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Cardiovascular Revascularization... Apr 2022To assess the safety and efficacy of the Amplatzer Septal Occluder in the closure of secundum type atrial septal defects. (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To assess the safety and efficacy of the Amplatzer Septal Occluder in the closure of secundum type atrial septal defects.
BACKGROUND
The Amplatzer Septal Occluder (ASO; Abbott, St. Paul, MN) is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). Previous small cohort trials have shown a favorable safety and technical efficacy profile.
METHODS
We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. The primary endpoint was the technical success rate of implantations. Secondary outcomes included proportions of arrhythmias and embolism specific-adverse events.
RESULTS
We included a total of 12 studies with 2972 patients. The ratio of device implantation was 2:1 by sex [female: male]. Pooled technical success rate of implantation was 98% (95% CI: 0.968-0.990, P < 0.01). The cumulative adverse event rate was 5.1% (95% CI: 0.035-0.068, P < 0.01), which included arrhythmia and embolism specific adverse event rates of 1.8% (95% CI: 0.007-0.032, P < 0.01) and 0.7% (95% CI: 0.002-0.013, P < 0.01), respectively. Sensitivity analysis did not significantly affect pooled outcomes for success rate and adverse events; both forest plot and Begg's and Egger's regression tests supported symmetricity.
CONCLUSION
A high likelihood of technical success can be expected when implanting the ASO in secundum type ASDs. Adverse event rates are expected for one in twenty patients, and thus, our results support the safe use of ASO in secundum type ASDs closure.
CONDENSED ABSTRACT
The AMPLATZER Septal Occluder is an FDA-approved device for percutaneous closure of secundum type atrial septal defects (ASD). We conducted a systemic review and meta-analysis of all prospective case series and controlled trials that evaluated the ASO's safety and implant efficacy. We included a total of 12 studies with 2972 patients. Pooled technical success rate of implantation was 98% (P < 0.01). The cumulative adverse event rate was 5.1% (P < 0.01), 1.8% (P < 0.01) rate of arrhythmias, and 0.7% (P < 0.01) rate of embolisms. A high likelihood of technical success can be expected with a low rate of adverse events.
Topics: Cardiac Catheterization; Cohort Studies; Female; Heart Septal Defects, Atrial; Humans; Male; Septal Occluder Device; Treatment Outcome
PubMed: 34183276
DOI: 10.1016/j.carrev.2021.06.002 -
BMC Public Health Jun 2016A study in frog and chicken embryos, and reports of a high incidence of birth defects in regions of intensive GM-soy planting have raised concerns on the teratogenic... (Review)
Review
BACKGROUND
A study in frog and chicken embryos, and reports of a high incidence of birth defects in regions of intensive GM-soy planting have raised concerns on the teratogenic potential of glyphosate-based herbicides. These public concerns prompted us to conduct a systematic review of the epidemiological studies testing hypotheses of associations between glyphosate exposure and adverse pregnancy outcomes including birth defects.
METHODS
A systematic and comprehensive literature search was performed in MEDLINE, TOXLINE, Bireme-BVS and SCOPUS databases using different combinations of exposure and outcome terms. A case-control study on the association between pesticides and congenital malformations in areas of extensive GM soy crops in South America, and reports on the occurrence of birth defects in these regions were reviewed as well.
RESULTS
The search found ten studies testing associations between glyphosate and birth defects, abortions, pre-term deliveries, small for gestational date births, childhood diseases or altered sex ratios. Two additional studies examined changes of time-to-pregnancy in glyphosate-exposed populations. Except for an excess of Attention Deficit Hyperactivity Disorder - ADHD (OR = 3.6, 1.3-9.6) among children born to glyphosate appliers, no significant associations between this herbicide and adverse pregnancy outcomes were described. Evidence that in South American regions of intensive GM-soy planting incidence of birth defects is high remains elusive.
