Progesterone for women with threatened miscarriage (STOP trial): a placebo-controlled randomized clinical trial.

STUDY QUESTION: In women with threatened miscarriage, does progesterone supplementation until the completion of the first trimester of pregnancy increase the probability of live birth? SUMMARY ANSWER: In women with threatened miscarriage, 400 mg vaginal progesterone nightly, from onset of bleeding until 12 weeks, did not increase live birth rates. WHAT IS KNOWN ALREADY: Limited evidence has indicated that vaginal micronized progesterone may make little or no difference to the live birth rate when compared with placebo in women with threatened miscarriage. Subgroup analysis of one recent randomized trial reported that in women with bleeding and at least one previous miscarriage, progesterone might be of benefit. STUDY DESIGN, SIZE, DURATION: We performed a randomized, double-blinded, placebo-controlled trial between February 2012 and April 2019. Eligible pregnant women under 10 weeks gestation, experiencing a threatened miscarriage as apparent from vaginal bleeding were randomized into two groups in a 1:1 ratio: the intervention group received 400 mg progesterone as vaginal pessaries, the control group received placebo vaginal pessaries, both until 12 weeks gestation. The primary endpoint was live birth. We planned to randomize 386 women (193 per group). The study was stopped at a planned interim analysis for futility after randomization of 278 women. PARTICIPANTS/MATERIALS, SETTING, METHODS: This trial was conducted at the Mater Mothers' Hospital, a tertiary centre for maternity care in South Brisbane, Queensland, Australia. We randomized 139 women to the intervention group and 139 women to the placebo group. Primary outcome data were available for 136 women in the intervention group and 133 women in the placebo group. MAIN RESULTS AND THE ROLE OF CHANCE: The live birth rates were 82.4% (112/136) and 84.2% (112/133) in the intervention group and placebo group, respectively (risk ratio (RR) 0.98, 95% CI 0.88 to 1.09; risk difference -0.02, 95% CI -0.11 to 0.07; P = 0.683). Among women with at least one previous miscarriage, live birth rates were 80.6% (54/67) and 84.4% (65/77) (RR 0.95, 95% CI 0.82-1.11; P = 0.550). No significant effect was seen from progesterone in women with two (RR 1.28, 95% CI 0.96-1.72; P = 0.096) or more (RR 0.79, 95% CI 0.53-1.19; P = 0.267) previous miscarriages. Preterm birth rates were 12.9% and 9.3%, respectively (RR 1.38; 95% CI 0.69 to 2.78; P = 0.361). Median birth weight was 3310 vs 3300 g (P = 0.992). There were also no other significant differences in obstetric and perinatal outcomes. LIMITATIONS, REASONS FOR CAUTION: Our study was single centre and did not reach the planned sample size because it was stopped prematurely at an interim analysis. WIDER IMPLICATIONS OF THE FINDINGS: We did not find evidence supporting the treatment effect of vaginal progesterone in women with threatened miscarriage. Progesterone in this setting should not be routinely used for threatened miscarriage. The treatment effect in women with threatened miscarriage after previous miscarriages warrants further research. STUDY FUNDING/COMPETING INTEREST(S): Mothers' and babies Golden Casket Clinical Fellowship (L.A.M.). Progesterone and placebo pessaries were provided by Perrigo Australia.B.W.J.M. reports grants from NHMRC, personal fees from ObsEva, personal fees from Merck KGaA, personal fees from Guerbet, personal fees from iGenomix, outside the submitted work. TRIAL REGISTRATION NUMBER: ACTRN12611000405910. TRIAL REGISTRATION DATE: 19 April 2011. DATE OF FIRST PATIENT'S ENROLMENT: 06 February 2012.

Validation of updated antenatal vaginal birth after caesarean section prediction model without race and ethnicity in Australia.

