Women's and clinician's acceptability of participation in a hypothetical obstetric randomized controlled trial: a qualitative survey.

BACKGROUND: Involving patients and consumers in research design helps ensure relevance for those affected by the problem being investigated and can optimize recruitment to clinical trials. This is particularly important when conducting research involving pregnant women. AIMS: We investigated women's motivations to participate in a hypothetical randomized control trial (RCT) of a third-trimester screening test for intrapartum fetal compromise (IFC) and adverse perinatal outcomes. MATERIALS AND METHODS: Women attending for routine antenatal care at a tertiary center were invited to complete a short, anonymized patient acceptability survey. The survey was developed with the assistance of the Perinatal Society of Australia and New Zealand's Consumer Advisory Panel and consisted of Likert scales and open-ended questions. It was designed to ascertain women's responses to research issues, particularly the acceptability of being randomized to a non-revealed arm of a screening test RCT. RESULTS: 100 pregnant women took part; 40% indicated that they would agree/strongly agree to participate in a hypothetical RCT regardless of whether they were given the result of a screening test and 31% were unsure. Randomization to either an intervention or control group was acceptable to 47%, 30% were unsure and 23% were not willing to be randomized. Reasons to participate included the desire to contribute to research and to improve pregnancy care. CONCLUSIONS: Participation in an RCT of a screening test for IFC involving non-disclosure of the test result was acceptable to a large minority of pregnant women. This finding supports the feasibility of conducting a large-scale study of this design.

The impact on obstetric and perinatal outcomes in term infants following the introduction of a colour-coded, hierarchical cardiotocography classification system: A retrospective non-inferiority study.

BACKGROUND: Queensland introduced a colour-coded cardiotocograph (CTG) classification system (green, blue, yellow and red) to complement the Royal Australian and New Zealand College of Obstetricians and Gynaecologists prose-based classification system of 'low, unlikely, maybe or likely' fetal compromise. AIMS: The aim of the study was to determine the clinical impact of the introduction of the colour-coded CTG classification system compared to the prose-based system. We hypothesised there would be no change in the rate of operative delivery for intrapartum fetal compromise (OD-IFC). MATERIALS AND METHODS: This retrospective non-inferiority study from November 2014 to May 2018 used routinely collected data from the Mater Mother's Hospital. Non-insured women with a singleton, non-anomalous, cephalic fetus at term, attempting a vaginal birth with continuous intrapartum CTG were included. The primary outcome was OD-IFC. Secondary outcomes included various obstetric and perinatal outcomes. Non-inferiority analysis was performed with a pre-specified non-inferiority margin of 2% risk difference. RESULTS: Eleven thousand seven hundred and twenty-seven participants were included. The OD-IFC rate was similar across the study groups (prose-based 15.1% vs colour-coded 15.3%, adjusted odds ratio (aOR) 1.02, 95% CI 0.93-1.13) with the adjusted risk difference of 0.29% (95% CI -0.98 to 1.56), which did not exceed the inferiority margin. There were more spontaneous (aOR 1.11, 95% CI 1.04-1.19) and fewer instrumental (aOR 0.87, 95% CI 0.80-0.95) vaginal births in the colour-coded cohort. There were no differences in neonatal outcomes. CONCLUSIONS: Reassuringly, the colour-coded CTG classification system was non-inferior to the prose-based system, did not influence OD-IFC but was associated with more spontaneous vaginal deliveries.

Measuring the impact of cardiotocograph decision support software on neonatal outcomes: A propensity score-matched observational study.

BACKGROUND: This study follows the 2017 UK INFANT Collaborative Group RCT, which compared neonatal outcomes with and without the use of the INFANT cardiotocograph decision support system for over 46 000 patients in labour. The original trial failed to demonstrate a significant improvement to neonatal outcomes; however, the study design was subject to methodological critique. AIMS: This Australian retrospective cohort study aimed to report perinatal outcomes before and after the introduction of INFANT decision support software for cardiotocograph use in labour. MATERIALS AND METHODS: The study cohort was divided into two equivalent 18-month epochs, before and after the introduction of INFANT-Guardian® CTG decision support system. Propensity score matching analysis was undertaken to balance pre- and post-implementation groups by baseline covariates. The matched cohort included 11 154 public-funded women between November 2016 and 2019, with a singleton live fetus ≥34 + 0 weeks, being induced or in spontaneous labour. The main outcome measures were: a composite measure of serious adverse neonatal outcome comprising of one or more of: admission to intensive care nursery >48 h, Apgar <4 at 5 min, cord arterial pH <7.0, hypoxic ischaemic encephalopathy grade 2 or 3, therapeutic hypothermia, neonatal death. RESULTS: The incidence of the composite primary outcome was significantly lower following implementation of INFANT (0.57% vs. 1.00%; OR 0.57, 95%CI 0.37-0.88; P = 0.01). A significant reduction in nursery admission >48 h was also observed (0.05% vs. 0.30%; OR 0.18, 95%CI 0.05-0.60; P = 0.002). CONCLUSIONS: INFANT software is associated with a reduction in serious adverse neonatal outcomes, without increasing the rate of operative delivery.

