This study demonstrates that morbidity and mortality caused by HDFN is minimal. These results are reassuring for women at risk of HDFN as even severely affected cases are successfully managed in most instances. Further studies are needed to identify predictors of disease severity.

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Background Reducing the rate of stillbirth is an international priority. At least half of babies stillborn in high-income countries are small for gestational-age (SGA). The Growth Assessment Protocol (GAP), a complex antenatal intervention that aims to increase the rate of antenatal detection of SGA, was evaluated in the DESiGN type 2 hybrid effectiveness-implementation cluster randomised trial (n = 13 clusters). In this paper, we present the trial process evaluation. Methods A mixed-methods process evaluation was conducted. Clinical leads and frontline healthcare professionals were interviewed to inform understanding of context (implementing and standard care sites) and GAP implementation (implementing sites). Thematic analysis of interview text used the context and implementation of complex interventions framework to understand acceptability, feasibility, and the impact of context. A review of implementing cluster clinical guidelines, training and maternity records was conducted to assess fidelity, dose and reach. Results Interviews were conducted with 28 clinical leads and 27 frontline healthcare professionals across 11 sites. Staff at implementing sites generally found GAP to be acceptable but raised issues of feasibility, caused by conflicting demands on resource, and variable beliefs among clinical leaders regarding the intervention value. GAP was implemented with variable fidelity (concordance of local guidelines to GAP was high at two sites, moderate at two and low at one site), all sites achieved the target to train > 75% staff using face-to-face methods, but only one site trained > 75% staff using e-learning methods; a median of 84% (range 78–87%) of women were correctly risk stratified at the five implementing sites. Most sites achieved high scores for reach (median 94%, range 62–98% of women had a customised growth chart), but generally, low scores for dose (median 31%, range 8–53% of low-risk women and median 5%, range 0–17% of high-risk women) were monitored for SGA as recommended. Conclusions Implementation of GAP was generally acceptable to staff but with issues of feasibility that are likely to have contributed to variation in implementation strength. Leadership and resourcing are fundamental to effective implementation of clinical service changes, even when such changes are well aligned to policy mandated service-change priorities. Trial registration Primary registry and trial identifying number: ISRCTN 67698474. Registered 02/11/16. https://doi.org/10.1186/ISRCTN67698474.

Introduction Maternal serum PAPP-A (pregnancy associated plasma protein-A) is a part of combined screening. Previous studies have shown correlation between low PAPP-A and adverse pregnancy outcome. Objective The aim of this study is to establish the positive predictive value of low-PAPP-A in prediction of adverse pregnancy outcomes - pre-eclampsia (PET), pregnancy induced hypertension (PIH), delivery of small for gestational age neonates (SGA) and late pregnancy losses. Materials and Methods 16690 women underwent combined screening from 1/8/2008 to 1/8/2011. 326 women with low PAPP-A (=<0.3 MoM) were identified (1.95%). The median PAPP-A of the screening population was 1.074 MoM. Within this group of pregnancy with low PAPP-A, maternal serum PAPP-A was compared between the subgroups of adverse pregnancy outcome and normal-outcome. Results Abstract PF.43 Table Cases N PAPP-A MoM (Median) p PPV % Normal outcome 146 0.255 - - Adverse outcome 95 0.225 0.004* 39.4 PET 25 0.234 0.184 10.8 PIH 10 0.243 0.769 4.1 SGA 44 0.220 0.004* 21.4 Late pregnancy losses 15 0.191 0.024* 6.6 *Adjusted significance level P < 0.0125 - post hoc Bonferroni correction Conclusion In our screening population, median PAPP-A MoM was higher compared to some previous studies. Maternal serum PAPP-A in pregnancies with adverse outcome was significantly lower than those that resulted in a normal outcome. Compared to the pregnancies with low-PAPP-A but normal outcome, median PAPP-A MoM was significantly lower in pregnancies ending in delivery of small-for-gestational age neonate (customised BW < 10th-centile), and showed a trend towards a decrease in those ending in late-pregnancy losses (>24 weeks).

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