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American Journal of Obstetrics &... Jun 2024Counseling of pregnancies complicated by pre- and periviable premature rupture of membranes to reach shared decision-making is challenging, and the current limited... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Counseling of pregnancies complicated by pre- and periviable premature rupture of membranes to reach shared decision-making is challenging, and the current limited evidence hampers the robustness of the information provided. This study aimed to elucidate the rate of obstetrical and neonatal outcomes after expectant management for premature rupture of membranes occurring before or at the limit of viability.
DATA SOURCES
Medline, Embase, CINAHL, and Web of Science databases were searched electronically up to September 2023.
STUDY ELIGIBILITY CRITERIA
Our study included both prospective and retrospective studies of singleton pregnancies with premature rupture of membranes before and at the limit of viability (ie, occurring between 14 0/7 and 24 6/7 weeks of gestation).
METHODS
Quality assessment of the included studies was performed using the Newcastle-Ottawa Scale for cohort studies. Moreover, our study used meta-analyses of proportions to combine data and reported pooled proportions. Given the clinical heterogeneity, a random-effects model was used to compute the pooled data analyses. This study was registered with the International Prospective Register of Systematic Reviews database (registration number: CRD42022368029).
RESULTS
The pooled proportion of termination of pregnancy was 32.3%. After the exclusion of cases of termination of pregnancy, the rate of spontaneous miscarriage or fetal demise was 20.1%, whereas the rate of live birth was 65.9%. The mean gestational age at delivery among the live-born cases was 27.3 weeks, and the mean latency between premature rupture of membranes and delivery was 39.4 days. The pooled proportion of cesarean deliveries was 47.9% of the live-born cases. Oligohydramnios occurred in 47.1% of cases. Chorioamnionitis occurred in 33.4% of cases, endometritis in 7.0%, placental abruption in 9.2%, and postpartum hemorrhage in 5.3%. Hysterectomy was necessary in 1.2% of cases. Maternal sepsis occurred in 1.5% of cases, whereas no maternal death was reported in the included studies. When focusing on neonatal outcomes, the mean birthweight was 1022.8 g in live-born cases. The neonatal intensive care unit admission rate was 86.3%, respiratory distress syndrome was diagnosed in 66.5% of cases, pulmonary hypoplasia or dysplasia was diagnosed in 24.0% of cases, and persistent pulmonary hypertension was diagnosed in 40.9% of cases. Of the surviving neonates, the other neonatal complications included necrotizing enterocolitis in 11.1%, retinopathy of prematurity in 27.1%, and intraventricular hemorrhage in 17.5%. Neonatal sepsis occurred in 30.2% of cases, and the overall neonatal mortality was 23.9%. The long-term follow-up at 2 to 4 years was normal in 74.1% of the available cases.
CONCLUSION
Premature rupture of membranes before or at the limit of viability was associated with a great burden of both obstetrical and neonatal complications, with an impaired long-term follow-up at 2 to 4 years in almost 30% of cases, representing a clinical challenge for both counseling and management. Our data are useful when initially approaching such patients to offer the most comprehensive possible scenario on short- and long-term outcomes of this condition and to help parents in shared decision-making. El resumen está disponible en Español al final del artículo.
Topics: Humans; Fetal Membranes, Premature Rupture; Pregnancy; Female; Fetal Viability; Infant, Newborn; Pregnancy Outcome; Gestational Age; Cesarean Section; Watchful Waiting; Abortion, Induced
PubMed: 38648897
DOI: 10.1016/j.ajogmf.2024.101370 -
The Cochrane Database of Systematic... Nov 2015Fetal compromise in the term pregnancy is suspected when the following clinical indicators are present: intrauterine growth restriction (IUGR), decreased fetal movement... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Fetal compromise in the term pregnancy is suspected when the following clinical indicators are present: intrauterine growth restriction (IUGR), decreased fetal movement (DFM), or when investigations such as cardiotocography (CTG) and ultrasound reveal results inconsistent with standard measurements. Pathological results would necessitate the need for immediate delivery, but the management for 'suspicious' results remains unclear and varies widely across clinical centres. There is clinical uncertainty as to how to best manage women presenting with a suspected term compromised baby in an otherwise healthy pregnancy.