Changes in fetoplacental Doppler indices following intrapartum maternal sildenafil citrate treatment.

OBJECTIVE: Uterine contractions during labour can result in a 60 % decline in fetoplacental perfusion, predisposing the fetus to hypoxic brain injury. Sildenafil citrate (SC) has shown promise in increasing uteroplacental perfusion as well as reducing the risk of operative birth for intrapartum fetal compromise (IFC). The aim of this study was to investigate the effect of intrapartum SC administration on fetoplacental blood flow indices. METHODS: This was a subgroup analysis from an earlier Phase II double blind randomized controlled trial; assessing the effect of intrapartum SC administration (50 mg orally 8 -hly in labour) compared to placebo for the reduction of operative birth for IFC. An ultrasound scan measuring fetoplacental Doppler indices was performed prior to and 1-4 h after the administration of the first treatment dose. RESULTS: Of the 300 women randomized to the main study, pre-treatment ultrasound scans were performed in 261 participants who received the study medication; paired pre- and post-treatment scans were performed in 70 (26.8 %). SC resulted in an increase in the middle cerebral artery pulsatility index (PI) z-score [+0.08 (1.35) vs.-0.12 (1.15)], a decline in the umbilical artery-PI z-score [-0.07 (0.96) vs. + 0.04 (1.25)] and an increase in the cerebroplacental ratio [MCA-PI/UA-PI] (CPR) z-score [+0.10 (1.13) vs.-0.26 (1.14)] although these failed to reach statistical significance. Amongst those with a pre-treatment CPR above the 5th centile, SC significantly reduced the risk of operative birth for IFC compared to placebo [logrank p = 0.02; hazards ratio 0.48, 95 % CI 0.29-0.77, p = 0.003]. CONCLUSION: Although the differences in Doppler indices pre- and post- SC treatment were non-significant, there was a clear trend towards a reduction in the UA PI, a corresponding increase in the MCA PI and a rise in post treatment CPR values suggesting potential improvement in fetoplacental Dopplers with intrapartum SC treatment. However this study was limited by the small sample size. The results of this hypothesis generating study suggest that it may be possible to stratify women that would most benefit from this intervention based upon their pre-labour CPR.

Safety and efficacy of sildenafil citrate to reduce operative birth for intrapartum fetal compromise at term: a phase 2 randomized controlled trial.

BACKGROUND AND OBJECTIVE: Sildenafil citrate is a vasodilator used in erectile dysfunction and pulmonary hypertension. We tested whether it reduces emergency operative births for fetal compromise and improves fetal or uteroplacental perfusion in labor in a phase 2 double-blind randomized controlled trial. STUDY DESIGN: Women at term in early labor or undergoing scheduled induction of labor at Mater Mother's Hospital, Brisbane, Australia, were randomly allocated 50 mg of sildenafil citrate orally 8 hourly up to 150 mg or placebo. Intrapartum fetal monitoring followed Royal Australian and New Zealand College of Obstetricians and Gynaecologists guidelines. Primary outcomes were (1) emergency operative birth (by cesarean delivery or instrumental vaginal birth) for intrapartum fetal compromise and (2) mean indices of fetal and uteroplacental perfusion using Doppler ultrasound. Analysis was by intention-to-treat. TRIAL REGISTRATION NUMBER: ANZCTRN12615000319572 RESULTS: Between September 2015 and January 2019, 300 women were randomized equally to sildenafil citrate or placebo. Sildenafil citrate reduced the risk of emergency operative birth by 51% (18% vs 36.7%; relative risk, 0.49, 95% confidence interval, 0.33-0.73, P=.0004, number needed to treat = 5 [3-11]). There was no difference in indices of fetal and uteroplacental perfusion, but these were ascertained in only 71 women. Sildenafil citrate reduced the risk of meconium-stained liquor or pathologic fetal heart rate patterns by 43% (25.3% vs 44.7%; relative risk, 0.57, 95% confidence interval, 0.41-0.79, P=.0005), but its effects on fetal scalp sampling rates (2.0% vs 6.7%; relative risk, 0.30, 95% confidence interval, 0.08-1.07, P=.06) and adverse neonatal outcome (20.7% vs 21.3%; relative risk, 0.97, 95% confidence interval, 0.62-1.50, P=.89) were inconclusive. Only 3.6% of maternal levels of sildenafil citrate or its metabolite were detected in cord blood. No differences in maternal adverse events were seen. CONCLUSION: Sildenafil citrate reduced operative birth for intrapartum fetal compromise, but much larger phase 3 trials of its effects on mother and child are needed before it can be routinely recommended.

