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BMC Pregnancy and Childbirth Sep 2023Prelabour rupture of membranes at term affects approximately 10% of women during pregnancy, and it is often associated with a higher risk of infection than when the...
INTRODUCTION
Prelabour rupture of membranes at term affects approximately 10% of women during pregnancy, and it is often associated with a higher risk of infection than when the membranes are intact. In an attempt to control the risk of infection, two main approaches have been used most widely in clinical practice: induction of labour (IOL) soon after the rupture of membranes, also called active management (AM), and watchful waiting for the spontaneous onset of labour, also called expectant management (EM). In addition, previous studies have demonstrated that vaginal examinations increase the risk of chorioamnionitis. However, the effect of vaginal examinations in the context of prelabour rupture of membranes have not been researched to the same extent.
METHODS
This systematic review analyses and critiques the latest research on the management of term prelabour rupture of membranes, including the effect of vaginal examinations during labour, with a focus on the outcomes of both normal birth, and chorioamnionitis. Due to its complexity, three research questions were identified using the PICO diagram, and subsequently, the results from these searches were combined. The systematic review aimed to identify randomised controlled trials (RCTs) and observational studies that compared active vs expectant management, included number of vaginal examinations and had chorioamnionitis and/or normal birth as outcomes. The following databases were used: MEDLINE, EMBASE, Maternity and Infant care, LILACS, CINAHL and the Cochrane Central Register of Controlled trials. Quality was assessed using a tool developed especifically for this study that included questions from CASP and the Cochrane risk of bias tool. Due to the high degree of heterogeneity meta-analysis was not deemed appropriate. Therefore, simple narrative analysis was carried out.
RESULTS
Thirty-two studies met the inclusion criteria, of which 27 were RCTs and 5 observational studies. The overall quality of the studies wasn't high, 15 out of the 32 studies were deemed to be low quality and only 17 out of 32 studies were deemed to be of intermediate quality. The systematic review revealed that the management of term prelabour rupture of membranes continues to be controversial. Previous research has compared active management (Induction of labour shortly after the rupture of membrane) against expectant management (watchful waiting for the spontaneous onset of labour). Although previous studies have demonstrated that vaginal examinations increase the risk of chorioamnionitis, no prospective studies have included an intervention to reduce the number of vaginal examinations.
CONCLUSION
A RCT assessing the consequences of active management and expectant management as well as the effect of vaginal examinations during labour for term prelabour rupture of membranes is necessary.
Topics: Female; Pregnancy; Infant; Child; Humans; Chorioamnionitis; Delivery, Obstetric; Labor, Obstetric; Databases, Factual; Infant Care
PubMed: 37684576
DOI: 10.1186/s12884-023-05878-x -
The Cochrane Database of Systematic... Dec 2015Glaucoma is an optic neuropathy that leads to vision loss and blindness. It is the second most common cause of irreversible blindness worldwide. The main treatment for... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Glaucoma is an optic neuropathy that leads to vision loss and blindness. It is the second most common cause of irreversible blindness worldwide. The main treatment for glaucoma aims to reduce intraocular pressure (IOP) in order to slow or prevent further vision loss. IOP can be lowered with medications, and laser or incisional surgeries. Trabeculectomy is the most common incisional surgical procedure to treat glaucoma. Device-modified trabeculectomy is intended to improve drainage of the aqueous humor to lower IOP. Trabeculectomy-modifying devices include Ex-PRESS, Ologen, amniotic membrane, expanded polytetrafluoroethylene (E-PTFE) membrane, Gelfilm and others. However, the effectiveness and safety of these devices are uncertain.
OBJECTIVES
To assess the relative effectiveness, primarily with respect to IOP control and safety, of the use of different devices as adjuncts to trabeculectomy compared with standard trabeculectomy in eyes with glaucoma.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2014, Issue 12), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to December 2014), EMBASE (January 1980 to December 2014), PubMed (1948 to December 2014), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to December 2014), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com), ClinicalTrials.gov (www.clinicaltrials.gov), and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 22 December 2014.
SELECTION CRITERIA
We included randomized controlled trials comparing devices used during trabeculectomy with trabeculectomy alone. We also included studies where antimetabolites were used in either or both treatment groups.
DATA COLLECTION AND ANALYSIS
We used standard procedures expected by Cochrane.
