Julia Sanders

Standard haemostatic tests following major obstetric haemorrhage.

BACKGROUND Postpartum haemorrhage is an important cause of maternal morbidity and mortality. It is associated with haemostatic impairment which may exacerbate bleeding. METHODS All deliveries over a 3-year period in a large UK unit were reviewed and cases of haemorrhage of 1500 mL or more identified. Laboratory records were reviewed and the lowest value for haemoglobin, platelet count and fibrinogen, and longest value for prothrombin time and activated partial thromboplastin time within 24h of delivery were recorded. RESULTS Of 18,501 deliveries there were 456 bleeds of 1500 mL or more (2.5%). Fibrinogen levels correlated best with blood loss (r -0.48 P<0.01) and fell progressively as volume increased. Activated partial thromboplastin time was less sensitive (r 0.4 P<0.01) to increasing blood loss. Prothrombin time did not correlate with blood loss (r 0.01). Activated partial thromboplastin time and prothrombin time remained within the normal range in most women despite large bleeds. Similar results were observed in women who received four or more units of red blood cells. Haemoglobin level was adequately maintained irrespective of blood loss. Based on UK national guidelines only 13 of 456 (3%) women should have received fresh frozen plasma, although it was given to 45; despite this, fibrinogen levels below the pregnancy-related normal range were observed in most cases. CONCLUSION Fibrinogen level was the parameter that best correlated with increasing volume of haemorrhage and was the most useful marker of developing haemostatic impairment. Guidelines for fresh frozen plasma use in major postpartum haemorrhage were rarely followed and should be reviewed.

Fibrin-based clot formation as an early and rapid biomarker for progression of postpartum hemorrhage: a prospective study.

This prospective, observational study investigated the utility of Fibtem A5 and Clauss fibrinogen as predictors of progression of postpartum hemorrhage (PPH). A consecutive cohort of 356 women experiencing 1000 to 1500 mL PPH was recruited. Fibtem and fibrinogen were measured and subsequent transfusions, invasive procedures, and bleed volume recorded. Women progressing to 8 U blood products (red blood cells [RBCs] + fresh frozen plasma [FFP] + platelets) had a median (interquartile range) fibrinogen and Fibtem A5 of 2.1 (1.8-3.4) g/L and 12 (7-17) mm, respectively, compared with 3.9 (3.2-4.5) and 19 (17-23) for those not progressing. On multivariate analysis, Fibtem was an independent predictor for progression to bleeds >2500 mL (95% confidence interval [CI], 0.85 [0.77-0.95]). Receiver operating characteristic area under the curve (95% CI) for progression to RBC transfusion was 0.67 (0.60-0.74) for fibrinogen and 0.61 (0.54-0.68) for Fibtem, and progression to >2500 mL was 0.71 (0.61-0.81) and 0.75 (0.66-0.85) for fibrinogen and Fibtem, respectively. Fibtem A5 <10 mm was associated with more prolonged bleeds (median [95% CI], 127 [44-210] compared with 65 [59-71] minutes; P = .018) and longer stay in the high-dependency unit (23.5 [18.4-28.5] compared with 10.8 [9.7-11.8] hours). Fibtem is a rapidly available early biomarker for progression of PPH.

Measurement of blood loss during postpartum haemorrhage

BACKGROUND We set out to validate the accuracy of gravimetric quantification of blood loss during simulated major postpartum haemorrhage and to evaluate the technique in a consecutive cohort of women experiencing major postpartum haemorrhage. The study took part in a large UK delivery suite over a one-year period. All women who experienced major postpartum haemorrhage were eligible for inclusion. METHODS For the validation exercise, in a simulated postpartum haemorrhage scenario using known volumes of artificial blood, the accuracy of gravimetric measurement was compared with visual estimation made by delivery suite staff. In the clinical observation study, the blood volume lost during postpartum haemorrhage was measured gravimetrically according to our routine institutional protocol and was correlated with fall in haemoglobin. The main outcome measure was the accuracy of gravimetric measurement of blood loss. RESULTS Validation exercise: the mean percentage error of gravimetrically measured blood volume was 4.0±2.7% compared to visually estimated blood volume with a mean percentage error of 34.7±32.1%. Clinical observation study: 356 out of 6187 deliveries were identified as having major postpartum haemorrhage. The correlation coefficient between measured blood loss and corrected fall in haemoglobin for all patients was 0.77; correlation was stronger (0.80) for postpartum haemorrhage >1500mL, and similar during routine and out-of-hours working. CONCLUSION The accuracy of the gravimetric method was confirmed in simulated postpartum haemorrhage. The clinical study shows that gravimetric measurement of blood loss is correlated with the fall in haemoglobin in postpartum haemorrhage where blood loss exceeds 1500mL. The method is simple to perform, requires only basic equipment, and can be taught and used by all maternity services during major postpartum haemorrhage.

