Evaluation of a novel uterine sound sparing approach for copper intrauterine device insertion

FERTILITY AND STERILITY(2017)

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摘要
To explore a novel and simplified approach for copper IUD insertion without using uterine sound Randomized controlled study (NCT02842177; Clinicaltrials.gov). Eligible women attended the Family Planning Clinic requesting Copper IUD insertion for family planning were counseled to participate if they didn’t have any contraindication for insertion according to WHO eligibility criteria. Enrolled women were randomized into 2 groups; group І included women subjected to classic approach for IUD insertion and group II included women had IUD insertion using the uterine sound-sparing approach (USSA). This approach utilized transvaginal ultrasound (TV/US) for assessment of the uterine cavity length and position before IUD insertion without using uterine sounding. A follow-up visit was scheduled after the next menses to detect late complications of IUD (displacement, expulsion, and perforation). IUD placement was checked by TV/US and the distance between IUD and the end of endometrial line was measured. The main study outcome was the ideal IUD insertion as defined when IUD was clearly visualized by ultrasonography in a sagittal view and the upper end located in the fundus and the lower end at the internal os. The secondary outcomes included the rate of IUD insertion failure; the duration of insertion, the difference in women's satisfaction score at the end of insertion, and the rate of late complications at the follow-up visit. Wilcoxon rank sum test and Fisher's exact test were utilized for analysis of the outcomes. Eighty-seven women were finally analyzed; 44 were in group І and 43 women in group ІІ. Both groups were homogeneous regard the age, parity, BMI, and the previous route of delivery. USSA approach reported comparable successful insertions with classic approach without statistically significant difference (91.3% vs. 93.5%; p=0.87).The ease score of IUD insertion was significantly higher in the USSA group (median[IQR]: 8.75[8-9] vs 7.5 [6-8], p=0.04). Moreover; significant shorter duration of insertion (mean±SD: 2.2±0.2 vs 3.9±0.2; p=0.002) was reported in USSA group. Additionally, there was a statistically significant difference in satisfaction score between the study groups. The mean satisfaction scores were 6.12±1.7 in group I and 8.23±1.54 in group II respectively (p=0.0001). At the 4 weeks follow-up; TV/US showed that all IUDs were in place in all women without statistical significant difference in the mean distance between the IUD and the end of endometrial line (2.1±0.5 vs 1.9±0.7mm; p=0.71). Copper IUD can be inserted successfully without using uterine sound provided utilizing TV/US prior to insertion. This approach associated with greater ease at insertion for clinicians and greater women satisfaction during insertion with shorter duration.
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关键词
copper,sound
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