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JAMA Psychiatry Dec 2019Antidepressant use is increasing worldwide. Yet, contrasting evidence on the safety of antidepressants is available from meta-analyses, and the credibility of these...
IMPORTANCE
Antidepressant use is increasing worldwide. Yet, contrasting evidence on the safety of antidepressants is available from meta-analyses, and the credibility of these findings has not been quantified.
OBJECTIVE
To grade the evidence from published meta-analyses of observational studies that assessed the association between antidepressant use or exposure and adverse health outcomes.
DATA SOURCES
PubMed, Scopus, and PsycINFO were searched from database inception to April 5, 2019.
EVIDENCE REVIEW
Only meta-analyses of observational studies with a cohort or case-control study design were eligible. Two independent reviewers recorded the data and assessed the methodological quality of the included meta-analyses. Evidence of association was ranked according to established criteria as follows: convincing, highly suggestive, suggestive, weak, or not significant.
RESULTS
Forty-five meta-analyses (17.9%) from 4471 studies identified and 252 full-text articles scrutinized were selected that described 120 associations, including data from 1012 individual effect size estimates. Seventy-four (61.7%) of the 120 associations were nominally statistically significant at P ≤ .05 using random-effects models. Fifty-two associations (43.4%) had large heterogeneity (I2 > 50%), whereas small-study effects were found for 17 associations (14.2%) and excess significance bias was found for 9 associations (7.5%). Convincing evidence emerged from both main and sensitivity analyses for the association between antidepressant use and risk of suicide attempt or completion among children and adolescents, autism spectrum disorders with antidepressant exposure before and during pregnancy, preterm birth, and low Apgar scores. None of these associations remained supported by convincing evidence after sensitivity analysis, which adjusted for confounding by indication.
CONCLUSIONS AND RELEVANCE
This study's findings suggest that most putative adverse health outcomes associated with antidepressant use may not be supported by convincing evidence, and confounding by indication may alter the few associations with convincing evidence. Antidepressant use appears to be safe for the treatment of psychiatric disorders, but more studies matching for underlying disease are needed to clarify the degree of confounding by indication and other biases. No absolute contraindication to antidepressants emerged from this umbrella review.
Topics: Adolescent; Antidepressive Agents; Apgar Score; Autism Spectrum Disorder; Child; Female; Humans; Mental Disorders; Meta-Analysis as Topic; Observational Studies as Topic; Pregnancy; Premature Birth; Prenatal Exposure Delayed Effects; Suicide, Attempted; Suicide, Completed
PubMed: 31577342
DOI: 10.1001/jamapsychiatry.2019.2859 -
Acta Paediatrica (Oslo, Norway : 1992) Mar 2021
Topics: Apgar Score; Humans; Infant, Newborn; Resuscitation
PubMed: 33135250
DOI: 10.1111/apa.15629 -
The Cochrane Database of Systematic... Jun 2021Misoprostol given orally is a commonly used labour induction method. Our Cochrane Review is restricted to studies with low-dose misoprostol (initially ≤ 50 µg), as... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Misoprostol given orally is a commonly used labour induction method. Our Cochrane Review is restricted to studies with low-dose misoprostol (initially ≤ 50 µg), as higher doses pose unacceptably high risks of uterine hyperstimulation.
OBJECTIVES
To assess the efficacy and safety of low-dose oral misoprostol for labour induction in women with a viable fetus in the third trimester of pregnancy.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (14 February 2021) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised trials comparing low-dose oral misoprostol (initial dose ≤ 50 µg) versus placebo, vaginal dinoprostone, vaginal misoprostol, oxytocin, or mechanical methods; or comparing oral misoprostol protocols (one- to two-hourly versus four- to six-hourly; 20 µg to 25 µg versus 50 µg; or 20 µg hourly titrated versus 25 µg two-hourly static).
