| 1. |
- Baranov, Anton, et al.
(författare)
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Validation of the prediction model for success of vaginal birth after cesarean delivery at the university hospital in Barcelona
- 2017
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Ingår i: Journal of Maternal-Fetal and Neonatal Medicine. - : Informa UK Limited. - 1476-7058 .- 1476-4954. ; 30:24, s. 2998-3003
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To validate the prediction model for successful vaginal birth after cesarean delivery (VBAC) based on variables easily obtainable at the first antenatal visit, in a Spanish population. Methods: Retrospective observational study. Women with a single live fetus in cephalic presentation with one previous low-transverse CD who underwent trial of labor after cesarean delivery (TOLAC) at ≥37 gestational weeks between January 2011 and December 2015 were identified in the hospital’s information system. Their antenatal medical records and delivery summary reports were reviewed and individual probabilities of successful VBAC were calculated, according to a previously published model. These probabilities were categorized into deciles. For calibration, each decile of predicted probabilities was compared to the observed rates. To assess the accuracy of the prediction model, receiver operating characteristic curve was constructed and the area under the curve (AUC) was calculated. Results: In total, 630 women who underwent TOLAC had all required information and were included in the study. Among them, 450 (71.4%) women had successful VBAC. The AUC was 0.70 (95% confidence interval 0.66–0.74). Conclusion: Prediction ability of the validated model was in agreement with the original study.
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| 2. |
- Basuki, Tri Rahmat, et al.
(författare)
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Third-trimester conditional reference values for longitudinal fetal growth assessment
- 2018
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Ingår i: Fetal Diagnosis and Therapy. - : S. Karger AG. - 1015-3837 .- 1421-9964. ; 43:1, s. 34-39
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The aim of this study was to derive longitudinal reference values of fetal growth (estimated fetal weight [EFW] and abdominal circumference [AC]) during the third trimester and to develop coefficients for conditional growth assessment. Patients and Methods: A prospective cohort study was conducted involving consecutive singleton pregnancies in a low-risk population for a routine third-trimester scan at 30+0-34+6 weeks and follow-up at 37+0-38+6 weeks for an additional ultrasound. Statistical analysis was based on multilevel modeling using MLwiN software. Unconditional centiles were calculated from z-values at each gestational age, and conditional centiles were calculated from z-values at a given measurement (30-34 weeks) and the expected measurement (37-38 weeks). Results: At 30-34 weeks, 8 and 9.3% of the fetuses had an unconditional EFW below the 10th and above the 90th centile, respectively. At 37-38 weeks, these figures were 10.3 and 9.3%, respectively. Regarding the unconditional AC, at the first scan, 8.9 and 9.6% had values below the 10th and above the 90th centile, while at the second scan 10.5 and 10.5% had values below the 10th and above the 90th centile, respectively. The proportion with a conditional EFW below the 10th and above the 90th centile was 10.2 and 9.4% at the second scan, respectively. For conditional AC, these figures were 10.7 and 10.3%, respectively. Conclusion: We have produced reference centiles for EFW and AC growth during the third trimester as a useful tool for quantifying growth.
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| 3. |
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| 4. |
- Gumus, Hatice Gulcin, et al.
(författare)
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Ultrasound-Guided Intrauterine Labeling of Rat Fetuses
- 2017
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Ingår i: Gynecologic and Obstetric Investigation. - : S. Karger AG. - 0378-7346 .- 1423-002X.
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Tidskriftsartikel (refereegranskat)abstract
- Aim: To compare intra-amniotic versus fetal subcutaneous injections for selective fetal labeling in multifetal rat pregnancies. Methods: A total of 14 pregnant rats were randomized to receive intra-amniotic injections of dyes (including Fluorescein, Indigo Carmine, or Evans Blue) or fetal subcutaneous injections (of commercial tattoo ink) both guided by ultrasound at 15-17 days of gestation. Survival, injection, and labeling success rates of both techniques were compared. Results: Survival rates (84.4% for intra-amniotic injections vs. 90.9% for fetal subcutaneous injections) and injection success rates (94% for intra-amniotic injections vs. 100% for fetal subcutaneous injections) were similar among both groups. None of the neonates from the intra-amniotic injections group were labeled at birth, while 93% of the neonates from fetal subcutaneous injections group were tagged, showing a visible spot in the skin at birth. Conclusion: Our results suggest that ultrasound-guided fetal subcutaneous injections might be an adequate strategy for selectively labeling fetuses in multifetal pregnant animals.
