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Fetal Diagnosis and Therapy 2022Midtrimester prelabor rupture of membranes (PROM) between 16 and 24 weeks of gestational age is a major obstetric complication with high rates of perinatal morbidity and... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Midtrimester prelabor rupture of membranes (PROM) between 16 and 24 weeks of gestational age is a major obstetric complication with high rates of perinatal morbidity and mortality. Amnioinfusion has been proposed in women with midtrimester PROM to target oligohydramnios and subsequently enhance pulmonary development and perinatal outcomes.
MATERIAL AND METHODS
The purpose of this study was to perform a systematic review and meta-analysis including all randomized clinical trials investigating amnioinfusion versus no intervention in women with PROM between 16+0 and 24+0 weeks of gestational age. Databases Central, Embase, Medline, ClinicalTrials.gov and references of identified articles were searched from inception of database to December 2021. The primary outcome was perinatal mortality. Secondary outcomes included neonatal, maternal, and long-term developmental outcomes as defined in the core outcome set for preterm birth studies. Summary measures were reported as pooled relative risk (RR) or mean difference with corresponding 95% confidence interval (CI).
RESULTS
Two studies (112 patients, 56 in the amnioinfusion group and 56 in the no intervention group) were included in this review. Pooled perinatal mortality was 66.1% (37/56) in the amnioinfusion group compared with 71.4% (40/56) in no intervention group (RR 0.92, 95% CI: 0.72-1.19). Other neonatal and maternal core outcomes were similar in both groups, although due to the relatively small number of events and wide CIs, there is a possibility that amnioinfusion can be associated with clinically important benefits and harms. Long-term healthy survival was seen in 35.7% (10/28) of children assessed for follow-up and treated with amnioinfusion versus 28.6% (8/28) after no intervention (RR 1.30, 95% CI: 0.47-3.60, "best case scenario").
CONCLUSIONS
Based on these findings, the benefits of amnioinfusion for midtrimester PROM <24 weeks of gestational age are unproven, and the potential harms remain undetermined.
Topics: Pregnancy; Child; Infant, Newborn; Humans; Female; Fetal Membranes, Premature Rupture; Pregnancy Trimester, Second; Premature Birth; Delivery, Obstetric; Perinatal Mortality; Perinatal Death; Randomized Controlled Trials as Topic
PubMed: 35835036
DOI: 10.1159/000526020 -
Frontiers in Pediatrics 2021Pulmonary hypertension is one of the most common co-morbidities in infants with bronchopulmonary dysplasia (BPD), but its risk factors are unclear. The onset of...
Pulmonary hypertension is one of the most common co-morbidities in infants with bronchopulmonary dysplasia (BPD), but its risk factors are unclear. The onset of pulmonary hypertension in BPD has been associated with poor morbidity- and mortality-related outcomes in infants. Two review and meta-analysis studies have evaluated the risk factors and outcomes associated with pulmonary hypertension in infants with BPD. However, the limitations in those studies and the publication of recent cohort studies warrant our up-to-date study. We designed a systematic review and meta-analysis to evaluate the risk factors and outcomes of pulmonary hypertension in infants with BPD. To systematically evaluate the risk factors and outcomes associated with pulmonary hypertension in infants with BPD. We systematically searched the academic literature according to the PRISMA guidelines across five databases (Web of Science, EMBASE, CENTRAL, Scopus, and MEDLINE). We conducted random-effects meta-analyses to evaluate the pulmonary hypertension risk factors in infants with BPD. We also evaluated the overall morbidity- and mortality-related outcomes in infants with BPD and pulmonary hypertension. We found 15 eligible studies (from the initial 963 of the search result) representing data from 2,156 infants with BPD (mean age, 25.8 ± 0.71 weeks). The overall methodological quality of the included studies was high. Our meta-analysis in infants with severe BPD revealed increased risks of pulmonary hypertension [Odds ratio (OR) 11.2], sepsis (OR, 2.05), pre-eclampsia (OR, 1.62), and oligohydramnios (OR, 1.38) of being small for gestational age (3.31). Moreover, a comparative analysis found -to- effects of pulmonary hypertension on the total duration of hospital stay (Hedge's , 0.50), the total duration of oxygen received (, 0.93), the cognitive score (, -1.5), and the overall mortality (g, 0.83) in infants with BPD. We identified several possible risk factors (i.e., severe BPD, sepsis, small for gestational age, pre-eclampsia) which promoted the onset of pulmonary hypertension in infants with BPD. Moreover, our review sheds light on the morbidity- and mortality-related outcomes associated with pulmonary hypertension in these infants. Our present findings are in line with the existing literature. The findings from this research will be useful in development of efficient risk-based screening system that determine the outcomes associated with pulmonary hypertension in infants with BPD.
