A.W. Welsh

Caseload midwifery care versus standard maternity care for women of any risk: M@NGO, a randomised controlled trial

BACKGROUND Women at low risk of pregnancy complications benefit from continuity of midwifery care, but no trial evidence exists for women with identified risk factors. We aimed to assess the clinical and cost outcomes of caseload midwifery care for women irrespective of risk factors. METHODS In this unblinded, randomised, controlled, parallel-group trial, pregnant women at two metropolitan teaching hospitals in Australia were randomly assigned to either caseload midwifery care or standard maternity care by a telephone-based computer randomisation service. Women aged 18 years and older were eligible if they were less than 24 weeks pregnant at the first booking visit. Those who booked with another care provider, had a multiple pregnancy, or planned to have an elective caesarean section were excluded. Women allocated to caseload care received antenatal, intrapartum, and postnatal care from a named caseload midwife (or back-up caseload midwife). Controls received standard care with rostered midwives in discrete wards or clinics. The participant and the clinician were not masked to assignment. The main primary outcome was the proportion of women who had a caesarean section. The other primary maternal outcomes were the proportions who had an instrumental or unassisted vaginal birth, and the proportion who had epidural analgesia during labour. Primary neonatal outcomes were Apgar scores, preterm birth, and admission to neonatal intensive care. We analysed all outcomes by intention to treat. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000349246. FINDINGS Publicly insured women were screened at the participating hospitals between Dec 8, 2008, and May 31, 2011. 1748 pregnant women were randomly assigned, 871 to caseload and 877 to standard care. The proportion of caesarean sections did not differ between the groups (183 [21%] in the caseload group vs 204 [23%] in the standard care group; odds ratio [OR] 0·88, 95% CI 0·70-1·10; p=0·26). The proportion of women who had elective caesarean sections (before onset of labour) differed significantly between caseload and standard care (69 [8%] vs 94 [11%]; OR 0·72, 95% CI 0·52-0·99; p=0·05). Proportions of instrumental birth were similar (172 [20%] vs 171 [19%]; p=0·90), as were the proportions of unassisted vaginal births (487 [56%] vs 454 [52%]; p=0·08) and epidural use (314 [36%] vs 304 [35%]; p=0·54). Neonatal outcomes did not differ between the groups. Total cost of care per woman was AUS

Guidelines for the use of recombinant activated factor VII in massive obstetric haemorrhage

566·74 (95% 106·17-1027·30; p=0·02) less for caseload midwifery than for standard maternity care. INTERPRETATION Our results show that for women of any risk, caseload midwifery is safe and cost effective. FUNDING National Health and Medical Research Council (Australia).

Reproducibility of regional placental vascularity/perfusion measurement using 3D power Doppler

Recombinant activated factor VII (rFVIIa) is emerging as a novel therapy for the treatment of life or fertility‐threatening post‐partum haemorrhage (PPH) unresponsive to standard therapy that in some cases may prevent the need for peripartum hysterectomy. The level of evidence to date for use of rFVIIa in PPH is limited to case reports and case series with one nonrandomised study. No high‐quality randomised controlled trials have been published at this stage, precluding a quality systematic review. Guidelines have been published for the use of rFVIIa in non‐obstetric haemorrhage, though to date none are available for PPH. A multidisciplinary group of Australian and New Zealand clinicians from the fields of obstetrics, anaesthesia and haematology, who have both clinical experience in and/or knowledge of rFVIIa was convened by the manufacturer. This group produced an opinion and guideline based on their experience and the published international literature on the use of rFVIIa. This is intended to be used as a guideline and algorithm for the use of rFVIIa, though any use should be tailored to local practice and resources.

Evaluation of conventional Doppler fetal cardiac function parameters: E/A ratios, outflow tracts, and myocardial performance index.

To assess reproducibility and regional variability of placental perfusion measurement using three‐dimensional (3D) power Doppler VOCAL™ (Virtual Organ Computer‐aided AnaLysis).

Cervical screening for preterm delivery

Structural evaluation of the fetal heart is well established. Functional evaluation using pulsed-wave Doppler may also be performed. E/A ratios express the relationship between the maximal velocities of the E and A waveforms of ventricular filling. In normal fetuses, E/A ratios are usually <1 but show a constant increment during gestation, mainly related to the increment of the E wave. In intrauterine growth restriction (IUGR) fetuses, E/A ratios are lower compared to values in normally grown fetuses at the same gestational age. Cardiac outflows provide information on the time-velocity integral that, combined with the vessel area, allows calculation of the left and right cardiac outputs. In normal fetuses there is a predominance of the right ventricle (55–60%) in contributing to the combined cardiac output. In IUGR fetuses this predominance shifts to the left ventricle in order to increase the flow to the upper part of the fetal body and brain. The myocardial performance index (MPI) also provides information on systolic and diastolic cardiac function. The MPI is an early and consistent marker of cardiac dysfunction which becomes altered in early stages of chronic hypoxia or in cases with cardiac overload such as in twin-to-twin transfusion syndrome.