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| 5. |
- Miranda, Jezid, et al.
(författare)
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Metabolic profiling and targeted lipidomics reveals a disturbed lipid profile in mothers and fetuses with intrauterine growth restriction
- 2018
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Ingår i: Scientific Reports. - : Springer Science and Business Media LLC. - 2045-2322. ; 8:1
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Tidskriftsartikel (refereegranskat)abstract
- Fetal growth may be impaired by poor placental function or maternal conditions, each of which can influence the transfer of nutrients and oxygen from the mother to the developing fetus. Large-scale studies of metabolites (metabolomics) are key to understand cellular metabolism and pathophysiology of human conditions. Herein, maternal and cord blood plasma samples were used for NMR-based metabolic fingerprinting and profiling, including analysis of the enrichment of circulating lipid classes and subclasses, as well as the number of sub-fraction particles and their size. Changes in phosphatidylcholines and glycoproteins were prominent in growth-restricted fetuses indicating significant alterations in their abundance and biophysical properties. Lipoprotein profiles showed significantly lower plasma concentrations of cholesterol-intermediate density lipoprotein (IDL), triglycerides-IDL and high-density lipoprotein (HDL) in mothers of growth-restricted fetuses compared to controls (p < 0.05). In contrast, growth-restricted fetuses had significantly higher plasma concentrations of cholesterol and triglycerides transporting lipoproteins [LDL, IDL, and VLDL, (p < 0.005; all)], as well as increased VLDL particle types (large, medium and small). Significant changes in plasma concentrations of formate, histidine, isoleucine and citrate in growth-restricted fetuses were also observed. Comprehensive metabolic profiling reveals that both, mother and fetuses of pregnancies complicated with fetal growth restriction have a substantial disruption in lipid metabolism.
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| 6. |
- Moreno-Espinosa, Ana L., et al.
(författare)
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Prediction of Neonatal Respiratory Morbidity Assessed by Quantitative Ultrasound Lung Texture Analysis in Twin Pregnancies
- 2022
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Ingår i: Journal of Clinical Medicine. - : MDPI AG. - 2077-0383. ; 11:16
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Tidskriftsartikel (refereegranskat)abstract
- The objective of this study was to evaluate the performance of quantitative ultrasound of fetal lung texture analysis in predicting neonatal respiratory morbidity (NRM) in twin pregnancies. This was an ambispective study involving consecutive cases. Eligible cases included twin pregnancies between 27.0 and 38.6 weeks of gestation, for which an ultrasound image of the fetal thorax was obtained within 48 h of delivery. Images were analyzed using quantusFLM® version 3.0. The primary outcome of this study was neonatal respiratory morbidity, defined as the occurrence of either transient tachypnea of the newborn or respiratory distress syndrome. The performance of quantusFLM® in predicting NRM was analyzed by matching quantitative ultrasound analysis and clinical outcomes. This study included 166 images. Neonatal respiratory morbidity occurred in 12.7% of cases, and it was predicted by quantusFLM® analysis with an overall sensitivity of 42.9%, specificity of 95.9%, positive predictive value of 60%, and negative predictive value of 92.1%. The accuracy was 89.2%, with a positive likelihood ratio of 10.4, and a negative likelihood ratio of 0.6. The results of this study demonstrate the good prediction capability of NRM in twin pregnancies using a non-invasive lung texture analysis software. The test showed an overall good performance with high specificity, negative predictive value, and accuracy.