DATA COLLECTION AND ANALYSIS
Using Covidence, two review authors independently screened reports, extracted trial data, and performed quality assessments. Our primary outcomes were vaginal birth within 24 hours, caesarean section, and hyperstimulation with foetal heart changes.
MAIN RESULTS
We included 61 trials involving 20,026 women. GRADE assessments ranged from moderate- to very low-certainty evidence, with downgrading decisions based on imprecision, inconsistency, and study limitations. Oral misoprostol versus placebo/no treatment (four trials; 594 women) Oral misoprostol may make little to no difference in the rate of caesarean section (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.59 to 1.11; 4 trials; 594 women; moderate-certainty evidence), while its effect on uterine hyperstimulation with foetal heart rate changes is uncertain (RR 5.15, 95% CI 0.25 to 105.31; 3 trials; 495 women; very low-certainty evidence). Vaginal births within 24 hours was not reported. In all trials, oxytocin could be commenced after 12 to 24 hours and all women had pre-labour ruptured membranes. Oral misoprostol versus vaginal dinoprostone (13 trials; 9676 women) Oral misoprostol probably results in fewer caesarean sections (RR 0.84, 95% CI 0.78 to 0.90; 13 trials, 9676 women; moderate-certainty evidence). Subgroup analysis indicated that 10 µg to 25 µg (RR 0.80, 95% CI 0.74 to 0.87; 9 trials; 8652 women) may differ from 50 µg (RR 1.10, 95% CI 0.91 to 1.34; 4 trials; 1024 women) for caesarean section. Oral misoprostol may decrease vaginal births within 24 hours (RR 0.93, 95% CI 0.87 to 1.00; 10 trials; 8983 women; low-certainty evidence) and hyperstimulation with foetal heart rate changes (RR 0.49, 95% CI 0.40 to 0.59; 11 trials; 9084 women; low-certainty evidence). Oral misoprostol versus vaginal misoprostol (33 trials; 6110 women) Oral use may result in fewer vaginal births within 24 hours (average RR 0.81, 95% CI 0.68 to 0.95; 16 trials, 3451 women; low-certainty evidence), and less hyperstimulation with foetal heart rate changes (RR 0.69, 95% CI 0.53 to 0.92, 25 trials, 4857 women, low-certainty evidence), with subgroup analysis suggesting that 10 µg to 25 µg orally (RR 0.28, 95% CI 0.14 to 0.57; 6 trials, 957 women) may be superior to 50 µg orally (RR 0.82, 95% CI 0.61 to 1.11; 19 trials; 3900 women). Oral misoprostol probably does not increase caesarean sections overall (average RR 1.00, 95% CI 0.86 to 1.16; 32 trials; 5914 women; low-certainty evidence) but likely results in fewer caesareans for foetal distress (RR 0.74, 95% CI 0.55 to 0.99; 24 trials, 4775 women). Oral misoprostol versus intravenous oxytocin (6 trials; 737 women, 200 with ruptured membranes) Misoprostol may make little or no difference to vaginal births within 24 hours (RR 1.12, 95% CI 0.95 to 1.33; 3 trials; 466 women; low-certainty evidence), but probably results in fewer caesarean sections (RR 0.67, 95% CI 0.50 to 0.90; 6 trials; 737 women; moderate-certainty evidence). The effect on hyperstimulation with foetal heart rate changes is uncertain (RR 0.66, 95% CI 0.19 to 2.26; 3 trials, 331 women; very low-certainty evidence). Oral misoprostol versus mechanical methods (6 trials; 2993 women) Six trials compared oral misoprostol to transcervical Foley catheter. Misoprostol may increase vaginal birth within 24 hours (RR 1.32, 95% CI 0.98 to 1.79; 4 trials; 1044 women; low-certainty evidence), and probably reduces the risk of caesarean section (RR 0.84, 95% CI 0.75 to 0.95; 6 trials; 2993 women; moderate-certainty evidence). There may be little or no difference in hyperstimulation with foetal heart rate changes (RR 1.31, 95% CI 0.78 to 2.21; 4 trials; 2828 women; low-certainty evidence). Oral misoprostol one- to two-hourly versus four- to six-hourly (1 trial; 64 women) The evidence on hourly titration was very uncertain due to the low numbers reported. Oral misoprostol 20 µg hourly titrated versus 25 µg two-hourly static (2 trials; 296 women) The difference in regimen may have little or no effect on the rate of vaginal births in 24 hours (RR 0.97, 95% CI 0.80 to 1.16; low-certainty evidence). The evidence is of very low certainty for all other reported outcomes.