Effectiveness and acceptability of lidocaine spray in reducing perineal pain during spontaneous vaginal delivery: randomised controlled trial

Abstract Objectives To evaluate the effectiveness and acceptability of a lidocaine spray in reducing perineal pain during spontaneous vaginal delivery. Design Randomised controlled trial. Setting Consultant led obstetric unit. Participants 185 women who had a spontaneous vaginal delivery without epidural analgesia. Interventions Topically applied local anaesthetic spray (93 women) and placebo spray (92 women). Main outcome measure Primary outcome measure was pain during delivery (0-100 scale). The 16 secondary outcome measures included second degree perineal trauma during delivery, trauma of the genital tract, and dyspareunia by two months. Results Lidocaine spray did not reduce pain during spontaneous vaginal delivery: mean 77 and 72 on a scale of 0-100 in the lidocaine and placebo groups, respectively (difference between means 4.8, 95% confidence interval −1.7 to 11.2). Lidocaine spray may reduce genital tract trauma during delivery, in particular second degree perineal trauma. The intervention was highly acceptable to the women and midwives. Conclusions Although lidocaine spray applied to the perineum during spontaneous vaginal delivery did not reduce perineal pain, it was acceptable to both the women and the midwives. Trial registration Current controlled trials ISRCTN99732966 [controlled-trials.com].

Viscoelastometric-guided early fibrinogen concentrate replacement during postpartum haemorrhage: OBS2, a double-blind randomized controlled trial

Background Postpartum haemorrhage (PPH) can be exacerbated by haemostatic failure. We hypothesized that early fibrinogen replacement, guided by viscoelastometric testing, reduces blood product usage and bleed size. Methods Women with PPH 1000-1500 ml were enrolled. If Fibtem A5 was ≤15 mm and bleeding continued, subjects were randomized to fibrinogen concentrate or placebo. The primary outcome compared the number of units of red blood cells, plasma, cryoprecipitate and platelets transfused. Results Of 663 women enrolled 55 were randomized. The adjusted incidence rate ratio (IRR) (95% CI) for the number of allogeneic units transfused in the fibrinogen group compared with placebo was 0.72 (0.3-1.7), P =0.45. In pre-specified subgroup analyses, subjects who had a Fibtem A5 ≤12 mm at the time of randomization and who received fibrinogen concentrate received a median (25th-75th centile) of 1 (0-4.5) unit of allogeneic blood products and had an additional 300 (100-350) ml blood loss whereas those who received placebo also received 3 (0-6) units of allogeneic blood products and had 700 (200-1550) ml additional blood loss; these differences were not statistically significantly different. There was one thrombotic event in each group. Conclusions Infusion of fibrinogen concentrate triggered by Fibtem A5 ≤15 mm did not improve outcomes in PPH. Pre-specified subgroup analyses suggest that fibrinogen replacement is not required if the Fibtem A5 is > 12 mm or Clauss fibrinogen >2 g litre -1 , but an effect below these levels cannot be excluded. The raised fibrinogen at term appears to be a physiological buffer rather than required for haemostasis. Trial registration ISRCTN46295339 ( http://www.isrctn.com/ISRCTN46295339 , last accessed 5 July 2017), EudraCT 2012-005511-11 ( https://www.clinicaltrialsregister.eu/ctr-search/search?query=2012-005511-11 , last accessed 5 July 2017).

A wall of information? Exploring the public health component of maternity care in England

BACKGROUND midwives have traditionally had an important role in providing public health messages to women. The range and diversity of the public health remit within maternity services has expanded rapidly over the past decade and maternity support workers as well as midwives are now engaged in public health work in many areas. Given these changes a review of current practice was indicated. OBJECTIVE to identify student midwives׳, midwives׳ and midwifery support workers׳ current knowledge of and involvement in the public health agenda in England. DESIGN descriptive qualitative study using online discussion forums. SETTING England, United Kingdom PARTICIPANTS undergraduate student midwives, midwives and maternity support workers employed by the National Health Service in England and University employed Leads for Midwifery Education. FINDINGS key themes identified were: the scope of the midwives׳ public health role, training and support for public health role, barriers and facilitators, specific client groups, specialist referral services. Student midwives, midwives and maternity support workers view engagement with, and delivery of, public health initiatives as an integral component of their roles, but are on occasions frustrated by constraints of time, training and public engagement. KEY CONCLUSIONS the National Health Service in England aims to engage pregnant women and new mothers in a diverse range of population based and individualised, public health initiatives. Currently, there are high levels of involvement in the public health agenda from the maternity workforce across a wide range of activities. However, midwives and maternity support workers are restricted by barriers of time, training and resources. These barriers will need addressing for optimal maternity care engagement in public health to be realised. IMPLICATIONS FOR PRACTICE policy makers, commissioners and National Health Service providers need to provide clear guidance on the expectations of the public health remit of midwives and maternity support workers and ensure that such expectations are appropriately resourced to provide effective delivery.