Reference centiles for maternal placental growth factor levels at term from a low-risk population.

INTRODUCTION: Placental growth factor (PLGF) is a biomarker of placental function. The aim of this study was to define reference ranges for maternal PLGF levels in a normotensive cohort ≥36 + 0 weeks. METHOD: Prospective observational data from Mater Mothers' Hospital, Brisbane. PLGF levels were measured in women at ≥36 + 0 weeks with singleton, non-anomalous pregnancies. Women with hypertension and fetal growth restriction were excluded. PLGF (pg/mL) was assayed using DELFIA® Xpress (PerkinElmer Inc). The Generalised Additive Model for Location, Shape and Scale (GAMLSS) method was used for the calculation of gestational age-adjusted centiles. Data analysis was performed with Stata 13 (StataCorp, LLC) and R software (R Foundation for Statistical Computing, Vienna, Austria). In all women, PLGF was measured within 2 weeks of delivery. RESULTS: The study cohort comprised of 845 women (36 weeks n = 73, 37 weeks n = 230, 38 weeks n = 214, 39 weeks n = 172, 40 weeks n = 115, 41weeks n = 41). PLGF levels were negatively correlated with gestational age (r = -0.20, p < 0.001). Median PLGF levels dropped significantly from 36 weeks to 41 weeks (169.0 pg/mL to 96.6 pg/mL, p < 0.001). Gestational age specific maternal PLGF centiles were reported using fractional polynomial additive term and Box-Cox t distribution. PLGF did not perform adequately as a predictive test for adverse perinatal outcomes (AUC <0.6). DISCUSSION: We have created gestational centile reference ranges for maternal PLGF from a normotensive cohort. These novel data suggest maternal PLGF levels decline ≥36 + 0 weeks. The utility of PLGF as a predictor of adverse perinatal outcomes at term, should be further investigated with clinical trials.

Changes in intrapartum maternal placental growth factor levels in pregnancies complicated by fetal compromise at term.

BACKGROUND: Intrapartum fetal compromise (IFC) may result from the gradual decline in placental function during labour and can precipitate adverse neonatal outcomes. Placental growth factor (PlGF) is a biomarker of placental function. This study aims to investigate maternal PlGF levels and adverse perinatal outcomes in term labour. METHODS: Prospective observational study (Mater Mothers' Hospital, Brisbane). Eligibility: 37+0- 42+0 weeks gestation, singleton, cephalic, non-anomalous pregnancies. Cases of pre-eclampsia and fetal growth restriction were excluded. Maternal PlGF was sampled at the onset of the first stage of labour (1st PlGF) and again at the second stage (2nd PlGF). RESULTS: Sixty-three participants met inclusion criteria. Women requiring operative delivery (n = 11) for IFC had lower 1st PlGF (90.8 vs. 111.8 pg/ml) and 2nd PlGF (65.8 vs. 83.7 pg/ml) compared to the no-IFC cohort (n = 52). PlGF levels decreased significantly during labour in both the IFC (90.8 vs. 65.8 pg/ml, p = 0.021) and no-IFC (111.8 v 83.7, p < 0.001) cohorts, although the decline in PlGF levels was greater in the IFC cohort (-41.8% vs. -23.4%, p = 0.385). Maternal PlGF levels were significantly lower in those with an abnormal fetal heart rate pattern, cord arterial pH < 7.2, nursery admission and composite adverse neonatal outcome (CANO). PlGF decline was not correlated to duration of labour but was influenced by nulliparity and induced labour. CONCLUSIONS: Maternal PlGF levels are lower in pregnancies complicated by IFC and CANO, and declines more sharply during labour compared to the no-IFC cohort. The utility of PlGF as a predictor of IFC should be further investigated with clinical trials.

