Redesigning antenatal care: Prospective use of an implementation framework to establish a population-based multidisciplinary first-trimester screening, assessment and prevention service.

BACKGROUND: Australian rates of adverse obstetric outcomes have improved little despite guidelines recommending history-based screening and intervention. The first trimester provides a unique opportunity to predict and prevent complications, yet population-based screening has failed to be translated into broad clinical practice. AIMS: This study aimed to redesign antenatal care within an Australian public healthcare centre to align with evidence-based maternity care, including population-based first-trimester screening with early initiation of preventative strategies in high-risk pregnancies. METHODS: A five-phase action-process model, sharing key elements with implementation science theory, was used to explore barriers to change in antenatal care, co-design a novel service with consumers and establish a population-based antenatal pathway commencing with a multidisciplinary first-trimester screening, assessment and planning visit. RESULTS: The case for change and associated barriers were defined from the perspective of antenatal care stakeholders. Key needs of each group were established, and solutions were created using co-design methodology, allowing the team to create a novel approach to antenatal care which directly addressed identified barriers. Implementation of the service was associated with a fall in the median gestation at first specialist maternity care provider visit from 20 to 13 weeks. CONCLUSIONS: This study confirms the feasibility of establishing a comprehensive first-trimester screening program within a public Australian healthcare setting and highlights a co-design process which places individualised assessment at the forefront of antenatal care. This framework may be applicable to most public maternity settings in Australia, with expansion aimed at providing equity of care, including in rural and remote settings.

Do first-trimester screening algorithms for preeclampsia aligned to use of preventative therapies reduce the prevalence of pre-term preeclampsia: A systematic review and meta-analysis.

OBJECTIVE: Traditional obstetric practice relies upon history-based assessment to screen for preeclampsia and guide preventative therapies but is hampered by low sensitivity, high false-positive rates and low treatment rates. First-trimester screening algorithms represent the most efficacious approach for risk prediction and could target early initiation of aspirin to well-defined high-risk populations. A large randomised controlled trial has demonstrated the clinical benefits of this approach, but widespread practice implementation has remained elusive. METHODS: We performed a systematic review and meta-analysis summarising studies linking first-trimester preeclampsia screening algorithms with the initiation of preventative therapy and examined their effect on pre-term preeclampsia rates compared with standard maternity care. Odds ratios were calculated together with 95% confidence intervals. RESULTS: 7 studies with a total of 377,790 participants were included. Within singleton populations, early initiation of aspirin in response to a high-risk screening algorithm result reduced the prevalence of pre-term preeclampsia by 39% compared with routine antenatal care (odds ratio 0.61; 95% CI: 0.52-0.70). There were significant reductions in the prevalence of preeclampsia at <32-34 weeks, preeclampsia at any gestation and stillbirth. CONCLUSION: First-trimester screening algorithms for preeclampsia aligned with early initiation of preventative therapy with aspirin reduce the prevalence of pre-term preeclampsia.

Does low dose aspirin prescribed for risk of early onset preeclampsia reduce the prevalence of preterm prelabor rupture of membranes?

Background: Placental dysfunction, inflammation and degradation of fetal membranes has been hypothesized as a cause of preterm prelabor of rupture of membranes.Objective: To examine the effect of aspirin, an anti-inflammatory agent, on the prevalence of preterm prelabor rupture of membranes (PPRoMs).Methods: A retrospective analysis was conducted to examine the effect of aspirin on the prevalence of PPRoM. Aspirin (150 mg, nocte) was prescribed to women who were identified through a screening program at 11-13+6 weeks' gestation as being at high risk for developing early-onset preeclampsia. Women who were at low risk for developing preeclampsia did not receive aspirin. The prevalence of PPRoM was compared with an observational cohort.Results: In the observational cohort, there were 3027 women, including 32 (1.1%) cases of PPRoM. The prevalence of PPRoM in the high risk group was 3.1% (4/128) and was statistically significantly higher compared to the low risk group (1.0%) (28/2899). The relative risk was 3.02 (95% CI 1.2-7.7; p= .04). In the interventional cohort, there were 7280 women, with 114 (1.6%) cases of PPRoM. The prevalence of PPRoM in the high risk group who were treated with aspirin was 1.8% (14/766) compared to 1.5% (100/6516) in the low risk group (p= .54). The prevalence of PPRoM in high risk patients in the observational group (who did not receive aspirin) compared with the high risk patients in the interventional group (who were treated with aspirin) was not statistically significant (p= .31).Conclusions: PPRoM is significantly associated with a description of high risk for ePET; although, this algorithm is not a good screening tool for predicting PPRoM. Aspirin treatment of women deemed high risk for ePET is safe in the context of PPRoM and there may be some reduction in prevalence of PPRoM in treated high risk women; although, this study was not powered to demonstrate a small reduction in the prevalence of PPRoM. The findings merit further investigation through a larger prospective study with adequate sample size.