MAIN RESULTS
We found 33 studies that met our inclusion criteria, of which 30 were published as full-length journal articles and three as conference abstracts. Only five studies have been registered. The 33 studies included a total of 1542 participants with glaucoma, and compared five types of devices implanted during trabeculectomy versus trabeculectomy alone. Five studies reported the use of Ex-PRESS (386 participants), eight studies reported the use of Ologen (327 participants), 18 studies reported the use of amniotic membrane (726 participants), one study reported the use of E-PTFE (60 participants), and one study reported the use of Gelfilm (43 participants). These studies were conducted in North America, South America, Europe, Asia, and the Middle East. Planned participant follow-up periods ranged from three months to five years. The studies were reported poorly which limited our ability to judge risk of bias for many domains. Only two studies explicitly masked outcome assessment so, we rated 31 studies at high risk of detection bias.Low-quality evidence from three studies showed that use of Ex-PRESS compared with trabeculectomy alone may be associated with a slightly lower IOP at one year (mean difference (MD) -1.58 mm Hg, 95% confidence interval (CI) -2.74 to -0.42; 165 eyes). Cataract surgery and hyphema may be less frequent in the Ex-PRESS group than in the trabeculectomy-alone group (cataract surgery: risk ratio (RR) 0.32, 95% CI 0.14 to 0.74, 3 studies, low-quality evidence; hyphema: RR 0.33, 95% CI 0.12 to 0.94, 4 studies, low-quality evidence). The effect of whether Ex-PRESS prevents hypotony was uncertain (RR 0.92, 95% CI 0.63 to 1.33, 2 studies, very low-quality evidence). All these studies received funding from the device manufacturer.Very low-quality evidence from five studies suggests that use of Ologen compared with trabeculectomy alone is associated with slightly higher IOP at one year (MD 1.40 mm Hg, 95% CI -0.57 to 3.38; 177 eyes). The effect of Ologen on preventing hypotony was uncertain (RR 0.75, 95% CI 0.47 to 1.19, 5 studies, very low-quality evidence). Differences between the two treatment groups for other reported complications also were inconclusive.Low-quality evidence from nine studies suggests that use of amniotic membrane with trabeculectomy may be associated with lower IOP at one year compared with trabeculectomy alone (MD -3.92 mm Hg, 95% CI -5.41 to -2.42; 356 eyes). Low-quality evidence showed that use of amniotic membrane may prevent adverse events and complications, such as hypotony (RR 0.40, 95% CI 0.17 to 0.94, 5 studies, low-quality evidence).The report from the only E-PTFE study (60 eyes) showed no important differences for postoperative IOP at one year (MD -0.44 mm Hg, 95% CI -1.76 to 0.88) between the trabeculectomy + E-PTFE versus the trabeculectomy-alone groups. Hypotony was the only postoperative complication observed less frequently in the E-PTFE group compared to the trabeculectomy-alone group (RR 0.29, 95% CI 0.11 to 0.77).The one Gelfilm study reported uncertainty in the difference in IOP and complication rates between the two groups at one year; no further data were provided in the study report.
AUTHORS' CONCLUSIONS
Overall, the use of devices with standard trabeculectomy may help with greater IOP reduction at one-year follow-up than trabeculectomy alone; however, due to potential biases and imprecision in effect estimates, the quality of evidence is low. When we examined outcomes within subgroups based on the type of device used, our findings suggested that the use of an Ex-PRESS device or an amniotic membrane as an adjunct to trabeculectomy may be slightly more effective in reducing IOP at one year after surgery compared with trabeculectomy alone. The evidence that these devices are as safe as trabeculectomy alone is unclear. Due to various limitations in the design and conduct of the included studies, the applicability of this evidence synthesis to other populations or settings is uncertain. Further research is needed to determine the effectiveness and safety of other devices and in subgroup populations, such as people with different types of glaucoma, of various races and ethnicity, and with different lens types (e.g. phakic, pseudophakic).