BACKGROUND: The Grobman antenatal nomogram to predict likelihood of successful vaginal birth after caesarean section (VBAC) has been validated in multiple institutions. However, due to concerns regarding inclusion of ethnicity, a new nomogram has been developed. AIM: The aim was to evaluate the efficacy of the updated Grobman nomogram without ethnicity in a regional hospital in Australia. MATERIALS AND METHODS: This was a retrospective cohort study of women electing to have a VBAC at a regional hospital over a nine-year period. Maternal demographics and obstetric outcomes were collected. Women were assigned a predicted likelihood of successful VBAC using the updated Grobman nomogram, with variables such as age, pre-pregnancy weight, height and arrest disorder as indications for previous caesarean birth, previous vaginal birth, previous VBAC and treated chronic hypertension. The predicted likelihood of successful VBAC was compared with actual successful VBAC rates. RESULTS: A total of 541 women attempted VBAC with a VBAC success rate of 74.3% (402/541). The nomogram demonstrated good fit, with a receiver operating curve area under the curve of 0.707 (95% confidence interval 0.659-0.755). Using a cut-off value of 0.5, the success rate of classification with this model was 74.3%. On comparing each predicted decile, the nomogram performed poorly in those predicted to have a <40% chance of successful VBAC. CONCLUSIONS: This study confirms the use of the updated Grobman nomogram without ethnicity, alongside usual counselling, to provide individualised advice for informed decision-making. However, clinicians should be mindful of the limitation of poor accuracy in women with a low predicted probability of VBAC.

Incidence and predictors of surgical site infection in women who are obese and give birth by elective caesarean section: A secondary analysis.

BACKGROUND: Surgical site infection (SSI) after a caesarean section is of concern (CS) is of concern to both clinicians and women themselves. AIMS: The aim of this study is to identify the cumulative incidence and predictors of SSI in women who are obese and give birth by elective CS. MATERIALS AND METHODS: The method used was planned secondary analysis of data from women with a pre-pregnancy body mass index (BMI) ≥30 kg/m2 giving birth by elective CS in a multicentre randomised controlled trial of a prophylactic closed-incision negative pressure wound therapy dressing. Data were collected from medical records, direct observations of the surgical site and self-reported signs and symptoms from October 2015 to December 2019. The Centers for Disease Control and Prevention definition was used to identify SSI. Women were followed up once in hospital just before discharge and then weekly for four weeks after discharge. Blinded outcome assessors determined SSI. After the cumulative incidence of SSI was calculated, multiple variable logistic regression models were used to identify independent risk factors for SSI. RESULTS: SSI incidence in 1459 women was 8.4% (122/1459). Multiple variable-adjusted odds ratios (OR) for SSI were BMI ≥40 kg/m2 (OR 1.55, 95% confidence interval (CI) 1.30-1.86) as compared to BMI 30-34.9 0 kg/m2 , ≥2 previous pregnancies (OR 1.38, 95% CI 1.00-1.80) as compared to no previous pregnancies and pre-CS vaginal cleansing (OR 0.55, 95% CI 0.33-0.99). CONCLUSIONS: Our findings may inform preoperative counselling and shared decision-making regarding planned elective CS for women with pre-pregnancy BMI ≥30 kg/m2 .

Work-related musculoskeletal injuries among obstetricians and gynaecologists: A cross-sectional survey of Fellows of Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG).

BACKGROUND: Obstetricians and gynaecologists (O&Gs) are at a risk of work-related musculoskeletal injuries (WRMI) on a daily basis. AIMS: To describe the prevalence of WRMI among O&Gs in Australia and New Zealand, explore risk factors for such injuries, and evaluate their impact. METHODS: An online survey of Fellows of Royal Australian and New Zealand College of Obstetricians and Gynaecologists was conducted in July 2016. It comprised questions on personal attributes, type of work, site and cause of WRMI, if any and treatment required. RESULTS: We received responses from 765 O&Gs giving a response rate of 38.3% (765/1997). Four hundred and ten specialists (53.6%) reported suffering a WRMI at some point, including 252 (32.9%) who reported multiple injuries. In multivariable analysis, females had increased risk of WRMI (odds ratio (OR): 2.12; 95% CI: 1.54-2.91) and among generalists and subspecialists, gynaecological oncologists had highest risk for WRMI (OR: 3.13; 95% CI: 1.21-8.14). Commonest sites of injury were back (218/633, 34.4%) and shoulder (131/633, 20.7%). Laparoscopic surgery (117/633, 18.5%) was the commonest cause of injury. Treatment was required for 88.6% of injuries (561/633) including 8.4% (53/633) of cases which required surgery. Ongoing symptoms post-injury were reported for 52.1% of injuries (330/633) and in 25.8% (163/633) of instances the practitioner needed to modify their scope of work. CONCLUSION: This survey among a large cohort of O&Gs shows a high prevalence of WRMI with a profound negative impact on the practitioner and profession. There is a pressing need to advocate for improved ergonomics in their workplaces.

