-
Acta Obstetricia Et Gynecologica... Nov 2021The objective was to report the role of intrapartum ultrasound examination in affecting maternal and perinatal outcome in women undergoing instrumental vaginal delivery. (Meta-Analysis)
Meta-Analysis
INTRODUCTION
The objective was to report the role of intrapartum ultrasound examination in affecting maternal and perinatal outcome in women undergoing instrumental vaginal delivery.
MATERIAL AND METHODS
MEDLINE, Embase, CINAHL, Google Scholar and ClinicalTrial.gov databases were searched. Inclusion criteria were randomized controlled trials comparing ultrasound assessment of fetal head position vs routine standard care (digital examination) before instrumental vaginal delivery (either vacuum or forceps). The primary outcome was failed instrumental delivery extraction followed by cesarean section. Secondary outcomes were postpartum hemorrhage, 3rd or 4th degree perineal lacerations, episiotomy, prolonged hospital stay, Apgar score<7 at 5 min, umbilical artery pH <7.0 and base excess greater than -12 mEq, admission to neonatal intensive care unit (NICU), shoulder dystocia, birth trauma, a composite score of adverse maternal and neonatal outcome and incorrect diagnosis of fetal head position. Risk of bias was assessed using the Revised Cochrane risk-of-bias tool for randomized trials (RoB-2). The quality of evidence and strength of recommendations were assessed using the Grading of Recommendations Assessment Development and Evaluation (GRADE) methodology. Head-to-head meta-analyses using a random-effect model were used to analyze the data and results are reported as relative risk with their 95% confidence intervals.
RESULTS
Five studies were included (1463 women). There was no difference in the maternal, pregnancy or labor characteristics between the two groups. An ultrasound assessment prior to instrumental vaginal delivery did not affect the cesarean section rate compared with standard care (p = 0.805). Likewise, the risk of composite adverse maternal outcome (p = 0.428), perineal lacerations (p = 0.800), postpartum hemorrhage (p = 0.303), shoulder dystocia (p = 0.862) and prolonged stay in hospital (p = 0.059) were not different between the two groups. Composite adverse neonatal outcome was not different between the women undergoing and those not undergoing ultrasound assessment prior to instrumental delivery (p = 0.400). Likewise, there was no increased risk with abnormal Apgar score (p = 0.882), umbilical artery pH < 7.2 (p = 0.713), base excess greater than -12 (p = 0.742), admission to NICU (p = 0.879) or birth trauma (p = 0.968). The risk of having an incorrect diagnosis of fetal head position was lower when ultrasound was performed before instrumental delivery, with a relative risk of 0.16 (95% confidence interval 0.1-0.3; I :77%, p < 0.001).
CONCLUSIONS
Although ultrasound examination was associated with a lower rate of incorrect diagnoses of fetal head position and station, this did not translate to any improvement of maternal or neonatal outcomes.
Topics: Birth Injuries; Cesarean Section; Extraction, Obstetrical; Female; Humans; Postpartum Hemorrhage; Pregnancy; Pregnancy Outcome; Ultrasonography, Prenatal
PubMed: 34314520
DOI: 10.1111/aogs.14236 -
Frontiers in Medicine 2021Mild gestational diabetes (GDM) refers to the gestational hyperglycemia, which does not fulfill the diagnostic criteria for GDM. The results of studies on adverse...