Topics: Amnion; Biocompatible Materials; Collagen; Gelatin; Glaucoma; Glaucoma Drainage Implants; Glycosaminoglycans; Humans; Intraocular Pressure; Polytetrafluoroethylene; Randomized Controlled Trials as Topic; Trabeculectomy; Visual Acuity
PubMed: 26625212
DOI: 10.1002/14651858.CD010472.pub2 -
BMC Medical Genomics Jun 2015Preterm birth (PTB), or birth before 37 weeks of gestation, is the leading cause of newborn death worldwide. PTB is a critical area of scientific study not only due to... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Preterm birth (PTB), or birth before 37 weeks of gestation, is the leading cause of newborn death worldwide. PTB is a critical area of scientific study not only due to its worldwide toll on human lives and economies, but also due to our limited understanding of its pathogenesis and, therefore, its prevention. This systematic review and meta-analysis synthesizes the landscape of PTB transcriptomics research to further our understanding of the genes and pathways involved in PTB subtypes.
METHODS
We evaluated published genome-wide pregnancy studies across gestational tissues and pathologies, including those that focus on PTB, by performing a targeted PubMed MeSH search and systematically reviewing all relevant studies.
RESULTS
Our search yielded 2,361 studies on gestational tissues including placenta, decidua, myometrium, maternal blood, cervix, fetal membranes (chorion and amnion), umbilical cord, fetal blood, and basal plate. Selecting only those original research studies that measured transcription on a genome-wide scale and reported lists of expressed genetic elements identified 93 gene expression, 21 microRNA, and 20 methylation studies. Although 30 % of all PTB cases are due to medical indications, 76 % of the preterm studies focused on them. In contrast, only 18 % of the preterm studies focused on spontaneous onset of labor, which is responsible for 45 % of all PTB cases. Furthermore, only 23 of the 10,993 unique genetic elements reported to be transcriptionally active were recovered 10 or more times in these 134 studies. Meta-analysis of the 93 gene expression studies across 9 distinct gestational tissues and 29 clinical phenotypes showed limited overlap of genes identified as differentially expressed across studies.
CONCLUSIONS
Overall, profiles of differentially expressed genes were highly heterogeneous both between as well as within clinical subtypes and tissues as well as between studies of the same clinical subtype and tissue. These results suggest that large gaps still exist in the transcriptomic study of specific clinical subtypes as well in the generation of the transcriptional profile of well-studied clinical subtypes; understanding the complex landscape of prematurity will require large-scale, systematic genome-wide analyses of human gestational tissues on both understudied and well-studied subtypes alike.
Topics: DNA Methylation; Female; Gene Expression Profiling; Gene Expression Regulation, Developmental; Genome-Wide Association Study; Humans; Phenotype; Placenta; Pregnancy; Premature Birth; Risk Factors; Term Birth; Transcriptome
PubMed: 26044726
DOI: 10.1186/s12920-015-0099-8 -
Ultrasound in Obstetrics & Gynecology :... Jun 2023It is debated whether fetal endoscopic tracheal occlusion (FETO) is beneficial to fetuses with congenital diaphragmatic hernia (CDH) and whether FETO has different... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
It is debated whether fetal endoscopic tracheal occlusion (FETO) is beneficial to fetuses with congenital diaphragmatic hernia (CDH) and whether FETO has different effects in moderate and severe CDH. We conducted a systematic review and meta-analysis including the latest evidence to assess the overall effects of FETO on clinical outcomes of CDH.
METHODS
We searched PubMed, EMBASE, The Cochrane Library, China National Knowledge Infrastructure, China Science and Technology Journal Database and Wanfang Database to retrieve eligible studies published before 8 September 2022. No language or study design restrictions were applied. Studies were included if CDH fetuses underwent FETO surgery and were compared with a cohort that underwent expectant management, with at least one outcome reported. The primary outcomes were mortality at 1, 6 and 12 months after birth, rates of pulmonary hypertension, use of extracorporeal membrane oxygenation (ECMO) and prematurity. Meta-analysis was conducted to obtain pooled odds ratios (ORs) and mean differences. The quality of included studies and pooled evidence was also assessed.
RESULTS
A total of 1187 CDH fetuses from 20 studies were included in the quantitative synthesis. FETO significantly reduced 1-month (OR, 0.56 (95% CI, 0.34-0.93); P = 0.02, number needed to treat (NNT) = 7.67) and 6-month (OR, 0.34 (95% CI, 0.18-0.65); P = 0.0009, NNT = 5.26) CDH mortality (moderate/low quality of evidence). Subgroup analysis suggested that the effects of FETO on the rates of pulmonary hypertension and ECMO usage were significant in severe CDH (low/moderate quality of evidence) but not in moderate CDH (low/very low quality of evidence). FETO was also associated with an increased risk of preterm prelabor rupture of membranes before 37 weeks' gestation (OR, 4.94 (95% CI, 2.25-10.88); P < 0.0001, number needed to harm (NNH) = 3.13) and preterm birth before 37 weeks (OR, 5.24 (95% CI, 3.33-8.23); P < 0.00001, NNH = 2.79) (high/moderate quality of evidence). However, FETO was not associated with severe complications, such as preterm birth before 32 weeks, placental abruption or chorioamnionitis (very low/low quality of evidence).