OBJECTIVES
To assess, using the best available evidence, the effects of immediate delivery versus expectant management of the term suspected compromised baby on neonatal, maternal and long-term outcomes.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015) and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised or quasi-randomised controlled trials comparing expectant management versus planned early delivery for women with a suspected compromised fetus from 37 weeks' gestation or more.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trials for inclusion and assessed trial quality. Two review authors independently extracted data. Data were checked for accuracy. We assessed the quality of the evidence using the GRADE approach.
MAIN RESULTS
Of the 20 reports identified by the search strategy, we included three trials (546 participants: 269 to early delivery and 277 to expectant management), which met our inclusion criteria. Two of the trials compared outcomes in 492 pregnancies with IUGR of the fetus, and one in 54 pregnancies with oligohydramnios. All three trials were of reasonable quality and at low risk of bias. The level of evidence was graded moderate, low or very low, downgrading mostly for imprecision and for some indirectness. Overall, there was no difference in the primary neonatal outcomes of perinatal mortality (no deaths in either group, one trial, 459 women, evidence graded moderate), major neonatal morbidity (risk ratio (RR) 0.15, 95% confidence interval (CI) 0.01 to 2.81, one trial, 459 women, evidence graded low), or neurodevelopmental disability/impairment at two years of age (RR 2.04, 95% CI 0.62 to 6.69,one trial, 459 women, evidence graded low). There was no difference in the risk of necrotising enterocolitis (one trial, 333 infants) or meconium aspiration (one trial, 459 infants), There was also no difference in the reported primary maternal outcomes: maternal mortality (RR 3.07, 95% CI 0.13 to 74.87, one trial, 459 women, evidence graded low), and significant maternal morbidity (RR 0.92, 95% CI 0.38 to 2.22, one trial, 459 women, evidence graded low).The gestational age at birth was on average 10 days earlier in women randomised to early delivery (mean difference (MD) -9.50, 95% CI -10.82 to -8.18, one trial, 459 women) and women in the early delivery group were significantly less likely to have a baby beyond 40 weeks' gestation (RR 0.10, 95% CI 0.01 to 0.67, one trial, 33 women). Significantly more infants in the planned early delivery group were admitted to intermediate care nursery (RR 1.28, 95% CI 1.02 to 1.61, two trials, 491 infants). There was no difference in the risk of respiratory distress syndrome, (one trial, 333 infants), Apgar score less than seven at five minutes (three trials, 546 infants), resuscitation required (one trial, 459 infants), mechanical ventilation (one trial, 337 infants), admission to neonatal intensive care unit (NICU) (RR 0.88, 95% CI 0.35 to 2.23, three trials, 545 infants, evidence graded very low), length of stay in NICU/SCN (one trial, 459 infants), and sepsis (two trials, 366 infants).Babies in the expectant management group were more likely to be < 2.3rd centile for birthweight (RR 0.51, 95% CI 0.36 to 0.73, two trials, 491 infants), however there was no difference in the proportion of babies with birthweight < 10th centile (RR 0.98, 95% CI 0.88 to 1.10). There was no difference in any of the reported maternal secondary outcomes including: caesarean section rates (RR 1.02, 95% CI 0.65 to 1.59, three trials, 546 women, evidence graded low), placental abruption (one trial, 459 women), pre-eclampsia (one trial, 459 women), vaginal birth (three trials 546 women), assisted vaginal birth (three trials 546 women), breastfeeding rates (one trial, 218 women), and number of weeks of breastfeeding after delivery one trial, 124 women). There was an expected increase in induction in the early delivery group (RR 2.05, 95% CI 1.78 to 2.37, one trial, 459 women).No data were reported for the pre-specified secondary neonatal outcomes of the number of days of mechanical ventilation, moderate-severe hypoxic ischaemic encephalopathy or need for therapeutic hypothermia. Likewise, no data were reported for secondary maternal outcomes of postnatal infection, maternal satisfaction or views of care.