Mild gestational diabetes (GDM) refers to the gestational hyperglycemia, which does not fulfill the diagnostic criteria for GDM. The results of studies on adverse pregnancy outcomes among women with mild GDM are controversial. Therefore, the aim of this systematic review and meta-analysis was to investigate the impact of mild GDM on the risk of adverse maternal and neonatal outcomes. A thorough literature search was performed to retrieve articles that investigated adverse maternal and neonatal outcomes in women with mild GDM in comparison with non-GDM counterparts. All populations were classified to three groups based on their diagnostic criteria for mild GDM. Heterogeneous and non-heterogeneous results were analyzed using the fixed/random effects models. Publication bias was assessed using the Harbord test. DerSimonian and Laird, and inverse variance methods were used to calculate the pooled relative risk of events. Subgroup analysis was performed based on mild GDM diagnostic criteria. Quality and risk of bias assessment were performed using standard questionnaires. Seventeen studies involving 11,623 pregnant women with mild GDM and 53,057 non-GDM counterparts contributed to the meta-analysis. For adverse maternal outcomes, the results of meta-analysis showed that the women with mild GDM had a significantly higher risk of cesarean section (pooled RR: 1.3, 95% CI 1.2-1.5), pregnancy-induced hypertension (pooled RR: 1.4, 95% CI 1.1-1.7), preeclampsia (pooled RR: 1.3, 95% CI 1.1-1.5) and shoulder dystocia (pooled RR: 2.7, 95% CI 1.5-5.1) in comparison with the non-GDM population. For adverse neonatal outcomes, the pooled relative risk of macrosomia (pooled RR = 0.4, 95% CI: 1.1-1.7), large for gestational age (pooled RR = 1.7, 95% CI: 1.3-2.3), hypoglycemia (pooled RR = 1.6, 95% CI: 1.1-2.3), hyperbilirubinemia (pooled RR = 1.1, 95% CI: 1-1.3), 5 min Apgar <7 (pooled RR = 1.6, 95% CI: 1.1-2.4), admission to the neonatal intensive care unit (pooled RR = 1.5, 95% CI: 1.1-2.1), respiratory distress syndrome (pooled RR = 3.2, 95% CI: 1.8-5.5), and preterm birth (pooled RR = 1.4, 95% CI: 1.1-1.7) was significantly increased in the mild GDM women as compared with the non-GDM population. However, the adverse events of small for gestational age and neonatal death were not significantly different between the groups. Analysis of composite maternal and neonatal outcomes revealed that the risk of those adverse outcomes in the women with mild GDM in all classifications were significantly higher than the non-GDM population. Also, the meta-regression showed that the magnitude of those increased risks in both composite maternal and neonatal outcomes was similar. The risks of sever adverse neonatal outcomes including small for gestational age and neonatal mortality are not increased with mild GDM. However, the increased risks of most adverse maternal and neonatal outcomes are observed. The risks have similar magnitudes for all mild GDM diagnostic classifications.
PubMed: 34291067
DOI: 10.3389/fmed.2021.699412 -
BJOG : An International Journal of... Oct 2021To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with...
OBJECTIVE
To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM).
DESIGN
A consensus developmental study.
SETTING
International.
POPULATION
Two hundred and five stakeholders completed the first round.
METHODS
The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three-round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS.
MAIN OUTCOME MEASURES
All outcomes were extracted from the literature.
RESULTS
We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester-specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy-induced hypertension, pre-eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death.
CONCLUSIONS
This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM.
TWEETABLE ABSTRACT
165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy.
Topics: Consensus; Delphi Technique; Diabetes, Gestational; Female; Humans; International Cooperation; Outcome Assessment, Health Care; Pregnancy; Prenatal Care; Randomized Controlled Trials as Topic; Stakeholder Participation; Treatment Outcome
PubMed: 34218508
DOI: 10.1111/1471-0528.16825 -
International Journal of Environmental... May 2021Objective-to overview, compare and generalize results of randomized clinical trials analyzing different oxytocin doses to prevent postpartum hemorrhage, initiate and... (Review)
Review
Objective-to overview, compare and generalize results of randomized clinical trials analyzing different oxytocin doses to prevent postpartum hemorrhage, initiate and maintain uterine contraction after Caesarean delivery. Methods-'PubMed', 'EMBASE', 'CENTRAL', and 'CINAHL' electronic databases were searched for clinical trials analyzing the effectiveness of different dose of oxytocin given intravenously during surgery for uterine contraction and to reduce postpartum hemorrhage. A systematic review of relevant literature sources was performed. Results-our search revealed 813 literature sources. A total of 15 randomized clinical trials, comparing different doses of oxytocin bolus and infusion used after caesarean delivery have met the selection criteria. Conclusion-oxytocin bolus 0.5-3 UI is considered an effective prophylactic dose. Recommended effective prophylactic oxytocin infusion dose is 7.72 IU/h, but it is unanswered whether we really need a prophylactic infusion of oxytocin if we choose effective bolus dose size and rate. Adverse hemodynamic effects were observed when a 5 UI oxytocin bolus was used. However, topics such as bolus dose size, infusion dose size and requirement as well as bolus injection rate, still remain unanswered. The doses that are recommended in the guidelines of peripartum hemorrhage prophylaxis are not confirmed by randomized controlled double-blind trials and more research should cover this topic.
