scholarly journals Effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes in low risk pregnancy (the IRIS study): nationwide, pragmatic, multicentre, stepped wedge cluster randomised trial

BMJ ◽  
2019 ◽  
pp. l5517 ◽  
Author(s):  
Jens Henrichs ◽  
Viki Verfaille ◽  
Petra Jellema ◽  
Laura Viester ◽  
Eva Pajkrt ◽  
...  
Keyword(s):  
Usual Care ◽  
Randomised Trial ◽  
Intervention Strategy ◽  
Perinatal Outcomes ◽  
Low Risk ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Third Trimester ◽  
The Third ◽  
Adverse Perinatal Outcomes

AbstractObjectivesTo investigate the effectiveness of routine ultrasonography in the third trimester in reducing adverse perinatal outcomes in low risk pregnancies compared with usual care and the effect of this policy on maternal outcomes and obstetric interventions.DesignPragmatic, multicentre, stepped wedge cluster randomised trial.Setting60 midwifery practices in the Netherlands.Participants13 046 women aged 16 years or older with a low risk singleton pregnancy.Interventions60 midwifery practices offered usual care (serial fundal height measurements with clinically indicated ultrasonography). After 3, 7, and 10 months, a third of the practices were randomised to the intervention strategy. As well as receiving usual care, women in the intervention strategy were offered two routine biometry scans at 28-30 and 34-36 weeks’ gestation. The same multidisciplinary protocol for detecting and managing fetal growth restriction was used in both strategies.Main outcome measuresThe primary outcome measure was a composite of severe adverse perinatal outcomes: perinatal death, Apgar score <4, impaired consciousness, asphyxia, seizures, assisted ventilation, septicaemia, meningitis, bronchopulmonary dysplasia, intraventricular haemorrhage, periventricular leucomalacia, or necrotising enterocolitis. Secondary outcomes were two composite measures of severe maternal morbidity, and spontaneous labour and birth.ResultsBetween 1 February 2015 and 29 February 2016, 60 midwifery practices enrolled 13 520 women in mid-pregnancy (mean 22.8 (SD 2.4) weeks’ gestation). 13 046 women (intervention n=7067, usual care n=5979) with data based on the national Dutch perinatal registry or hospital records were included in the analyses. Small for gestational age at birth was significantly more often detected in the intervention group than in the usual care group (179 of 556 (32%) v 78 of 407 (19%), P<0.001). The incidence of severe adverse perinatal outcomes was 1.7% (n=118) for the intervention strategy and 1.8% (n=106) for usual care. After adjustment for confounders, the difference between the groups was not significant (odds ratio 0.88, 95% confidence interval 0.70 to 1.20). The intervention strategy showed a higher incidence of induction of labour (1.16, 1.04 to 1.30) and a lower incidence of augmentation of labour (0.78, 0.71 to 0.85). Maternal outcomes and other obstetric interventions did not differ between the strategies.ConclusionIn low risk pregnancies, routine ultrasonography in the third trimester along with clinically indicated ultrasonography was associated with higher antenatal detection of small for gestational age fetuses but not with a reduced incidence of severe adverse perinatal outcomes compared with usual care alone. The findings do not support routine ultrasonography in the third trimester for low risk pregnancies.Trial registrationNetherlands Trial Register NTR4367.

High-Grade Fetal Vascular Malperfusion Is Associated With Diffuse Chorionic Hemosiderosis

2021 ◽  
pp. 109352662110646
Author(s):  
Eoghan E. Mooney ◽  
Emma Crotty
Keyword(s):  
Perinatal Outcomes ◽  
Low Grade ◽  
High Grade ◽  
Third Trimester ◽  
The Third ◽  
Term Delivery ◽  
Venous Bleeding ◽  
Placental Membranes ◽  
Adverse Perinatal Outcomes ◽  
Cord Length