Systematic review of maternal Placental Growth Factor levels in late pregnancy as a predictor of adverse intrapartum and perinatal outcomes.

AIM: This systematic review evaluates the utility of maternal Placental Growth Factor (PlGF) when measured in late pregnancy (>20 weeks) as a predictor of adverse obstetric and perinatal outcomes. METHODS: Pubmed and Embase were searched using the term "placental growth factor" in combination with relevant perinatal outcomes. Studies were included if they measured PlGF levels in pregnant women after 20 + 0 weeks gestation and reported relevant adverse obstetric or perinatal outcomes related to placental insufficiency (excluding pre-eclampsia). RESULTS: Twenty-six studies were eligible for inclusion with 21 studies investigating the relationship between PlGF and small for gestational age (SGA) and 7 studies investigating PlGF for the prediction of other adverse perinatal outcomes. In all studies, maternal PlGF levels were significantly lower in the SGA group compared to controls. Other outcomes investigated included caesarean section (CS) for fetal compromise, low Apgar score, neonatal intensive care unit (NICU) admission, neonatal acidosis, stillbirth, and intrapartum fetal compromise. The results generally showed a significant association between low PlGF levels and CS for fetal compromise, NICU admission and stillbirth. CONCLUSION: Low maternal PlGF levels in late pregnancy are strongly associated with SGA. Findings across studies were variable in relation to PlGF and the prediction of other adverse intrapartum and perinatal outcomes, however there was a consistent association between low PlGF levels and CS for fetal compromise, NICU admission and stillbirth. This review suggests that the use of PlGF for the prediction of adverse outcomes is promising. Its predictive value may potentially be enhanced if used in combination with other biomarkers or biophysical measures of fetal well-being.

Changes in maternal placental growth factor levels during term labour.

Placental growth factor (PlGF) has important angiogenic function that is critical to placental development. Lower levels of PlGF are associated with fetal growth restriction, pre-eclampsia and intrapartum fetal compromise. The aim of this study was to investigate the effect of labour on maternal PlGF levels. METHOD: This was a prospective observational cohort study. Normotensive women with a singleton, normally grown, non-anomalous, fetus between 37 + 0 and 42 + 0 weeks gestation were eligible for inclusion. PlGF was assayed at two time-points in labour. Women undergoing elective caesarean section served as controls. The primary outcome was the intrapartum change in maternal PlGF levels. RESULTS: Fifty-nine labouring and 43 non-labouring participants were included. Median PlGF decreased from 105.5 pg/mL to 80.9 pg/mL during labour (-23.9%, p < 0.001). PlGF levels were significantly lower in the second stage of labour irrespective of onset of labour, parity, mode of birth or gestation ≥40 weeks. Compared to multiparous women, nulliparous women had significantly lower PlGF levels at both time-points but had similar overall decline in PlGF. Women who required operative vaginal delivery or emergency caesarean section had lower median PlGF levels at both PlGF time-points and greater drop in PlGF during labour compared to spontaneous vaginal deliveries but these were not statistically significant. No correlation was observed between duration of labour and decline in PlGF levels. CONCLUSION: Overall, median PlGF levels fall by nearly one quarter during labour. This decline may reflect deteriorating placental function during labour.

Maternal age is a risk factor for caesarean section following induction of labour.

BACKGROUND: In Australia, more than 20% of women giving birth are 35 years or older. Advanced maternal age (AMA) is a risk factor for stillbirth, and many clinicians now recommend induction of labour (IOL) at around term gestation. The aim of this study is to determine if AMA is associated with emergency caesarean section (CS) following IOL. METHODS: A retrospective cohort study was undertaken using routinely collected de-identified data. Live-born, singleton, cephalic, non-anomalous pregnancies undergoing IOL between 37 + 0 and 42 + 0 weeks were included. Previous CS and privately insured admission status were excluded. Mode of delivery was compared for women ≥38 years (AMA) and women <38 years. The primary outcome was birth by CS. Bivariate and multivariate logistic regression analyses were undertaken. RESULTS: A total of 7459 women were included (≥38 years n = 718, 9.6%; <38 years n = 6741, 90.4%). AMA women had similar rates of unassisted vaginal births (OR 1.15, 95% CI 0.98-1.35, P = 0.080) and CS (OR 1.08, 95% CI 0.90-1.30, P = 0.407) but fewer instrumental deliveries (OR 0.69, 95% CI 0.55-0.87, P = 0.002) compared to women <38 years. When controlled for confounders, AMA was independently associated with a two-fold increase in birth by CS following IOL (adjusted OR 2.29; 95% CI 1.64-3.20; P < 0.001). There were no differences in neonatal outcomes. CONCLUSION: Following IOL, AMA was associated with a two-fold increased likelihood of birth by CS in both nulliparous and multiparous women. However, the majority of AMA women birthed vaginally. Clinicians may find this information useful when counselling older women who are undergoing term IOL.