Topics: Cesarean Section; Female; Humans; Oxytocics; Oxytocin; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic; Uterine Inertia
PubMed: 34068723
DOI: 10.3390/ijerph18095029 -
Frontiers in Endocrinology 2021It is uncertain whether the treatment of mild gestational diabetes mellitus (GDM) improves pregnancy outcomes. The aim of this systemic review and meta-analysis was to... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
It is uncertain whether the treatment of mild gestational diabetes mellitus (GDM) improves pregnancy outcomes. The aim of this systemic review and meta-analysis was to investigate the effect of mild GDM treatment on adverse pregnancy outcomes.
METHODS
A comprehensive literature search was conducted on the databases of PubMed, Scopus, and Google Scholar to retrieve studies that compared interventions for the treatment of mild GDM with usual antenatal care. The fixed/random effects models were used for the analysis of heterogeneous and non-heterogeneous results. Publication bias was assessed using the Harbord test. Also, the DerSimonian and Laird, and inverse variance methods were used to calculate the pooled odds ratio of events. The quality assessment of the included studies was performed using the Modified Newcastle-Ottawa Quality Assessment scale and the CONSORT checklist. In addition, the risk of bias was evaluated using the Cochrane Collaboration's tool for assessing risk of bias.
RESULTS
The systematic review and meta-analysis involved ten studies consisting of 3317 pregnant women who received treatment for mild GDM and 4407 untreated counterparts. Accordingly, the treatment of mild GDM significantly reduced the risk of macrosomia (OR = 0.3; 95%CI = 0.3-0.4), large for gestational age (OR = 0.4; 95%CI = 0.3-0.5), shoulder dystocia (OR = 0.3; 95%CI = 0.2-0.6), caesarean-section (OR = 0.8; 95%CI = 0.7-0.9), preeclampsia (OR = 0.4; 95%CI = 0.3-0.6), elevated cord C-peptide (OR = 0.7; 95%CI = 0.6-0.9), and respiratory distress syndrome (OR = 0.7; 95%CI = 0.5-0.9) compared to untreated counterparts. Moreover, the risk of induced labor significantly increased in the treated group compared to the untreated group (OR = 1.3; 95%CI = 1.0-1.6). However, no statistically significant difference was observed between the groups in terms of small for gestational age, hypoglycemia, hyperbilirubinemia, birth trauma, admission to the neonatal intensive care unit, and preterm birth. Sensitivity analysis based on the exclusion of secondary analysis data was all highly consistent with the main data analysis.
CONCLUSION
Treatment of mild GDM reduced the risk of selected important maternal outcomes including preeclampsia, macrosomia, large for gestational age, cesarean section, and shoulder dystocia without increasing the risk of small for gestational age. Nevertheless, the treatment could not reduce the risk of neonatal metabolic abnormalities or several complications in newborn.
Topics: Diabetes, Gestational; Female; Fetal Macrosomia; Humans; Infant, Newborn; Infant, Newborn, Diseases; Infant, Small for Gestational Age; Male; Metabolic Diseases; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Premature Birth; Risk
PubMed: 33841332
DOI: 10.3389/fendo.2021.640004 -
Obstetrics and Gynecology Jun 2021To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient compared with the inpatient setting, or different methods of ripening... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To assess the comparative effectiveness and potential harms of cervical ripening in the outpatient compared with the inpatient setting, or different methods of ripening in the outpatient setting alone.
DATA SOURCES
Searches for articles in English included MEDLINE, EMBASE, CINAHL, Cochrane Library, ClinicalTrials.gov, and reference lists (up to August 2020).
METHODS OF STUDY SELECTION
Using predefined criteria and DistillerSR software, 10,853 citations were dual-reviewed for randomized controlled trials (RCTs) and cohort studies of outpatient cervical ripening using prostaglandins and mechanical methods in pregnant women at or beyond 37 weeks of gestation.
TABULATION, INTEGRATION, AND RESULTS
Using prespecified criteria, study data abstraction and risk of bias assessment were conducted by two reviewers, random-effects meta-analyses were conducted and strength of evidence was assessed. We included 30 RCTs and 10 cohort studies (N=9,618) most generalizable to women aged 25-30 years with low-risk pregnancies. All findings were low or insufficient strength of evidence and not statistically significant. Incidence of cesarean delivery was not different for any comparison of inpatient and outpatient settings, or comparisons of different methods in the outpatient setting (most evidence available for single-balloon catheters and dinoprostone). Harms were inconsistently reported or inadequately defined. Differences were not found for neonatal infection (eg, sepsis) with outpatient compared with inpatient dinoprostone, birth trauma (eg, cephalohematoma) with outpatient compared with inpatient single-balloon catheter, shoulder dystocia with outpatient dinoprostone compared with placebo, maternal infection (eg, chorioamnionitis) with outpatient compared with inpatient single-balloon catheters or outpatient prostaglandins compared with placebo, and postpartum hemorrhage with outpatient catheter compared with inpatient dinoprostone. Evidence on misoprostol, hygroscopic dilators, and other outcomes (eg, perinatal mortality and time to vaginal birth) was insufficient.
