Effectiveness Of Anti-adhesion Diaphragm Used In Uterine After Induced Abortion To Prevent Intrauterine Adhesion:RCT Study

ObejectiveTo evaluate the effectiveness and acceptability of anti-adhesion diaphragm in the uterine after induced abortion to prevent intrauterine adhesion.MethodsThis study is a randomized,controlled and multi-center clinical trial.Womens hospital school of medicine Zhejiang University(Center 1),Tongde hospital of Zhejiang Province(Center 2),Guangxing Hospital affiliated to Zhejiang University of Traditional Chinese Medicine(Center 3)were selected.120 cases of termination of pregnancy by induced abortion within 6-8 weeks after menopause were randomly divided into three groups,including 40 cases of intrauterine anti-adhesion diaphragm group,40 cases of balloon stent group and 40 cases of control group(without intervention).All the three groups received routine oral antibiotics to prevent infection after operation.The subjects were observed from June 2018 to March 2019.The incidence of intrauterine adhesion were compared among the three groups.Changes of menstrual patterns,comfort,acceptability and safety were compared between intrauterine anti-adhesion diaphragm group and balloon stent group.Result1.The incidence of intrauterine adhesion was 2.5%(1/40)in intrauterine anti-adhesion diaphragm group and 0%(0/40)in the balloon stent group.There was no significant difference between the two groups(Fisher's exact probability method,bilateral test,P=1.0).Compared with 17.5%(7/40)in the control group,there was also no significant difference(X2=3.47,P=0.06).There was significant difference between the balloon stent group and the control group(P=0.012).2.The duration of menstruation after induced abortion in balloon stent group was significantly shorter than that before operation,5.2 ±0.7 days vs 6.1±1.2 days(t=-9.97,P<0.001).The change of menstrual cycle after operation in balloon stent was 22.5%(9/40)significantly different from that before(P=0.02),but there was no significant difference between balloon stent group and control group(15%(6/40)(X2=7.34,P=0.39).There was no significant difference in the change of menstrual cycle,menstrual period,menstrual volume and dysmenorrhea in intrauterine anti-adhesion diaphragm group(P>0.05).3.The comfort evaluation of intrauterine anti-adhesion diaphragm group was higher than that of balloon stent group(50%vsl5%,P=0.001);95.0%were willing to use diaphragm again and 85.0%were willing to recommend it to others,compared with balloon group(52.5%?47.5%).The OR ratios respectively were 8.14(95%CI 2.44-27.17,P=0.000)?6.26(95%CI 2.16-18.20,P=0.000).4.The incidence of pelvic inflammation in the intrauterine anti-adhesion diaphragm group was 5.0%(2/40),which was not significantly different from that in the control group 17.5%(7/40)(X2=2.00,P=0.16).In the balloon stent group,3 cases fell off during balloon stent placement,and no other possible adverse events occurred.ConlusionThe effect to prevent intrauterine adhesion in intrauterine anti-adhesion diaphragm group after induced abortion is not inferior to that of balloon stent and does not cause menstrual disorder.It is more comfortable and acceptable.