PubMed: 34249820
DOI: 10.3389/fped.2021.695610 -
BMC Cancer Apr 2021Over than one third (28-58%) of pregnancy-associated breast cancer (PABC) cases are characterized by positive epidermal growth factor receptor 2-positive (HER2)...
BACKGROUND
Over than one third (28-58%) of pregnancy-associated breast cancer (PABC) cases are characterized by positive epidermal growth factor receptor 2-positive (HER2) expression. Trastuzumab anti-HER2 monoclonal antibody is still the benchmark treatment of HER2-positive breast tumors. However, FDA has categorized Trastuzumab as a category D drug for pregnant patients with breast cancer. This systemic review aims to synthesize all currently available data of trastuzumab administration during pregnancy and provide an updated view of the effect of trastuzumab on fetal and maternal outcome.
METHODS
Eligible articles were identified by a search of MEDLINE bibliographic database and ClinicalTrials.gov for the period up to 01/09/2020; The algorithm consisted of a predefined combination of the words "breast", "cancer", "trastuzumab" and "pregnancy". This study was performed in accordance with the PRISMA guidelines.
RESULTS
A total of 28 eligible studies were identified (30 patients, 32 fetuses). In more than half of cases, trastuzumab was administered in the metastatic setting. The mean duration of trastuzumab administration during gestation was 15.7 weeks (SD: 10.8; median: 17.5; range: 1-32). Oligohydramnios or anhydramnios was the most common (58.1%) adverse event reported in all cases. There was a statistically significant decrease in oligohydramnios/anhydramnios incidence in patients receiving trastuzumab only during the first trimester (P = 0.026, Fisher's exact test). In 43.3% of cases a completely healthy neonate was born. 41.7% of fetuses exposed to trastuzumab during the second and/or third trimester were born completely healthy versus 75.0% of fetuses exposed exclusively in the first trimester. All mothers were alive at a median follow-up of 47.0 months (ranging between 9 and 100 months). Of note, there were three cases (10%) of cardiotoxicity and decreased ejection fraction during pregnancy.
CONCLUSIONS
Overall, treatment with trastuzumab should be postponed until after delivery, otherwise pregnancy should be closely monitored.
Topics: Adult; Amniotic Fluid; Antineoplastic Agents, Immunological; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Cardiotoxicity; Female; Fetus; Humans; Middle Aged; Oligohydramnios; Pregnancy; Pregnancy Complications, Neoplastic; Pregnancy Trimesters; Receptor, ErbB-2; Time Factors; Trastuzumab; Young Adult
PubMed: 33902516
DOI: 10.1186/s12885-021-08162-3 -
Health Technology Assessment... Feb 2021Currently, pregnant women are screened using ultrasound to perform gestational aging, typically at around 12 weeks' gestation, and around the middle of pregnancy....
BACKGROUND
Currently, pregnant women are screened using ultrasound to perform gestational aging, typically at around 12 weeks' gestation, and around the middle of pregnancy. Ultrasound scans thereafter are performed for clinical indications only.
OBJECTIVES
We sought to assess the case for offering universal late pregnancy ultrasound to all nulliparous women in the UK. The main questions addressed were the diagnostic effectiveness of universal late pregnancy ultrasound to predict adverse outcomes and the cost-effectiveness of either implementing universal ultrasound or conducting further research in this area.
DESIGN
We performed diagnostic test accuracy reviews of five ultrasonic measurements in late pregnancy. We conducted cost-effectiveness and value-of-information analyses of screening for fetal presentation, screening for small for gestational age fetuses and screening for large for gestational age fetuses. Finally, we conducted a survey and a focus group to determine the willingness of women to participate in a future randomised controlled trial.