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| 7. |
- Padilla, Nelly F., et al.
(författare)
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Quantitative tissue echogenicity of the neonatal brain assessed by ultrasound imaging
- 2009
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Ingår i: Ultrasound in Medicine and Biology. - : Elsevier BV. - 0301-5629. ; 35:9, s. 1421-1426
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Tidskriftsartikel (refereegranskat)abstract
- The aim of this study was to propose a method for measuring the echogenicity of several neonatal brain structures for quantitative interpretation of ultrasound images. To do this, 40 preterm neonates (24-34 weeks' gestation) with adequate birth weight for gestational age were studied. On the third day after delivery, anterior fontanelle ultrasound imaging of the brain was performed in standard coronal and sagittal views. Four regions-of-interest (ROIs) were identified: periventricular, choroid plexus, cerebellar vermis and basal ganglia. Two consecutive images from each ROI were digitally stored. For off-line analysis, the ROI corresponding to each structure was delineated and the mean pixel brightness (PB) calculated. In addition, the brightness of hone tissue obtained at the same depth of the studied ROI was calculated. This value was considered as the maximum possible echogenicity for that individual image. The relative echogenicity (RE) was then calculated as: PB ROI/PB BONE*100. Differences in RE between the ROIs and RE variations according to gestational age and reliability reproducibility were determined. We found that among the studied structures, RE values (mean/SD) were significantly higher in the choroid plexus (mean [SD] 56.38 [6.0] and in the cerebellar vermis 51.20 [6.0] than in the basal ganglia 37.29 [5.7] and the periventricular area 37.04 [5.6]) (p < 0.05). These values showed no variation in relation to gestational age at birth. Interobserver reproducibility was 0.91 in the choroid plexus, 0.89 in the cerebellar vermis, 0.82 in basal ganglia and 0.77 in the anterior periventricular area. In conclusion, semiquantitative estimation of RE offers a reproducible method for evaluating at-risk areas of the neonatal brain. (E-mail: fpadilla@clinic.ub.es) Published by Elsevier Inc. on behalf of World Federation for Ultrasound in Medicine & Biology.
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| 8. |
- Palacio, Montse, et al.
(författare)
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Prediction of neonatal respiratory morbidity by quantitative ultrasound lung texture analysis: a multicenter study.
- 2017
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Ingår i: American journal of obstetrics and gynecology. - : Elsevier BV. - 1097-6868 .- 0002-9378. ; 217:2
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Tidskriftsartikel (refereegranskat)abstract
- Prediction of neonatal respiratory morbidity may be useful to plan delivery in complicated pregnancies. The limited predictive performance of the current diagnostic tests together with the risks of an invasive procedure limits the use of fetal lung maturity assessment.The objective of the study was to evaluate the performance of quantitative ultrasound texture analysis (quantusFLM) to predict neonatal respiratory morbidity in preterm and early-term (<39.0 weeks) deliveries.This was a prospective multicenter study in 20 centers worldwide. Fetal lung ultrasound images were obtained at 25.0-38.6 weeks' gestation within 48 hours of delivery, stored in Digital Imaging and Communication in Medicine format, and analyzed with quantusFLM. Physicians were blinded to the analysis. At delivery, perinatal outcomes and the occurrence of neonatal respiratory morbidity, defined as either respiratory distress syndrome or transient tachypnea of the newborn, were registered. The performance of the ultrasound texture analysis test to predict neonatal respiratory morbidity was evaluated.A total of 883 images were collected, but 17.2% were discarded because of poor image quality or exclusion criteria, leaving 730 observations for the final analysis. The prevalence of neonatal respiratory morbidity was 13.8% (101 of 730). The quantusFLM predicted neonatal respiratory morbidity with a sensitivity, specificity, and positive and negative predictive value of 74.3% (75 of 101), 88.6% (557 of 629), 51.0% (75 of 147), and 95.5% (557 of 583), respectively. Accuracy was 86.5% (632 of 730) and positive and negative likelihood ratios were 6.5 and 0.3, respectively.The quantusFLM predicted neonatal respiratory morbidity with an accuracy similar to that previously reported for other tests with the advantage of being a noninvasive technique.