CONCLUSIONS
Current epidemiological evidence, albeit limited to a few studies using non-quantitative and indirect estimates and dichotomous analysis of exposures, does not lend support to public concerns that glyphosate-based pesticides might pose developmental risks to the unborn child. Nonetheless, owing to methodological limitations of existing analytical observational studies, and particularly to a lack of a direct measurement (urine and/or blood levels), or an indirect estimation of exposure that has proven valid, these negative findings cannot be taken as definitive evidence that GLY, at current levels of occupational and environmental exposures, brings no risk for human development and reproduction.
Topics: Abortion, Spontaneous; Agriculture; Case-Control Studies; Congenital Abnormalities; Environmental Exposure; Epidemiologic Studies; Female; Glycine; Herbicides; Humans; Incidence; Infant, Newborn; Male; Pregnancy; Pregnancy Outcome; South America; Glyphosate
PubMed: 27267204
DOI: 10.1186/s12889-016-3153-3 -
Human Reproduction Update 2013It has been 10 years since we carried out a systematic search of the literature on birth defect risk in infants born following assisted reproductive technology (ART)... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
It has been 10 years since we carried out a systematic search of the literature on birth defect risk in infants born following assisted reproductive technology (ART) compared with non-ART infants. Because of changes to ART practice since that review and the publication of more studies the objective of this review was to include these more recent studies to estimate birth defect risk after ART and to examine birth defect risk separately in ART singletons and multiples.
METHODS
We searched Medline, Embase and Current Contents databases (1978-2012). We used the same data extraction sheet and questionnaire we had used previously with the addition of a quality score to the questionnaire. Pooled relative risk (RR) estimates were calculated using a random effects model. All data were analysed using Comprehensive Meta-Analysis V2.
RESULTS
There were 45 cohort studies included in this review. ART infants (n = 92 671) had a higher risk of birth defects [RR 1.32, 95% confidence interval (CI) 1.24-1.42] compared with naturally conceived infants (n = 3 870 760). The risk further increased when data were restricted to major birth defects (RR 1.42, 95% CI 1.29-1.56) or singletons only (RR 1.36, 95% CI 1.30-1.43). The results for ART multiples were less clear. When all data for multiples were pooled the RR estimate was 1.11 (95% CI 0.98-1.26) but this increased to 1.26 (0.99-1.60) when the analysis was restricted to studies of ART twins where some adjustment was made for differences in zygosity distribution between ART and non-ART multiples.
CONCLUSIONS
Birth defects remain more common in ART infants. Further research is required to examine risks for important subgroups of ART exposure.
Topics: Congenital Abnormalities; Humans; Infant; Reproductive Techniques, Assisted; Risk Factors; Twins
PubMed: 23449641
DOI: 10.1093/humupd/dmt006 -
International Journal of Environmental... Aug 2022The objective of this systematic review was (a) to explore the current clinical applications of AI/ML (Artificial intelligence and Machine learning) techniques in... (Review)
Review
OBJECTIVE
The objective of this systematic review was (a) to explore the current clinical applications of AI/ML (Artificial intelligence and Machine learning) techniques in diagnosis and treatment prediction in children with CLP (Cleft lip and palate), (b) to create a qualitative summary of results of the studies retrieved.
MATERIALS AND METHODS
An electronic search was carried out using databases such as PubMed, Scopus, and the Web of Science Core Collection. Two reviewers searched the databases separately and concurrently. The initial search was conducted on 6 July 2021. The publishing period was unrestricted; however, the search was limited to articles involving human participants and published in English. Combinations of Medical Subject Headings (MeSH) phrases and free text terms were used as search keywords in each database. The following data was taken from the methods and results sections of the selected papers: The amount of AI training datasets utilized to train the intelligent system, as well as their conditional properties; Unilateral CLP, Bilateral CLP, Unilateral Cleft lip and alveolus, Unilateral cleft lip, Hypernasality, Dental characteristics, and sagittal jaw relationship in children with CLP are among the problems studied.
