Effectiveness And Safety Of Dinoprostone Insert For Induction In Southern China:a Multicenter Retrospective Study

ObjectiveTo analyze the effectiveness and safety of controlled-release dinoprostone insert for different cervical maturity for induction at term in southern China from January 2010 to December 2015.Provide the important variables in determining whether a woman have a safe and successful delivery when induced by controlled-releasedinoprostone insert.And to provide ample convincing evidence of the effectiveness and safety of dinoprostone vaginal insert.Materials and methodsMaterials:For the research of the effectiveness and safety of controlled-release dinoprostone insert,3 provincial hospitals and 7 municipal hospitals in southern China which used controlled-release dinoprostone insert for induction at term were selected as research units.In accordance with strict inclusion criteria and exclusion criteria,2729 pregnant women who inducted by controlled-release dinoprostone insert were retrospectively analyzed for the effectiveness and safety with another 2027 pregnant women who inducted by oxytocin as control group.For the research of the important variables in determining whether a woman has a safe and successful delivery when induced by dinoprostone,2729 pregnant women who were induced by dinoprostone above were divided into two groups:2255 in the successful group and 474 in the unsuccessful group.Methods:Assessment indicators:the interval from induction to delivery;the interval of labor stages(latent phase,active phase,first stage of labor,second stage of labor,third stage of labor,total stage of labor);the rate of delivery by vagina;the adverse reactions(emergency birth,uterine tachysystole or uterine hyperstimulation,fetal distress,amniotic fluid contamination,postpartum haemorrhage and amniotic fluid embolism);the rate of Apgar score≤7 at 1/5-min.Statistical methods:statistical analysis was carried out using the SPSS(?)statistical package(version 20.0).Results were expressed as means 士 SD or n(%).Statistical analyses were performed with independent sample T-test and χ2-test/Fisher’s Exact.Influencing factor analysis were performed with Logistic regression analysis.Each P value was two-tailed,and the significance level was set at P=0.05.ResultsAll the pregnant women came from south China,covered Anhui,Beijing,Fujian,Guandong,Guangxi,Guizhou,Hainan,Hubei,Hunan,Jiangsu,Sichuang,Yunnan,Zhejiang.We didn’t find any clinically significant differences between the groups in the mean maternal age,weight,height,body mass index(BMI),gestational age at delivery or the proportion of nulliparity.There was significant differences between the two cohorts in the rates of vaginal deliveries.Overall 2255 vaginal deliveries were achieved(82.63%)in dinoprostone insert cohort and 1592 were achieved(78.54%)in oxytocin cohort.We also found that when Bishop score were between 0 to 3and 4 to 6,there was also significant differences between the two groups in the rates of vaginal deliveries.While when Bishop score were more than 7,no significant differences between the two groups were found.Moreover,we further analysis the interval from induction to delivery and the interval of labor stages(latent phase,active phase,first stage of labor,second stage of labor,third stage of labor,total stage of labor).The results,including the target parameters,were similar when Bishop score were between 0 to 3 and 4 to 6,with a longer latent phase and a shorter active phase in the dinoprostone insert group(P=0.042/P=0.024;P=0.009/P=0.000).No significant differences were found in the time from induction to delivery and the time of labor stages when Bishop score were more than 7.We found that when Bishop score were between 0 to 3 and 4 to 6,uterine tachysystole or uterine hyperstimulation was greater in dinoprostone insert group than in oxytocin group(0.72%vs.2.64%,P = 0.008;1.29%vs.2.52%,P = 0.027),whereas abnormal fetal monitoring were performed less frequently in the dinoprostone insert group(17.62%vs.5.77%,P = 0.000;14.83%vs.10.09%,P =0.000).Moreover,amniotic fluid contamination and emergency birth was greater in the oxytocin group than in dinoprostone group when Bishop score were between 4 to 6(12.34%vs.9.89%,P= 0.048;6.63%vs.3.32%,P = 0.000).No significant differences were found between the other groups including Bishop score were more than 7.Overall,there were 2 cases of amniotic fluid embolism in dinoprostone insert cohort and 1 case in oxytocin cohort,and by timely rescue all of them were cured.Univariate analysis revealed that the factors impacting the prognosis were parity,premature rupture of fetal membranes,the time from induction to delivery and the birth weight of newborn.Multivariate analysis revealed that multipara,women with shorter interval from induction to delivery,newborn with lower birth weight will have a higher rate to have a safe and successful deliveryConclusionDinoprostone inset promotes cervical ripening and labor naturally effectively,and has better effectiveness and safety than oxytocin,especially for women with an unfavorable cervix.Our findings provide ample convincing evidence of the effectiveness and safety of dinoprostone vaginal insert,and has important guiding meaning.for labor induction in Southern China.Multipara,women with shorter interval from induction to delivery,newborn with lower birth weight will have a higher rate to have a safe and successful delivery.