AUTHORS' CONCLUSIONS
Low-dose oral misoprostol is probably associated with fewer caesarean sections (and therefore more vaginal births) than vaginal dinoprostone, and lower rates of hyperstimulation with foetal heart rate changes. However, time to birth may be increased, as seen by a reduced number of vaginal births within 24 hours. Compared to transcervical Foley catheter, low-dose oral misoprostol is associated with fewer caesarean sections, but equivalent rates of hyperstimulation. Low-dose misoprostol given orally rather than vaginally is probably associated with similar rates of vaginal birth, although rates may be lower within the first 24 hours. However, there is likely less hyperstimulation with foetal heart changes, and fewer caesarean sections performed due to foetal distress. The best available evidence suggests that low-dose oral misoprostol probably has many benefits over other methods for labour induction. This review supports the use of low-dose oral misoprostol for induction of labour, and demonstrates the lower risks of hyperstimulation than when misoprostol is given vaginally. More trials are needed to establish the optimum oral misoprostol regimen, but these findings suggest that a starting dose of 25 µg may offer a good balance of efficacy and safety.
Topics: Administration, Intravaginal; Administration, Oral; Apgar Score; Cesarean Section; Dinoprostone; Drug Administration Schedule; Female; Heart Rate, Fetal; Humans; Intensive Care, Neonatal; Labor, Induced; Misoprostol; Oxytocics; Oxytocin; Parturition; Placebos; Pregnancy; Randomized Controlled Trials as Topic; Time Factors; Uterus
PubMed: 34155622
DOI: 10.1002/14651858.CD014484 -
JAMA Network Open Sep 2023The Apgar score is used worldwide as an assessment tool to estimate the vitality of newborns in their first minutes of life. Its applicability to estimate...
IMPORTANCE
The Apgar score is used worldwide as an assessment tool to estimate the vitality of newborns in their first minutes of life. Its applicability to estimate neurodevelopmental outcomes in infants born extremely preterm (EPT; <28 weeks' gestation) is not well established.
OBJECTIVE
To investigate the association between the Apgar score and neurodevelopmental outcomes in infants born EPT.
DESIGN, SETTING, AND PARTICIPANTS
This cohort study was conducted using data from the Effective Perinatal Intensive Care in Europe-Screening to Improve Health in Very Preterm Infants in Europe (EPICE-SHIPS) study, a population-based cohort in 19 regions of 11 European countries in 2011 to 2012. Clinical assessments of cognition and motor function at age 5 years were performed in infants born EPT and analyzed in January to July 2023.
EXPOSURES
Apgar score at 5 minutes of life categorized into 4 groups (0-3, 4-6, 7-8, and 9-10 points).
MAIN OUTCOMES AND MEASURES
Cognitive and motor outcomes were assessed using the Wechsler Preschool and Primary Scale of Intelligence test of IQ derived from locally normed versions by country and the Movement Assessment Battery for Children-Second Edition. Parents additionally provided information on communication and problem-solving skills using the Ages and Stages Questionnaire, third edition (ASQ-3). All outcomes were measured as continuous variables.