Viscoelastometry guided fresh frozen plasma infusion for postpartum haemorrhage: OBS2, an observational study

Background Postpartum haemorrhage (PPH) can be exacerbated by haemostatic failure. Based on data from trauma studies, empirical infusions of fresh frozen plasma (FFP) are often given during severe PPH if coagulation tests are unavailable. This study observed a cohort of women with moderate/severe PPH in whom FFP infusion was guided by the use of viscoelastometric point-of-care testing (VE-POCT) and clinical assessment. Methods Women were enrolled into this observational study when blood loss was measured or suspected to be about 1000 mL. If Fibtem A5 determined by Rotem ® thromboelastometry remained >15 mm, or bleeding stopped, FFP was withheld. If Fibtem A5 was ≤15 mm and bleeding ongoing, women were randomized into an interventional study as previously reported. Clinical and laboratory outcomes were recorded. Results The study recruited 605 women and 98% had FFP withheld. The median (25 th -75 th centile) total blood loss was 1500 (1300-2000) mL with 300 (50-545) mL occurring after enrolment. Total blood loss was >2500 mL in 40/605 (6.6%) women. RBCs were transfused in 141/605 (23.3%) patients and 11 (1.8%) received ≥4 units. At least one invasive procedure was performed in 283/605 (46.8%) women. Level 3 care was required for 10/605 (1.7%) women. No women developed clinically significant haemostatic impairment. Conclusions Restrictive use of FFP guided by clinical assessment of bleeding and VE-POCT is feasible and did not result in clinically significant haemostatic impairment. Studies should compare the clinical and cost effectiveness of empirical FFP infusions, according to current guidelines, with targeted use of FFP based on VE-POCT. Clinical trial registration ISRCTN46295339 ( http://www.isrctn.com/ISRCTN46295339 ) (accessed July 24, 2017), EudraCT 2012-005511-11 ( https://www.clinicaltrialsregister.eu/ctr-search?query=2011-005511-11 ) (accessed July 24, 2017).

A realist review of one-to-one breastfeeding peer support experiments conducted in developed country settings

The World Health Organisation guidance recommends breastfeeding peer support (BFPS) as part of a strategy to improve breastfeeding rates. In the UK, BFPS is supported by National Institute for Health and Care Excellence guidance and a variety of models are in use. The experimental evidence for BFPS in developed countries is mixed and traditional methods of systematic review are ill-equipped to explore heterogeneity, complexity, and context influences on effectiveness. This review aimed to enhance learning from the experimental evidence base for one-to-one BFPS intervention. Principles of realist review were applied to intervention case studies associated with published experimental studies. The review aimed (a) to explore heterogeneity in theoretical underpinnings and intervention design for one-to-one BFPS intervention; (b) inform design decisions by identifying transferable lessons developed from cross-case comparison of context-mechanism-outcome relationships; and (c) inform evaluation design by identifying context-mechanism-outcome relationships associated with experimental conditions. Findings highlighted poor attention to intervention theory and considerable heterogeneity in BFPS intervention design. Transferable mid-range theories to inform design emerged, which could be grouped into seven categories: (a) congruence with local infant feeding norms, (b) integration with the existing system of health care, (c) overcoming practical and emotional barriers to access, (d) ensuring friendly, competent, and proactive peers, (e) facilitating authentic peer-mother interactions, (f) motivating peers to ensure positive within-intervention amplification, and (g) ensuring positive legacy and maintenance of gains. There is a need to integrate realist principles into evaluation design to improve our understanding of what forms of BFPS work, for whom and under what circumstances.

