10% lidocaine spray for pain control during intrauterine device insertion: a randomised, double-blind, placebo-controlled trial.

BACKGROUND: Various medications have been investigated for their efficacy in pain reduction during intrauterine device (IUD) insertion, but there is currently no standard recommendation. This study aimed to investigate the efficacy of 10% lidocaine spray in reducing pain during copper-containing intrauterine device (Cu-IUD) insertion. METHODS: This study was a randomised, double-blind, placebo-controlled trial. Reproductive-age women were randomised at a 1:1 ratio into 10% lidocaine spray or placebo spray group. A 10 cm visual analogue scale (VAS) was used to evaluate pain during several steps of the IUD insertion procedure, and after the procedure. RESULTS: One hundred and twenty-four women were included and 62 women were randomised in each group. Baseline characteristics between groups were similar. The 10% lidocaine spray group demonstrated significantly lower median VAS immediately after IUD insertion than the placebo group (2.95 (IQR=1.00-5.63) vs 5.00 (IQR=3.35-7.00), respectively; p=0.002). Similarly, women receiving 10% lidocaine spray reported significantly lower median VAS than those receiving placebo during tenaculum use and uterine sounding. The maximum median VAS occurred immediately after Cu-IUD insertion. The proportion of women who reported VAS≥4 during uterine sounding and after IUD placement was significantly lower in the 10% lidocaine group than in the placebo group (p<0.05). Median change in VAS from baseline to IUD placement was significantly different between 10% lidocaine spray group and placebo group (1.85 (IQR=0.08-4.03) vs 3.6 (IQR=2.40-5.80), respectively; p=0.004). CONCLUSION: 10% lidocaine spray was found to be an effective local anaesthetic method for reducing pain during insertion of Cu-IUD. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT03870711.

Risk assessment of copper-containing contraceptives: the impact for women with implanted intrauterine devices during clinical MRI and CT examinations.

OBJECTIVES: To assess the risks for implant users with copper-containing intrauterine devices (IUDs) during MR and CT examinations. METHODS: A tissue-mimicking phantom suitable for all experiments within this study was developed. Seven different types of copper IUDs were evaluated. Heating and dislocation of each IUD were investigated at two clinically relevant positions in 1.5 T and 3 T MR scanners. Artifacts in the field of view caused by each tested IUD were determined for clinical MR and CT imaging. RESULTS: No significant heating of any tested IUD was detected during MR measurements. The temperature increase was less than 0.6 K for all IUDs. Neither angular deflection nor translation of any IUD was detected. Artifacts in MR images were limited to the very vicinity of the IUDs except for one IUD containing a steel-visualizing element. Streaking artifacts in CT were severe (up to 75.5%) in the slices including the IUD. CONCLUSION: No significant risk possibly harming the patient was determined during this phantom study, deeming MR examinations safe for women with an implanted copper IUD. Image quality was more impaired for CT than for MR imaging and needs careful consideration during diagnosis. KEY POINTS: • Risk assessment of copper-containing IUDs with regard to heating, dislocation, and artifacts during MR and CT imaging. • Neither significant heating nor dislocation was determined in MR; image quality was more impaired for CT than for MR imaging and needs careful consideration during diagnosis. • The tested IUDs pose no additional risks for implant users during MR and CT examinations.

Comparison of three types of intrauterine device inserted immediately after artificial abortion: a multicentral randomized controlled trial / 中华全科医师杂志

Objective To compare the safety and effectiveness of three types of intrauterine device (IUD) inserted immediately after artificial abortion.Methods A randomized controlled clinical trial was performed in 4 family planning service stations in Pudong New Area from January to December 2012.Total 1 200 eligible women were randomly assigned to receive three types of IUD:MYCu,TCu380A or G-Cu200 (n =400 in each group) immediately after vacuum aspiration.All subjects were followed up for 12 months.The cumulative rates of termination of three IUD after 12 months were analyzed with WHO LTA 2.0 life table.Results Total 1 199 subjects were followed up for 12 months with a drop-out rate of 0.08％ (1/1 200).No any uterine perforation was found.During the 12 months the pregnancy rates with IUD in situ in MYCu,TCu380A and G-Cu200 groups were 0.26/100 women year,0 and 0.52/100 women year,respectively (x2 =1.951,P ≥ 0.2).The rates of expulsion in three groups were 0.26/100 women year,1.84/100 women year and 2.05/100 women year,respectively(x2 =5.539,P =0.066).The remove rates related to bleeding and paining in three groups were 1.26/100 women year,7.29/100 women year and 2.76/100 women year,respectively (x2 =21.625,P =0.001).The discontinuation rates related to IUD use in there groups were 3.25/100 women year,9.00/100 women year and 5.50/100 women year,respectively(x2 =12.191,P =0.004).The rates of Abnormal position in three groups were 1.51/100 women year,0 and 0.26/100 women year,respectively (x2 =8.649,P =0.014).Conclusion Three IUDs inserted immediately after vacuum aspiration are all effective.Among three IUDs,MYCu shows lower expulsion rate,lower discontinuation rate related to IUD use and higher continuous rate; but the abnormal position rate of MYCu is higher than other two types IUD.