RESULTS
From the total cohort of 4395 infants born EPT, 2522 infants were live born, 1654 infants survived to age 5 years, and 996 infants (478 females [48.0%]) followed up had at least 1 of 3 outcome measures. After adjusting for sociodemographic variables, perinatal factors, and severe neonatal morbidities, there was no association of Apgar score with IQ, even for scores of 3 or less (β = -3.3; 95% CI, -10.5 to 3.8) compared with the score 9 to 10 category. Similarly, no association was found for ASQ-3 (β = -2.1; 95% CI, -24.6 to 20.4). Congruent results for Apgar scores of 3 or less were obtained for motor function scores for all children (β = -4.0; 95% CI, -20.1 to 12.1) and excluding children with a diagnosis of cerebral palsy (β = 0.8, 95% CI -11.7 to 13.3).
CONCLUSIONS AND RELEVANCE
This study found that low Apgar scores were not associated with longer-term outcomes in infants born EPT. This finding may be associated with high interobserver variability in Apgar scoring, reduced vitality signs and poorer responses to resuscitation after birth among infants born EPT, and the association of more deleterious exposures in the neonatal intensive care unit or of socioeconomic factors with greater changes in outcomes during the first 5 years of life.
Topics: Infant, Newborn; Child; Female; Pregnancy; Child, Preschool; Humans; Infant; Apgar Score; Cohort Studies; Infant, Extremely Premature; Cerebral Palsy; Cognition
PubMed: 37672271
DOI: 10.1001/jamanetworkopen.2023.32413 -
BMC Pregnancy and Childbirth Mar 2020The objective of our study was to evaluate the association between perinatal asphyxia and hypoxic-ischemic encephalopathy (HIE) with the presence of ante and intrapartum... (Observational Study)
Observational Study
BACKGROUND
The objective of our study was to evaluate the association between perinatal asphyxia and hypoxic-ischemic encephalopathy (HIE) with the presence of ante and intrapartum risk factors and/or abnormal fetal heart rate (FHR) findings, in order to improve maternal and neonatal management.
METHODS
We did a prospective observational cohort study from a network of four hospitals (one Hub center with neonatal intensive care unit and three level I Spoke centers) between 2014 and 2016. Neonates of gestational age ≥ 35 weeks, birthweight ≥1800 g, without lethal malformations were included if diagnosed with perinatal asphyxia, defined as pH ≤7.0 or Base Excess (BE) ≤ - 12 mMol/L in Umbical Artery (UA) or within 1 h, 10 min Apgar < 5, or need for resuscitation > 10 min. FHR monitoring was classified in three categories according to the American College of Obstetricians and Gynecologists (ACOG). Pregnancies were divided into four classes: 1) low risk; 2) antepartum risk; 3) intrapartum risk; 4) and both ante and intrapartum risk. In the first six hours of life asphyxiated neonates were evaluated using the Thomson score (TS): if TS ≥ 5 neonates were transferred to Hub for further assessment; if TS ≥ 7 hypothermia was indicated.
RESULTS
Perinatal asphyxia occurred in 21.5‰ cases (321/14,896) and HIE in 1.1‰ (16/14,896). The total study population was composed of 281 asphyxiated neonates: 68/5152 (1.3%) born at Hub and 213/9744 (2.2%) at Spokes (p < 0.001, OR 0.59, 95% CI 0.45-0.79). 32/213 (15%) neonates were transferred from Spokes to Hub. Overall, 12/281 were treated with hypothermia. HIE occurred in 16/281 (5.7%) neonates: four grade I, eight grade II and four grade III. Incidence of HIE was not different between Hub and Spokes. Pregnancies resulting in asphyxiated neonates were classified as class 1) 1.1%, 2) 52.3%, 3) 3.2%, and 4) 43.4%. Sentinel events occurred in 23.5% of the cases and FHR was category II or III in 50.5% of the cases. 40.2% cases of asphyxia and 18.8% cases of HIE were not preceded by sentinel events or abnormal FHR.
CONCLUSIONS
We identified at least one risk factor associated with all cases of HIE and with most cases of perinatal asphyxia. In absence of risk factors, the probability of developing perinatal asphyxia resulted extremely low. FHR monitoring alone is not a reliable tool for detecting the probability of eventual asphyxia.
