Gill Gyte

Use of recombinant activated factor VII in primary postpartum hemorrhage - The northern European registry 2000-2004

OBJECTIVE: To collect data from nine European countries for cases of obstetric hemorrhage between 2000 and 2004 in which recombinant activated factor VII (rFVIIa) was used. METHODS: The cases were identified through national surveys. Standardized case report forms included sociodemographic details, past medical and obstetric history, and details of the progress and management of labor in which the postpartum hemorrhage occurred. Clinicians were asked to describe subjectively the effect of rFVIIa administration using two mutually exclusive categories: 1) bleeding reduced or 2) bleeding unchanged or worse. RESULTS: A total of 113 forms were returned (88%) with 97 (86%) classified as treatment, and 16 (14%) as “secondary prophylaxis.” Clinicians noted improvements after a single dose for 80% of women in the treatment group, and for 75% in the secondary “prophylaxis” group. However, rFVIIa failed in 15 cases (13.8%). Few serious adverse events were noted related to rFVIIa administration; there were four cases of thromboembolism, one myocardial infarction, and one skin rash. CONCLUSION: Clinical reports and hematologic data suggest improvement for more than 80% of women after rFVIIa administration and few adverse effects. LEVEL OF EVIDENCE: II

Achieving sustainable quality in maternity services - using audit of incontinence and dyspareunia to identify shortfalls in meeting standards.

BackgroundSome complications of childbirth (for example, faecal incontinence) are a source of social embarrassment for women, and are often under reported. Therefore, it was felt important to determine levels of complications (against established standards) and to consider obstetric measures aimed at reducing them.MethodsClinical information was collected on 1036 primiparous women delivering at North and South Staffordshire Acute and Community Trusts over a 5-month period in 1997. A questionnaire was sent to 970 women which included self-assessment of levels of incontinence and dyspareunia prior to pregnancy, at 6 weeks post delivery and 9 to 14 months post delivery.ResultsThe response rate was 48%(470/970). Relatively high levels of obstetric interventions were found. In addition, the rates of instrumental deliveries differed between the two hospitals. The highest rates of postnatal symptoms had occurred at 6 weeks, but for many women problems were still present at the time of the survey. At 9–14 months high rates of dyspareunia (29%(102/347)) and urinary incontinence (35%(133/382)) were reported. Seventeen women (4%) complained of faecal incontinence at this time. Similar rates of urinary incontinence and dyspareunia were seen regardless of mode of delivery.ConclusionFurther work should be undertaken to reduce the obstetric interventions, especially instrumental deliveries. Improvements in a number of areas of care should be undertaken, including improved patient information, improved professional communication and improved professional recognition and management of third degree tears. It is likely that these measures would lead to a reduction in incontinence and dyspareunia after childbirth.

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the analytical (theoretical/philosophical) research

BackgroundConducting clinical trials with pre-term or sick infants is important if care for this population is to be underpinned by sound evidence. Yet, approaching the parents of these infants at such a difficult time raises challenges to obtaining valid informed consent for such research. In this study, we asked, What light does the analytical literature cast on an ethically defensible approach to obtaining informed consent in perinatal clinical trials?MethodsIn a systematic search, we identified 30 studies. We began our analysis by applying philosophical frameworks, which were then refined as concepts emerged from the analytical studies, to present a coherent picture of a broad literature.ResultsBetween them, the studies addressed four themes. The first three were the ethical basis for parental informed consent for neonatal and/or perinatal research, the validity of parental consent in this context, and the range of possible options in methods for gaining consent. The last was the issue of risk and the possibility of a double-standard or asymmetry in the current approaches to the requirement for consent for research and consent for clinical treatment.ConclusionsIn addressing these issues, the analysed studies showed that, whilst there are a variety of possible defences for seeking parental ‘consent’ to neonatal and/or perinatal clinical trials, these are all consistent with the strongly and widely held view that it is important that parents do give (or decline) consent for such research. So far as the method of obtaining consent is concerned, none of the existing consent processes reviewed by the research is satisfactory, and there are philosophical reasons for supposing that at least some parents will fail to give valid consent in a neonatal context. Furthermore, in giving parental ‘consent’ in a perinatal context, parents are authorising infant participation, not giving ‘proxy consent’. Finally, there are reasons for giving weight to both parental ‘consent’ and the infant’s best interests in both research and clinical treatment. However, there are also reasons to treat these factors differently in the two contexts, and this may be partly due to the differing relevance of risk in each case. A significant gap is the lack of any detailed discussion of a process of emergency and/or urgent ‘assent’, in which parents assent or refuse their baby’s participation as best they can during the emergency and later give full consent to continuing participation and follow-up.