Three‐dimensional Doppler evaluation of single spherical samples from the placenta: intra‐ and interobserver reliability

The ability of sonographic cervical length screening to detect those at risk of spontaneous preterm delivery has been extensively explored over the past few years. This applies both to high-risk and low-risk groups. Cervical length measurement appears to be superior to biochemical, microbiological or hormonal methods of screening. The screening technique has been standardized, but the cervical length for intervention and the timing and nature of intervention have not been defined. Cervical cerclage appears to be of use to prevent or arrest the progress of cervical dilation in high-risk cases, but the management of the screen-positive low-risk case has yet to be determined. Future management may be stratified according to actual cervical length, and prospective randomized trials of treatment for the short cervix are needed.

A common sleep disorder in pregnancy: Restless legs syndrome and its predictors

To evaluate the intra‐ and interobserver reliability of assessment of three‐dimensional power Doppler (3D‐PD) indices from single spherical samples of the placenta.

The "volumetric" pulsatility index as evaluated by spatiotemporal imaging correlation (STIC): a preliminary description of a novel technique, its application to the endometrium and an evaluation of its reproducibility.

Restless legs syndrome (RLS) is common in the third trimester of pregnancy. In this case–control study, 22.5% of 211 women had RLS. The RLS cases had a history of growing pains (GP) more frequently than controls (P = 0.042). A family history of GP (P = 0.025) and RLS (P = 0.018) was more frequent among cases than controls. RLS in pregnancy is predicted by family history of RLS and GP, and by childhood history of GP.

Quantification of power Doppler and the index ‘fractional moving blood volume’ (FMBV)

We propose new volumetric indices derived from three-dimensional (3-D) power Doppler (PD) using spatiotemporal imaging correlation (STIC) to overcome the influence of machine settings and attenuation. In this study, we describe these indices and evaluate their interobserver reliability: two static-3-D and two STIC PD datasets were acquired from 60 women and two observers (blinded analysis) evaluated vascularization index (VI), the flow index (FI) and the vascularization flow index (VFI) of standardized spherical samples of endometrium. Three new indices were determined based on maximum, minimum and mean values (vPI, vRI(max-min), vS/D(max-min)) and two indices from frames subjectively defined as systole and diastole (vRI(sys-dia), vS/D(sys-dia)). Highest intraclass coefficient correlations (ICCs) were obtained from vPI derived from VI or VFI (0.77-0.76), followed by vRI(max-min) (0.72-0.72) and vS/D(max-min) (0.52-0.49). ICCs from indices based on subjectively systole and diastole or FI were consistently lower (<0.40). We conclude that the subjective choice of systolic and diastolic frames only lacks reliability but indices based on complete evaluation may reliably be used.

Methodological considerations for the correct application of quantitative three‐dimensional power Doppler angiography

Complete fetal assessment should ideally encompass both structural and functional components. Accurate assessment of regional blood flow, in particular impaired or redistributed flow, is necessary for functional fetal assessment. Various methods of evaluating perfusion in the adult have been well summarized by Jansson et al.1, but the mainstay in the fetus has been Doppler ultrasound2. Doppler ultrasound allows the evaluation of moving particles within the fetal circulation but has not yet been proved useful for direct measurement of regional perfusion. It would appear simple to use quantified Doppler to evaluate flow volumes in single large vessels, by combining accurate gray-scale measurement of vessel diameter with spectral Doppler calculation of the speed of movement of the blood cells within that vessel3–5. However, even for isolated large vessels, inaccuracies in both the gray-scale and the Doppler component have so far precluded accurate volume flow measurements, with the pulsatile expansion of vessels such as the fetal aorta being in the range of 10–15% of the minimum diameter3. This becomes significantly more complex when extrapolated to tissue perfusion, where blood vessels are tortuous and multidirectional, prohibiting accurate vascular diameter measurement or angle of insonation correction for the Doppler frequency shift. For this reason fetal vascular assessment has so far relied upon the measurement of indices of resistance to blood flow in isolated blood vessels, including the systolic/diastolic ratio, the resistance index and the pulsatility index. The advantage of these measurements has been that an alteration in the angle of insonation will result in an equal increment in both the numerator and the denominator, and thus the ratio remains consistent. Based upon these ratios, comments on tissue perfusion and vascular compliance may be made, as an extrapolation from the perceived resistance to flow; the most studied cases are the progressive changes in the indices of the umbilical and middle cerebral arteries and ductus venosus in fetal growth restriction6.