The suture fixation of the levonorgestrel-releasing intrauterine device with hysteroscope for the treatment of adenomyosis in patients at high risk of device expulsion-a prospective observational study.

BACKGROUND: This study aimed to investigate the safety and efficacy of suture fixation of the levonorgestrel-releasing intrauterine device (LNG-IUD) by hysteroscope for the treatment of adenomyosis in patients at high risk of device expulsion, to provide a viable treatment option for these patients. METHODS: Twenty-one patients with large symptomatic adenomyosis were sewed and fixed with the LNG-IUD in the uterus by hysteroscopy to prevent the device expulsion. RESULTS: In this prospective case series, all 21 patients were successfully sewed and fixed with the LNG-IUD in the uterus by hysteroscopy. The amount of menstruation was significantly decreased and dysmenorrhea was significantly relieved in 3, 6, and 12 months after surgery compared with before surgery. Only one patient underwent a laparoscopic hysterectomy due to dysmenorrhea which was not alleviated one month later. Serious IUD complications including expulsion and perforation were not observed. There was no development of new side effects than LNG-IUD insertion. CONCLUSION: Our findings indicate that suture fixation of the LNG-IUD by hysteroscope is a safe, effective, and minimally invasive surgical procedure to prevent the device expulsion. It is a good solution for the treatment of large symptomatic adenomyosis and has shown to be effective in managing symptoms related to adenomyosis.

Placement of an intrauterine device within 48 hours after early medical abortion-a randomized controlled trial.

BACKGROUND: Intrauterine devices are safe, well-tolerated, and known to reduce the risk of unwanted pregnancies. At medical abortion, intrauterine devices are placed at a follow-up visit. Patients who miss this visit risk being left without contraception. OBJECTIVE: This study aimed to investigate if placement of an intrauterine device within 48 hours of completed medical abortion at up to 63 days' gestation leads to higher user rates at 6 months after the abortion compared with placement at 2 to 4 weeks after abortion. Furthermore, we aimed to compare continued use of intrauterine devices, safety, and patient satisfaction between groups. STUDY DESIGN: We performed an open-label, randomized, controlled, multicenter, superiority trial (phase 3). A total of 240 patients requesting medical abortion at up to 63 days' gestation and opting for an intrauterine device were allocated to placement within 48 hours of complete medical abortion (intervention group) or at 2 to 4 weeks after abortion (control group). We defined the abortion as complete after bleeding with clots and cessation of heavy bleeding following the use of misoprostol. Patients answered questionnaires at 3, 6, and 12 months. The primary outcome was use of intrauterine device at 6 months postabortion. Secondary outcomes included expulsion rate, pain at placement, adverse events and complications from the abortion, acceptability, and pregnancies and their outcomes. Differences in nonparametric continuous variables were analyzed with the Mann-Whitney U test and differences in dichotomous variables with the chi square or Fisher exact tests. A P value of <.05 was considered statistically significant. RESULTS: In the intervention group, 91 of 111 (82%) participants used an intrauterine device at 6 months after the abortion vs 87 of 112 (77.7%) in the control group, with a difference in proportion of 4.3% (95% confidence interval, -0.062 to 0.148; P=.51). Attendance rate and rate of successful intrauterine device placement were similar between the groups. Patients in the intervention group had lower pain scores at placement of the intrauterine device (mean pain score [visual analogue scale], 32.3; standard deviation, 29) compared with the control group (mean pain score [visual analogue scale], 43.4; standard deviation, 27.9; P=.002). Patients preferred their allocated time of placement significantly more often in the intervention group (83/111, 74.8%) than in the control group (70/114, 61.4%; P=.03). Use of ultrasound at intrauterine device placement (because of doubts concerning complete abortion) was more common in the intervention group (43/108, 39.8%) than in the control group (15/101, 14.9%; P<.001), and in one patient in the control group a retained gestational sac was found. Three patients in the intervention group and 2 in the control group had a vacuum aspiration. No difference was found in intrauterine device expulsion rates between the groups. Expulsion during the first 6 months after abortion was experienced by 9 of 97 (9.3%) patients in the intervention group and 4 of 89 (4.5%; P=.25) in the control group. There were no perforations or infections requiring antibiotic treatment. CONCLUSION: Placement of an intrauterine device within 48 hours after medical abortion at ≤63 days' gestation does not lead to higher user rates at 6 months after the abortion compared with intrauterine device placement at 2 to 4 weeks after abortion. When compared with placement at a follow-up visit after 2 to 4 weeks, intrauterine device placement within 48 hours after early medical abortion seems safe, is preferred by patients, and is associated with lower pain scores.