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| 9. |
- Rodríguez-Trujillo, Adriano, et al.
(författare)
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Gestational age is more important for short-term neonatal outcome than microbial invasion of the amniotic cavity or intra-amniotic inflammation in preterm prelabor rupture of membranes.
- 2016
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Ingår i: Acta obstetricia et gynecologica Scandinavica. - : Wiley. - 1600-0412 .- 0001-6349. ; 95:8, s. 926-33
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Tidskriftsartikel (refereegranskat)abstract
- The aim of this study was to evaluate, in women with preterm prelabor rupture of membranes (PPROM), the impact on short-term neonatal outcome of microbial invasion of the amniotic cavity (MIAC), intra-amniotic inflammation (IAI), and the microorganisms isolated in women with MIAC, when gestational age is taken into account.Prospective cohort study. We included women with PPROM (22.0-34.0 weeks of gestation) with available information about MIAC, IAI and short-term neonatal outcome. MIAC was defined as positive aerobic/anaerobic/genital Mycoplasma culture in amniotic fluid. Definition of IAI was based on interleukin-6 levels in amniotic fluid. Main outcome measures were Apgar score <7 at 5 min, umbilical artery pH ≤7.0, days in the neonatal intensive care unit, and composite neonatal morbidity, including any of the following: intraventricular hemorrhage grade III-IV, respiratory distress syndrome, early-onset neonatal sepsis, periventricular leukomalacia, necrotizing enterocolitis, and fetal or neonatal death. Labor was induced after 32.0 weeks if lung maturity was confirmed; and otherwise after 34.0 weeks.MIAC and IAI were found in 38% (72/190) and 67% (111/165), respectively. After adjustment for gestational age at delivery, no differences in short-term neonatal outcome were found between women with either MIAC or IAI, compared with the non-infection/non-inflammation ("No-MIAC/No-IAI") group. Furthermore, short-term neonatal outcome did not differ between the MIAC caused by Ureaplasma spp. group, the MIAC caused by other microorganisms group and the "No-MIAC/No-IAI" group.Gestational age at delivery seems to be more important for short-term neonatal outcome than MIAC or IAI in PPROM.
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| 10. |
- Sabra, Sally, et al.
(författare)
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Differential correlations between maternal hair levels of tobacco and alcohol with fetal growth restriction clinical subtypes
- 2018
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Ingår i: Alcohol. - : Elsevier BV. - 0741-8329. ; 70, s. 43-49
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Tidskriftsartikel (refereegranskat)abstract
- Maternal exposure to tobacco and alcohol is a known cause, among others, for fetal growth restriction (FGR). Clinically, FGR can be subclassified into two forms: intrauterine growth restriction (IUGR) and small for gestational age (SGA), based on the severity of the growth retardation, and abnormal uterine artery Doppler or cerebro-placental ratio. This study aimed at investigating any differential correlation between maternal exposures to these toxins with the two clinical forms of FGR. Therefore, a case-control study was conducted in Barcelona, Spain. Sixty-four FGR subjects, who were further subclassified into IUGR (n = 36) and SGA (n = 28), and 89 subjects matched appropriate-for-gestational age (AGA), were included. The levels of nicotine (NIC) and ethyl glucuronide (EtG), biomarkers of tobacco and alcohol exposure, respectively, were assessed in the maternal hair in the third trimester. Our analysis showed 65% of the pregnant women consumed alcohol, 25% smoked, and 19% did both. The odds ratios (ORs) of IUGR were 21 times versus 14 times for being SGA with maternal heavy smoking, while with alcohol consumption the ORs for IUGR were 22 times versus 37 times for the SGA group. The differential correlations between these toxins with the two subtypes of FGR suggest different mechanisms influencing fetal weight. Our alarming data of alcohol consumption during pregnancy should be considered for further confirmation among Spanish women.