Review: Systematic review of the utility of the fetal cerebroplacental ratio measured at term for the prediction of adverse perinatal outcome.

AIM: This systematic review evaluates the utility of the fetal cerebroplacental ratio (CPR) when assessed at term (from 37 + 0 weeks gestation) as a predictor of adverse obstetric and perinatal outcomes. DATA SOURCES AND SEARCH STRATEGY: An electronic search of Pubmed and Embase using variations of 'cerebroplacental ratio' and 'cerebroumbilical ratio' was conducted by two independent reviewers. Full text studies written in English that reported on low CPR and its correlation with relevant obstetric and perinatal outcomes were included. RESULTS: Twenty one studies satisfied inclusion with 13 prospective and eight retrospective analyses. Fetal CPR was predictive of caesarean section for intrapartum fetal compromise, small for gestational age and fetal growth restriction and neonatal intensive care unit admission. Low CPR was also significantly associated with abnormal fetal heart rate pattern, meconium stained liquor, low Apgar score, acidosis at birth and composite adverse perinatal outcome scores. The CPR when taken at term had comparable if not better predictive value than that when taken at preterm. Most studies included small for gestational age fetuses and postdate pregnancies. Subtle variation existed in the threshold for low CPR. CONCLUSION: The CPR at term has a strong association with adverse obstetric and perinatal outcomes. This review suggests the predictive utility of CPR at term is promising however there is insufficient evidence to demonstrate its value as a stand-alone test. Inclusion of CPR as a component of clinical care may help better identify fetuses at risk of adverse outcome, and this should be tested with randomised control trials.

Sildenafil in Pregnancy: A Systematic Review of Maternal Tolerance and Obstetric and Perinatal Outcomes.

INTRODUCTION: This systematic review evaluates maternal tolerance and obstetric and perinatal outcomes following sildenafil citrate (SC) use in human pregnancy. DATA SOURCES: Scopus, PubMed, Cochrane Library, Web of Science, Embase, and Google Scholar were searched. Relevant full-text studies including case series and reports in English were included. Publications were excluded if the pregnancy was terminated or if SC was used only at conception. RESULTS: Sixteen studies were included (n = 165). Indications for use and outcomes were variably reported. Maternal outcomes reported were headache (45.8%, 49/107), visual disturbances (17.3%, 14/81), dyspepsia/epigastric pain (15.8%, 15/95), and hypotension (0%, 0/39). There were more caesarean (83.3%, 55/66) than vaginal deliveries (16.7%, 11/66) and postpartum haemorrhage occurred in 3.9% (3/76) of women exposed to SC. Neonatal outcomes including nursery admission (67.3%, 35/52), Apgar scores <7 at 5 min (7.1%, 4/56), and cord arterial pH <7.1 (0%, 0/17) were reported. Stillbirths (4.3%, 3/69) and neonatal deaths (3.9%, 5/129) were comparable to SC-naïve groups. There were no congenital malformations (0%, 0/35). CONCLUSIONS: Despite limited data, overall there does not appear to be any severe adverse maternal side effects nor any increase in the rate of stillbirths, neonatal deaths, or congenital anomalies attributed to SC.

Reducing the risk of fetal distress with sildenafil study (RIDSTRESS): a double-blind randomised control trial.