Does aspirin prescribed to women deemed high risk for preterm pre-eclampsia at 11-13+6 weeks gestation affect the prevalence of small for gestational age neonates?

BACKGROUND: Aspirin has been shown to reduce prevalence of both early-onset pre-eclampsia (ePET) and fetal growth restriction (FGR). AIMS: To determine whether aspirin prescribed for risk of ePET reduces the prevalence of small for gestational age (SGA) neonates. MATERIAL AND METHODS: Two prospective cohorts were consecutively recruited in a large university hospital in Sydney. The Observational cohort (April 2010 to March 2012) validated an algorithm for ePET screening, where risk for ePET was modelled on history, mean arterial pressure, uterine artery pulsatility index and pregnancy-associated plasma protein A. The Interventional cohort (April 2012 to December 2017) were screened and allocated women at high risk of developing ePET to aspirin 150 mg. The prevalence of preterm and term SGA was compared using regression analysis. RESULT: There were 3013 and 8424 women screened in the Observational and Interventional cohorts respectively. Women who screened high risk for ePET were three to four times more likely to give birth to a neonate classified as SGA in the Observational (6.8% vs 1.9%) and Interventional cohorts (6.0% vs 1.8%). In women who screened high risk, there were no statistically significant differences in the prevalence of SGA neonates (6.6% vs 6.0%; adjusted odds ratio 0.84 (0.50-1.42)) in women who received aspirin compared to women who did not. CONCLUSIONS: Women who screen high risk for ePET have an increased chance of delivering an SGA infant. A reduction in the prevalence of SGA neonates when aspirin was prescribed to women who screened high risk for ePET did not reach clinical significance in our cohort.

Be Healthe for Your Heart: A Pilot Randomized Controlled Trial Evaluating a Web-Based Behavioral Intervention to Improve the Cardiovascular Health of Women with a History of Preeclampsia.

This pilot randomized controlled trial (RCT) aimed to determine the acceptability and preliminary efficacy of a web-based cardiovascular disease (CVD) prevention intervention for women following preeclampsia. Australian women with a recent history (≤4 years post diagnosis) of preeclampsia were randomized into two study arms: (1) Be Healthe for your Heart, a web-based behavioral intervention or; (2) Control, access to the National Heart Foundation website. Assessments were conducted at baseline, and after three months. Intervention acceptability and impact on absolute CVD 30-year risk score, CVD risk markers and health behaviors were assessed. Twenty-four of 31 (77.4%) women completed the three-month assessment. Eleven out of 13 intervention participants (84.6%) agreed/strongly agreed they were satisfied with the program, with a mean score of 4.2 ± 0.9 (maximum of five). There were no significant between or within group differences in absolute CVD risk, CVD risk markers or health behaviors from baseline to three months. Women with a history of preeclampsia were successfully recruited and retained and they reported high levels of acceptability with the Be Healthe for your Heart program. Further research is therefore needed from powered trials to determine the impact of web-based lifestyle interventions on CVD risk in this at-risk group.

First-Trimester Prediction of Preterm Prelabour Rupture of Membranes.

BACKGROUND: Preterm prelabour rupture of membranes (PPRoM) is commonly associated with preterm delivery and affects up to 3% of all pregnancies. It is associated with high rates of morbidity and mortality for the mother and the newborn. OBJECTIVES: To identify risk factors for PPRoM and develop a model for first-trimester prediction of risk of PPRoM. METHODS: A retrospective analysis of a series of women who had first-trimester (11-13+6 weeks) screening for aneuploidy and pre-eclampsia and delivered in the same institution was performed. Univariate and multivariate logistic regression analyses were used to identify maternal and pregnancy factors and then develop a clinical prediction model for PPRoM. RESULTS: 10,280 women were screened between April 2010 and October 2016. 144 (1.4%) had PPRoM. Maternal factors predictive of PPRoM included nulliparity (parous women, OR 0.53; 95% CI 0.4-0.8), pre-existing diabetes mellitus (DM) (Type 1 DM, OR 6.7; 95% CI 2.3-19.4, Type 2 DM, OR 5.3; 95% CI 1.6-18.3), maternal age group (p = 0.004), and BMI category (p = 0.012). Uterine artery pulsatility index (UAPI) and biochemical parameters (PAPP-A, free ßHCG) did not reach statistical significance. The predictive model had moderate efficacy with an area under the ROC curve of 0.67. CONCLUSIONS: Several maternal characteristics collected during first-trimester screening predict PPRoM. Biomarkers currently measured during first-trimester screening (PAPP-A, ßHCG, and UAPI) do not predict PPRoM. Whilst a predictive model can be generated with information currently collected at 11-13+6 weeks, this has only modest screening performance. First-trimester screening provides a structured framework where other predictors could improve model performance, and future studies should focus on the addition of other risk factors and biomarkers that may improve screening efficacy.