Prospective cohort study: Causes of stillbirth in Australia 2013-2018.

BACKGROUND: Stillbirth is a major public health problem that is slow to improve in Australia. Understanding the causes of stillbirth through appropriate investigation is the cornerstone of prevention and important for parents to understand why their baby died. AIM: The aim of this study is to assess compliance with the Perinatal Society of Australia and New Zealand (PSANZ) Perinatal Mortality Clinical Practice Guidelines (2009) for stillbirths. METHODS: This is a prospective multi-centred cohort study of stillbirths at participating hospitals (2013-2018). Data were recorded into a purpose-built database. The frequency of the recommended core investigations was calculated, and χ2 test was performed for subgroup analyses by gestational age groups and timing of fetal death. A 70% compliance threshold was defined for investigations. The cause of death categories was provided according to PSANZ Perinatal Death Classification. RESULTS: Among 697 reported total stillbirths, 562 (81%) were antepartum, and 101 (15%) were intrapartum. The most common cause of death categories were 'congenital abnormality' (12.5%), 'specific perinatal conditions' (12.2%) and 'unexplained antepartum death' (29%). According to 2009 guidelines, there were no stillbirths where all recommended investigations were performed (including or excluding autopsy). A compliance of 70% was observed for comprehensive history (82%), full blood count (94%), cytomegalovirus (71%), toxoplasmosis (70%), renal function (75%), liver function (79%), external examination (86%), post-mortem examination (84%) and placental histopathology (92%). The overall autopsy rate was 52%. CONCLUSIONS: Compliance with recommended investigations for stillbirth was suboptimal, and many stillbirths remain unexplained. Education on the value of investigations for stillbirth is needed. Future studies should focus on understanding the yield and value of investigations and service delivery gaps that impact compliance.

Evaluation of fetal fibronectin for threatened preterm labour in reducing inappropriate interventions.

BACKGROUND: Preterm birth is associated with significant perinatal morbidity and mortality. The fetal fibronectin test (fFN) is used to manage women presenting with threatened preterm labour (TPTL). AIM: To evaluate the use of fFN in women presenting with TPTL with regard to hospital admission, tertiary hospital transfer and use of tocolytics and steroids in our hospital, against recommended guidelines. The ability of fFN <10 ng/mL, 10-49 ng/mL, 50-199 ng/mL and >200 ng/mL to predict outcome was also examined. MATERIAL AND METHODS: This was a single-centre retrospective study from January 2015 to June 2017. All women who presented to Ipswich hospital, a level two facility for births at >32 weeks of gestation, between 23 and 346  weeks of gestation with TPTL and who had fFN tests were included in the study. RESULTS: Fetal fibronectin <50 ng/mL had a negative predictive value of 93.5% (95% CI 86.5-97.1). Despite this assurance, one in four presentations resulted in hospital admission and nearly one in ten in steroids and tocolysis administration. Birth <34 weeks was 0% for fFN <10 and 2% for women with fFN levels <200 ng/mL compared to nearly 30% for levels >200 ng/mL. CONCLUSION: There is noncompliance with use of fFN to its full potential. This small study also provides support for the use of a 200 ng/mL cut-off fFN level for birth <34 weeks. This would avoid the need to transfer to a tertiary facility many women who present with TPTL.

Does fentanyl epidural analgesia affect breastfeeding: A prospective cohort study.