CONCLUSIONS
FETO is associated with a reduction in mortality, rate of pulmonary hypertension and ECMO usage in severe CDH, while it reduces only the risk of mortality in moderate CDH. Although FETO increases the risk of late prematurity, it does not result in extreme prematurity. © 2023 International Society of Ultrasound in Obstetrics and Gynecology.
Topics: Infant, Newborn; Female; Humans; Pregnancy; Hernias, Diaphragmatic, Congenital; Fetoscopy; Hypertension, Pulmonary; Premature Birth; Placenta; Fetus; Trachea
PubMed: 36704940
DOI: 10.1002/uog.26164 -
The Cochrane Database of Systematic... Feb 2016A pterygium is a fleshy, wing-shaped growth from the conjunctiva, crossing over the limbus onto the cornea. Prevalence ranges widely around the world. Evidence suggests... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
A pterygium is a fleshy, wing-shaped growth from the conjunctiva, crossing over the limbus onto the cornea. Prevalence ranges widely around the world. Evidence suggests that ultraviolet light is a major contributor in the formation of pterygia. Pterygia impair vision, limit eye movements, and can cause eye irritation, foreign body sensation, and dryness. In some susceptible patients, the pterygium can grow over the entire corneal surface, blocking the visual axis.Surgery is the only effective treatment for pterygium, though recurrences are common. With simple excision techniques (that is, excising the pterygium and leaving bare sclera), the risk of recurrence has been reported to be upwards of 80%. Pterygium excision combined with a tissue graft has a lower risk of recurrence. In conjunctival autograft surgery, conjunctival tissue from another part of the person's eye along with limbal tissue is resected in one piece and used to cover the area from which the pterygium was excised. Another type of tissue graft surgery for pterygium is amniotic membrane graft, whereby a piece of donor amniotic membrane is fixed to the remaining limbus and bare sclera area after the pterygium has been excised.
OBJECTIVES
The objective of this review was to assess the safety and effectiveness of conjunctival autograft (with or without adjunctive therapy) compared with amniotic membrane graft (with or without adjunctive therapy) for pterygium. We also planned to determine whether use of MMC yielded better surgical results and to assess the direct and indirect comparative costs of these procedures.
SEARCH METHODS
We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (Issue 10, 2015), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to November 2015), EMBASE (January 1980 to November 2015), PubMed (1948 to November 2015), Latin American and Caribbean Health Sciences Literature Database (LILACS) (1982 to November 2015), the metaRegister of Controlled Trials (mRCT) (www.controlled-trials.com) (last searched 21 November 2014), ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en). We did not use any date or language restrictions in the electronic search for trials. We last searched the electronic databases on 23 November 2015.
SELECTION CRITERIA
We included in this review randomized controlled trials that had compared conjunctival autograft surgery (with or without adjunctive therapy) with amniotic membrane graft surgery (with or without adjunctive therapy) in people with primary or recurrent pterygium.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened search results and assessed full-text reports from among the potentially eligible trials. Two review authors independently extracted data from the included trials and assessed the trial characteristics and risk of bias. The primary outcome was the risk of recurrence of pterygium at 3 months and 6 months after surgery. We combined results from individual studies in meta-analyses using random-effects models. Risk of recurrence of pterygium was reported using risk ratios to compare conjunctival autograft with amniotic membrane transplant.