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| 11. |
- Sabra, Sally, et al.
(författare)
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Heavy metals exposure levels and their correlation with different clinical forms of fetal growth restriction
- 2017
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Ingår i: PLoS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 12:10
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Tidskriftsartikel (refereegranskat)abstract
- Background: Prenatal heavy metals exposure has shown a negative impact on birth weight. However, their influence on different clinical forms of fetal smallness was never assessed. Objectives: To investigate whether there is a differential association between heavy metals exposure and fetal smallness subclassification into intrauterine growth restriction (IUGR) and small-for-gestational age (SGA). Method: In this prospective case-control study, we included 178 mother–infant pairs; 96 of appropriate for gestational age (AGA) and 82 of small fetuses diagnosed in third trimester. The small ones were further subclassified into IUGR, n = 49 and SGA, n = 33. Cadmium (Cd), mercury (Hg), lead (Pb), arsenic (As) and zinc (Zn) levels were measured in the maternal and cord serum, and in the placentas of the three groups. Results: Maternal serum level of Cd (p<0.001) was higher in the small fetuses compared to AGA. Fetal serum level of Cd (p<0.001) was increased in the small fetuses compared to AGA. Fetal serum level of Hg (p<0.05) showed an increase in SGA compared to both IUGR and AGA. Fetal serum level of Zn was increased in the AGA (p < 0.001) compared to each of the small fetuses groups. Only differences in the levels between the small fetuses’ subgroups were detected in the fetal serum levels of Cd and Hg. Fetal birth weight was negatively correlated with the fetal serum level of Cd (p < 0.001). No differences in the placental heavy metal levels were observed among the groups. Conclusion: Fetal serum levels of Cd showed differential correlation between small fetuses’ clinical subclassification, which together with the increased Cd levels in both maternal and fetal serum of the small fetuses reinforce the negative influence of heavy metals on birth weight. These findings provide more opportunities to verify the role of heavy metals exposure in relation to small fetuses’ subclassification.
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| 12. |
- Sepúlveda-Martínez, Alvaro, et al.
(författare)
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Atrioventricular plane displacement versus mitral and tricuspid annular plane systolic excursion : a comparison between cardiac magnetic resonance and M-mode echocardiography
- 2021
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Ingår i: Clinical Physiology and Functional Imaging. - : Wiley. - 1475-0961 .- 1475-097X. ; 41:3, s. 262-270
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Both echocardiography and CMR imaging are used to quantify longitudinal function. Inter-method variability for mitral (MAPSE) and tricuspid (TAPSE) annular plane systolic excursion, and variability between directly measured MAPSE and TAPSE and as based on atrio-ventricular plane displacement (AVPD) analysis by CMR, are however not known. This study therefore assessed inter-method variability and variability between annular plane systolic excursion and AVPD-based values in a healthy adult population.METHODS: Echocardiography and CMR were performed in 111 adults (35 [32 - 38] years). Method comparisons were assessed with Deming regression, Bland-Altman analysis and coefficient of variation. Observer reproducibility was assessed by the concordance correlation coefficient.RESULTS: Echocardiography and semi-automatic CMR agreed on MAPSE (17±2mm vs. 17±2mm, p=0.1) and TAPSE (25±3mm vs. 25±3mm, p=0.5), correlated highly between methods (fitted-slope 1.22 [95% CI 1.07-1.38] and 1.12 [95% CI 0.95-1.29]) and showed low bias (0.42 [95% CI -2.05-2.88] and -0.18 [95% CI -4.78-4.43]). Intra-/inter-observer reproducibility was high for both methods for both MAPSE (echocardiography 0.96/0.86; CMR 0.87/0.85) and TAPSE (echocardiography 0.96/0.95; CMR 0.97/0.96). MAPSE (16 ± 2 mm vs. 17 ± 2 mm; p<0.001) and TAPSE (24 ± 3 vs. 25 ± 3 mm; p<0.001) based on AVPD were similar but statistically different compared to semi-automatic CMR.CONCLUSIONS: Echocardiography and semi-automatic CMR have low variability and provide similar values for MAPSE and TAPSE, and are thus interchangeable for follow-up studies. Lateral values based on tracked data from AVPD analysis are not clinically significantly different and could be used as a representation of annular displacement.