RESULTS
Based on the predefined search strings with accompanying database keywords, a total of 44 articles were found in Scopus, PubMed, and Web of Science search results. After reading the full articles, 12 papers were included for systematic analysis.
CONCLUSIONS
Artificial intelligence provides an advanced technology that can be employed in AI-enabled computerized programming software for accurate landmark detection, rapid digital cephalometric analysis, clinical decision-making, and treatment prediction. In children with corrected unilateral cleft lip and palate, ML can help detect cephalometric predictors of future need for orthognathic surgery.
Topics: Artificial Intelligence; Child; Cleft Lip; Cleft Palate; Humans; Machine Learning
PubMed: 36078576
DOI: 10.3390/ijerph191710860 -
Journal of Vascular Surgery. Venous and... Jan 2020Percutaneous sclerotherapy is a commonly used modality for treatment of lymphatic malformations (LMs) of the head, face, and neck. The safety and efficacy of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Percutaneous sclerotherapy is a commonly used modality for treatment of lymphatic malformations (LMs) of the head, face, and neck. The safety and efficacy of sclerotherapy with various agents for diverse pathologic types of LMs have not been fully established. We present the results of a systematic review and meta-analysis examining the safety and efficacy of percutaneous sclerotherapy for treatment of LMs of the head, face, and neck.
METHODS
We searched PubMed, MEDLINE, and Embase from 2000 to 2018 for studies evaluating the safety and efficacy of percutaneous sclerotherapy of head, face, and neck LMs. Two independent reviewers selected studies and abstracted data. The primary outcomes were complete and partial resolution of the LM. Data were analyzed using random-effects meta-analysis.
RESULTS
There were 25 studies reporting on 726 patients included. The overall rate of complete cure of any pathologic type of LM after percutaneous sclerotherapy with any agent was 50.5% (95% confidence interval, 36.6%-64.3%). Macrocystic lesions had a cure rate of 53.1% compared with cure rates of 35.1% for microcystic lesions and 31.1% for mixed lesions. Regarding agents, doxycycline had the highest cure rate (62.4%) compared with all other agents. Overall permanent morbidity or mortality was 1.2% (95% confidence interval, 0.4%-2.0%) with no deaths. I values were >50% for most outcomes, indicating substantial heterogeneity.
CONCLUSIONS
Our systematic review and meta-analysis of 25 studies and >700 patients found that percutaneous sclerotherapy is a safe and effective modality for treatment of LMs of the head, neck, and face.
Topics: Adolescent; Adult; Child; Child, Preschool; Female; Head; Humans; Infant; Lymphatic Abnormalities; Lymphatic System; Male; Neck; Risk Assessment; Risk Factors; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Young Adult
PubMed: 31734224
DOI: 10.1016/j.jvsv.2019.09.007 -
BMJ Paediatrics Open Jul 2023To evaluate the pooled prevalence and identify risk factors of congenital anomalies among neonates in Africa. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the pooled prevalence and identify risk factors of congenital anomalies among neonates in Africa.
METHODS
The pooled birth prevalence of congenital anomalies was the first outcome of this review, and the pooled measure of association between congenital anomalies and related risk factors in Africa was the second. We conducted a thorough search of the databases PubMed/ Medline, PubMed Central, Hinary, Google, Cochrane Library, African Journals Online, Web of Science and Google Scholar up to 31 January 2023. The JBI appraisal checklist was used to evaluate the studies. STATA V.17 was used for the analysis. The I test and Eggers and Beggs tests were used to measure study heterogeneity and publication bias respectively. The pooled prevalence of congenital anomalies was calculated using DerSimonian and Laird random-effect model. Subgroup analysis, sensitivity analysis and meta-regression were also performed.