AUTHORS' CONCLUSIONS
A policy for planned early delivery versus expectant management for a suspected compromised fetus at term does not demonstrate any differences in major outcomes of perinatal mortality, significant neonatal or maternal morbidity or neurodevelopmental disability. In women randomised to planned early delivery, the gestational age at birth was on average 10 days earlier, women were less likely to have a baby beyond 40 weeks' gestation, they were more likely to be induced and infants were more likely to be admitted to intermediate care nursery. There was also a significant difference in the proportion of babies with a birthweight centile < 2.3rd, however this did not translate into a reduction in morbidity. The review is informed by only one large trial and two smaller trials assessing fetuses with IUGR or oligohydramnios and therefore cannot be generalised to all term pregnancies with suspected fetal compromise. There are other indications for suspecting compromise in a fetus at or near term such as maternal perception of DFM, and ultrasound and/or CTG abnormalities. Future randomised trials need to assess effectiveness of timing of delivery for these indications.
Topics: Delivery, Obstetric; Developmental Disabilities; Female; Fetal Growth Retardation; Gestational Age; Humans; Infant; Infant, Newborn; Oligohydramnios; Perinatal Mortality; Pregnancy; Pregnancy Outcome; Randomized Controlled Trials as Topic; Watchful Waiting
PubMed: 26599471
DOI: 10.1002/14651858.CD009433.pub2 -
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 -
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 -
JBI Database of Systematic Reviews and... Feb 2019The objective of this review was to identify, assess and synthesize the best available evidence on the effects of induction prior to post-term on the mother and fetus....
OBJECTIVE
The objective of this review was to identify, assess and synthesize the best available evidence on the effects of induction prior to post-term on the mother and fetus. Maternal and fetal outcomes after routine labor induction in low-risk pregnancies at 41+0 to 41+6 gestational weeks (prior to post-term) were compared to routine labor induction at 42+0 to 42+6 gestational weeks (post-term).
INTRODUCTION
Induction of labor when a pregnancy exceeds 14 days past the estimated due date has long been used as an intervention to prevent adverse fetal and maternal outcomes. Over the last decade, clinical procedures have changed in many countries towards earlier induction. A shift towards earlier inductions may lead to 15-20% more inductions. Given the fact that induction as an intervention can cause harm to both mother and child, it is essential to ensure that the benefits of the change in clinical practice outweigh the harms.
INCLUSION CRITERIA
This review included studies with participants with expected low-risk deliveries, where both fetus and mother were considered healthy at inclusion and with no known risks besides the potential risk of the ongoing pregnancy. Included studies evaluated induction at 41+1-6 gestational weeks compared to 42+1-6 gestational weeks. Randomized control trials (n = 2), quasi-experimental trials (n = 2), and cohort studies (n = 3) were included. The primary outcomes of interest were cesarean section, instrumental vaginal delivery, low Apgar score (≤ 7/5 min.), and low pH (< 7.10). Secondary outcomes included additional indicators of fetal or maternal wellbeing related to prolonged pregnancy or induction.
METHODS
The following information sources were searched for published and unpublished studies: PubMed, CINAHL, Embase, Scopus, Swemed+, POPLINE; Cochrane, TRIP; Current Controlled Trials; Web of Science, and, for gray literature: MedNar; Google Scholar, ProQuest Nursing & Allied Health Source, and guidelines from the Royal College of Obstetricians and Gynaecologists, and American College of Obstetricians and Gynecologists, according to the published protocol. In addition, OpenGrey and guidelines from the National Institute for Health and Care Excellence, World Health Organization, and Society of Obstetricians and Gynaecologists of Canada were sought. Included papers were assessed by all three reviewers independently using the Joanna Briggs Institute System for the Unified Management, Assessment and Review of Information (JBI SUMARI). The standardized data extraction tool from JBI SUMARI was used. Data were pooled in a statistical meta-analysis model using RevMan 5, when the criteria for meta-analysis were met. Non-pooled results were presented separately.