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| 13. |
- Spencer, Rebecca, et al.
(författare)
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EVERREST prospective study : A 6-year prospective study to define the clinical and biological characteristics of pregnancies affected by severe early onset fetal growth restriction
- 2017
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Ingår i: BMC Pregnancy and Childbirth. - : Springer Science and Business Media LLC. - 1471-2393. ; 17:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: Fetal growth restriction (FGR) is a serious obstetric condition for which there is currently no treatment. The EVERREST Prospective Study has been designed to characterise the natural history of pregnancies affected by severe early onset FGR and establish a well phenotyped bio-bank. The findings will provide up-to-date information for clinicians and patients and inform the design and conduct of the EVERREST Clinical Trial: a phase I/IIa trial to assess the safety and efficacy of maternal vascular endothelial growth factor (VEGF) gene therapy in severe early onset FGR. Data and samples from the EVERREST Prospective Study will be used to identify ultrasound and/or biochemical markers of prognosis in pregnancies with an estimated fetal weight (EFW) <3rd centile between 20+0 and 26+6 weeks of gestation. Methods: This is a 6 year European multicentre prospective cohort study, recruiting women with a singleton pregnancy where the EFW is <3rd centile for gestational age and <600 g at 20+0 to 26+6 weeks of gestation. Detailed data are collected on: maternal history; antenatal, peripartum, and postnatal maternal complications; health economic impact; psychological impact; neonatal condition, progress and complications; and infant growth and neurodevelopment to 2 years of corrected age in surviving infants. Standardised longitudinal ultrasound measurements are performed, including: fetal biometry; uterine artery, umbilical artery, middle cerebral artery, and ductus venosus Doppler velocimetry; and uterine artery and umbilical vein volume blood flow. Samples of maternal blood and urine, amniotic fluid (if amniocentesis performed), placenta, umbilical cord blood, and placental bed (if caesarean delivery performed) are collected for bio-banking. An initial analysis of maternal blood samples at enrolment is planned to identify biochemical markers that are predictors for fetal or neonatal death. Discussion: The findings of the EVERREST Prospective Study will support the development of a novel therapy for severe early onset FGR by describing in detail the natural history of the disease and by identifying women whose pregnancies have the poorest outcomes, in whom a therapy might be most advantageous. The findings will also enable better counselling of couples with affected pregnancies, and provide a valuable resource for future research into the causes of FGR. Trial registration:NCT02097667registered 31st October 2013.
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| 14. |
- Spencer, Rebecca, et al.
(författare)
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Maternal PlGF and umbilical Dopplers predict pregnancy outcomes at diagnosis of early-onset fetal growth restriction
- 2023
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Ingår i: Journal of Clinical Investigation. - 0021-9738. ; 133:18
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND. Severe, early-onset fetal growth restriction (FGR) causes significant fetal and neonatal mortality and morbidity. Predicting the outcome of affected pregnancies at the time of diagnosis is difficult, thus preventing accurate patient counseling. We investigated the use of maternal serum protein and ultrasound measurements at diagnosis to predict fetal or neonatal death and 3 secondary outcomes: fetal death or delivery at or before 28+0 weeks, development of abnormal umbilical artery (UmA) Doppler velocimetry, and slow fetal growth. METHODS. Women with singleton pregnancies (n = 142, estimated fetal weights [EFWs] below the third centile, less than 600 g, 20+0 to 26+6 weeks of gestation, no known chromosomal, genetic, or major structural abnormalities) were recruited from 4 European centers. Maternal serum from the discovery set (n = 63) was analyzed for 7 proteins linked to angiogenesis, 90 additional proteins associated with cardiovascular disease, and 5 proteins identified through pooled liquid chromatography and tandem mass spectrometry. Patient and clinician stakeholder priorities were used to select models tested in the validation set (n = 60), with final models calculated from combined data. RESULTS. The most discriminative model for fetal or neonatal death included the EFW z score (Hadlock 3 formula/Marsal chart), gestational age, and UmA Doppler category (AUC, 0.91; 95% CI, 0.86-0.97) but was less well calibrated than the model containing only the EFW z score (Hadlock 3/Marsal). The most discriminative model for fetal death or delivery at or before 28+0 weeks included maternal serum placental growth factor (PlGF) concentration and UmA Doppler category (AUC, 0.89; 95% CI, 0.83-0.94). CONCLUSION. Ultrasound measurements and maternal serum PlGF concentration at diagnosis of severe, early-onset FGR predicted pregnancy outcomes of importance to patients and clinicians.