Conventional manual technique of post placental IUD insertion versus intra-cesarean post placental introducer withdrawal IUD insertion technique: a new standardized technique for IUD insertion during cesarean section: a randomized controlled trial.

BACKGROUND: Inserting IUDs during cesarean section reduces the need for more manipulation and discomfort. The current conventional manual technique for IUD insertion during cesarean section is not standardized with many modifications and high rates of expulsion, displacement, missed threads, and discontinuation. This study aims to find a standard technique for IUD insertion during cesarean section with the least possible problems, especially displacement and missed threads. METHODS: A randomized controlled study was conducted at Kasr Al-Ainy Maternity Hospital, Cairo University, Egypt. The study was performed over 12 months, from September 2020 to September 2021. Two groups of patients were selected; each group included 420 patients with a desire for IUD insertion during cesarean section. Group (A) (Control group) was subjected to a post-placental intrauterine device (Copper T380) during cesarean section using a conventional manual method; Group (B) (Study group): the IUD (Copper T380) was placed at the top of the uterine fundus using a new technique (intra-cesarean post placental introducer withdrawal IUD insertion technique). RESULTS: There was a significant statistical difference between the two groups regarding displacement of the IUDs at the end of puerperium, at 6 months, non-visibility of IUD threads, and continuation of use with p-value < 0.05. There was no significant statistical difference in the term of duration of surgery. CONCLUSION: The new technique of post-placental IUD insertion can be the standard technique of intra-cesarean section IUD insertion as it is associated with more favorable outcomes among the included women in the form of lower incidence of IUD displacement, non-visibility of IUD threads, and higher rates of continuation without increasing the duration of surgery as compared with the conventional manual technique. TRIAL REGISTRATION: ClinicalTrial.gov ID: NCT05788354, registration date: 28/03/2023 (retrospectively registered).

Early vs Interval Postpartum Intrauterine Device Placement: A Randomized Clinical Trial.