The reproductive toxicity of rat models implanted with copper-bearing intrauterine device at teratogenic sensitive period by continuous extraction method / 中国组织工程研究

BACKGROUND:At present, the copper-bearing intrauterine device, a kind of class III medical devices, is commonly used in China. However, there is no clear conclusion about whether it has impact on the embryo or fetus in some cases, such as unexpected pregnancy during long-term implantation and pregnancy in a short time after removing it. OBJECTIVE: To evaluate the safety of copper-bearing intrauterine device by observing the influence of copper-bearing intrauterine device extracts on pregnant rats and rat fetuses by tail vein injection in the sensitive period of teratogenesis. METHODS: A total of 60 fertilized rats were divided into control group, high dosage group, middle dosage group, and low dosage group. The copper-bearing intrauterine device extracts were prepared by the continuous extraction method. Different concentrations (0.2, 0.1, 0.05 g/mL) of copper-bearing intrauterine device extracts were injected by the tail vein at the 1st day of pregnancy in the latter three groups at a dosage of 0.01 mL/g per day. The control group was given the same amount of normal saline. The injection lasted for 20 days. Then, the pregnant rats were sacrificed to measure body mass, check both sides of the uterus and internal organs, isolate fetal rats, as wel as record the quality of uterus and fetal rats, corpus luteum, implantation numbers, the number of stilbirths, then number of live births and the number of fetal absorption. The fetal rats were determined in the folowing aspects: body mass, body height, tail length, the ossification degree and appearance of the occipital bone, bone and visceral anomalies. RESULTS AND CONCLUSION: The number of births, implantation numbers, the number of live births, the number of corpus luteum, the percentages of live births and stilbirths, the number of resorbed fetuses, and the weight of uterus and fetal rats in the control group showed no difference from those in the other three groups (P > 0.05). No malformation in the internal organs occurred. Compared with the control group, the high, middle and low dosage groups showed no difference in the height, tail length, body mass, and ossification degree of the occipital bone of fetal rats (P > 0.05). No malformation in the appearance, skeleton and internal organs occurred in the fetal rats. These findings indicate that there were no maternal toxicity, abnormal embryonic growth or rat fetus anomalies after injecting copper-bearing intrauterine device extracts into pregnant rats in sensitive period of teratogenesis.

Chinical effects of three kinds of active IUD inserted immediately after induced abortion / 中国基层医药

Objective To compare the effects of three types intrauterine device(IUD)insertion immediately after vacuum aspiration.Methods 120 cases of artificial abortion immediately placed IUD women were selected.According to the IUD type,the patients were divided into the TCu3s0AIUD group 40 cases,active gamma type 40 cases in group IUD,palace copper 40 cases in ZooIUD group,followed up for 12 months.Results All of the subjects were not with IUD pregnancy.The termiration rate was Palace copper ZooIUD group 27.5％,active gamma type IUD group7.5％ TCu3s0AIUD 15.0％,three groups of termination rate had a significant difference(F=5.88,P＜0.05);threegroup IUD complications had no statistical difference(all P＞0.05).Follow-up for 12 months,palace copper group ZooIUD menstruation increase incidence rate of 42.5％,significantly higher than the other two groups 15.0％,20.0％(F=8.96,P＜0.05);the difference between the three groups in irregular bleeding was significant(F=17.77,P＜0.01).Conclusion The three kinds of IUD has good contraception effect,wherein the active gamma IUD has smaller adverse reaction,continue to use rate is high,so it is worthy of clinical application.