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Viable extreme preterm birth and some neonatal outcomes in double cerclage versus traditional cerclage: a randomized clinical trial.

ABSTRACT: The pregnant women at higher risk of preterm labor, referred to the perinatal clinic of Kosar University Hospital in Urmia district of Iran, were enrolled into a parallel randomized clinical trial. In the investigational arm of the clinical trial, a double cervical cerclage procedure was performed addition to McDonald cerclage. In the control group however, only McDonald cerclage was performed. Extreme preterm labor (GA < 33 weeks) was the primary endpoint of this clinical trial. Age, gestational age at cerclage time, and gravidity were not found to be statistically different between the groups. Means of gestational age were 37.4 and 36.2 weeks, respectively, for the investigational and control groups. The gestational age was 1.2 weeks longer for double cerclage group but the difference was not found to be statistically significant. Preterm birth before 33 weeks of gestation was not experienced by any of the patients who received double cerclage, but five women in control group developed such an extreme preterm labor (P < 0.05). The absolute risk reduction in using double cerclage over traditional method was 18 percent (95% confidence interval, 4%-32%). Double cerclage appeared to have higher efficacy than traditional cerclage in preventing preterm labor <33 weeks of gestation.

SUBMITTER: Broumand F

PROVIDER: S-EPMC3201694 | biostudies-other | 2011

REPOSITORIES: biostudies-other

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Project description:BackgroundBronchopulmonary dysplasia continues to cause important respiratory morbidity throughout life, and new therapies are needed. The common denominator of all BPD cases is preterm birth, however most preclinical research in this area focusses on the effect of hyperoxia or mechanical ventilation. In this study we investigated if and how prematurity affects lung structure and function in neonatal rabbits.MethodsPups were delivered on either day 28 or day 31. For each gestational age a group of pups was harvested immediately after birth for lung morphometry and surfactant protein B and C quantification. All other pups were hand raised and harvested on day 4 for the term pups and day 7 for the preterm pups (same corrected age) for lung morphometry, lung function testing and qPCR. A subset of pups underwent microCT and dark field imaging on day 0, 2 and 4 for terms and on day 0, 3, 5 and 7 for preterms.ResultsPreterm pups assessed at birth depicted a more rudimentary lung structure (larger alveoli and thicker septations) and a lower expression of surfactant proteins in comparison to term pups. MicroCT and dark field imaging revealed delayed lung aeration in preterm pups, in comparison to term pups. Preterm birth led to smaller pups, with smaller lungs with a lower alveolar surface area on day 7/day 4. Furthermore, preterm birth affected lung function with increased tissue damping, tissue elastance and resistance and decreased dynamic compliance. Expression of vascular endothelial growth factor (VEGFA) was significantly decreased in preterm pups, however in the absence of structural vascular differences.ConclusionsPreterm birth affects lung structure and function at birth, but also has persistent effects on the developing lung. This supports the use of a preterm animal model, such as the preterm rabbit, for preclinical research on BPD. Future research that focuses on the identification of pathways that are involved in in-utero lung development and disrupted by pre-term birth, could lead to novel therapeutic strategies for BPD.

Project description:BackgroundPreterm birth preceded by spontaneous preterm labour often occurs in the clinical setting of sterile intra-amniotic inflammation (SIAI), a condition that currently lacks treatment.MethodsProteomic and scRNA-seq human data were analysed to evaluate the role of IL-6 and IL-1α in SIAI. A C57BL/6 murine model of SIAI-induced preterm birth was developed by the ultrasound-guided intra-amniotic injection of IL-1α. The blockade of IL-6R by using an aIL-6R was tested as prenatal treatment for preterm birth and adverse neonatal outcomes. QUEST-MRI evaluated brain oxidative stress in utero. Targeted transcriptomic profiling assessed maternal, foetal, and neonatal inflammation. Neonatal biometrics and neurodevelopment were tested. The neonatal gut immune-microbiome was evaluated using metagenomic sequencing and immunophenotyping.FindingsIL-6 plays a critical role in the human intra-amniotic inflammatory response, which is associated with elevated concentrations of the alarmin IL-1α. Intra-amniotic injection of IL-1α resembles SIAI, inducing preterm birth (7% vs. 50%, p = 0.03, Fisher's exact test) and neonatal mortality (18% vs. 56%, p = 0.02, Mann-Whitney U-test). QUEST-MRI revealed no foetal brain oxidative stress upon in utero IL-1α exposure (p > 0.05, mixed linear model). Prenatal treatment with aIL-6R abrogated IL-1α-induced preterm birth (50% vs. 7%, p = 0.03, Fisher's exact test) by dampening inflammatory processes associated with the common pathway of labour. Importantly, aIL-6R reduces neonatal mortality (56% vs. 22%, p = 0.03, Mann-Whitney U-test) by crossing from the mother to the amniotic cavity, dampening foetal organ inflammation and improving growth. Beneficial effects of prenatal IL-6R blockade carried over to neonatal life, improving survival, growth, neurodevelopment, and gut immune homeostasis.InterpretationIL-6R blockade can serve as a strategy to treat SIAI, preventing preterm birth and adverse neonatal outcomes.FundingNICHD/NIH/DHHS, Contract HHSN275201300006C. WSU Perinatal Initiative in Maternal, Perinatal and Child Health.