Topics: Apgar Score; Asphyxia Neonatorum; Female; Heart Rate, Fetal; Humans; Hypoxia-Ischemia, Brain; Incidence; Infant; Infant, Newborn; Italy; Male; Pregnancy; Probability; Prospective Studies; Risk Factors
PubMed: 32228514
DOI: 10.1186/s12884-020-02876-1 -
European Review For Medical and... Aug 2022Coagulation parameters are used to diagnose hematological diseases. The correlation between the coagulation parameters and Apgar score at 5 min is yet to be elucidated....
OBJECTIVE
Coagulation parameters are used to diagnose hematological diseases. The correlation between the coagulation parameters and Apgar score at 5 min is yet to be elucidated. The present study aimed at describing the neonatal coagulation parameters in preterm infants with a low Apgar score at 5 min.
PATIENTS AND METHODS
In this case-control study, 32 serious preterm infants were compared with 20 preterm infants, according to the Apgar score at 5 min. The prothrombin time (PT), thrombin time (TT), fibrinogen (Fbg), activated partial thromboplastin time (APTT), calculated international normalized ratio (INR), D-dimer (D2), fructose diphosphate sodium (FDP), and procalcitonin (PCT) values were recorded. The linear correlation between coagulation parameters and Apgar score at 5 min was analyzed by linear regression. The two groups were compared using GraphPad Prism 8 (LaJolla, CA, USA).
RESULTS
In the study, the mean coagulation parameters were significantly higher in the serious preterm infants with low the Apgar score at 5 min compared to the preterm infants with normal Agar scores at 5 min (p<0.05). The correlation between coagulation parameters and Apgar score at 5 min was recorded (PT: R=0.3984; APTT: R=0.3165; INR: R=0.4139).
CONCLUSIONS
The coagulation parameters were significantly higher in serious preterm infants with a low Apgar score at 5 min. Also, the coagulation parameters and Apgar score at 5 min are associated with severity in preterm infants.
Topics: Apgar Score; Blood Coagulation; Case-Control Studies; Humans; Infant; Infant, Newborn; Infant, Premature; Partial Thromboplastin Time
PubMed: 35993644
DOI: 10.26355/eurrev_202208_29417 -
Maedica Jun 2022Maternal serum biomarkers assist in identifying various maternal and foetal complications. In this manner, the present study was conducted to assess the birth of...
Maternal serum biomarkers assist in identifying various maternal and foetal complications. In this manner, the present study was conducted to assess the birth of high-risk infants using β-hCG level and neutrophil lymphocyte ratio and their correlation with the development of low birth weight and poor APGAR score. A tertiary hospital-based prospective observation study was conducted among primi gravida attending the Department of Obstetrics & Gynaecology of Vardhaman Mahavir Medical College and Safdarjung Hospital, New Delhi, India. Written informed consent was obtained from prim gravida who met the eligibility criteria. Basic details on socio-demographics and selective blood investigations, , β-hCG and neutrophil-to-lymphocyte ratio (NLR), were examined and followed-up until postdelivery to assess the neonatal outcome. Data was analysed using SPSS version 21.0 with appropriate statistical methods. The contamination rate was calculated by dividing the total number of contaminated blood cultures by the total number of cultures multiplied by 100. The mean (±SD) age of participants (N=440) was 23.7 (±1.6). Overall, the mean (±SD) of birth weight and APGAR score at five minutes were 2.6 (±0.6), and 8.8 (±1.2), respectively, within the normal limits. Maternal values of NLR and β-hCG (IU/mL) were negatively correlated to neonatal outcomes, , low birth weight and poor APGAR score. The mean values of NLR were significantly high in neonates with poor outcomes (LBW, poor APGAR). The sensitivity and specificity of β-hCG as a predictor for poor APGAR score was 83% and 66% at 16-18 weeks (AUC -0.82, cut-off 22721) and 83%, and 90%, respectively at 32-34 weeks (AUC-0.79, cut-off 14825). The sensitivity and specificity of NLR as a predictor for poor APGAR score were 78% and 61% at 16-18 weeks (AUC-0.76, cut-off 4.5), and 89% and 53%, respectively at 32-34 weeks (AUC-0.74, cut-off 4.5). High levels of maternal NLR and β-hCG resulted in low birth weight neonates and poor APGAR score. The negative impact of these biomarkers should be further explored on a larger scale basis. Ascertaining this would lead to reduction in poor fetal outcomes.