CONCLUSION
In women with low-risk pregnancies, outpatient cervical ripening with dinoprostone or single-balloon catheters did not increase cesarean deliveries. Although there were no clear differences in harms when comparing outpatient with inpatient cervical ripening, the certainty of evidence is low or insufficient to draw definitive conclusions.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42020167406.
Topics: Ambulatory Care; Catheters; Cervical Ripening; Cesarean Section; Dilatation; Dinoprostone; Female; Hospitalization; Humans; Labor, Induced; Obstetric Labor Complications; Oxytocics; Pregnancy
PubMed: 33752219
DOI: 10.1097/AOG.0000000000004382 -
Reproductive Health Mar 2021Obstructed labor is a preventable obstetric complication. However, it is an important cause of maternal mortality and morbidity and of adverse outcomes for newborns in... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Obstructed labor is a preventable obstetric complication. However, it is an important cause of maternal mortality and morbidity and of adverse outcomes for newborns in resource-limited countries in which undernutrition is common resulting in a small pelvis in which there is no easy access to functioning health facilities with a capacity to carry out operative deliveries. Therefore, this systematic review and meta-analysis aimed to estimate the incidence, causes, and maternofetal outcomes of obstructed labor among mothers who gave birth in Ethiopia.
METHOD
for this review, we used the standard PRISMA checklist guideline. Different online databases were used for the review: PubMed, Google Scholar, EMBASE, Cochrane Library, HINARI, AFRO Library Databases, and African Online Journals. Based on the adapted PICO principles, different search terms were applied to achieve and access the essential articles. The search included all published and unpublished observational studies written only in the English language and conducted in Ethiopia. Microsoft Excel 16 was used for data entrance, and Stata version 11.0 (Stata Corporation, College Station, Texas, USA) was used for data analysis.
RESULTS
I included sixteen (16) primary studies with twenty-eight thousand five hundred ninety-one (28,591) mothers who gave birth in Ethiopia. The pooled incidence of obstructed labor in Ethiopia was 12.93% (95% CI: 10.44-15.42, I = 98.0%, p < 0.001). Out of these, 67.3% (95% CI: 33.32-101.28) did not have antenatal care follow-up, 77.86% (95% CI: 63.07-92.66) were from the rural area, and 58.52% (95% CI: 35.73- 82.31) were referred from health centers and visited hospitals after 12 h of labor. The major causes of obstructed labor were cephalo-pelvic disproportion 64.65% (95% CI: 57.15- 72.14), and malpresentation and malposition in 27.24% (95% CI: 22.05-32.42) of the cases. The commonest complications were sepsis in 38.59% (95% CI: 25.49-51.68), stillbirth in 38.08% (95% CI: 29.55-46.61), postpartum hemorrhage in 33.54% (95% CI:12.06- 55.02), uterine rupture in 29.84% (95% CI: 21.09-38.58), and maternal death in 17.27% (95% CI: 13.47-48.02) of mothers who gave birth in Ethiopia.
CONCLUSION
This systematic review and meta-analysis showed that the incidence of obstructed labor was high in Ethiopia. Not having antenatal care follow-up, rural residency, and visiting hospitals after 12 h of labor increased the incidence of obstructed labor. The major causes of obstructed labor were cephalo-pelvic disproportion, and malpresentation and malpresentation. Additionally, the commonest complications were sepsis, stillbirth, postpartum hemorrhage, uterine rupture, and maternal death. Thus, promoting antenatal care service utilization, a good referral system, and availing comprehensive obstetric care in nearby health institutions are recommended to prevent the incidence of obstructed labor and its complications.
Topics: Cephalopelvic Disproportion; Dystocia; Ethiopia; Female; Humans; Incidence; Infant, Newborn; Maternal Mortality; Obstetric Labor Complications; Pregnancy; Pregnancy Outcome; Prenatal Care; Sepsis; Uterine Rupture
PubMed: 33691736
DOI: 10.1186/s12978-021-01103-0 -
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