RESULT
This systematic review and meta-analysis includes 32 studies with a total of 626 983 participants. The pooled prevalence of congenital anomalies was 23.5 (95% CI 20 to 26.9) per 1000 newborns. Not taking folic acid (pooled OR=2.67; 95% CI (1.42 to 5.00)), history of maternal illness (pooled OR=2.44, 95% CI (1.2 to 4.94)), history of drug use (pooled OR=2.74, 95% CI (1.29 to 5.81)), maternal age (>35 years.) (Pooled OR=1.97, 95% CI (1.15 to 3.37)), drinking alcohol (pooled OR=3.15, 95% CI (1.4 to 7.04)), kchat chewing (pooled OR=3.34, 5% CI (1.68 to 6.65)) and urban residence (pooled OR=0.58, 95% CI (0.36 to 0.95)) were had significant association with congenital anomalies.
CONCLUSION
The pooled prevalence of congenital abnormalities in Africa was found to be substantial, with significant regional variation. Appropriate folate supplementation during pregnancy, proper management of maternal sickness, proper antenatal care, referring healthcare personnel before using drugs, avoiding alcohol intake and kchat chewing are all important in lowering the occurrence of congenital abnormalities among newborns in Africa.
Topics: Adult; Female; Humans; Infant, Newborn; Pregnancy; Africa; Congenital Abnormalities; Risk Factors
PubMed: 37429669
DOI: 10.1136/bmjpo-2023-002022 -
Ultrasound in Obstetrics & Gynecology :... Jan 2014Studies have demonstrated an association between congenital heart disease (CHD) and neurodevelopmental delay. Neuroimaging studies have also demonstrated a high... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
Studies have demonstrated an association between congenital heart disease (CHD) and neurodevelopmental delay. Neuroimaging studies have also demonstrated a high incidence of preoperative brain abnormalities. The aim of this study was to perform a systematic review to quantify the non-surgical risk of brain abnormalities and of neurodevelopmental delay in infants with CHD.
METHODS
MEDLINE, EMBASE and The Cochrane Library were searched electronically without language restrictions, utilizing combinations of the terms congenital heart, cardiac, neurologic, neurodevelopment, magnetic resonance imaging, ultrasound, neuroimaging, autopsy, preoperative and outcome. Reference lists of relevant articles and reviews were hand-searched for additional reports. Cohort and case-control studies were included. Studies reporting neurodevelopmental outcomes and/or brain lesions on neuroimaging in infants with CHD before heart surgery were included. Cases of chromosomal or genetic abnormalities, case reports and editorials were excluded. Between-study heterogeneity was assessed using the I(2) test.
RESULTS
The search yielded 9129 citations. Full text was retrieved for 119 and the following were included in the review: 13 studies (n = 425 cases) reporting on brain abnormalities either preoperatively or in those who did not undergo congenital cardiac surgery and nine (n = 512 cases) reporting preoperative data on neurodevelopmental assessment. The prevalence of brain lesions on neuroimaging was 34% (95% CI, 24-46; I(2) = 0%) in transposition of the great arteries, 49% (95% CI, 25-72; I(2) = 65%) in left-sided heart lesions and 46% (95% CI, 40-52; I(2) =18.1%) in mixed/unspecified cardiac lesions, while the prevalence of neurodevelopmental delay was 42% (95% CI, 34-51; I(2) = 68.9).
CONCLUSIONS
In the absence of chromosomal or genetic abnormalities, infants with CHD are at increased risk of brain lesions as revealed by neuroimaging and of neurodevelopmental delay. These findings are independent of the surgical risk, but it is unclear whether the time of onset is fetal or postnatal.
Topics: Brain; Developmental Disabilities; Early Diagnosis; Female; Heart Defects, Congenital; Humans; Infant; Infant, Newborn; Magnetic Resonance Imaging; Male; Neuroimaging; Risk Assessment; Risk Factors
PubMed: 23737029
DOI: 10.1002/uog.12526 -
Journal of Osteopathic Medicine Apr 2022Ehlers-Danlos syndromes (EDS) are disorders of connective tissue that lead to a wide range of clinical presentations. While we are beginning to understand the... (Review)
Review
CONTEXT
Ehlers-Danlos syndromes (EDS) are disorders of connective tissue that lead to a wide range of clinical presentations. While we are beginning to understand the association between EDS and psychological manifestations, it is critical that we further elucidate the relationship between the two. Understanding the correlation between EDS and mental health will better ensure swift diagnosis and effective treatment for patients.