BACKGROUND: Labour is perhaps the most hazardous time in pregnancy. As many as 20 % of cerebral palsy cases in term infants result from intrapartum events and up to 63 % of babies who develop intrapartum compromise have no prior risk factors. Sildenafil citrate (SC), a phosphodiesterase 5 inhibitor, improves uterine blood supply through vasodilatation and potentially could improve placental perfusion and hence reduce the risk of intrapartum fetal hypoxia. The aim of this study is to evaluate the efficacy of SC to reduce the risk of intrapartum fetal compromise and the need for emergency operative delivery. METHODS/DESIGN: This is a single centre, double-blind, randomised, phase II clinical trial of SC or placebo given during labour to women (18-50 years of age) with a single, appropriately grown, non-anomalous baby at term (37-42 weeks gestation). Those with cardiovascular, renal, hepatic, ocular or hypertensive disease or contraindication to SC will be excluded. Participants will be randomised to either SC 50 mg or placebo capsules eight hourly (SC maximum 150 mg) to commence when admitted to birth suite for management of labour. Within 3 h of the first dose, a repeat ultrasound scan will be performed to measure any changes in uteroplacental and fetal Doppler indices. Labour will continue otherwise in accordance with hospital clinical guidelines. The primary outcome is emergency caesarean section for intrapartum fetal compromise. Secondary outcomes include the effect of SC on fetal and uteroplacental blood flow, meconium liquor, fetal heart rate abnormalities and neonatal outcomes (admission to neonatal intensive care, Apgar <7 at 5 min, cord pH <7.1 or lactate >4.0 mmol/L, neonatal encephalopathy, death). CONCLUSION: This is the first reported study evaluating the efficacy of SC on reducing the risk intrapartum fetal compromise. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry ACTRN12615000319572.

Gender specific intrapartum and neonatal outcomes for term babies.

OBJECTIVE: The purpose of this study is to document the gender specific intrapartum and neonatal outcomes in term, singleton, appropriately grown babies. STUDY DESIGN: De-identified, routinely collected data of all women meeting inclusion criteria between 2001 and 2011 were examined (n=9223). Inclusion criteria were public (non-insured), primiparous women who had delivered singleton, appropriately grown babies at term. In this retrospective cohort study, we estimated 95% confidence intervals. Outcomes measured were maternal demographics, mode of delivery, birthweight, APGAR score, cord blood acidemia, respiratory distress, any resuscitation requirement, nursery admission and stillbirth rates. RESULTS: The sex ratio of male babies was 1.05:1 (4718 males; 4505 females, p=0.85). Male babies were more likely to be delivered by instrumental (p=0.004) or caesarean (p<0.001). Birthweight was found to be a significant influencing factor on mode of delivery. Even after adjusting for birthweight, male babies were more likely to be delivered by instrumental delivery (OR 1.24, p<0.001), as well as by emergency caesarean for failure to progress (OR 1.24, p=0.04) and fetal distress (OR 1.38, p<0.001). Male babies, despite having greater birthweights than female babies (p<0.001), were more likely to have lower APGAR scores at 5 min (p=0.004), require neonatal resuscitation (p<0.001), develop respiratory distress (p=0.005) and require nursery admission (p<0.001). No statistical difference between male and female babies was found for cord blood acidemia (p=0.58) or stillbirth (p=0.49). CONCLUSION: This large cohort study demonstrates that term, appropriately grown male babies in primiparous pregnancies fare more poorly in the intrapartum and neonatal periods than female babies. Even when birthweight was accounted for, male babies still required higher rates of intervention in the intrapartum and neonatal periods. This suggests gender may play an independent role in influencing pregnancy outcomes, although the underlying contributing physiology is not definitively established. The gender of the baby perhaps should be considered when counselling parents in the antepartum period.

Family Involvement in School-Based Health Promotion: Bringing Nutrition Information Home.

Family-school collaboration related to children's physical development has become increasingly important as childhood obesity rates continue to rise. The present study described the development and implementation of a literacy-based, family component of a school-based health education program and investigated its viability, acceptability, and effectiveness. Interactive children's books were the mechanism by which students, parents, and teachers received consistent messages at home and school regarding nutrition information. The home-school intervention served to bridge home and school cultures in an urban population. Preliminary process evaluation results indicated that the interactive children's books were feasible to implement in the school context. Parents, children, and teachers had positive perceptions of the books. Parents who received the books demonstrated increased knowledge of 5 a Day, the primary nutrition message communicated in the program. Although not statistically significant, after the first and second years of intervention, parents in the experimental group reported that their children were eating 0.54 and 0.36 additional servings of fruit and vegetables per day compared with children in the control group. The program did not seem to impact the availability and accessibility of fruits and vegetables at home.