Introduction Diffuse chorionic hemosiderosis (DCH) is an abnormality of the placental membranes characterized by the deposition of iron pigment. It is usually secondary to recurrent venous bleeding in early pregnancy. In many papers, it is associated with pre-term delivery. Fetal vascular malperfusion (FVM) is an abnormality of the feto-placental circulation that may be seen at any stage of gestation, but most often in the third trimester. It may be graded as low grade (LGFVM) or high grade (HGFVM). No link has been identified in the placental literature between DCH and FVM, but we have noted the 2 co-existing in placentas submitted for analysis. This study explored a possible association of these 2 entities. Methods Laboratory records were searched for singleton cases coded as DCH based on diagnosis on H&E stain over a 6-year period. Of 4478 placentas reported, 66 cases were coded as DCH (1.5%). These were classified as showing HGFVM, LGFVM, or no FVM. Controls (n = 132) were gestational age-matched cases without DCH. Cord length, coiling, insertion, or other abnormalities were noted. Membranes were classified as normal or circumvallate. Results were analyzed using Graphpad. Results Gestation ranged between 16 and 41 weeks gestation. 14/66 (21%) cases of DCH showed HGFVM and 2/66 (3%) showed LGFVM. 16/132 (12%) controls showed HGFVM and 21/132 (15.9%) had LGFVM. Where FVM is present, high-grade FVM is significantly associated with DCH versus controls ( P < .0031 Fischer’s Test). Discussion HGFVM occurs significantly more often in placentas with DCH than in controls. Both FVM and DCH are associated with adverse perinatal outcomes, and a possible relationship between the 2 remains to be clarified.

scholarly journals A Comparison of Prediction of Adverse Perinatal Outcomes between Hadlock and INTERGROWTH-21st Standards at the Third Trimester

2019 ◽  
Vol 2019 ◽  
pp. 1-9
Author(s):  
Chen Zhu ◽  
Yun-Yun Ren ◽  
Jiang-Nan Wu ◽  
Qiong-Jie Zhou
Keyword(s):  
Sensitivity And Specificity ◽  
Predictive Accuracy ◽  
Characteristic Curve ◽  
Perinatal Outcomes ◽  
Third Trimester ◽  
Clinical Value ◽  
Cutoff Value ◽  
The Third ◽  
Increased Risk ◽  
Adverse Perinatal Outcomes

Little is known about the clinical value of the Hadlock and INTERGROWTH-21st EFW standards for predicting adverse perinatal outcomes (APOs) in the third trimester. The purpose of this study was to study the association between low estimated fetal weight percentile (EFWc) in the third trimester and the risk of APOs and compare predictions of APOs between Hadlock and INTERGROWTH-21st EFW standards. A prospective cohort of 690 singleton pregnancies with ultrasonography performed in the third trimester between March 2015 and March 2016 in China was conducted. EFW and the corresponding EFWc were measured using the Hadlock and INTERGROWTH-21st standards, respectively. Cox proportional hazard models were used to assess the relationship between low EFWc (i.e., <5 percentile, P5) and the risk of APOs. Compared with fetuses with ≥P5 of the EFWc, fetuses with <P5 of the EFWc were much more likely to have an APO, with adjusted hazard ratios of 35.0 (95% confidence interval, 13.9-88.5) and 17.5 (7.7-39.6) for the Hadlock and INTERGROWTH standards, respectively. The Hadlock-EFWc had a higher predictive accuracy for APOs than the INTERGROWTH-EFWc, with area under the receiver operating characteristic curve of 0.94 (0.92-0.95) and 0.90 (0.87-0.92), respectively (P=0.007). The cutoff value for the INTERGROWTH-EFWc was percentile 11.61 with a sensitivity and specificity of 87.9% and 80.5%, respectively. For the Hadlock-EFWc, the corresponding sensitivity and specificity were 93.9% and 81.2%, with a cutoff value of percentile 8.65. Fetuses with low EFWc (i.e., <P5) were associated with an increased risk of APOs. APOs were more accurately predicted when EFWc was measured by the Hadlock standard than by the INTERGROWTH-21st standard.

The effect of maternal position on fetal middle cerebral artery Doppler indices and its association with adverse perinatal outcomes: a pilot study

2020 ◽  
Vol 48 (4) ◽  
pp. 317-321
Author(s):  
Rodney McLaren ◽  
Bharati Kalgi ◽  
Chima Ndubizu ◽  
Peter Homel ◽  
Shoshana Haberman ◽  
...  
Keyword(s):  
High Risk ◽  
Middle Cerebral Artery ◽  
Cerebral Artery ◽  
Repeated Measures ◽  
Adverse Outcome ◽  
Perinatal Outcomes ◽  
Low Risk ◽  
Doppler Velocity ◽  
Chronic Hypertension ◽  
Adverse Perinatal Outcomes

