Summary Background Previous prospective cohort studies have shown that angiogenic factors have a high diagnostic accuracy in women with suspected pre-eclampsia, but we remain uncertain of the effectiveness of these tests in a real-world setting. We therefore aimed to determine whether knowledge of the circulating concentration of placental growth factor (PlGF), an angiogenic factor, integrated with a clinical management algorithm, decreased the time for clinicians to make a diagnosis in women with suspected pre-eclampsia, and whether this approach reduced subsequent maternal or perinatal adverse outcomes. Methods We did a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial in 11 maternity units in the UK, which were each responsible for 3000–9000 deliveries per year. Women aged 18 years and older who presented with suspected pre-eclampsia between 20 weeks and 0 days of gestation and 36 weeks and 6 days of gestation, with a live, singleton fetus were invited to participate by the clinical research team. Suspected pre-eclampsia was defined as new-onset or worsening of existing hypertension, dipstick proteinuria, epigastric or right upper-quadrant pain, headache with visual disturbances, fetal growth restriction, or abnormal maternal blood tests that were suggestive of disease (such as thrombocytopenia or hepatic or renal dysfunction). Women were approached individually, they consented for study inclusion, and they were asked to give blood samples. We randomly allocated the maternity units, representing the clusters, to blocks. Blocks represented an intervention initiation time, which occurred at equally spaced 6-week intervals throughout the trial. At the start of the trial, all units had usual care (in which PlGF measurements were also taken but were concealed from clinicians and women). At the initiation time of each successive block, a site began to use the intervention (in which the circulating PlGF measurement was revealed and a clinical management algorithm was used). Enrolment of women continued for the duration of the blocks either to concealed PlGF testing, or after implementation, to revealed PlGF testing. The primary outcome was the time from presentation with suspected pre-eclampsia to documented pre-eclampsia in women enrolled in the trial who received a diagnosis of pre-eclampsia by their treating clinicians. This trial is registered with ISRCTN, number 16842031. Findings Between June 13, 2016, and Oct 27, 2017, we enrolled and assessed 1035 women with suspected pre-eclampsia. 12 (1%) women were found to be ineligible. Of the 1023 eligible women, 576 (56%) women were assigned to the intervention (revealed testing) group, and 447 (44%) women were assigned to receive usual care with additional concealed testing (concealed testing group). Three (1%) women in the revealed testing group were lost to follow-up, so 573 (99%) women in this group were included in the analyses. One (<1%) woman in the co...
ProblemIn Zimbabwe, many health facilities are not able to manage serious obstetric complications. Staff most commonly identified inadequate training as the greatest barrier to preventing avoidable maternal deaths.ApproachWe established an onsite obstetric emergencies training programme for maternity staff in the Mpilo Central Hospital. We trained 12 local staff to become trainers and provided them with the equipment and resources needed for the course. The trainers held one-day courses for 299 staff at the hospital.Local settingMaternal mortality in Zimbabwe has increased from 555 to 960 per 100 000 pregnant women from 2006 to 2011 and 47% of the deaths are believed to be avoidable. Most obstetric emergencies trainings are held off-site, away from the clinical area, for a limited number of staff.Relevant changesFollowing an in-hospital train-the-trainers course, 90% (138/153) of maternity staff were trained locally within the first year, with 299 hospital staff trained to date. Local system changes included: the introduction of a labour ward board, emergency boxes, colour-coded early warning observation charts and a maternity dashboard. In this hospital, these changes have been associated with a 34% reduction in hospital maternal mortality from 67 maternal deaths per 9078 births (0.74%) in 2011 compared with 48 maternal deaths per 9884 births (0.49%) in 2014.Lessons learntIntroducing obstetric emergencies training and tools was feasible onsite, improved clinical practice, was sustained by local staff and associated with improved clinical outcomes. Further work to study the implementation and effect of this intervention at scale is required.
AimsWe wished to assess the feasibility of a future randomised controlled trial of parathyroid hormone (PTH) supplements to aid healing of trochanteric fractures of the hip, by an open label prospective feasibility and pilot study with a nested qualitative sub study. This aimed to inform the design of a future powered study comparing the functional recovery after trochanteric hip fracture in patients undergoing standard care, versus those who undergo administration of subcutaneous injection of PTH for six weeks.Patients and MethodsWe undertook a pilot study comparing the functional recovery after trochanteric hip fracture in patients 60 years or older, admitted with a trochanteric hip fracture, and potentially eligible to be randomised to either standard care or the administration of subcutaneous PTH for six weeks. Our desired outcomes were functional testing and measures to assess the feasibility and acceptability of the study.ResultsA total of 724 patients were screened, of whom 143 (20%) were eligible for recruitment. Of these, 123 were approached and 29 (4%) elected to take part. However, seven patients did not complete the study. Compliance with the injections was 11 out of 15 (73%) showing the intervention to be acceptable and feasible in this patient population.Take home message: Only 4% of patients who met the inclusion criteria were both eligible and willing to consent to a study involving injections of PTH, so delivering this study on a large scale would carry challenges in recruitment and retention. Methodological and sample size planning would have to take this into account. PTH administration to patients to enhance fracture healing should still be considered experimental.Cite this article: Bone Joint J 2016;98-B:840–5.
Objective To calculate the cost‐effectiveness of implementing PlGF testing alongside a clinical management algorithm in maternity services in the UK, compared with current standard care. Design Cost‐effectiveness analysis. Setting Eleven maternity units participating in the PARROT stepped‐wedge cluster‐randomised controlled trial. Population Women presenting with suspected pre‐eclampsia between 20+0 and 36+6 weeks’ gestation. Methods Monte Carlo simulation utilising resource use data and maternal adverse outcomes. Main outcome measures Cost per maternal adverse outcome prevented. Results Clinical care with PlGF testing costs less than current standard practice and resulted in fewer maternal adverse outcomes. There is a total cost‐saving of UK£149 per patient tested, when including the cost of the test. This represents a potential cost‐saving of UK£2,891,196 each year across the NHS in England. Conclusions Clinical care with PlGF testing is associated with the potential for cost‐savings per participant tested when compared with current practice via a reduction in outpatient attendances, and improves maternal outcomes. This economic analysis supports a role for implementation of PlGF testing in antenatal services for the assessment of women with suspected pre‐eclampsia. Tweetable abstract Placental growth factor testing for suspected pre‐eclampsia is cost‐saving and improves maternal outcomes.
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