RESULTS
Induction at 41+0-6 gestational weeks compared to 42+0-6 gestational weeks was found to be associated with an increased risk of overall cesarean section (relative risk [RR] = 1.11, 95% confidence interval [CI] 1.09-1.14), cesarean section due to failure to progress (RR = 1.43, 95% CI 1.01-2.01), chorioamnionitis (RR = 1.13, 95% CI 1.05-1.21), labor dystocia (RR = 1.29, 95% CI 1.22-1.37), precipitate labor (RR = 2.75, 95% CI 1.45-5.2), uterine rupture (RR = 1.97, 95% CI 1.54-2.52), pH < 7.10 (RR = 1.9, 95% CI 1.48-2.43), and a decreased risk of oligohydramnios (RR = 0.4, 95% CI 0.24-0.67) and meconium stained amniotic fluid (RR = 0.82, 95% CI 0.75-0.91). Data lacked statistical power to draw conclusions on perinatal death. No differences were seen for postpartum hemorrhage, shoulder dystocia, meconium aspiration, 5-minute Apgar score < 7, or admission to neonatal intensive care unit. A policy of awaiting spontaneous onset of labor until 42+0-6 gestational weeks showed, that approximately 70% went into spontaneous labor.
CONCLUSIONS
Induction prior to post-term was associated with few beneficial outcomes and several adverse outcomes. This draws attention to possible iatrogenic effects affecting large numbers of low-risk women in contemporary maternity care. According to the World Health Organization, expected benefits from a medical intervention must outweigh potential harms. Hence, our results do not support the widespread use of routine induction prior to post-term (41+0-6 gestational weeks).
Topics: Adult; Apgar Score; Case-Control Studies; Cesarean Section; Chorioamnionitis; Delivery, Obstetric; Dystocia; Female; Fetus; Gestational Age; Humans; Infant, Newborn; Labor, Induced; Labor, Obstetric; Maternal Health Services; Meconium Aspiration Syndrome; Middle Aged; Oligohydramnios; Perinatal Death; Pregnancy; Pregnancy Outcome; Uterine Rupture
PubMed: 30299344
DOI: 10.11124/JBISRIR-2017-003587 -
Journal of Clinical Epidemiology Jan 2024To evaluate the strength of the evidence for, and the extent of, overdiagnosis in noncancer conditions.
OBJECTIVES
To evaluate the strength of the evidence for, and the extent of, overdiagnosis in noncancer conditions.
STUDY DESIGN AND SETTING
We systematically searched for studies investigating overdiagnosis in noncancer conditions. Using the 'Fair Umpire' framework to assess the evidence that cases diagnosed by one diagnostic strategy but not by another may be overdiagnosed, two reviewers independently identified whether a Fair Umpire-a disease-specific clinical outcome, a test result or risk factor that can determine whether an additional case does or does not have disease-was present. Disease-specific clinical outcomes provide the strongest evidence for overdiagnosis, follow-up or concurrent tests provide weaker evidence, and risk factors provide only weak evidence. Studies without a Fair Umpire provide the weakest evidence of overdiagnosis.
RESULTS
Of 132 studies, 47 (36%) did not include a Fair Umpire to adjudicate additional diagnoses. When present, the most common Umpire was a single test or risk factor (32% of studies), with disease-specific clinical outcome Umpires used in only 21% of studies. Estimates of overdiagnosis included 43-45% of screen-detected acute abdominal aneurysms, 54% of cases of acute kidney injury, and 77% of cases of oligohydramnios in pregnancy.
CONCLUSION
Much of the current evidence for overdiagnosis in noncancer conditions is weak. Application of the framework can guide development of robust studies to detect and estimate overdiagnosis in noncancer conditions, ultimately informing evidence-based policies to reduce it.
Topics: Female; Pregnancy; Humans; Medical Overuse; Overdiagnosis; Risk Factors
PubMed: 37952702
DOI: 10.1016/j.jclinepi.2023.11.005