Be Healthe for Your Heart: Protocol for a Pilot Randomized Controlled Trial Evaluating a Web-Based Behavioral Intervention to Improve the Cardiovascular Health of Women With a History of Preeclampsia.

Background: Women with a history of preeclampsia are at greater risk of cardiovascular disease (CVD) related morbidity. Despite this knowledge, there is a lack of interventions available for women with a history of preeclampsia for the prevention of CVD. The aim of this pilot randomized controlled trial (RCT) is to determine the acceptability and preliminary efficacy of a web-based behavioral intervention targeted to women with a history of preeclampsia (Be Healthe for your Heart). Method: Australian women aged 18-45 years, with a recent history (≤4 years post diagnosis) of preeclampsia will be recruited for a 3-months, 2-arm parallel group pilot RCT. Participants will be randomized into 2 study arms: (1) Be Healthe for your Heart or; (2) Control, with assessments conducted at baseline, and after 3-months. Be Healthe for your Heart is an intervention delivered online via the program website, with weekly emails to support changes in modifiable CVD risk factors (excess body weight, physical inactivity, poor diet, and stress), using behavior change techniques (e.g., self-monitoring, goal setting). Intervention acceptability (satisfaction, usability, appropriateness, and usage) and impact on absolute full CVD 30-years risk score, CVD risk markers, and modifiable risk factors will be assessed. Discussion: No studies to date have evaluated acceptability and preliminary efficacy of a web-based intervention for the prevention of CVD in this high-risk population with preeclampsia. This pilot trial will inform development of a fully powered RCT if acceptability and preliminary efficacy are demonstrated.

Clinical evaluation of a first trimester pregnancy algorithm predicting the risk of small for gestational age neonates.

BACKGROUND: The Fetal Medicine Foundation developed a multiple logistic regression algorithm for risk prediction of delivering a small for gestational age neonate. AIM: To validate this algorithm in an Australian population. METHODS: At the combined first trimester screen participants' medical histories, demographic data, mean arterial pressure, uterine artery pulsatility index and pregnancy-associated plasma protein-A were assessed. After delivery, risk of delivering a small for gestational age neonate at <37 or ≥37 weeks gestation was retrospectively calculated using the Fetal Medicine Foundation algorithm. RESULTS: Three thousand and eight women underwent prediction of risk for delivering a small for gestational age neonate. The algorithm detected 15.0% (95% CI: 3.2-37.9) of small for gestational age neonates delivered <37 weeks gestation at a fixed 10% false positive rate (or 35.0% (95% CI: 15.4-59.2) at a fixed 20% false positive rate). It detected 23.4% (95% CI: 16.1-30.7) of small for gestational age neonates delivered ≥37 weeks gestation at a fixed 10% false positive rate (or 39.1% (95% CI: 30.7-47.5) at a fixed 20% false positive rate). The algorithm performed significantly better than individual parameters (P < 0.05). The area under the receiver operating characteristic curve was 0.68 (95% CI: 0.56-0.80) and 0.70 (95% CI: 0.65-0.74) for small for gestational age neonates at <37 and ≥37 weeks gestation, respectively. CONCLUSIONS: The Fetal Medicine Foundation algorithm for first trimester prediction of small for gestational age neonates does not perform as well in an Australian population as in the original United Kingdom cohort. However, it performs significantly better than any individual test parameter in both preterm and term neonates. Incorporation of further variables may help improve screening efficacy.

Fetal Midgut Volvulus with Meconium Peritonitis Detected on Prenatal Ultrasound.