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| 15. |
- Spencer, Rebecca N., et al.
(författare)
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Development of standard definitions and grading for Maternal and Fetal Adverse Event Terminology
- 2022
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Ingår i: Prenatal Diagnosis. - : Wiley. - 0197-3851 .- 1097-0223. ; 42:1, s. 15-26
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Adverse event (AE) monitoring is central to assessing therapeutic safety. The lack of a comprehensive framework to define and grade maternal and fetal AEs in pregnancy trials severely limits understanding risks in pregnant women. We created AE terminology to improve safety monitoring for developing pregnancy drugs, devices and interventions. Method: Existing severity grading for pregnant AEs and definitions/indicators of ‘severe’ and ‘life-threatening’ conditions relevant to maternal and fetal clinical trials were identified through a literature search. An international multidisciplinary group identified and filled gaps in definitions and severity grading using Medical Dictionary for Regulatory Activities (MedDRA) terms and severity grading criteria based on Common Terminology Criteria for Adverse Event (CTCAE) generic structure. The draft criteria underwent two rounds of a modified Delphi process with international fetal therapy, obstetric, neonatal, industry experts, patients and patient representatives. Results: Fetal AEs were defined as being diagnosable in utero with potential to harm the fetus, and were integrated into MedDRA. AE severity was graded independently for the pregnant woman and her fetus. Maternal (n = 12) and fetal (n = 19) AE definitions and severity grading criteria were developed and ratified by consensus. Conclusions: This Maternal and Fetal AE Terminology version 1.0 allows systematic consistent AE assessment in pregnancy trials to improve safety.
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| 16. |
- Youssef, Lina, et al.
(författare)
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Fetal cardiac remodeling and dysfunction is associated with both preeclampsia and fetal growth restriction
- 2020
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Ingår i: American Journal of Obstetrics and Gynecology. - : Elsevier BV. - 0002-9378. ; 222:1, s. 1-79
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Tidskriftsartikel (refereegranskat)abstract
- Background: Preeclampsia and fetal growth restriction share some pathophysiologic features and are both associated with placental insufficiency. Fetal cardiac remodeling has been described extensively in fetal growth restriction, whereas little is known about preeclampsia with a normally grown fetus. Objective: To describe fetal cardiac structure and function in pregnancies complicated by preeclampsia and/or fetal growth restriction as compared with uncomplicated pregnancies. Study design: This was a prospective, observational study including pregnancies complicated by normotensive fetal growth restriction (n=36), preeclampsia with a normally grown fetus (n=35), preeclampsia with fetal growth restriction (preeclampsia with a normally grown fetus–fetal growth restriction, n=42), and 111 uncomplicated pregnancies matched by gestational age at ultrasound. Fetal echocardiography was performed at diagnosis for cases and recruitment for uncomplicated pregnancies. Cord blood concentrations of B-type natriuretic peptide and troponin I were measured at delivery. Univariate and multiple regression analysis were conducted. Results: Pregnancies complicated by preeclampsia and/or fetal growth restriction showed similar patterns of fetal cardiac remodeling with larger hearts (cardiothoracic ratio, median [interquartile range]: uncomplicated pregnancies 0.27 [0.23–0.29], fetal growth restriction 