MAIN RESULTS
We identified 20 studies that had analyzed a total of 1947 eyes of 1866 participants (individual studies ranged from 8 to 346 participants who were randomized). The studies were conducted in eight different countries: one in Brazil, three in China, three in Cuba, one in Egypt, two in Iran, two in Thailand, seven in Turkey, and one in Venezuela. Overall risk of bias was unclear, as many studies did not provide information on randomization methods or masking to prevent performance and detection bias.The risk ratio for recurrence of pterygium using conjunctival autograft versus amniotic membrane transplant was 0.87 (95% confidence interval (CI) 0.43 to 1.77) and 0.53 (95% CI 0.33 to 0.85) at 3 months and 6 months, respectively. These estimates include participants with primary and recurrent pterygia. We performed a subgroup analysis to compare participants with primary pterygia with participants with recurrent pterygia. For participants with primary pterygia, the risk ratio was 0.92 (95% CI 0.37 to 2.30) and 0.58 (95% CI 0.27 to 1.27) at 3 months and 6 months, respectively. We were only able to estimate the recurrence of pterygia at 6 months for participants with recurrent pterygia, and the risk ratio comparing conjunctival autograft with amniotic membrane transplant was 0.45 (95% CI 0.21 to 0.99). One included study was a doctoral thesis and did not use allocation concealment. When this study was excluded in a sensitivity analysis, the risk ratio for pterygium recurrence at 6 months' follow-up was 0.43 (95% CI 0.30 to 0.62) for participants with primary and recurrent pterygium. One of the secondary outcomes, the proportion of participants with clinical improvement, was analyzed in only one study. This study reported clinical outcome as the risk of non-recurrence, which was seen in 93.8% of participants in the conjunctival limbal autograft group and 93.3% in the amniotic membrane transplant group at 3 months after surgery.We did not analyze data on the need for repeat surgery, vision-related quality of life, and direct and indirect costs of surgery due to an insufficient number of studies reporting these outcomes.Thirteen studies reported adverse events associated with conjunctival autograft surgery and amniotic membrane transplant surgery. Adverse events that occurred in more than one study were granuloma and pyogenic granuloma and increased intraocular pressure. None of the included studies reported that participants had developed induced astigmatism.
AUTHORS' CONCLUSIONS
In association with pterygium excision, conjunctival autograft is associated with a lower risk of recurrence at six months' after surgery than amniotic membrane transplant. Participants with recurrent pterygia in particular have a lower risk of recurrence when they receive conjunctival autograft surgery compared with amniotic membrane transplant. There are few studies comparing the two techniques with respect to visual acuity outcomes, and we identified no studies that reported on vision-related quality of life or direct or indirect costs. Comparison of these two procedures in such outcome measures bears further investigation. There were an insufficient number of studies that used adjunctive mitomycin C to estimate the effects on pterygium recurrence following conjunctival autograft or amniotic membrane transplant.
Topics: Amnion; Autografts; Conjunctiva; Humans; Pterygium; Randomized Controlled Trials as Topic; Recurrence; Time Factors
PubMed: 26867004
DOI: 10.1002/14651858.CD011349.pub2 -
PLoS Medicine Aug 2023The optimal approach to prevent preterm birth (PTB) in twins has not been fully established yet. Recent evidence suggests that placement of cervical cerclage in twin... (Meta-Analysis)
Meta-Analysis
Cervical cerclage for prevention of preterm birth and adverse perinatal outcome in twin pregnancies with short cervical length or cervical dilatation: A systematic review and meta-analysis.
BACKGROUND
The optimal approach to prevent preterm birth (PTB) in twins has not been fully established yet. Recent evidence suggests that placement of cervical cerclage in twin pregnancies with short cervical length at ultrasound or cervical dilatation at physical examination might be associated with a reduced risk of PTB. However, such evidence is based mainly on small studies thus questioning the robustness of these findings. The aim of this systematic review was to determine the role of cervical cerclage in preventing PTB and adverse maternal or perinatal outcomes in twin pregnancies.