BACKGROUND: Concerns have been expressed in relation to a possible negative effect of fentanyl epidural analgesia on breastfeeding rates. A 2016 systematic review was inconclusive and suggested cohort studies be performed with control groups to allow for other potential confounding factors. AIMS: To assess the effect of fentanyl epidural analgesia in labour on breastfeeding practices. MATERIAL AND METHODS: A prospective cohort study, conducted at a metropolitan hospital, Ipswich, Queensland. Eligible women were first-time mothers, wishing to breastfeed after a vaginal birth at term. Women who had fentanyl epidural only (107) were compared with women who had subcutaneous morphine only (90), and women who had neither subcutaneous morphine nor epidural (107). RESULTS: Fewer women in the fentanyl epidural analgesia group were fully breastfeeding when leaving hospital (54.2% compared to 69.2% in the no analgesia group and 77.8% in the subcutaneous morphine group; P < 0.05). At 6 weeks postpartum, there was no evidence of difference between the groups (43% for fentanyl epidural analgesia, 52.3% for no analgesia group and 48.9% for subcutaneous morphine group; P = 0.63). Rates of induction of labour, instrumental birth and admission to special care nursery differed significantly between groups and when controlled for these, there was no association between fentanyl epidural analgesia and breastfeeding at discharge (adjusted odds ratio (OR) 0.74; 95% CI 0.39-1.41) or at 6 weeks postpartum (OR 0.75; 95% CI 0.41-1.38). CONCLUSION: Our study did not find an association between fentanyl epidural analgesia in labour and rates of fully breastfeeding at discharge and at 6 weeks postpartum.

Prostaglandin gel versus oxytocin - prelabour rupture of membranes at term - A randomised controlled trial.

BACKGROUND: Pre-labour rupture of membranes (PROM) at term is a common event with early induction of labour reducing infectious morbidity without increasing the caesarean rate. Syntocinon is commonly used for induction but prostaglandins are also routinely used. Large studies have shown no difference in the maternal and neonatal outcomes with either method. AIM: To assess the safety and efficacy of vaginal prostaglandin (PG) compared to syntocinon for induction of labour in term-PROM. METHOD: This was a single-centre randomised controlled trial at Ipswich Hospital of women presenting at ≥37 weeks gestation with PROM. Women were randomised and managed in labour as per local guidelines. Analysis was by intention to treat. RESULTS: One hundred and eighty-four women were recruited, 90 in the PG group and 94 in the oxytocin group. Women in both arms were of similar demographics and 53% of women in the PG group did not require any oxytocin. There was a statistically significant lower incidence of fetal heart rate abnormality in the PG group, 4.4% versus 12.8%. There was no difference in epidural use, caesarean section, maternal infection, admission to special care nursery or neonatal sepsis. Time to onset of labour was significantly longer in the PG group, 25.7 h versus 19.7 h but with no difference in the length of first stage. Maternal satisfaction was high in both groups with no significant difference in breastfeeding rates. CONCLUSION: Induction of labour with oxytocin or vaginal prostaglandins are safe and efficacious options for women in the context of PROM at term.

Care of pregnant women with decreased fetal movements: Update of a clinical practice guideline for Australia and New Zealand.

The National Health and Medical Research Council (NHMRC) Centre of Research Excellence in Stillbirth and the Perinatal Society of Australia and New Zealand (PSANZ) have recently partnered in updating an important clinical practice guideline, Care of pregnant women with decreased fetal movements. This guideline offers 12 recommendations and a suggested care pathway, with the aim to improve the quality of care for women reporting decreased fetal movements through an evidence-based approach. Adoption of the guideline by clinicians and maternity hospitals could result in earlier identification of higher-risk pregnancies, improved perinatal health outcomes for women and their babies, and reduced stillbirth rates.

Utility of ßhCG monitoring in the follow-up of medical management of miscarriage.

