BACKGROUND The addition of azithromycin to standard regimens for antibiotic prophylaxis before cesarean delivery may further reduce the rate of postoperative infection. We evaluated the benefits and safety of azithromycin-based extended-spectrum prophylaxis in women undergoing nonelective cesarean section. METHODS In this trial conducted at 14 centers in the United States, we studied 2013 women who had a singleton pregnancy with a gestation of 24 weeks or more and who were undergoing cesarean delivery during labor or after membrane rupture. We randomly assigned 1019 to receive 500 mg of intravenous azithromycin and 994 to receive placebo. All the women were also scheduled to receive standard antibiotic prophylaxis. The primary outcome was a composite of endometritis, wound infection, or other infection occurring within 6 weeks. RESULTS The primary outcome occurred in 62 women (6.1%) who received azithromycin and in 119 (12.0%) who received placebo (relative risk, 0.51; 95% confidence interval [CI], 0.38 to 0.68; P<0.001). There were significant differences between the azithromycin group and the placebo group in rates of endometritis (3.8% vs. 6.1%, P = 0.02), wound infection (2.4% vs. 6.6%, P<0.001), and serious maternal adverse events (1.5% vs. 2.9%, P = 0.03). There was no significant between-group difference in a secondary neonatal composite outcome that included neonatal death and serious neonatal complications (14.3% vs. 13.6%, P = 0.63). CONCLUSIONS Among women undergoing nonelective cesarean delivery who were all receiving standard antibiotic prophylaxis, extended-spectrum prophylaxis with adjunctive azithromycin was more effective than placebo in reducing the risk of postoperative infection. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development; C/SOAP ClinicalTrials.gov number, NCT01235546.)
Background The significance of periconceptional nutrition for optimizing offspring and maternal health and reducing social inequalities warrants greater understanding of diet quality among U.S. women. Objective The objective was to evaluate racial/ethnic and education inequalities in periconceptional diet quality and sources of energy and micronutrients. Design Cross-sectional analysis of data from the Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b) cohort. Participants and setting Nulliparous women (n=7511) were enrolled across 8 U.S. medical centers from 2010 to 2013. Main outcome measures A semi-quantitative food frequency questionnaire assessing usual dietary intake in the 3 months around conception was self-administered in the first trimester. Diet quality, measured using the Healthy Eating Index-2010 (HEI-2010), and sources of energy and micronutrients were the outcomes. Statistical analyses Differences in diet quality were tested across maternal racial/ethnic and education groups using F-tests associated with analysis of variance and Chi-squared tests. Results HEI-2010 score increased with higher education, but the increase among non-Hispanic Black women was smaller than among non-Hispanic whites and Hispanics (interaction p<0.0001). For all groups, average scores for HEI-2010 components were below recommendations. Top sources of energy were sugar-sweetened beverages, pasta dishes, and grain desserts, but sources varied by race/ethnicity and education. Approximately 34% of energy consumed was from empty calories (the sum of energy from added sugars, solid fats, and alcohol beyond moderate levels). The primary sources of iron, folate, and vitamin C were juices and enriched breads. Conclusions Diet quality is suboptimal around conception, particularly among women who are non-Hispanic Black, Hispanic, or who had less than a college degree. Diet quality could be improved by substituting intakes of refined grains and foods empty in calories with vegetables, peas and beans (legumes), seafood, and whole grains.
OBJECTIVE Our aim was to compare good candidates for trial of labor after cesarean (TOLAC) who underwent repeat cesarean to those who chose TOLAC. STUDY DESIGN Data for all deliveries at 14 regional hospitals over an 8-year period were reviewed. Women with a primary cesarean and 1 subsequent delivery in the dataset were included. The choice of elective repeat cesarean vs TOLAC was assessed in the first delivery following the primary cesarean. Women with ≥70% chance of successful vaginal birth after cesarean as calculated by a published nomogram were considered good candidates for TOLAC. Good candidates who chose an elective repeat cesarean were compared to those who chose TOLAC. Women who were delivered at 2 preselected tertiary centers by a general obstetrician-gynecologist practice were subanalyzed to determine whether there was an effect of physician group. RESULTS In all, 5445 women had a primary cesarean and a subsequent delivery. A total of 3120 women were calculated to be good TOLAC candidates. Of this group, 925 (29.7%) chose TOLAC. Women managed by a family practitioner or who were obese were less likely to choose TOLAC while women who were managed by a midwife or had a prior vaginal delivery were more likely to choose TOLAC. At the 2 tertiary centers, 1 general obstetrician-gynecologist group had significantly more patients who chose TOLAC compared to the other obstetrician-gynecologist physician groups (P < .001), with 63% of their patients choosing TOLAC. CONCLUSION Less than one-third of the good candidates for TOLAC chose TOLAC. Managing provider influences this decision.
BackgroundPreterm birth is a main determinant of neonatal mortality and morbidity and a major contributor to the overall mortality and burden of disease. However, research of the preterm birth is hindered by the imprecise definition of the clinical phenotype and complexity of the molecular phenotype due to multiple pregnancy tissue types and molecular processes that may contribute to the preterm birth. Here we comprehensively evaluate the mRNA transcriptome that characterizes preterm and term labor in tissues comprising the pregnancy using precisely phenotyped samples. The four complementary phenotypes together provide comprehensive insight into preterm and term parturition.MethodsSamples of maternal blood, chorion, amnion, placenta, decidua, fetal blood, and myometrium from the uterine fundus and lower segment (n = 183) were obtained during cesarean delivery from women with four complementary phenotypes: delivering preterm with (PL) and without labor (PNL), term with (TL) and without labor (TNL). Enrolled were 35 pregnant women with four precisely and prospectively defined phenotypes: PL (n = 8), PNL (n = 10), TL (n = 7) and TNL (n = 10). Gene expression data were analyzed using shrunken centroid analysis to identify a minimal set of genes that uniquely characterizes each of the four phenotypes. Expression profiles of 73 genes and non-coding RNA sequences uniquely identified each of the four phenotypes. The shrunken centroid analysis and 10 times 10-fold cross-validation was also used to minimize false positive finings and overfitting. Identified were the pathways and molecular processes associated with and the cis-regulatory elements in gene’s 5′ promoter or 3′-UTR regions of the set of genes which expression uniquely characterized the four phenotypes.ResultsThe largest differences in gene expression among the four groups occurred at maternal fetal interface in decidua, chorion and amnion. The gene expression profiles showed suppression of chemokines expression in TNL, withdrawal of this suppression in TL, activation of multiple pathways of inflammation in PL, and an immune rejection profile in PNL. The genes constituting expression signatures showed over-representation of three putative regulatory elements in their 5′and 3′ UTR regions.ConclusionsThe results suggest that pregnancy is maintained by downregulation of chemokines at the maternal-fetal interface. Withdrawal of this downregulation results in the term birth and its overriding by the activation of multiple pathways of the immune system in the preterm birth. Complications of the pregnancy associated with impairment of placental function, which necessitated premature delivery of the fetus in the absence of labor, show gene expression patterns associated with immune rejection.
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