METHODS AND FINDINGS
Key databases searched and date of last search: MEDLINE, Embase, and CINAHL were searched electronically on 20 April 2023. Eligibility criteria: Inclusion criteria were observational studies assessing the risk of PTB among twin pregnancies undergoing cerclage versus no cerclage and randomized trials in which twin pregnancies were allocated to cerclage for the prevention of PTB or to a control group (e.g., placebo or treatment as usual). The primary outcome was PTB <34 weeks of gestation. The secondary outcomes were PTB <37, 32, 28, 24 weeks of gestation, gestational age at birth, the interval between diagnosis and birth, preterm prelabor rupture of the membranes (pPROM), chorioamnionitis, perinatal loss, and perinatal morbidity. Subgroup analyses according to the indication for cerclage (short cervical length or cervical dilatation) were also performed. Risk of bias assessment: The risk of bias of the included randomized controlled trials (RCTs) was assessed using the Revised Cochrane risk-of-bias tool for randomized trials, while that of the observational studies using the Newcastle-Ottawa scale (NOS). Statistical analysis: Summary risk ratios (RRs) of the likelihood of detecting each categorical outcome in exposed versus unexposed women, and (b) summary mean differences (MDs) between exposed and unexposed women (for each continuous outcome), with their 95% confidence intervals (CIs) were computed using head-to-head meta-analyses. Synthesis of the results: Eighteen studies (1,465 twin pregnancies) were included. Placement of cervical cerclage in women with a twin pregnancy with a short cervix at ultrasound or cervical dilatation at physical examination was associated with a reduced risk of PTB <34 weeks of gestation (RR: 0.73, 95% CI [0.59, 0.91], p = 0.005 corresponding to a 16% difference in the absolute risk, AR), <32 (RR: 0.69, 95% CI [0.57, 0.84], p < 0.001; AR: 16.92%), <28 (RR: 0.54, 95% [CI 0.43, 0.67], 0.001; AR: 18.29%), and <24 (RR: 0.48, 95% CI [0.23, 0.97], p = 0.04; AR: 15.57%) weeks of gestation and a prolonged gestational age at birth (MD: 2.32 weeks, 95% [CI 0.99, 3.66], p < 0.001). Cerclage in twin pregnancy with short cervical length or cervical dilatation was also associated with a reduced risk of perinatal loss (RR: 0.38, 95% CI [0.25, 0.60], p < 0.001; AR: 19.62%) and composite adverse outcome (RR: 0.69, 95% CI [0.53, 0.90], p = 0.007; AR: 11.75%). Cervical cerclage was associated with a reduced risk of PTB <34 weeks both in women with cervical length <15 mm (RR: 0.74, 95% CI [0.58, 0.95], p = 0.02; AR: 29.17%) and in those with cervical dilatation (RR: 0.68, 95% CI [0.57, 0.80], p < 0.001; AR: 35.02%). The association between cerclage and prevention of PTB and adverse perinatal outcomes was exclusively due to the inclusion of observational studies. The quality of retrieved evidence at GRADE assessment was low.
CONCLUSIONS
Emergency cerclage for cervical dilation or short cervical length <15 mm may be potentially associated with a reduction in PTB and improved perinatal outcomes. However, these findings are mainly based upon observational studies and require confirmation in large and adequately powered RCTs.
Topics: Female; Humans; Infant, Newborn; Pregnancy; Cerclage, Cervical; Cervix Uteri; Labor Stage, First; Pregnancy, Twin; Premature Birth
PubMed: 37535682
DOI: 10.1371/journal.pmed.1004266 -
Microorganisms Jul 2023We conducted a systematic review and meta-analysis to evaluate the association between gestational diabetes mellitus and infections during pregnancy. We included... (Review)
Review
We conducted a systematic review and meta-analysis to evaluate the association between gestational diabetes mellitus and infections during pregnancy. We included cross-sectional, case-control, cohort studies and clinical trials, evaluating the frequency of infections in women with and without gestational diabetes mellitus. A search was conducted in Embase, PubMed, and Web of Science electronic databases and by manually searching references, until 23 March 2022, resulting in 16 studies being selected for review, with 111,649 women in the gestational diabetes mellitus group, and 1,429,659 in the controls. Cochrane's Q test of heterogeneity and I² were used to assess heterogeneity. Pooled odds ratio (OR) was calculated. Funnel plots and Egger test were used for assessment of publication bias. The results showed a significant association between gestational diabetes mellitus and infections (pooled-OR 1.3 95% CI [1.2-1.5]). Sub-analyses showed a significant association for urinary tract infections (pooled-OR of 1.2 95% CI [1.1-1.3]), bacterial infections (pooled-OR were 1.2 95% CI [1.1-1.4]), and SARS-CoV-2 (pooled-OR 1.5 95% CI [1.2-2.0]) but not to gingivitis or vaginal candidiasis. The results underscore the significance of acknowledging gestational diabetes mellitus as a risk factor for infections.