OBJECTIVE: To evaluate the percentage change in total ßeta-unit human chorionic gonadotropin (ßhCG) levels (%ΔßhCG) in the prediction of treatment outcomes following intravaginal misoprostol for missed miscarriage before 13 weeks. METHODS: A secondary analysis of a randomised controlled study of medical management of miscarriage was performed. Total ßhCG levels were collected before misoprostol (baseline) and after a planned seven day interval (follow-up), when a transvaginal ultrasound (TVUS) reported a gestational sac as present or not. If no sac at TVUS, surgery was indicated on clinical criteria. %ΔßhCG ((baseline ßhCG - follow-up ßhCG)/baseline ßhCG × 100) was evaluated in the prediction of a sac at TVUS and surgery on clinical criteria. RESULTS: %ΔßhCG was calculated for cases with ßhCG levels within two days of misoprostol and TVUS; calculation interval determined case number. The median %ΔßhCG for 24 cases with a persistent sac (6-9 day interval) was significantly lower than for 145 with no sac (58.75% (interquartile range (IQR): 37.59-76.69; maximum 86.54) vs 97.65% (IQR: 95.44-98.43); P < 0.0001). The median %ΔßhCG for eight cases needing surgery on clinical criteria (5-9 day interval) was significantly lower than for 140 cases with no sac not needing surgery (79.68% (IQR: 64.63-91.15; maximum 94.06) vs 97.68% (IQR: 95.61-98.50); P < 0.0001). The area under the receiver-operator curve was 0.975 for prediction of a persistent sac and 0.944 for prediction of surgery on clinical criteria, respectively. %ΔßhCG > 87% predicted no sac at TVUS. %ΔßhCG > 94.5% predicted no surgery on clinical criteria. CONCLUSION: %ΔßhCG calculation over one week reliably predicted treatment outcomes after medical management of missed miscarriage.

The Betadine trial - antiseptic wound irrigation prior to skin closure at caesarean section to prevent surgical site infection: A randomised controlled trial.

BACKGROUND: Surgical site infections (SSIs) occur in around 10% of women following a caesarean section. Efforts to reduce SSI include wound irrigation with povidone-iodine (PVI), but studies are nonconclusive, mostly old and few on women having caesarean section (CS). AIMS: To assess povidone-iodine (PVI) (Betadine) irrigation of wound prior to skin closure in reducing incidence of SSI after CS. Our hypothesis was that there would be no benefit with its use in reducing SSIs. MATERIALS AND METHODS: A randomised controlled trial with 3027 women. Women having CS were allocated to receive PVI irrigation or no irrigation after closure of fascia and before skin closure. Women were followed up to four weeks to assess for SSI. Main outcome measure was surgical site infection. RESULTS: The two groups (1520 in Betadine and 1507 on no Betadine group) were well balanced. The incidence of SSI was similar in the two groups (9.5% vs 9.8%, RR 0.97; 95% CI 0.78-1.21). There was no difference between groups (2.6% vs 2.0%, RR 1.29, 95% CI 0.81-2.06 Betadine vs no Betadine, respectively) in readmission for wound infection requiring intravenous antibiotics; this was so in both the elective CS group as well as CS in labour group. CONCLUSION: PVI irrigation after the closure of fascia and before closure of skin is of no benefit in the prevention of SSI in women undergoing CS.

Intrauterine anaesthetic after hysteroscopy to reduce post-operative pain - A double blind randomised controlled trial.

BACKGROUND: Pain after hysteroscopy is usually minimal but some women need additional analgesia while in the recovery ward and some require overnight hospital admission to control pain. Intrauterine installation of an anaesthetic after hysteroscopy may reduce pain. AIMS: To see if intrauterine levobupivacaine reduces post-procedure pain, need for analgesia and allow earlier return to normal activity. MATERIALS AND METHODS: This was a double-blind randomised controlled trial. Women having hysteroscopy under general anaesthesia were allocated to receive intrauterine instillation of levubupivacaine or normal saline at the end of the procedure. Women were assessed in the recovery ward by a verbal descriptor pain scale and need for additional analgesia and followed up on day 3 to further assess pain and return to normal activity. RESULTS: There were no significant differences in demographic characteristics or indication for surgery between the 224 women in the study group or the 214 women in the control group. At two hours post-procedure, 156/224 (70%) study women versus 119/214 (56%) control women had no pain; (relative risk (RR) 0.68 and 95% confidence interval (CI) 0.53-0.87). There were 182/224 (81%) study women versus 154/214 (72%) control women with a pain score < 5 (RR 0.67; 95% CI 0.47-0.95). Fewer women in the study group required additional analgesia 54/224 (24%) versus 88/214 (41%) (RR 0.58; 95% CI 0.44-0.78). There was no significant difference between groups with regards to pain at 24 h post-procedure or return to activity. CONCLUSION: Intrauterine instillation of levobupivacaine reduced post-procedure pain and need for additional pain relief.