BACKGROUND: Fetal volvulus is a rare, yet life-threatening condition that requires skilful diagnosis and management. Volvulus occurs when bowel loops become twisted and the twisting of the mesenteric artery leads to congestion, impaired venous return, and bowel necrosis. CASE DESCRIPTION: We present a case of fetal ileal volvulus suspected on third trimester ultrasound, complicated by premature labour, small bowel necrosis, and meconium peritonitis. Progressive dilatation and decreased peristalsis of echogenic bowel were noted in the early part of the third trimester. Daily surveillance ultrasound was performed and spontaneous labour occurred at 32 weeks' gestation. A proactive postnatal approach guided by prenatal sonographic findings allowed prompt treatment and an urgent laparotomy was performed for an ileal volvulus with necrosis and meconium peritonitis. A segment of small bowel volvulus was resected and an end-to-end anastomosis was performed with uneventful recovery. DISCUSSION: Clinically signs of fetal midgut volvulus are not pathognomonic, such as intestinal dilatation, abdominal mass, ascites, peritoneal calcifications, or polyhydramnios; thus, the diagnosis is often challenging. Complications reported in the literature include perforation and haemorrhagic ascites, which may lead to anaemia, hypovolemia, heart failure, and fetal demise. CONCLUSION: This case highlights the importance of assessing the fetal bowel as a part of routine third trimester ultrasound. The case describes the complexity of diagnosis in the fetus, important considerations along with multidisciplinary team approach to management.

Epidemic of large babies highlighted by use of INTERGROWTH21st international standard.

OBJECTIVE: To compare birth weights in central Sydney to the INTERGROWTH21st international standard to describe current trends in relation to optimal growth and to define areas that may benefit from improved obstetric surveillance and intervention. METHODS: Retrospective analysis of prospectively collected cohort. DESIGN: hospital-based cohort study. SETTING: Sydney Local Health District, Australia. POPULATION OR SAMPLE: women with singleton pregnancies who had first trimester screening for aneuploidy between 16 April, 2010 and 9 March, 2012. Analysis of 2966 births. MAIN OUTCOME MEASURES: Large for gestational age (LGA) >4000 g, >4500 g, >5000 g, >90th, >95th, >97th centiles and small for gestational age (SGA) <1500 g, <2500 g,

Evidence that fetal death is associated with placental aging.

BACKGROUND: The risk of unexplained fetal death or stillbirth increases late in pregnancy, suggesting that placental aging is an etiological factor. Aging is associated with oxidative damage to DNA, RNA, and lipids. We hypothesized that placentas at >41 completed weeks of gestation (late-term) would show changes consistent with aging that would also be present in placentas associated with stillbirths. OBJECTIVE: We sought to determine whether placentas from late-term pregnancies and unexplained stillbirth show oxidative damage and other biochemical signs of aging. We also aimed to develop an in vitro term placental explant culture model to test the aging pathways. STUDY DESIGN: We collected placentas from women at 37-39 weeks' gestation (early-term and term), late-term, and with unexplained stillbirth. We used immunohistochemistry to compare the 3 groups for: DNA/RNA oxidation (8-hydroxy-deoxyguanosine), lysosomal distribution (lysosome-associated membrane protein 2), lipid oxidation (4-hydroxynonenal), and autophagosome size (microtubule-associated proteins 1A/1B light chain 3B, LC3B). The expression of aldehyde oxidase 1 was measured by real-time polymerase chain reaction. Using a placental explant culture model, we tested the hypothesis that aldehyde oxidase 1 mediates oxidative damage to lipids in the placenta. RESULTS: Placentas from late-term pregnancies show increased aldehyde oxidase 1 expression, oxidation of DNA/RNA and lipid, perinuclear location of lysosomes, and larger autophagosomes compared to placentas from women delivered at 37-39 weeks. Stillbirth-associated placentas showed similar changes in oxidation of DNA/RNA and lipid, lysosomal location, and autophagosome size to placentas from late-term. Placental explants from term deliveries cultured in serum-free medium also showed evidence of oxidation of lipid, perinuclear lysosomes, and larger autophagosomes, changes that were blocked by the G-protein-coupled estrogen receptor 1 agonist G1, while the oxidation of lipid was blocked by the aldehyde oxidase 1 inhibitor raloxifene. CONCLUSION: Our data are consistent with a role for aldehyde oxidase 1 and G-protein-coupled estrogen receptor 1 in mediating aging of the placenta that may contribute to stillbirth. The placenta is a tractable model of aging in human tissue.

TNF-R1 as a first trimester marker for prediction of pre-eclampsia.