PubMed: 37630515
DOI: 10.3390/microorganisms11081956 -
Journal of Tissue Engineering and... Dec 2022Amniotic membrane (AM) has great potential as a scaffold for tissue regeneration in reconstructive surgery. To date, no systematic review of the literature has been... (Meta-Analysis)
Meta-Analysis Review
Amniotic membrane (AM) has great potential as a scaffold for tissue regeneration in reconstructive surgery. To date, no systematic review of the literature has been performed for the applications of AM in wound closure of internal organs. Therefore, in this systematic review and meta-analysis, we summarize the literature on the safety and efficacy of AM for the closure of internal organs. A systematic search was performed in MEDLINE-PubMed database and OVID Embase to retrieve human and controlled animal studies on wound closure of internal organs. The Cochrane Risk of Bias tool for randomized clinical trials and the SYRCLE risk of bias tool for animal studies were used. Meta-analyses (MAs) were conducted for controlled animal studies to assess efficacy of closure, mortality and complications in subjects who underwent surgical wound closure in internal organs with the application of AM. Sixty references containing 26 human experiments and 36 animal experiments were included. The MAs of the controlled animal studies showed comparable results with regard to closure, mortality and complications, and suggested improved mechanical strength and lower inflammation scores after AM application when compared to standard surgical closure techniques. This systematic review and MAs demonstrate that the application of AM to promote wound healing of internal organs appears to be safe, efficacious, and feasible.
Topics: Humans; Amnion; Wound Healing; Wound Closure Techniques; Plastic Surgery Procedures
PubMed: 36333859
DOI: 10.1002/term.3357 -
The Cochrane Database of Systematic... Sep 2022Ocular surface burns can be caused by chemicals (alkalis and acids) or direct heat. One effect of the burn is damage to the limbal epithelial stem cells of the ocular... (Review)
Review
BACKGROUND
Ocular surface burns can be caused by chemicals (alkalis and acids) or direct heat. One effect of the burn is damage to the limbal epithelial stem cells of the ocular surface with delayed re-epithelialisation, stem cell failure, and conjunctivalisation of the cornea. Amniotic membrane transplantation (AMT) performed in the acute phase (day 0 to day 7) following an ocular surface burn is claimed to reduce pain and accelerate healing. The surgery involves securing a layer of amniotic membrane (AM) to the eyelid margins as a patch to cover the entire ocular surface. However, there is debate about the severity of an ocular burn that may benefit from AMT and uncertainty of whether AMT improves outcomes.
OBJECTIVES
To compare the effect of AMT with medical therapy in the first seven days after an ocular surface burn, compared to medical therapy alone.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL; which contains the Cochrane Eyes and Vision Trials Register; 2021, Issue 9); Ovid MEDLINE; Ovid Embase; LILACS; the ISRCTN registry; ClinicalTrials.gov and the WHO ICTRP. We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 29 September 2021.
SELECTION CRITERIA
We included randomised trials that compared an AMT applied in the first seven days following an ocular surface burn in addition to medical therapy with medical therapy alone. The outcome measures were failure of re-epithelialisation by day 21 post injury, visual acuity at final follow-up, corneal neovascularisation, symblepharon, time to re-epithelialisation and adverse effects.
DATA COLLECTION AND ANALYSIS
Two review authors independently screened search results, assessed the included studies for risk of bias and extracted relevant data. We contacted trial investigators for missing information. We summarised data using risk ratios (RRs) and mean differences (MDs) as appropriate.