Project description:BACKGROUND:The preterm birth rate is rising in high-income countries and is associated with increased mortality and morbidity. Although the risks increase with greater prematurity and risk factors have been found to vary with gestational age and labour onset, few studies have focused on the myriad pathways to extreme preterm birth (20-27 weeks' gestation). The current study investigated trends in extreme preterm birth by labour onset type and examined the antecedent risks to further our understanding around the identification of high-risk pregnancies. METHODS:Retrospective cohort study including all singleton extreme preterm births in Western Australia between 1986 and 2010. De-identified data from six core population health datasets were linked and used to ascertain extreme preterm births (excluding medical terminations and birth defects) after spontaneous onset of labour, preterm pre-labour rupture of membranes, and medically indicated labour onset. Trends over time in extreme preterm birth were analysed using linear regression. Multivariable regression techniques were used to assess the relative risks associated with each salient, independent risk factor and to calculate Population Attributable Risks (PARs). RESULTS:The extreme preterm birth rate including medical terminations and birth defects significantly increased over time whereas the extreme preterm birth rate excluding medical terminations and birth defects did not change. After medical terminations and birth defects were excluded, the rate of medically indicated extreme preterm births significantly increased over time whereas the rate of preterm pre-labour rupture of membranes extreme preterm births significantly reduced, and the rate of spontaneous extreme preterm births did not significantly change. In the multivariate analyses, factors associated with placental dysfunction accounted for >10% of the population attributable risk within each labour onset type. CONCLUSIONS:First study to show that the increase in extreme preterm birth in high-income jurisdiction is no longer evident after medical terminations and birth defects are excluded. Interventions that identify and target women at risk of placental dysfunction presents the greatest opportunity to reduce extreme preterm births.

Project description:ObjectiveTo determine whether training traditional birth attendants to manage several common perinatal conditions could reduce neonatal mortality in the setting of a resource poor country with limited access to healthcare.DesignProspective, cluster randomised and controlled effectiveness study.SettingLufwanyama, an agrarian, poorly developed district located in the Copperbelt province, Zambia. All births carried out by study birth attendants occurred at mothers' homes, in rural village settings.Participants127 traditional birth attendants and mothers and their newborns (3559 infants delivered regardless of vital status) from Lufwanyama district.InterventionsUsing an unblinded design, birth attendants were cluster randomised to intervention or control groups. The intervention had two components: training in a modified version of the neonatal resuscitation protocol, and single dose amoxicillin coupled with facilitated referral of infants to a health centre. Control birth attendants continued their existing standard of care (basic obstetric skills and use of clean delivery kits).Main outcome measuresThe primary outcome was the proportion of liveborn infants who died by day 28 after birth, with rate ratios statistically adjusted for clustering. Secondary outcomes were mortality at different time points; and comparison of causes of death based on verbal autopsy data.ResultsAmong 3497 deliveries with reliable information, mortality at day 28 after birth was 45% lower among liveborn infants delivered by intervention birth attendants than control birth attendants (rate ratio 0.55, 95% confidence interval 0.33 to 0.90). The greatest reductions in mortality were in the first 24 hours after birth: 7.8 deaths per 1000 live births for infants delivered by intervention birth attendants compared with 19.9 per 1000 for infants delivered by control birth attendants (0.40, 0.19 to 0.83). Deaths due to birth asphyxia were reduced by 63% among infants delivered by intervention birth attendants (0.37, 0.17 to 0.81) and by 81% within the first two days after birth (0.19, 0.07 to 0.52). Stillbirths and deaths from serious infection occurred at similar rates in both groups.ConclusionsTraining traditional birth attendants to manage common perinatal conditions significantly reduced neonatal mortality in a rural African setting. This approach has high potential to be applied to similar settings with dispersed rural populations. Trial registration Clinicaltrials.gov NCT00518856.

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Viable extreme preterm birth and some neonatal outcomes in double cerclage versus traditional cerclage: a randomized clinical trial.

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