A novel peer-support intervention using motivational interviewing for breastfeeding maintenance: a UK feasibility study

BACKGROUND In total, 81% of women in the UK start breastfeeding, but fewer than half continue beyond 6 weeks. Peer support in the early postnatal period may encourage women to breastfeed for longer. OBJECTIVE To develop a breastfeeding peer-support intervention based on motivational interviewing (MI) for breastfeeding maintenance and to test the feasibility of delivering it to mothers in areas with high levels of social deprivation. DESIGN Intervention development and a non-randomised multisite feasibility study. SETTING Community maternity services in three areas with high levels of social deprivation and low breastfeeding initiation rates in England and Wales. PARTICIPANTS Pregnant women considering breastfeeding. Women who did not plan to breastfeed, who had a clinical reason that precluded breastfeeding continuation or who were unable to consent were excluded. INTERVENTION The intervention Mam-Kind was informed by a survey of infant feeding co-ordinators, rapid literature review, focus groups with service users and peer supporters and interviews with health-care professionals and a Stakeholder Advisory Group. It consisted of face-to-face contact at 48 hours after birth and proactive one-to-one peer support from the Mam-Kind buddy for 2 weeks, followed by mother-led contact for a further 2-6 weeks. MAIN OUTCOME MEASURES Recruitment and retention of Mam-Kind buddies, uptake of Mam-Kind by participants, feasibility of delivering Mam-Kind as specified and of data collection methods, and acceptability of Mam-Kind to mothers, buddies and health-care professionals. RESULTS Nine buddies were recruited to deliver Mam-Kind to 70 participants (61% of eligible women who expressed an interest in taking part in the study). Participants were aged between 19 and 41 years and 94% of participants were white. Intervention uptake was 75% and did not vary according to age or parity. Most contacts (79%) were initiated by the buddy, demonstrating the intended proactive nature of the intervention and 73% (n = 51) of participants received a contact within 48 hours. Follow-up data were available for 78% of participants at 10 days and 64% at 8 weeks. Data collection methods were judged feasible and acceptable. Data completeness was > 80% for almost all variables. Interviews with participants, buddies and health service professionals showed that the intervention was acceptable. Buddies delivered the intervention content with fidelity (93% of intervention objectives were met), and, in some cases, developed certain MI skills to a competency level. However, they reported difficulties in changing from an information-giving role to a collaborative approach. These findings were used to refine the training and intervention specification to emphasise the focus of the intervention on providing mother-centric support. Health-care professionals were satisfied that the intervention could be integrated with existing services. CONCLUSIONS The Mam-Kind intervention was acceptable and feasible to deliver within NHS maternity services and should be tested for effectiveness in a multicentre randomised controlled trial. The feasibility study highlighted the need to strengthen strategies for birth notification and retention of participants, and provided some insights on how this could be achieved in a full trial. LIMITATIONS The response rate to the survey of infant feeding co-ordinators was low (19.5%). In addition, the women who were recruited may not be representative of the study sites. FUNDING The National Institute for Health Research Health Technology Assessment programme.

Assessing the medium-term impact of a home-visiting programme on child maltreatment in England: protocol for a routine data linkage study

Introduction Child maltreatment involves acts of omission (neglect) or commission (abuse) often by caregivers that results in potential or actual harm to a child. The Building Blocks trial (ISRCTN23019866) assessed the short-term impact of an intensive programme of antenatal and postnatal visiting by specially trained nurses to support young pregnant women in England. The Building Blocks: 2–6 Study will assess the medium-term impacts of the programme for mothers and children (n=1562), through the linkage of routinely collected data to the trial data, with a particular emphasis on the programme’s impact on preventing child maltreatment. Methods and analysis We have developed a bespoke model of data linkage whereby outcome data for the trial cohort will be retrieved by linked anonymous data abstraction from NHS Digital, Office for National Statistics and the Department for Education’s National Pupil Database. Participants will be given reasonable opportunity to opt out of this study prior to data transfer. The information centres will match participants to the information held in their databases using standard identifiers and send extracts to a third-party safe haven. The study will have 80% power to detect a 4% difference (4%vs8%) for the binary primary outcome of child in need status (from birth to key stage 1) at a two-sided 5% alpha level by following up 602 children in each trial arm. Analysis will be by intention to treat using logistic multilevel modelling. A cost-and-consequences analysis will extend the time frame of the economic analysis from the original trial. Ethics and dissemination The study protocol has been approved by the National Health Service Wales Research Ethics Committee and the Health Research Authority’s Confidentiality Advisory Group. Methods of innovative study design and findings will be disseminated through peer-reviewed journals and conferences; results will be of interest to clinical and policy stakeholders in the UK. Trial registration number ISRCTN23019866.