AbstractObjectiveThe aim of this study was to compare position-related changes in fetal middle cerebral artery (MCA) Doppler pulsatility indices (PI).MethodsA prospective study of 41 women with conditions associated with placental-pathology (chronic hypertension, pregestational diabetes, and abnormal analytes) and 34 women without those conditions was carried out. Fetal MCA Doppler velocity flow waveforms were obtained in maternal supine and left lateral decubitus positions. MCA PI Δ was calculated by subtracting the PI in the supine position from the PI in the left lateral position. Secondary outcomes included a composite of adverse perinatal outcomes (fetal growth restriction, oligohydramnios, and preeclampsia). χ2 and Student t-tests and repeated-measures analysis of variance were used.ResultsMCA PI Δ was significantly less for high-risk pregnant women ([P = 0.03]: high risk, left lateral PI, 1.90 ± 0.45 vs. supine PI, 1.88 ± 0.46 [Δ = 0.02]; low risk, left lateral PI, 1.90 ± 0.525 vs. supine PI, 1.68 ± 0.40 [Δ = 0.22]). MCA PI Δ was not significantly different between women who had a composite adverse outcome and women who did not have a composite adverse outcome (P = 0.843).ConclusionOur preliminary study highlights differences in position-related changes in fetal MCA PI between high-risk and low-risk pregnancies. These differences could reflect an attenuated ability of women with certain risk factors to respond to physiologic stress.

scholarly journals PREPARE: protocol for a stepped wedge trial to evaluate whether a risk stratification model can reduce preterm deliveries among women with suspected or confirmed preterm pre-eclampsia

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Marcos Augusto Bastos Dias ◽  
◽  
Leandro De Oliveira ◽  
Arundhanthi Jeyabalan ◽  
Beth Payne ◽  
...  
Keyword(s):  
Knowledge Transfer ◽  
Adverse Events ◽  
Risk Stratification ◽  
Risk Reduction ◽  
Randomised Trial ◽  
Adverse Outcomes ◽  
Cluster Randomised Trial ◽  
Care Providers ◽  
Stepped Wedge ◽  
Number Of Patients

Abstract Background Preeclampsia (PE) is a major cause of short and long-term morbidity for affected infants, including consequences of fetal growth restriction and iatrogenic prematurity. In Brazil, this is a special problem as PE accounts for 18% of preterm births (PTB). In the PREPARE (Prematurity REduction by Pre-eclampsia cARE) study, we will test a novel system of integrated care based on risk stratification and knowledge transfer, to safely reduce PTB. Methods This is a stepped wedge cluster randomised trial that will include women with suspected or confirmed PE between 20 + 0 and 36 + 6 gestational weeks. All pregnant women presenting with these findings at seven tertiary centres in geographically dispersed sites, throughout Brazil, will be considered eligible and evaluated in terms of risk stratification at admission. At randomly allocated time points, sites will transition to risk stratification performed according to sFlt-1/PlGF (Roche Diagnostics) measurement and fullPIERS score with both results will be revealed to care providers. The healthcare providers of women stratified as low risk for adverse outcomes (sFlt-1/PlGF ≤38 AND fullPIERS< 10% risk) will receive the recommendation to defer delivery. sFlt-1/PlGF will be repeated once and fullPIERS score twice a week. Rates of prematurity due to preeclampsia before and after the intervention will be compared. Additionally, providers will receive an active program of knowledge transfer about WHO recommendations for preeclampsia, including recommendations regarding antenatal corticosteroids for foetal benefits, antihypertensive therapy and magnesium sulphate for seizure prophylaxis. This study will have 90% power to detect a reduction in PTB associated with PE from a population estimate of 1.5 to 1.0%, representing a 33% risk reduction, and 80% power to detect a reduction from 2.0 to 1.5% (25% risk reduction). The necessary number of patients recruited to achieve these results is 750. Adverse events, serious adverse events, both anticipated and unanticipated will be recorded. Discussion The PREPARE intervention expects to reduce PTB and improve care of women with PE without significant adverse side effects. If successful, this novel pathway of care is designed for rapid translation to healthcare throughout Brazil and may be transferrable to other low and middle income countries. Trial registration ClinicalTrials.gov: NCT03073317.

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