Findings of meta-analysis cannot be relied on

Mayor reports that a meta-analysis has linked planned home births with a twofold higher rate of neonatal mortality compared with hospital births.1 2 Closer inspection calls this finding into question. The quality of studies in any meta-analysis is critical, but no assessment was reported. Studies were observational with many not matched adequately for confounders. Neonatal …

An estimation of intrapartum-related perinatal mortality rates for booked home births in England and Wales between 1994 and 2003

Sir, Mori et al.1 in their study of intrapartum-related perinatal mortality (IPPM) attempted to use the ‘best available data’ to ascertain the safety of planned home birth. The validity of this study hinges on being able to determine accurately the numbers of planned home births. The authors took the number of actual home births and adjusted these using estimates for the numbers of both unintended home births and transfers. However, they have used inappropriate assumptions and have compounded these mistakes by making errors in their calculations. The authors use two ways to determine the numbers of unintended/unplanned home births, Calculation A and Calculation B, producing widely differing answers of 66 265 and 20 206. ‘Calculation A’ estimates unintended home births as a percentage of all home births (50.7%) and ‘Calculation B’ as a percentage of overall births (0.32%). There is no reason to suppose that the number of unplanned home births are affected by a rise or fall in planned home births. However, it is likely that a small consistent proportion of pregnant women concealed their pregnancy or had a precipitate birth at home. Indeed, Murphy et al.2 reported from 1970 to 1979 that unintended home births formed a relatively constant percentage of all births, around 0.35% (range 0.27–0.46%). In contrast, unintended home births increased from 17 to 57% when expressed as a percentage of all home births. This demonstrates that Calculation B is more reliable, yet Mori’s conclusions are based on Calculation A. In addition, calculations of the numbers of births and IPPM rates using Calculation A are subjected to a number of errors and are therefore invalid. The Murphy study2 data applicable to Calculation A are included in table 1 (34.1%) but omitted from the calculation of both the weighted mean and the sensitivity ranges used to create table 2. Using a revised weighted mean and lower range reduces the IPPM in table 2 for booked home birth, whether completed or not, and increases the range in which the true rates could lie. Furthermore, the study by Redshaw et al.3 is included in Calculation B, but not Calculation A, adding to the inaccuracy of table 2. There is also an error in table 2 in the completed home birth group, where 31 intrapartum-related deaths for 83 343–111 126 gives a range of 0.28–0.37, not 0.28–1.15 as reported. The authors inappropriately make a direct comparison between women who ‘planned home birth but transferred to hospital’, with ‘all women giving birth’. However, if such a comparison is made, it should be with a matched group of women who booked hospital birth and developed complications. The key finding that ‘there was no evidence of difference in the IPPM rate for the booked home birth group compared to the overall rate’ was not reported in the abstract as it should have been. DOI: 10.1111/j.1471-0528.2008.01835.x www.blackwellpublishing.com/bjog Correspondence

When should the umbilical cord be clamped

#### The bottom line At birth, if the umbilical cord is not clamped immediately blood flow between the baby and placenta continues for a short time; this continued placental transfusion is part of the physiological transition from fetal to neonatal circulation.1 Clamping the cord too quickly may restrict the infant’s ability to cope with this transition.2 3 Healthy babies at term usually adapt without major consequences, but this may affect wellbeing in those born preterm or with an impaired cardiorespiratory circulation. A brief delay in cord clamping may increase neonatal blood volume, but a longer delay may have other advantages, such as a smoother cardiorespiratory transition and more stable blood pressure, irrespective of net change in blood volume. For very preterm infants (<32 weeks’ gestation), improved blood pressure stability may reduce the risk of intraventricular haemorrhage.4 Concerns about deferring (delaying) cord clamping include exacerbation of jaundice, increased blood viscosity owing to greater red cell mass, delayed respiratory support, and hypothermia. There is no agreement on what constitutes early or deferred cord clamping. At term, placental transfusion is usually complete by two minutes but may continue for up to five minutes,5 and it contributes up to a …