Zinc supplementation for improving pregnancy and infant outcome.

BACKGROUND: It has been suggested that low serum zinc levels may be associated with suboptimal outcomes of pregnancy such as prolonged labour, atonic postpartum haemorrhage, pregnancy-induced hypertension, preterm labour and post-term pregnancies, although many of these associations have not yet been established. OBJECTIVES: To assess the effects of zinc supplementation in pregnancy on maternal, fetal, neonatal and infant outcomes. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 October 2014) and reference lists of retrieved studies. SELECTION CRITERIA: Randomised trials of zinc supplementation in pregnancy. We excluded quasi-randomised controlled trials. DATA COLLECTION AND ANALYSIS: Three review authors applied the study selection criteria, assessed trial quality and extracted data. When necessary, we contacted study authors for additional information. The quality of the evidence was assessed using GRADE. MAIN RESULTS: We included 21 randomised controlled trials (RCTs) reported in 54 papers involving over 17,000 women and their babies. One trial did not contribute data. Trials were generally at low risk of bias. Zinc supplementation resulted in a small reduction in preterm birth (risk ratio (RR) 0.86, 95% confidence interval (CI) 0.76 to 0.97 in 16 RCTs; 16 trials of 7637 women). This was not accompanied by a similar reduction in numbers of babies with low birthweight (RR 0.93, 95% CI 0.78 to 1.12; 14 trials of 5643 women). No clear differences were seen between the zinc and no zinc groups for any of the other primary maternal or neonatal outcomes, except for induction of labour in a single trial. No differing patterns were evident in the subgroups of women with low versus normal zinc and nutrition levels or in women who complied with their treatment versus those who did not. The GRADE quality of the evidence was moderate for preterm birth, small-for-gestational age, and low birthweight, and low for stillbirth or neonatal death and birthweight. AUTHORS' CONCLUSIONS: The evidence for a 14% relative reduction in preterm birth for zinc compared with placebo was primarily represented by trials involving women of low income and this has some relevance in areas of high perinatal mortality. There was no convincing evidence that zinc supplementation during pregnancy results in other useful and important benefits. Since the preterm association could well reflect poor nutrition, studies to address ways of improving the overall nutritional status of populations in impoverished areas, rather than focusing on micronutrient and or zinc supplementation in isolation, should be an urgent priority.

Intrahepatic cholestasis of pregnancy: diagnosis and management; a survey of Royal Australian and New Zealand College of Obstetrics and Gynaecology fellows.

BACKGROUND: Intrahepatic cholestasis of pregnancy (ICP) is an uncommon obstetric condition characterised by intense maternal pruritis and biochemical abnormality. There is a degree of contention regarding the diagnosis and management of ICP, and currently, there are no nationally accepted guidelines. AIMS: To conduct a survey of Fellows and Members of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) regarding their diagnosis and management ICP. METHODS: An online survey of currently practising RANZCOG Fellows and Members, utilising Survey Monkey. RESULTS: Thirty percent of those sent the survey responded, comprising approximately 40% of practising obstetricians. Fasting bile acid and serum transaminase elevation in association with the characteristic itch define the disease process for the majority of respondents and also inform management decisions. There was no critical level of bile acid elevation that mandated treatment for the majority of respondents. Nearly 90% of respondents induce women with ICP at 37-38 completed weeks of pregnancy, due to concerns regarding possible fetal demise. About one-third of respondents refer to the Royal College of Obstetricians and Gynaecologists (RCOG) Green-top Guideline to advise their decision-making process, and a similar proportion use local or hospital-based guidelines. CONCLUSIONS: Elevated fasting bile acids and abnormal liver function tests define the diagnosis and inform management of ICP by Australian obstetricians. Routine induction of labour for patients with ICP at 37-38 completed weeks of pregnancy is widely practised in Australia. An evidence-based guideline would assist clinicians who manage such cases in Australia.

