women with and without anaemia; and estimating the incidence of selected severe pregnancy complications.
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".