Importance: The early postpartum period, 2 to 4 weeks after birth, may be a convenient time for intrauterine device (IUD) placement; the placement could then coincide with early postpartum or well-baby visits. Objective: To determine expulsion rates for IUDs placed early postpartum compared with those placed at the standard interval 6-week visit. Design, Setting, and Participants: In this randomized noninferiority trial, people who had a vaginal or cesarean birth were randomly assigned to undergo early (14-28 days) or interval (42-56 days) postpartum IUD placement. Clinicians blinded to participant study group used transvaginal ultrasonography to confirm IUD presence and position at the 6-month postpartum follow-up. The study assessed 642 postpartum people from 4 US medical centers, enrolled a consecutive sample of 404 participants from March 2018 to July 2021, and followed up each participant for 6 months postpartum. Interventions: Early postpartum IUD placement, at 2 to 4 weeks postpartum, vs standard interval placement 6 to 8 weeks postpartum. Main Outcomes and Measures: The primary outcome was complete IUD expulsion by 6 months postpartum; the prespecified noninferiority margin was 6%. Secondary outcomes were partial IUD expulsion, IUD removal, pelvic infection, patient satisfaction, uterine perforation, pregnancy, and IUD use at 6 months postpartum. IUD malposition was an exploratory outcome. Results: Among 404 enrolled participants, 203 participants were randomly assigned to undergo early IUD placement and 201 to undergo interval IUD placement (mean [SD] age, 29.9 [5.4] years; 46 [11.4%] were Black, 228 [56.4%] were White, and 175 [43.3%] were Hispanic). By 6 months postpartum, 53 participants (13%) never had an IUD placed and 57 (14%) were lost to follow-up. Among the 294 participants (73%) who received an IUD and completed 6-month follow-up, complete expulsion rates were 3 of 149 (2.0% [95% CI, 0.4%-5.8%]) in the early placement group and 0 of 145 (0% [95% CI, 0.0%-2.5%]) in the interval placement group (between-group difference, 2.0 [95% CI, -0.5 to 5.7] percentage points). Partial expulsion occurred in 14 (9.4% [95% CI, 5.2%-15.3%]) participants in the early placement group and 11 (7.6% [95% CI, 3.9%-13.2%]) participants in the interval placement group (between-group difference, 1.8 [95% CI, -4.8 to 8.6] percentage points). IUD use at 6 months was similar between the groups: 141 (69.5% [95% CI, 62.6%-75.7%]) participants in the early group vs 139 (67.2% [95% CI, 60.2%-73.6%]) in the interval group. Conclusions and Relevance: Early IUD placement at 2 to 4 weeks postpartum compared with 6 to 8 weeks postpartum was noninferior for complete expulsion, but not partial expulsion. Understanding the risk of expulsion at these time points may help patients and clinicians make informed choices about the timing of IUD placement. Trial Registration: ClinicalTrials.gov Identifier: NCT03462758.

Does change in the shape of intrauterine contraceptive device Cu 375 and Cu T 380A affect the expulsion after post-partum insertion - a prospective randomized control trial.

PURPOSE: The objective of the study was to see the difference in expulsion rates of two types of Copper containing intrauterine contraceptive devices (IUCDs): Cu 375 & CuT 380 A, within or at 6 weeks after insertion. METHODS: It was a randomised control trial. A total of 396 pregnant women were recruited. Ultrasonography was done to look for the position of the IUCD at the time of discharge and at six weeks follow-up and the expulsion rate was calculated. RESULTS: Amongst 396 participants, 22 PPIUCDs were expelled completely at 6 weeks (modified intention to treat analysis [ITA]), 10 (5.3%) and 12 (6.7%) in the Cu 375 and CuT 380 A groups respectively. The expulsion rate was 6.02%. However, this difference was not statistically significant. When ultrasonologically assessed partial expulsions were also considered, the total expulsion rate in both groups (14.3% and 14.1% respectively) was also not significantly different. The expulsion rate was higher in the vaginal delivery group (10.7%) than in the caesarean section (3.6%) group (p = 0.007) and early postpartum insertion 12.3% than in the immediate post-placental insertion group, 3.7% (p = 0.002). CONCLUSIONS: The study concluded that the altered shape of Cu 375 has effectively no role in decreasing the expulsion rate. Placement of IUCD at or near the uterine fundus immediately after delivering the placenta (post-placental) decreases the expulsion rate, thereby increasing the contraceptive efficacy.SHORT CONDENSATIONThe altered shape of Cu 375 has effectively no role in decreasing the expulsion rate. Placement of IUCD at or near the uterine fundus immediately after delivering the placenta (post-placental) decreases the expulsion rate, thereby increasing the contraceptive efficacy.

Making the financial case for immediate postpartum intrauterine device: a budget impact analysis.