OBJECTIVE: To examine whether the maternal serum concentration of the soluble receptor-1 of tumor necrosis factor-α (TNF-R1) at 11-13 + 6 weeks of gestation is a predictor of development of pre-eclampsia (PE). METHODS: This is a nested case-control study in which the concentration of TNF-R1 at 11 + 0 to 13 + 6 weeks was measured in 426 pregnant women in the first trimester. TNF-R1 values were expressed as multiples of the median (MoM) adjusted for maternal factors. The distributions of log TNF-R1 MoM in the control group and hypertensive disorders (early-PE [ePE], late-PE [lPE] and gestational hypertension [GH]) groups were compared. Logistic regression analysis was used to determine whether maternal factors, TNF-R1 or their combination make a significant contribution to the prediction of PE. Screening performance was determined by analysis of receiver-operating characteristics curves. RESULTS: Median concentration of TNF-R1 (ng/ml) was higher in ePE (2.62 ± 0.67), lPE (2.12 ± 0.56) and GH (2.19 ± 0.45) compared to controls (2.04 ± 0.42), p = 0.001. Logistic regression analysis demonstrated that the addition of TNFR-1 to maternal factors did not make a significant contribution to the prediction of PE. CONCLUSIONS: The maternal serum TNF-R1 concentration at 11-13 + 6 weeks of gestation was increased in pregnancies which developed hypertensive disorders, however, the addition of TNFR-1 did not improve the detection rate of these conditions compared with maternal factors alone.

Transverse occiput position: Using manual Rotation to aid Normal birth and improve delivery OUTcomes (TURN-OUT): A study protocol for a randomised controlled trial.

BACKGROUND: Fetal occiput transverse position in the form of deep transverse arrest has long been associated with caesarean section and instrumental vaginal delivery. Occiput transverse position incidentally found in the second stage of labour is also associated with operative delivery in high risk cohorts. There is evidence from cohort studies that prophylactic manual rotation reduces the caesarean section rate. This is a protocol for a double blind, multicentre, randomised, controlled clinical trial to define whether this intervention decreases the operative delivery (caesarean section, forceps or vacuum delivery) rate. METHODS/DESIGN: Eligible participants will be ≥37 weeks pregnant, with a singleton pregnancy, and a cephalic presentation in the occiput transverse position on transabdominal ultrasound early in the second stage of labour. Based on a background risk of operative delivery of 49%, for a reduction to 35%, an alpha value of 0.05 and a beta value of 0.2, 416 participants will need to be enrolled. Participants will be randomised to either prophylactic manual rotation or a sham procedure. The primary outcome will be operative delivery. Secondary outcomes will be caesarean section, significant maternal mortality and morbidity, and significant perinatal mortality and morbidity. Analysis will be on an intention-to-treat basis. Primary and secondary outcomes will be compared using a chi-squared test. A logistic regression for the primary outcome will be undertaken to account for potential confounders. This study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District, Sydney, Australia, (protocol number: X110410). DISCUSSION: This trial addresses an important clinical question concerning a commonly used procedure which has the potential to reduce operative delivery and its associated complications. Some issues discussed in the protocol include methods of assessing risk of bias due to inadequate masking of a procedural interventions, variations in intervention efficacy due to operator experience and the recruitment difficulties associated with intrapartum studies. TRIAL REGISTRATION: This trial was registered with the Australian New Zealand Clinical Trials Registry (identifier: ACTRN12613000005752 ) on 4 January 2013.

Persistent Occiput Posterior position - OUTcomes following manual rotation (POP-OUT): study protocol for a randomised controlled trial.

