A Clinical Controlled Study Of Preconceptional Transvaginal Cervicoisthmic Cerclage And Transvaginal Cervicoisthmic Cerclage In Pregnancy In The Treatment Of Uterine Cervical Incompetence

ObjectiveTo compare the clinical efficacy of preconceptional transvaginal cervicoisthmic cerclage and transvaginal cervicoisthmic cerclage in pregnancy in the treatment of uterine cervical incompetence.MethodsThe study was undertaken in the Sir Run Run Shaw Hospital through February 2017.Sixty-two patients of uterine cervical incompetence with a history of recurrent second-trimester miscarriage were assigned to the preconceptional transvaginal cervicoisthmic cerclage group and the transvaginal cervicoisthmic cerclage in pregnancy group according to the cerclage type they took.The primary outcomes were spontaneous delivery after 37 weeks of gestation,spontaneous delivery after 34 weeks of gestation and neonatal survival rate.The second outcomes were operation time,hemorrhage during operation,side-effects of operation,spontaneous delivery after 28 weeks of gestation,gestational age at delivery,birthweight and composite neonatal outcomes.Results?Eighty-two patients met the inclusion criteria,including 39 patients in the group of preconceptional transvaginal cervicoisthmic cerclage and 43 patients in the group of transvaginal cervicoisthmic cerclage in pregnancy.In the group of preconceptional transvaginal cervicoisthmic cerclage,6 patients are pregnant and 3 are lost to follow up.In the group of transvaginal cervicoisthmic cerclage in pregnancy,10 patients are pregnant and 1 are lost to follow up.Finally,62 patients with the results of pregnancy outcomes were analyzed in the preconceptional transvaginal cerclage group(n=30)and the transvaginal cerclage in pregnancy group(n=32).?Overall,there were no significant difference in the baseline characteristics of maternal age,body-mass index,history of spontaneous abortion during the second trimester,history of intrauterine operation,history of operation of cervix,assessment of the patulous cervix with Hegar,the way of pregnancy,history of infertility(P>0.05).The preoperative closed cervical length at vaginal sonogram in the preconceptional cerclage group was 29.16±2.76 mm and 33.18±4.76mm in the cerclage in pregnancy group.In the preconceptional cerclage group,women had a natural pregnancy after cerclage for a mean time of 3.20 month,and the mean gestation age at cerclage placement in the group of cerclage in pregnancy was 15 weeks.?According to the result of MRI and intraoperative findings,our transvaginal cervicoisthmic cerclage could reach the level of uterine isthmus.?The operation time in the group of preconceptional cerclage was significant longer than the group of transvaginal cervicoisthmic cerclage in pregnancy(69.40±24.85 vs 51.41±12.06 min;P=0.001).There was also statistical difference in the hemorrhage during operation(20.17±34.53 vs 43.75±33.96 ml;P=0.009).Sixty-two operations were carried out successfully,only one patient in the group of transvaginal cervicoisthmic cerclage in pregnancy had slight vaginal bleeding.Neither group had complications of cervical laceration,preterm premature rupture of membranes or infection.The antibiotics use and hospital stays in the group of transvaginal cervicoisthmic cerclage in pregnancy were more than the group of preconceptional cerclage(3.66±1.13 vs 2.57±0.50 days;9.84±5.43 vs 4.00±0.74days;P<0.001).? In the aspect of pregnancy outcomes,the women in the preconceptional cerclage group had a full term pregnancy rate of 80.0%,spontaneous delivery after 34 weeks of 96.7%,spontaneous delivery after 28 weeks of 100%,neonatal survival rate of 100%,mean gestation age at delivery of 37.43±1.59 weeks,mean neonatal birthweight of 3163.33±516.03g;but the women in the group of cerclage in pregnancy group had a full term pregnancy rate of 96.9%,spontaneous delivery after 34 weeks of 100%,spontaneous delivery after 28 weeks of 100%and neonatal survival rate of 100%,mean gestation age at delivery of 38.09±1.09 weeks,mean neonatal birthweight of 3373.44±314.43 g;however,no statistically significant differences were found.One newborn with hyperbilirubinemia occurred in the group of preconceptional cervicoisthmic transvaginal cerclage.Two newborns with meconium aspiration syndrome and three newborn with hyperbilirubinemia occurred in the group of transvaginal cervicoisthmic cerclage in pregnancy.Neither groups had the complications of sepsis,necrotizing enteritis or intracranial hemorrhage.Also significant differences were not seen in cesarean section rate(86.7%vs 87.5%;P>0.05)and days in NICU(1.57±4.26 vs 0.81±2.13 days;P>0.05).Conclusion? The operation of transvaginal cervicoisthmic cerclage could reach the level of uterine isthmus without open of abdomen or Douglas' pouch.?The operation of transvaginal cervicoisthmic cerclage has a bright future for its advantages of efficacy,easy operation,safe and reliable.However,statistically significant differences were not seen in the pregnant outcomes between the preconceptional cervicoisthmic transvaginal cerclage group and the transvaginal cervicoisthmic cerclage in pregnancy group.?The sample size is limited,more studies with high quality should be performed to instruct the clinical application of cerclage.