BACKGROUND: Clinical guidelines support inpatient postpartum intrauterine device insertion. However, inpatient placement remains infrequent, in part because of inconsistent private insurance reimbursement. OBJECTIVE: The purpose of this study was to explore how the payer's costs and number of unintended pregnancies associated with a postpartum intrauterine device differed on the basis of placement timing. STUDY DESIGN: Using a decision tree model and following a hypothetical cohort of people who intend to use an intrauterine device after their delivery, we conducted a cost analysis comparing the planned approach of inpatient vs outpatient postpartum insertion. Using a 2-year time horizon, the probability and cost estimates were derived from literature review. Our primary outcome was the total accrued costs to the payer. Secondarily, we examined the rates of early repeat pregnancy and sensitivity to estimates of key inputs, including the expulsion rates and the intrauterine device cost. RESULTS: Although an inpatient intrauterine device placement's upfront costs were higher, the total cost of this approach was lower. Including the costs of managing expulsions and complications, our model suggests that for every 1000 people desiring a postpartum intrauterine device, the intended inpatient intrauterine device placement resulted in total cost savings of $211,100 and the prevention of 37 additional pregnancies compared with outpatient placement. The inpatient cost savings were superior to the outpatient savings, largely because of a known high proportion not returning for outpatient placement and the resulting higher number of unintended pregnancies among the patients desiring outpatient placement. In sensitivity analyses, we found that the total cost to the payer was sensitive to the probability of expulsion after immediate postpartum intrauterine device placement. CONCLUSION: For beneficiaries desiring postpartum intrauterine device, payers are likely to save money by fully reimbursing inpatient intrauterine device placement rather than incentivizing placement at the frequently missed postpartum visit. These results support the financial case for private insurers to fully and separately reimburse (ie, "unbundle" from the single payment for delivery) inpatient postpartum intrauterine device placement.

Association between intrauterine device type and risk of perforation and device expulsion: results from the Association of Perforation and Expulsion of Intrauterine Device study.

BACKGROUND: Intrauterine devices, including levonorgestrel-releasing and copper devices, are highly effective long-acting reversible contraceptives. The potential risks associated with intrauterine devices are low and include uterine perforation and device expulsion. OBJECTIVE: This study aimed to evaluate the risk of perforation and expulsion associated with levonorgestrel-releasing devices vs copper devices in clinical practice in the United States. STUDY DESIGN: The Association of Perforation and Expulsion of Intrauterine Device study was a retrospective cohort study of women aged ≤50 years with an intrauterine device insertion during 2001 to 2018 and information on intrauterine device type and patient and medical characteristics. Of note, 4 research sites with access to electronic health records contributed data for the study: 3 Kaiser Permanente-integrated healthcare systems (Northern California, Southern California, and Washington) and 1 healthcare system using data from a healthcare information exchange in Indiana (Regenstrief Institute). Perforation was classified as any extension of the device into or through the myometrium. Expulsion was classified as complete (not visible in the uterus or abdomen or patient reported) or partial (any portion in the cervix or malpositioned). We estimated the crude incidence rates and crude cumulative incidence by intrauterine device type. The risks of perforation and expulsion associated with levonorgestrel-releasing intrauterine devices vs copper intrauterine devices were estimated using Cox proportional-hazards regression with propensity score overlap weighting to adjust for confounders. RESULTS: Among 322,898 women included in this analysis, the incidence rates of perforation per 1000 person-years were 1.64 (95% confidence interval, 1.53-1.76) for levonorgestrel-releasing intrauterine devices and 1.27 (95% confidence interval, 1.08-1.48) for copper intrauterine devices; 1-year and 5-year crude cumulative incidence was 0.22% (95% confidence interval, 0.20-0.24) and 0.63% (95% confidence interval, 0.57-0.68) for levonorgestrel-releasing intrauterine devices and 0.16% (95% confidence interval, 0.13-0.20) and 0.55% (95% confidence interval, 0.44-0.68) for copper intrauterine devices, respectively. The incidence rates of expulsion per 1000 person-years were 13.95 (95% confidence interval, 13.63-14.28) for levonorgestrel-releasing intrauterine devices and 14.08 (95% confidence interval, 13.44-14.75) for copper intrauterine devices; 1-year and 5-year crude cumulative incidence was 2.30% (95% confidence interval, 2.24-2.36) and 4.52% (95% confidence interval, 4.40-4.65) for levonorgestrel-releasing intrauterine devices and 2.30% (95% confidence interval, 2.18-2.44) and 4.82 (95% confidence interval, 4.56-5.10) for copper intrauterine devices, respectively. Comparing levonorgestrel-releasing intrauterine devices with copper intrauterine devices, the adjusted hazard ratios were 1.49 (95% confidence intervals, 1.25-1.78) for perforation and 0.69 (95% confidence intervals, 0.65-0.73) for expulsion. CONCLUSION: After adjusting for potential confounders, levonorgestrel-releasing intrauterine devices were associated with an increased risk of uterine perforation and a decreased risk of expulsion relative to copper intrauterine devices. Given that the absolute numbers of these events are low in both groups, these differences may not be clinically meaningful.