0.31 [0.26–0.34], preeclampsia with a normally grown fetus 0.31 [0.29–0.33), and preeclampsia with fetal growth restriction 0.28 [0.26–0.33]; P<.001) and more spherical right ventricles (right ventricular sphericity index: uncomplicated pregnancies 1.42 [1.25–1.72], fetal growth restriction 1.29 [1.22–1.72], preeclampsia with a normally grown fetus 1.30 [1.33–1.51], and preeclampsia with fetal growth restriction 1.35 [1.27–1.46]; P=.04) and hypertrophic ventricles (relative wall thickness: uncomplicated pregnancies 0.55 [0.48–0.61], fetal growth restriction 0.67 [0.58–0.8], preeclampsia with a normally grown fetus 0.68 [0.61–0.76], and preeclampsia with fetal growth restriction 0.66 [0.58–0.77]; P<.001). Signs of myocardial dysfunction also were observed, with increased myocardial performance index (uncomplicated pregnancies 0.78 z scores [0.32–1.41], fetal growth restriction 1.48 [0.97–2.08], preeclampsia with a normally grown fetus 1.15 [0.75–2.17], and preeclampsia with fetal growth restriction 0.45 [0.54–1.94]; P<.001) and greater cord blood B-type natriuretic peptide (uncomplicated pregnancies 14.2 [8.4–30.9] pg/mL, fetal growth restriction 20.8 [13.1–33.5] pg/mL, preeclampsia with a normally grown fetus 31.8 [16.4–45.8] pg/mL and preeclampsia with fetal growth restriction 37.9 [15.7–105.4] pg/mL; P<.001) and troponin I as compared with uncomplicated pregnancies. Conclusion: Fetuses of preeclamptic mothers, independently of their growth patterns, presented cardiovascular remodeling and dysfunction in a similar fashion to what has been previously described for fetal growth restriction. Future research is warranted to better elucidate the mechanism(s) underlying fetal cardiac adaptation in these conditions.
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| 17. |
- Youssef, Lina, et al.
(författare)
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Hemopexin and α1-microglobulin heme scavengers with differential involvement in preeclampsia and fetal growth restriction
- 2020
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Ingår i: PLoS ONE. - : Public Library of Science (PLoS). - 1932-6203. ; 15:9 September
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Tidskriftsartikel (refereegranskat)abstract
- Hemopexin and α1-microglobulin act as scavengers to eliminate free heme-groups responsible for hemoglobin-induced oxidative stress. The present study evaluated maternal and fetal plasma concentrations of these scavengers in the different phenotypes of placenta-mediated disorders. Singleton pregnancies with normotensive fetal growth restriction [FGR] (n = 47), preeclampsia without FGR (n = 45) and preeclampsia with FGR (n = 51) were included prospectively as well as uncomplicated pregnancies (n = 49). Samples were collected at delivery and ELISA analysis was applied to measure the hemopexin and α1-microglobulin concentrations. In maternal blood in preeclampsia with and without FGR, hemopexin was significantly lower (p = 0.003 and p<0.001, respectively) and α1-microglobulin was significantly higher (p<0.001 in both) whereas no difference existed in normotensive FGR mothers compared to controls. In contrast, in fetal blood in growth restricted fetuses with and without preeclampsia, both hemopexin and α1-microglobulin were significantly lower (p<0.001 and p = 0.001 for hemopexin, p = 0.016 and p = 0.013 for α1-microglobulin, respectively) with no difference in fetuses from preeclampsia without FGR in comparison to controls. Thus, hemopexin and α1-microglobulin present significantly altered concentrations in maternal blood in the maternal disease -preeclampsia- and in cord blood in the fetal disease -FGR-, which supports their differential role in placenta-mediated disorders in accordance with the clinical presentation of these disorders.
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