MAIN RESULTS
We analysed two RCTs, but excluded individual patients who had been treated outside the acute phase in one of the studies (data provided by study authors). In total, 36 moderate burns from one RCT and 92 severe burns from two RCTs were evaluated separately. For both categories, the certainty of the evidence was downgraded principally as a result of high risks of performance and detection biases, and because of imprecision indicated by very wide confidence intervals. In addition, follow-up was insufficiently frequent to calculate time-to-epithelialisation precisely. Moderate severity ocular burns (Roper-Hall classification II-III) The relative risk of AMT on failure of epithelialisation by day 21 was 0.18 (0.02 to 1.31), and LogMAR visual acuity was 0.32 lower (0.55 to 0.09 lower) in the treatment group (i.e. better), suggesting a possible benefit of AMT. The GRADE assessment for failure of epithelialisation by day 21 was downgraded to very low due to the risk of bias and imprecision (very wide confidence intervals including no effect). The GRADE assessment for visual acuity at final follow-up was downgraded to low due to the risk of bias and imprecision (optimal information size not met). The relative effects of AMT on corneal neovascularisation (RR 0.56; 0.21 to 1.48), symblepharon (RR 0.41; 0.02 to 9.48) and time-to-epithelialisation (13 days lower; 26.30 lower to 0.30 higher) suggest possible benefit of AMT, but the wide confidence intervals indicate that both harm and benefit are possible. GRADE assessments for these outcomes were once again downgraded to very low due to the risk of bias and imprecision. Since adverse effects are rare, the small sample would have fewer occurrences of rare but potentially important adverse effects. The GRADE assessment for adverse effects was therefore considered to be low. Severe ocular burns (Roper-Hall classification IV) The relative risk of AMT on failure of epithelialisation by day 21 was 1.03 (0.94 to 1.12), and LogMAR visual acuity was 0.01 higher (0.29 lower to 0.31 higher) in the treatment group (i.e, worse), indicating no benefit of AMT. GRADE assessments for failure of epithelialisation by day 21 and final outcomes were downgraded to low. The relative effects of AMT on corneal neovascularisation (RR 0.84; 0.66 to 1.06), symblepharon (RR 0.89; 0.56 to 1.42) and time-to-epithelialisation (1.66 days lower; 11.09 lower to 7.77 higher) may include both benefit and harm. GRADE assessments for corneal neovascularisation, symblepharon and time-to-epithelialisation were downgraded to low due to risk of bias and imprecision. For adverse effects, the GRADE assessment was downgraded to low, reflecting the small sample sizes in the RCTs.
AUTHORS' CONCLUSIONS
There is uncertain evidence to support the treatment of moderate acute ocular surface burns with AMT in addition to standard medical therapy as a means of preventing failure of epithelialisation by day 21, improving visual outcome and reducing corneal neovascularisation, symblepharon formation and time-to-epithelialisation. For severe burns, the available evidence does not indicate any significant benefit of treatment with AMT.
Topics: Amnion; Corneal Neovascularization; Eye Burns; Humans; Visual Acuity; Wound Healing
PubMed: 36047788
DOI: 10.1002/14651858.CD009379.pub3 -
Stem Cells Translational Medicine Oct 2023Neonatal cell therapy applications are increasing; however, data on allogeneic cell therapy are limited.
BACKGROUND
Neonatal cell therapy applications are increasing; however, data on allogeneic cell therapy are limited.
OBJECTIVE
To summarize evidence on allogeneic cell therapy in term and preterm neonates.
METHODS
Cochrane Central Register of Controlled Trials, Embase, Ovid Medline, and various registries were searched for studies investigating the safety, feasibility, and efficacy of allogeneic cell therapy in neonates. Two authors independently selected the articles, extracted data, and assessed the risk of bias.
RESULTS
Twelve published (153 infants) and 21 ongoing studies were included. These studies predominantly sourced allogeneic cells from umbilical cord blood (UCB). Mesenchymal stromal cells (MSCs) were the main cell type used (134 of 153 infants); others included UCB-derived total nucleated cells (TNCs) and human amnion epithelial cells (hAECs). Applications included bronchopulmonary dysplasia (BPD; 113 infants), Krabbe disease (13 infants), intraventricular haemorrhage (10 infants), perinatal arterial ischemic stroke (10 infants), hypoxic-ischaemic encephalopathy (6 infants), and necrotizing enterocolitis (1 infant). Nine out of 12 studies did not report any serious adverse events (SAEs) related to cell administration. Three studies reported SAEs, such as graft versus host disease (GVHD) in 5 infants (UCB-derived TNCs for Krabbe disease); and transient cardiorespiratory compromise in 1 infant (hAECs for BPD). Data on efficacy outcomes were limited.
CONCLUSION
The safety and feasibility of allogeneic cell therapy applications in neonates are available, mainly from the use of MSCs. Further safety data for other cell types are required, and the risk of GVHD in different settings needs to be determined. Efficacy studies are largely lacking for all cell types.
PROTOCOL REGISTRATION
The protocol was registered with PROSPERO (registration number CRD42023397876), the international prospective register for systematic reviews (https://www.crd.york.ac.uk/PROSPERO).
PubMed: 37603845
DOI: 10.1093/stcltm/szad048