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To evaluate whether a synthetic osmotic cervical dilator is noninferior to oral misoprostol for cervical ripening.In an open-label, noninferiority randomized trial, pregnant women undergoing induction of labor at 37 weeks of gestation or more with Bishop scores less than 6 were randomized to either mechanical cervical dilation or oral misoprostol. Participants in the mechanical dilation group underwent insertion of synthetic osmotic cervical dilator rods, and those in the misoprostol group received up to six doses of 25 micrograms orally every 2 hours. After 12 hours of ripening, oxytocin was initiated, with artificial rupture of membranes. Management of labor was at the physician's discretion. The primary outcome was the proportion of women achieving vaginal delivery within 36 hours of initiation of study intervention. Secondary outcomes included increase in Bishop score, mode of delivery, induction-to-delivery interval, total length of hospital stay, and patient satisfaction. On the basis of a noninferiority margin of 10%, an expected primary outcome frequency of 65% for misoprostol and 71% for mechanical methods, and 85% power, a sample size of 306 participants was needed.From November 2018 through January 2021, 307 women were randomized, with 151 evaluable participants in the synthetic osmotic cervical dilator group and 152 in the misoprostol group (there were four early withdrawals). The proportion of women achieving vaginal delivery within 36 hours was higher with mechanical cervical dilation compared with misoprostol (61.6% vs 59.2%), with an absolute difference of 2.4% (95% CI -9% to 13%), indicating noninferiority for the prespecified margin. No differences were noted in the mode of delivery. Tachysystole was more frequent in the misoprostol group (70 [46.4%] vs 35 [23.3%]; P=.01). Participants in the synthetic osmotic cervical dilator group reported better sleep, less unpleasant abdominal sensations, and lower pain scores (P.05).Synthetic osmotic cervical dilator is noninferior to oral misoprostol for cervical ripening. Advantages of synthetic osmotic cervical dilator include a better safety profile and patient satisfaction, less tachysystole, lower pain scores, and U.S. Food and Drug Administration approval.ClinicalTrials.gov, NCT03670836.Medicem Technology s.r.o., Czech Republic.

Histological chorioamnionitis (HCA) is associated with preterm birth and adverse neonatal outcomes. We evaluated the rise in C-reactive protein (CRP) in preterm infants as a predictor of HCA severity and outcomes.Consecutive preterm infants, born January 2009 to January 2014 in the National Maternity Hospital, Dublin, under 32 weeks' gestation or1.5 kg birthweight, were included. Histological chorioamnionitis was staged as maternal inflammatory response, foetal inflammatory response and non-HCA.Preterm infants (n = 518) were included with a mean gestational age 28.5 ± 2.8 weeks, birthweight 1.1 ± 0.3 kg, and 53.5% were male. Histological chorioamnionitis was found in 25.4%. Histological chorioamnionitis was present in 93.7% when CRP 5 mg/L, 65.2% when CRP 1-5 mg/L and in 19.4% when CRP 1 mg/L. When both the immature to total neutrophil (IT) ratio was0.2 and the CRP 1 mg/L the positive predictive value and negative predictive value for HCA were 92.5% and 84.9%, respectively. Histological chorioamnionitis was associated with more resuscitation and respiratory distress syndrome (both P .001). A CRP 10 mg/L was associated with a foetal inflammatory response and increased early-onset sepsis.Higher early CRP was a surrogate predictor of HCA and correlated with the severity of HCA. Higher CRP and HCA were associated with adverse early outcomes.

Background Chorioamnionitis (CA) is associated with preterm birth and adverse neonatal outcomes. The correlation between stage of histological CA, and haematological parameters in the early postnatal period are incompletely defined. Aim To examine the relationship between CRP and grade of CA in VLBW infants and any associations with neonatal outcomes. Methods A retrospective review of consecutive infants born Results 509 infants were included and histological CA was found in 20% of placentas but 47.8% at 0.3 mg/L) in 61.8% of infants with FIR, 64.7% of infants with MIR and 18.8% with no CA. CRP on day 1 >5 mg/L was specific for 90.9% of FIR, 3% of MIR, and 6.1% of infants no CA. CRP >10 mg/L was 100% specific for CA but not sensitive.. Advanced FIR on histology (funisitis) correlated significantly with higher CRP. A pathogen was isolated in 0.6% of CA and blood cultures were positive in 0.02% of preterm infant with the following outcomes: died (n = 6); FIR (n = 8); Funisitis (n = 5); High CRP (n = 5). Conclusion CRP has good specificity (96% at 1 mg/L) for CA in preterm infants. Higher initial CRP levels in infants correlate with severity of histological CA.

Background Early infant CRP levels in the setting of Chorioamnionitis (CA) have not been fully defined as a predictor of cognitive, behavioural, and neuro-developmental outcomes among extremely preterm neonates. Methods 499 preterm neonates had Placental pathology, CRP level and Vermont Oxford outcomes recorded. Death and developmental outcomes at 2 yrs were examined for 247 preterm infants Results 499 preterm infants were included with mean birth weight of 1074 +/- 273 g and gestational age of 28.5 +/-2.7 weeks. Infants with CA (N = 127) had lower GA and birth weight and higher rates of early onset sepsis. The Fetal inflammatory response was associated with: Apgar Infants with Day 1 CRP >10 mg/L needed significantly more resuscitation in the Delivery room (DR) including adrenaline and cardiac compressions. They were significantly more at risk of RDS, ROP, grade III/IV IVH. Conclusion There is a correlation between both initial CRP and histological CA with adverse short term outcomes.