Association between menorrhagia and risk of intrauterine device-related uterine perforation and device expulsion: results from the Association of Uterine Perforation and Expulsion of Intrauterine Device study.

BACKGROUND: Intrauterine devices are effective instruments for contraception, and 1 levonorgestrel-releasing device is also indicated for the treatment of heavy menstrual bleeding (menorrhagia). OBJECTIVE: To compare the incidence of intrauterine device expulsion and uterine perforation in women with and without a diagnosis of menorrhagia within the first 12 months before device insertion STUDY DESIGN: This was a retrospective cohort study conducted in 3 integrated healthcare systems (Kaiser Permanente Northern California, Southern California, and Washington) and a healthcare information exchange (Regenstrief Institute) in the United States using electronic health records. Nonpostpartum women aged ≤50 years with intrauterine device (eg, levonorgestrel or copper) insertions from 2001 to 2018 and without a delivery in the previous 12 months were studied in this analysis. Recent menorrhagia diagnosis (ie, recorded ≤12 months before insertion) was ascertained from the International Classification of Diseases, Ninth and Tenth Revision, Clinical Modification codes. The study outcomes, viz, device expulsion and device-related uterine perforation (complete or partial), were ascertained from electronic medical records and validated in the data sources. The cumulative incidence and crude incidence rates with 95% confidence intervals were estimated. Cox proportional hazards models estimated the crude and adjusted hazard ratios using propensity score overlap weighting (13-16 variables) and 95% confidence intervals. RESULTS: Among 228,834 nonpostpartum women, the mean age was 33.1 years, 44.4% of them were White, and 31,600 (13.8%) had a recent menorrhagia diagnosis. Most women had a levonorgestrel-releasing device (96.4% of those with and 78.2% of those without a menorrhagia diagnosis). Women with a menorrhagia diagnosis were likely to be older, obese, and have dysmenorrhea or fibroids. Women with a menorrhagia diagnosis had a higher intrauterine device-expulsion rate (40.01 vs 10.92 per 1000 person-years) than those without, especially evident in the first few months after insertion. Women with a menorrhagia diagnosis had a higher cumulative incidence (95% confidence interval) of expulsion (7.00% [6.70-7.32] at 1 year and 12.03% [11.52-12.55] at 5 years) vs those without (1.77% [1.70-1.84] at 1 year and 3.69% [3.56-3.83] at 5 years). The risk of expulsion was increased for women with a menorrhagia diagnosis vs for those without (adjusted hazard ratio, 2.84 [95% confidence interval, 2.66-3.03]). The perforation rate was low overall (<1/1000 person-years) but higher in women with a diagnosis of menorrhagia vs in those without (0.98 vs 0.63 per 1000 person-years). The cumulative incidence (95% confidence interval) of uterine perforation was slightly higher for women with a menorrhagia diagnosis (0.09% [0.06-0.14] at 1 year and 0.39% [0.29-0.53] at 5 years) than those without it (0.07% [0.06-0.08] at 1 year and 0.28% [0.24-0.33] at 5 years). The risk of perforation was slightly increased in women with a menorrhagia diagnosis vs in those without (adjusted hazard ratio, 1.53; 95% confidence interval, 1.10-2.13). CONCLUSION: The risk of expulsion is significantly higher in women with a recent diagnosis of menorrhagia. Patient education and counseling regarding the potential expulsion risk is recommended at insertion. The absolute risk of perforation for women with a recent diagnosis of menorrhagia is very low. The increased expulsion and perforation rates observed are likely because of causal factors of menorrhagia.