OBJECTIVES
This study aims to systematically examine and report the prevalence of psychiatric disorders in the EDS population.
METHODS
The PubMed database was searched on June 14, 2021 for articles published from January 2011 to June 2021. We included original, evidence-based, peer-reviewed journal articles in English that reported information on psychiatric disorders among EDS patients. Psychiatric disorders and psychological conditions were limited to those included in the "psychology" and "mental disorders" Medical Subject Headings (MeSH) search terms defined by the National Library of Medicine. Publications identified utilizing this search strategy by M.K. were imported into the Covidence system, where they first underwent a title and abstract screening process by three independent reviewers (M.K., K.L., H.G.). During the full-text review, two independent reviewers read the full text of the questionable articles to assess their eligibility for inclusion. Studies were excluded if they did not meet our target objective or if they were not in English or if they were opinion pieces, conference abstracts, or review articles. Data were extracted from the shortlisted studies by reviewers. During the data extraction phase, the quality and risk of publication bias were assessed by two independent reviewers utilizing the National Institutes of Health (NIH) Study Quality Assessment Tools. Any disagreements in study selection, data extraction, or quality assessment were adjudicated via discussion between the two reviewers, utilizing a third reviewer as a decider if necessary.
RESULTS
Out of 73 articles identified, there were no duplicates. A total of 73 records were screened, but only 40 articles were assessed in full text for eligibility. A total of 23 articles were ultimately included, which collectively discussed 12,298 participants. Ten (43.5%) of the included studies were cross-sectional in design, three (13.0%) were case reports, and three (13.0%) were retrospective chart reviews. The remaining seven (30.4%) articles were either case-control, cohort, qualitative, controlled observational, or validation studies. Twelve (52.2%) of the studies reported data on depression disorders, six of which reported prevalence data. Nine (39.1%) of the studies reported data on anxiety disorders, five of which reported prevalence data. Studies that reported nonprevalence data presented odds-ratio, mean scores on psychiatric evaluations, and other correlation statistics. Psychiatric disorders that were most reported in these articles were mood disorders (n=11), anxiety disorders (n=9), and neurodevelopmental disorders (n=7). Although the reports varied, the highest psychiatric prevalence reports in EDS patients involved language disorders (63.2%), attention-deficit/hyperactivity disorder (ADHD) (52.4%), anxiety (51.2%), learning disabilities (42.4%), and depression (30.2%).
CONCLUSIONS
Although mood disorders were cited in more articles, the highest reported prevalence was for language disorders and ADHD. This discrepancy highlights the importance of performing more research to better understand the relationship between EDS and psychiatric disorders.
Topics: Anxiety; Ehlers-Danlos Syndrome; Humans; Language Disorders; Mental Disorders; Retrospective Studies; United States
PubMed: 35420002
DOI: 10.1515/jom-2021-0267 -
Journal of Vascular Surgery. Venous and... Sep 2022To assess through literature case analysis how advances in lymphatic imaging, interventional radiology, and lymphatic vascular microsurgery illuminate and improve the... (Review)
Review
OBJECTIVES
To assess through literature case analysis how advances in lymphatic imaging, interventional radiology, and lymphatic vascular microsurgery illuminate and improve the lymphatic-flow status in select patients with Noonan syndrome (NS) who have undergone surgical intervention as a part of their comprehensive and individualized treatment plan. Also, we sought to illustrate the spectrum of lymphatic complications that can occur in this patient population when lymphatic flow through abnormal vasculature is surgically disrupted.