PubMed: 36032616
DOI: 10.26574/maedica.2022.17.2.317 -
Journal of Clinical Medicine Mar 2022(1) Background: We aimed to study whether a low 5 min Apgar score is associated with pediatric neurological morbidities throughout childhood. (2) Methods: A...
(1) Background: We aimed to study whether a low 5 min Apgar score is associated with pediatric neurological morbidities throughout childhood. (2) Methods: A population-based retrospective cohort study was conducted. The exposed group was defined as offspring with a 5 min Apgar score <7, and the remaining offspring served as the comparison group. The primary outcome was defined as pediatric hospitalizations with any neurological morbidity. Multivariable survival models were used to evaluate the association between the exposure and outcome while adjusting for potential confounders. Additional models were used to study this association separately among term- and preterm-born offspring. (3) Results: The study population included 349,385 singletons born between the years 1991 and 2021, 0.6% (n = 2030) of whom had a 5 min Apgar score <7 (exposed). The cohort was followed for up to 18 years (median ~ 10.6). The incidence of neurological morbidity-related hospitalizations was higher among the exposed group versus the unexposed group (11.3% versus 7.5%, hazard ratio = 1.84; 95%CI 1.58−2.13). A low 5 min Apgar score remained a significant risk factor for neurological hospitalizations after adjusting for preterm delivery, maternal age, hypertension during pregnancy, gestational diabetes mellitus, chorioamnionitis, and delivery mode (adjusted hazard ratio = 1.61; 95%CI 1.39−1.87). However, after modeling term and preterm offspring separately, a low 5 min Apgar score was independently associated with neurological hospitalizations only among offspring born at term (adjusted hazard ratio = 1.16; 95%CI 0.87−1.55 and 1.70; 95%CI 1.42−2.02 for preterm and term offspring, respectively). (4) Conclusions: A low 5 min Apgar score is independently associated with childhood neurological morbidity, specifically among term-born offspring. Although not designed to identify risk for long-term health complications, Apgar scores may be a marker of risk for short- and long-term neurological morbidities among term newborns.
PubMed: 35407530
DOI: 10.3390/jcm11071922 -
Journal of Perinatal Medicine May 2023To review how the Apgar score is used in published clinical research as well as who uses it, and how this may have changed between 1989-90 and 2018-19.
OBJECTIVES
To review how the Apgar score is used in published clinical research as well as who uses it, and how this may have changed between 1989-90 and 2018-19.
METHODS
Pubmed search for English publications using MeSH Terms "apgar score" OR "apgar" AND "score" AND "humans" for epochs 1989-90 & 2018-19. The location and specialty of first author, primary purpose and how the Apgar score was used was recorded.
RESULTS
There was a 61% increase in number of publications in 2018-19 compared to 1989-90, from all regions except North America. The most common purpose for using the Apgar was to assess newborn status after pregnancy/delivery interventions. There were 50 different definitions of a significant score. Definition of significance was influenced by specialty in 2018-19 and by study purpose in both epochs.
CONCLUSIONS
Most studies using the Apgar score are focused on the mother. There is no consistent definition of a significant score. Development of any future newborn assessment tools should account for the multiple purposes for which the Apgar score is used.
Topics: Infant, Newborn; Pregnancy; Female; Humans; Apgar Score
PubMed: 36410713
DOI: 10.1515/jpm-2022-0340