A test of agreement of customised birthweight models.

BACKGROUND: The objective of this study was to determine whether the physiological effects on birthweight as described by customised birthweight models (CBMs) from various populations and locations are consistent when applied to a single sample. METHODS: The predicted birthweight was calculated for 52 826 White-European singleton term births between 1997 and 2008 from a large Australian hospital using the same set of variables from 12 published CBMs. The accuracy of prediction was tested against both the actual birthweight and a reference model. Intraclass correlation coefficients (ICCs) along with 95% confidence intervals of the measurements, paired differences (predicted-actual birthweight) and absolute values of the paired differences are reported. RESULTS: The average difference in predicted and actual birthweight was <200 g for all CBMs, with ICCs for all but one model indicating fair agreement (between 0.3 and 0.5). When compared with the reference model, eight of the 11 models had a difference in predicted birthweight of <220 g, and the ICCs indicated that the majority of models had strong agreement. CONCLUSION: All published CBMs demonstrated ability to predict birthweight with reasonable accuracy. The effects of maternal and fetal characteristics on birthweight appear to be consistent across birthweight models. This finding is a further step in validating the CBM, and provides greater evidence for the creation of a global model.

The medical management of missed miscarriage: outcomes from a prospective, single-centre, Australian cohort.

OBJECTIVE: To report the prospective outcomes of medical management of missed miscarriage before 13 weeks' gestation from an Australian cohort. DESIGN: Descriptive study of a cohort selected out of a randomised controlled trial. SETTING: Outpatient management at a maternity hospital between 1 May 2007 and 28 July 2010. PARTICIPANTS: 264 women requesting medical management of missed miscarriage. MAIN OUTCOME MEASURES: Number of doses of misoprostol required, unscheduled visits for care, findings at ultrasound follow-up, requirement for surgical management, number of cases of gestational trophoblastic disease (GTD), and self-reported patient experience. RESULTS: 107 women (40.5%) received a repeat dose of misoprostol, and 79 women (29.9%) made unscheduled visits for care. Among the 241 women with Day 7 ultrasound follow-up, a gestational sac was found in 32 women (13.3%), indicating failure of medical management. Complete miscarriage was induced without the need for surgery in 206 women (78.0%). Surgery was performed as an emergency in 13 women (4.9%). Twelve women (4.5%) had surgery for ongoing bleeding after medical management, and four of these did not have chorionic villi on histopathological examination. Five women (1.9%) had GTD, which was managed incidentally under the protocol. Among those who returned patient questionnaires, 73.0% participants (116/159) indicated that they would recommend medical management of miscarriage to other women, while 18.2% (29/159) indicated that they would undergo surgery next time. CONCLUSION: The medical management of missed miscarriage on an outpatient basis is safe and effective. TRIAL REGISTRATION: ACTRN12612000150842.

Customised birthweight models: do they increase identification of at-risk infants?

AIM: The study aims to describe the cohort of women and babies who are classified as small-for-gestational age (SGA) at term by both an Australian customised birthweight model (CBM) and a commonly used population-based standard, and to investigate and compare the utility of these models in identifying babies at risk of experiencing adverse outcomes METHODS: Routinely collected data on 54 890 singleton-term births at the Mater Mothers' Hospitals, Brisbane, with birthweight less than 4000 g between January 1997 and December 2008, was extracted. Each birth was classified as SGA (<10th centile) or not SGA by either and/or both methods: population-based standards (SGApop ) and CBM (SGAcust ). Babies classified as SGApop , SGAcust or SGAboth were compared with those not classified as SGA by both methods using relative risk and 95% confidence interval, and those only classified as SGAcust were compared with those only classified as SGApop . Maternal demographics, maternal risk factors for fetal growth restriction, pregnancy and labour complications and adverse neonatal outcomes are reported. RESULTS: A total of 4768 (8.7%) births were classified as SGApop , while 6479 (11.8%) were SGAcust of whom 4138 (63.9%) were also classified as SGApop . Maternal risk factors such as smoking and hypertension were statistically higher for the SGAcust group when compared with SGApop . For the majority of adverse neonatal outcomes, a trend was noted to increased identification using the CBM. CONCLUSION: The CBM provides a modest improvement when compared to a population-based standard to identity term infants at birth who are at risk of adverse neonatal outcomes.