DATA SOURCES
We searched MEDLINE, EMBASE and the Cochrane Library from inception to June 2019.
REVIEW METHODS
The protocol for the review was designed a priori and registered. Eligible studies were identified using keywords, with no restrictions for language or location. The risk of bias in studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Health economic modelling employed a decision tree analysed via Monte Carlo simulation. Health outcomes were from the fetal perspective and presented as quality-adjusted life-years. Costs were from the perspective of the public sector, defined as NHS England, and the costs of special educational needs. All costs and quality-adjusted life-years were discounted by 3.5% per annum and the reference case time horizon was 20 years.
RESULTS
Umbilical artery Doppler flow velocimetry, cerebroplacental ratio, severe oligohydramnios and borderline oligohydramnios were all either non-predictive or weakly predictive of the risk of neonatal morbidity (summary positive likelihood ratios between 1 and 2) and were all weakly predictive of the risk of delivering a small for gestational age infant (summary positive likelihood ratios between 2 and 4). Suspicion of fetal macrosomia is strongly predictive of the risk of delivering a large infant, but it is only weakly, albeit statistically significantly, predictive of the risk of shoulder dystocia. Very few studies blinded the result of the ultrasound scan and most studies were rated as being at a high risk of bias as a result of treatment paradox, ascertainment bias or iatrogenic harm. Health economic analysis indicated that universal ultrasound for fetal presentation only may be both clinically and economically justified on the basis of existing evidence. Universal ultrasound including fetal biometry was of borderline cost-effectiveness and was sensitive to assumptions. Value-of-information analysis indicated that the parameter that had the largest impact on decision uncertainty was the net difference in cost between an induced delivery and expectant management.
LIMITATIONS
The primary literature on the diagnostic effectiveness of ultrasound in late pregnancy is weak. Value-of-information analysis may have underestimated the uncertainty in the literature as it was focused on the internal validity of parameters, which is quantified, whereas the greatest uncertainty may be in the external validity to the research question, which is unquantified.
CONCLUSIONS
Universal screening for presentation at term may be justified on the basis of current knowledge. The current literature does not support universal ultrasonic screening for fetal growth disorders.
FUTURE WORK
We describe proof-of-principle randomised controlled trials that could better inform the case for screening using ultrasound in late pregnancy.
STUDY REGISTRATION
This study is registered as PROSPERO CRD42017064093.
FUNDING
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 15. See the NIHR Journals Library website for further project information.
Topics: Cost-Benefit Analysis; Female; Gestational Age; Humans; Infant, Newborn; Mass Screening; Parity; Pregnancy; Randomized Controlled Trials as Topic; Ultrasonography
PubMed: 33656977
DOI: 10.3310/hta25150 -
Mayo Clinic Proceedings. Innovations,... Aug 2020The aim of this study was to investigate the effect of serial amnioinfusion therapy (SAT) for pulmonary hypoplasia in lower urinary tract obstruction (LUTO) or...
Serial Amnioinfusion as Regenerative Therapy for Pulmonary Hypoplasia in Fetuses With Intrauterine Renal Failure or Severe Renal Anomalies: Systematic Review and Future Perspectives.
The aim of this study was to investigate the effect of serial amnioinfusion therapy (SAT) for pulmonary hypoplasia in lower urinary tract obstruction (LUTO) or congenital renal anomalies (CRAs), introduce patient selection criteria, and present a case of SAT in bilateral renal agenesis. We conducted a search of the MEDLINE, EMBASE, Web of Science, and Scopus databases for articles published from database inception to November 10, 2017. Eight studies with 17 patients (7 LUTO, 8 CRA, and 2 LUTO + CRA) were included in the study. The median age of the mothers was 31 years (N=9; interquartile range [IQR], 29-33.5 years), the number of amnioinfusions was 7 (N=17; IQR, 4.5-21), gestational age at first amnioinfusion was 23 weeks and 4 days (N=17; IQR, 21-24.07), gestational age at delivery was 32 weeks and 2 days (N=17; IQR, 30 weeks to 35 weeks and 6.5 days), birthweight of newborns was 3.7 kg (N= 9; IQR, 2.7-3.7 kg), Apgar score at 1 minute was 2.5 (N=8; IQR, 1-6.5), and Apgar score at 5 minutes was 5.5 (N=8; IQR, 0-7.75). In conclusion, SAT may provide fetal pulmonary palliation by reducing the risk of newborn pulmonary compromise secondary to oligohydramnios. Multidisciplinary research efforts are required to further inform treatment and counseling guidelines. We propose a multidisciplinary approach to prenatal classification of fetuses with LUTO to inform patient selection.