METHODS
A literature review was performed by searching "Noonan AND Lymphatic AND Imaging" in the PubMed database. Inclusion criteria for this study were (1) diagnosis and clinical description of at least one original patient with NS, (2) imaging figures depicting lymphatic structure and function or a description of lymphatic imaging findings when a figure is not present, and (3) documentation of either lymphatic surgical intervention or lymphatic complications resulting from other procedures. Patient cases were first grouped by documented surgical intervention type, then clinical outcomes and lymphatic imaging results were compared.
RESULTS
A total of 18 patient cases from 10 eligible publications were included in our review. Lymphatic imaging findings across all patients included lymphatic vessel dysplasia along with flow disruption (n = 16), thoracic duct malformations (n = 12), dermal lymphatic reflux (n = 7), and dilated lymphatic vessels (n = 4). Lymphovenous anastomosis (n = 4) resulted in rapid improvement of patient symptoms and signs. New-onset lymphatic manifestations noted over 10 to 20 years for two of these patients were chylothorax (n = 1), erysipelas (n = 1), and gradual-onset nonchylous scrotal lymphorrhea (n = 1). Targeted endovascular lymphatic disruption via sclerosis, embolization, or ablation (n = 8) results were mixed depending on the degree of central lymphatic involvement and included resolution of symptoms (n = 1), postoperative abdominal hemorrhage (n = 1), stable condition or minor improvement (n = 5), and death (n = 2). Large lymphatic vessel ligation or accidental incision (n = 6) occurred during thoracotomy (n = 4), scrotoplasty (n = 1), or inguinal lymph node biopsy (n = 1). These resulted in postoperative onset of new-onset regional lymphatic reflux (n = 5), chylothorax (n = 4), death (n = 3), or persistent or unchanged symptoms (n = 1).
CONCLUSIONS
Imaging of the central lymphatics enabled characterization of lymphatic developmental features and guided operative management of lymphatic vascular defects in patients with NS. This review of the literature suggests that the surgical preservation or enhancement of central lymphatic return in patients with NS may improve interventional outcomes, whereas the disruption of central lymph flow has significant potential to cause severe postoperative complications and worsening of the patient's clinical condition.
Topics: Humans; Lymphatic Vessels; Noonan Syndrome; Surgery, Computer-Assisted
PubMed: 35561969
DOI: 10.1016/j.jvsv.2022.03.017 -
The Cochrane Database of Systematic... Oct 2015Topical corticosteroids are the most frequently prescribed dermatological treatment and are often used by pregnant women with skin conditions. However, little is known... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Topical corticosteroids are the most frequently prescribed dermatological treatment and are often used by pregnant women with skin conditions. However, little is known about their safety in pregnancy.
OBJECTIVES
To assess the effects of topical corticosteroids on pregnancy outcomes in pregnant women.
SEARCH METHODS
This is an update of a review previously published in 2009. We updated our searches of the following databases to July 2015: the Cochrane Skin Group Specialised Register, the Cochrane Pregnancy and Childbirth Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 6), MEDLINE, EMBASE, and LILACS. We also searched five trials registers and checked the reference lists of included studies, published reviews, articles that had cited the included studies, and one author's literature collection, for further references to relevant RCTs.
SELECTION CRITERIA
Randomised controlled trials and cohort studies of topical corticosteroids in pregnant women, as well as case-control studies comparing maternal exposure to topical corticosteroids between cases and controls when studies reported pre-specified outcomes. The primary outcomes included mode of delivery, major congenital abnormality, birth weight, and preterm delivery (delivery before 37 completed weeks gestation); the secondary outcomes included foetal death, minor congenital abnormality, and low Apgar score (less than seven at 5 min).
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by Cochrane. Two authors independently applied selection criteria, extracted data, and assessed the quality of the included studies. A third author was available for resolving differences of opinion. A further author independently extracted data from included studies that were conducted by authors of this systematic review.