Can we use a lower intravaginal dose of misoprostol in the medical management of miscarriage? A randomised controlled study.

BACKGROUND: The optimal dose of misoprostol to be used in the medical management of miscarriage before 13 weeks has not been resolved. AIM: To evaluate the effectiveness and side effect profile of two different dosages of misoprostol. METHODS: A randomised controlled, equivalence study comparing 400 vs 800 µg misoprostol per vaginum (PV) on an outpatient basis. The allocated dose was repeated the next day if clinically the products of conception had not been passed. Complete miscarriage was evaluated using two methods: ultrasound criteria on Day 7 and the need for surgical management (clinical criteria). Equivalence was demonstrated if the 95% confidence interval [CI] of the observed risk difference between the two doses for complete miscarriage lay between -15.0 and 15.0%. Differences in side effects and patient satisfaction were evaluated using patient-completed questionnaires. RESULTS: One hundred and fifty-eight women were allocated to receive 400 µg and 152 women to 800 µg misoprostol for the management of missed (91.3%) or incomplete (8.7%) miscarriage. The rate of induced complete miscarriage was equivalent using both ultrasound criteria (observed risk difference (ORD) -4.6%, 95% CI -12.8 to 3.7%; P = 0.313) and clinical criteria (ORD -5.6%, 95% CI -14.8 to 3.6%; P = 0.273). Following the 400 µg dose, the reported rate of fever/rigors was lower (ORD -15.6%, 95% CI -28.1 to -3.0%; P = 0.015), and more women reported their decision to undergo medical management as a good decision (ORD 15.2%, 95% CI 2.8 to 27.7%; P = 0.018). CONCLUSION: Four hundred-microgram misoprostol PV can be recommended for the medical management of miscarriage on an outpatient basis.

Decreased fetal movements - An audit of predictors and an evaluation of management based on a locally developed flow chart.

OBJECTIVES: Decreased fetal movements (DFM) is associated with adverse pregnancy outcomes. We aimed to look at the risk factors associated with DFM and outcomes of women who presented with and without DFM and outcomes before and after the implementation of a locally developed flow chart based on an evidence-based guideline. STUDY DESIGN: This was a retrospective audit of 1165 women ≥ 28 weeks' gestation with a singleton pregnancy who presented with concerns regarding DFM. We compared labor and neonatal outcomes to 4706 in a control group who did not present with concerns regarding FM. We also compared the same pregnancy outcomes before and after the implementation of hospital guidelines on the management of DFM. Statistical analyses were performed primarily using Chi square analysis and relative risk. RESULTS AND CONCLUSIONS: 1165 women presented 1645 times with DFM. Women presenting with DFM were younger, (82.8% vs 79.0%, p= <0.01 were 20 to 34-years old), tended to have a higher BMI (42.9% vs 34.4%, p=<0.001 with BMI ≥ 30) and were more likely to have mental health conditions (31.1% vs 24.2%, p=<0.01). There was no difference in the composite neonatal outcome including stillbirth, 5 min APGAR < 7 and Special Care Nursery (SCN) admission between DFM and control (22.9 vs 24.8% respectively, P = 0.18). There was no difference in perinatal outcomes pre- and post-implementation of the hospital guidelines on DFM management. Women presenting with DFM were more likely to have an induction (40.7% vs 29.9% p=<0.01) but not more likely to have a caesarean section (30.9% vs 28.8% respectively, p = 0.16). There were increasing rates of IOL with increasing number of presentations for DFM. Adoption of and adherence to locally developed guidelines was an opportunity to ensure all clinicians provide consistent advice on management and timing of birth for women presenting with DFM.