PubMed: 32793867
DOI: 10.1016/j.mayocpiqo.2020.04.008 -
Taiwanese Journal of Obstetrics &... Jan 2020Electrical injuries can occur in pregnant women but currently their incidence is not completely known. Notwithstanding, those represent clinical important events such...
Electrical injuries can occur in pregnant women but currently their incidence is not completely known. Notwithstanding, those represent clinical important events such maternal and fetal death, which can be avoided if properly managed. The objective of this paper is to describe the results of electrical injury (high and low voltage), in pregnant women in scientific reports. A systematic search was performed with keywords "electrical injuries", "lightning injuries", "lightning strike", "pregnant women" and "pregnancy", using the databases: MedLine, Scielo, Lilacs, Clinical key, Web of Science, Scopus, Springer, Science Direct, Embase and Medic Latina. Filters like language, time, design and availability of text were not used. Descriptive analyses were carried out for variables such as maternal-fetal consequences, voltage and type of exposure, based on the reports identified. From the total 74 cases identified, 71.1% survived after the exposition. From the total live-births 28.6% did not show any alteration, 7.1% presented maceration and burns, while 64.3% had another outcome. Electric injury leads to fetal compromise and death in exposed pregnant women, mainly in the first hours after the injury. However, monitoring should be continued for the risk of complications such as placenta abruption, oligohydramnios and fetal distress. It is possible an underreporting of these events.
Topics: Electric Injuries; Female; Fetal Death; Fetal Distress; Humans; Maternal Exposure; Pregnancy; Prenatal Injuries
PubMed: 32039774
DOI: 10.1016/j.tjog.2019.11.001 -
PloS One 2019The number of studies associating the use of sildenafil in gestation is increasing. This drug inhibits phosphodiesterase type 5 (PDE5), an enzyme responsible for... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The number of studies associating the use of sildenafil in gestation is increasing. This drug inhibits phosphodiesterase type 5 (PDE5), an enzyme responsible for degradation of nitric oxide, and its efficacy is greater in the placental territory, as the maternal side of the placenta have more PDE5 than other sites. For this reason, promising results have been observed related to the prevention of preeclampsia and intrauterine growth restriction and to improvement of maternal-fetal morbidity in cases of placental insufficiency.
OBJECTIVE
To evaluate the benefits of using sildenafil in pregnancy.
SEARCHED STRATEGY
MEDLINE, ClinicalTrials.gov, Embase, LILACS and Cochrane databases were searched through September 2018. There was no restriction in language or year of publication. This study was registered in PROSPERO (CRD42017060288).
SELECTION CRITERIA
Randomized clinical trials which used sildenafil for treatment or prevention of obstetric diseases compared with placebo were selected.
DATA COLLECTION AND ANALYSIS
The results were obtained using the inverse variance method for continuous variables and Man-Whitney for categorical variables.
MAIN RESULTS
Among a population of 598 pregnant women from the seven clinical trials included, 139 had pre-eclampsia, 275 had intrauterine growth restriction, and 184 had oligohydramnios. A significant increase of 222.58 grams [27.75 to 417.41] was observed in the fetal weight at birth of patients taking sildenafil. The other outcomes did not show any statistical significance. This may be due to the small number of patients used in each study and the great heterogeneity between the groups.
CONCLUSIONS
Sildenafil could be associated with increasing fetal weight at birth in placental insufficiency despite the limitations of this meta-analysis, even though more studies in this field are needed to introduce this drug into obstetric clinical practice.
Topics: Birth Weight; Delivery, Obstetric; Female; Fetus; Gestational Age; Headache; Humans; Infant; Infant Mortality; Labor, Obstetric; Pregnancy; Pregnancy Outcome; Publication Bias; Risk; Sildenafil Citrate; Umbilical Arteries
PubMed: 31339910
DOI: 10.1371/journal.pone.0219732