MAIN RESULTS
We included 7 new observational studies in this update, bringing the total number to 14, including 5 cohort and 9 case-control studies, with 1,601,515 study subjects.Most studies found no causal associations between maternal exposure to topical corticosteroids of any potency and pregnancy outcomes when compared with no exposure. These outcomes included: mode of delivery (risk ratio (RR) 1.04, 95% confidence interval (CI) 0.95 to 1.15, 1 cohort study, n = 9904, low quality evidence); congenital abnormalities, including orofacial cleft or cleft palate and hypospadias (where the urethral opening is on the underside of the penis) (RR 0.82, 95% CI 0.34 to 1.96, 2 cohort studies, n = 9512, low quality evidence; and odds ratio (OR) 1.07, 95% CI 0.71 to 1.60, 1 case-control study, n = 56,557); low birth weight (RR 1.08, 95% CI 0.86 to 1.36; n = 59,419, 4 cohort studies; very low quality evidence); preterm delivery (RR 0.93, 95% CI 0.81 to 1.08, 4 cohort studies, n = 59,419, low quality evidence); foetal death (RR 1.02, 95% CI 0.60 to 1.73, 4 cohort studies, n = 63,885, very low quality evidence); and low Apgar score (RR 0.84, 95% CI 0.54 to 1.31, 1 cohort study, n = 9220, low quality evidence).We conducted stratified analyses of mild or moderate potency, and potent or very potent topical corticosteroids, but we found no causal associations between maternal exposure to topical corticosteroid of any potency and congenital abnormality, orofacial clefts, preterm delivery, or low Apgar score. For low birth weight, although the meta-analysis based on study-level data was not significant for either mild to moderate corticosteroids (pooled RR 0.90, 95% CI 0.74 to 1.09, 3 cohort studies, n > 55,713) or potent to very potent corticosteroids (pooled RR 1.58, 95% CI 0.96 to 2.58, 4 cohort studies, n > 47,651), there were significant differences between the two subgroups (P = 0.04). The results from three of the individual studies in the meta-analysis indicated an increased risk of low birth weight in women who received potent to very potent topical corticosteroids. Maternal use of mild to moderate potency topical steroids was associated with a decreased risk of foetal death (pooled RR 0.70, 95% CI 0.64 to 0.77, 2 studies, n = 48,749; low quality evidence), but we did not observe this effect when potent to very potent topical corticosteroids were given during pregnancy (pooled RR 1.14, 95% CI 0.69 to 1.88, 3 studies, n = 37,086, low quality evidence).We used the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) Working Group approach to rate the overall quality of the evidence. Data from observational studies started at low quality. We further downgraded the evidence because of imprecision in low birth weight and inconsistency in foetal death. Lower quality evidence resulted in lower confidence in the estimate of effect for those outcomes.
AUTHORS' CONCLUSIONS
This update adds more evidence showing no causal associations between maternal exposure to topical corticosteroids of all potencies and pregnancy outcomes including mode of delivery, congenital abnormalities, preterm delivery, foetal death, and low Apgar score, which is consistent with the previous version of this review. This update provides stratified analyses based on steroid potency; we found no association between maternal use of topical corticosteroids of any potency and an increase in adverse pregnancy outcomes, including mode of delivery, congenital abnormality, preterm delivery, foetal death, and low Apgar score. Similar to the previous version of the review, this update identified a probable association between low birth weight and maternal use of potent to very potent topical corticosteroids, especially when the cumulative dosage of topical corticosteroids throughout the pregnancy is very large, which warrants further investigation. The finding of a possible protective effect of mild to moderate topical corticosteroids on foetal death could also be examined.
Topics: Abnormalities, Drug-Induced; Administration, Topical; Adrenal Cortex Hormones; Birth Weight; Case-Control Studies; Cleft Lip; Cleft Palate; Cohort Studies; Dermatologic Agents; Female; Humans; Infant, Low Birth Weight; Observational Studies as Topic; Pregnancy; Pregnancy Complications; Premature Birth; Skin Pigmentation
PubMed: 26497573
DOI: 10.1002/14651858.CD007346.pub3