BACKGROUND: Occiput posterior position is the most common malpresentation in labour, contributes to about 18% of emergency caesarean sections and is associated with a high risk of assisted delivery. Caesarean section is now a major contributing factor to maternal mortality and morbidity following childbirth in developed countries. Obstetric intervention by forceps and ventouse delivery is associated with complications to the maternal genital tract and to the neonate, respectively. There is level 2 evidence that prophylactic manual rotation reduces the caesarean section rate and assisted vaginal delivery. But there has been no adequately powered randomised controlled trial. This is a protocol for a double-blinded, multicentre, randomised controlled clinical trial to define whether this intervention decreases the operative delivery (caesarean section, forceps or vacuum delivery) rate. METHODS/DESIGN: Eligible participants will be (greater than or equal to) 37 weeks' with a singleton pregnancy and a cephalic presentation in the occiput posterior position on transabdominal ultrasound early in the second stage of labour. Based on a background risk of operative delivery of 68%, then for a reduction to 50%, an alpha value of 0.05 and a beta value of 0.2, 254 participants will need to be enrolled. This study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District, Sydney, Australia, and protocol number X110410. Participants with written consent will be randomised to either prophylactic manual rotation or a sham procedure. The primary outcome will be operative delivery (defined as vacuum, forceps and/or caesarean section deliveries). Secondary outcomes will be caesarean section, significant maternal mortality/morbidity and significant perinatal mortality/morbidity. Analysis will be by intention-to-treat. Primary and secondary outcomes will be compared using a chi-squared test. A logistic regression for the primary outcome will be undertaken to account for potential confounders. The results of the trial will be presented at one or more medical conferences. The trial will be submitted to peer review journals for consideration for publication. There will be potential to incorporate the results into professional guidelines for obstetricians and midwives. TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry ACTRN12612001312831 . Trial registered 12 December 2012.

The first trimester: prediction and prevention of the great obstetrical syndromes.

A number of groups are currently examining the potential of screening for pre-eclampsia and gestational diabetes at 12 weeks' gestation. This can be performed at the time of combined first-trimester screening for aneuploidy using a similar method of regression analysis to combine multiple demographic and investigative factors. At present, research into the prediction of pre-eclampsia is more robust and is associated with the potential for therapeutic intervention that can reduce the prevalence of early-onset pre-eclampsia and improve maternal and neonatal outcomes.

Demographic factors that can be used to predict early-onset pre-eclampsia.

OBJECTIVE: To define the maternal demographic factors that predicts the risk of developing early-onset pre-eclampsia (requiring delivery before 34 weeks' gestation) in an Australian population. These are compared to risk factors described in a British population to determine whether the Fetal Medicine Foundation (FMF) risk algorithm for predicting early-onset pre-eclampsia needs to be modified for an Australian population. METHODS: A secondary analysis of prospective cohorts in Australia and in the United Kingdom was conducted. Demographic details and past medical history were obtained. Odds ratios (ORs) for the development of early-onset pre-eclampsia were calculated for maternal factors in both populations. Forest plots were used to compare the two sets of odds ratios. RESULTS: In the Australian population, pre-existing hypertension (OR 19.89, 95% CI 4.17-94.93) and body mass index >40 kg/m(2) (OR 9.04, 95% CI 1.13-72.40) predicted risk of developing early-onset pre-eclampsia. There were no significant differences in the odds ratios for maternal factors in the two populations. CONCLUSIONS: This study shows that the ORs used to describe risks associated with maternal characteristics in the FMF algorithm for early-onset pre-eclampsia are consistent with those found in our local population. There does not appear to be any value in changing the weighting of demographic factors included in the FMF algorithm for an Australian population.

Clinical evaluation of a first trimester algorithm predicting the risk of hypertensive disease of pregnancy.

BACKGROUND: The aim of this study is to validate the Fetal Medicine Foundation (FMF) multiple logistic regression algorithm for prediction of risk of pre-eclampsia in an Australian population. This model, which predicts risk using the population rate of pre-eclampsia, a variety of demographic factors, mean maternal arterial blood pressure (MAP), uterine artery PI (UtA PI) and pregnancy-associated plasma protein A (PAPP-A), has been shown to predict early-onset pre-eclampsia (delivery prior to 34 weeks) in 95% of women at a 10% false-positive rate. METHODS: All women who attended first trimester screening at the Royal Prince Alfred Hospital had their body mass index (BMI), MAP and UtA PI assessed in addition to factors traditionally used to assess aneuploidy (including PAPP-A MoM). After delivery, risks of early-onset (delivery prior to 34 weeks) pre-eclampsia, late pre-eclampsia and gestational hypertension were calculated using the FMF risk algorithm. RESULTS: A total of 3099 women were screened and delivered locally. 3066 (98.9%) women had all data to perform pre-eclampsia screening available. This included 3014 (98.3%) women with a live birth, where risks of early pre-eclampsia were calculated. Twelve women were delivered before 34 weeks because of early pre-eclampsia with a prevalence of early pre-eclampsia of 1 in 256 pregnancies. Risks generated through the use of maternal history, MAP, UtA PI and PAPP-A detected 41.7 and 91.7% of early pre-eclampsia at a false-positive rate of 5 and 10%, respectively. CONCLUSIONS: This study shows that the FMF early pre-eclampsia algorithm is effective in an Australian population.