Design of the Association of Uterine Perforation and Expulsion of Intrauterine Device study: a multisite retrospective cohort study.

BACKGROUND: Intrauterine devices are effective and safe, long-acting reversible contraceptives, but the risk of uterine perforation occurs with an estimated incidence of 1 to 2 per 1000 insertions. The European Active Surveillance Study for Intrauterine Devices, a European prospective observational study that enrolled 61,448 participants (2006-2012), found that women breastfeeding at the time of device insertion or with the device inserted at ≤36 weeks after delivery had a higher risk of uterine perforation. The Association of Uterine Perforation and Expulsion of Intrauterine Device (APEX-IUD) study was a Food and Drug Administration-mandated study designed to reflect current United States clinical practice. The aims of the APEX-IUD study were to evaluate the risk of intrauterine device-related uterine perforation and device expulsion among women who were breastfeeding or within 12 months after delivery at insertion. OBJECTIVE: We aimed to describe the APEX-IUD study design, methodology, and analytical plan and present population characteristics, size of risk factor groups, and duration of follow-up. STUDY DESIGN: APEX-IUD study was a retrospective cohort study conducted in 4 organizations with access to electronic health records: Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and Regenstrief Institute in Indiana. Variables were identified through structured data (eg, diagnostic, procedural, medication codes) and unstructured data (eg, clinical notes) via natural language processing. Outcomes include uterine perforation and device expulsion; potential risk factors were breastfeeding at insertion, postpartum timing of insertion, device type, and menorrhagia diagnosis in the year before insertion. Covariates include demographic characteristics, clinical characteristics, and procedure-related variables, such as difficult insertion. The first potential date of inclusion for eligible women varies by research site (from January 1, 2001 to January 1, 2010). Follow-up begins at insertion and ends at first occurrence of an outcome of interest, a censoring event (device removal or reinsertion, pregnancy, hysterectomy, sterilization, device expiration, death, disenrollment, last clinical encounter), or end of the study period (June 30, 2018). Comparisons of levels of exposure variables were made using Cox regression models with confounding adjusted by propensity score weighting using overlap weights. RESULTS: The study population includes 326,658 women with at least 1 device insertion during the study period (Kaiser Permanente Northern California, 161,442; Kaiser Permanente Southern California, 123,214; Kaiser Permanente Washington, 20,526; Regenstrief Institute, 21,476). The median duration of continuous enrollment was 90 (site medians 74-177) months. The mean age was 32 years, and the population was racially and ethnically diverse across the 4 sites. The mean body mass index was 28.5 kg/m2, and of the women included in the study, 10.0% had menorrhagia ≤12 months before insertion, 5.3% had uterine fibroids, and 10% were recent smokers; furthermore, among these women, 79.4% had levonorgestrel-releasing devices, and 19.5% had copper devices. Across sites, 97,824 women had an intrauterine device insertion at ≤52 weeks after delivery, of which 94,817 women (97%) had breastfeeding status at insertion determined; in addition, 228,834 women had intrauterine device insertion at >52 weeks after delivery or no evidence of a delivery in their health record. CONCLUSION: Combining retrospective data from multiple sites allowed for a large and diverse study population. Collaboration with clinicians in the study design and validation of outcomes ensured that the APEX-IUD study results reflect current United States clinical practice. Results from this study will provide valuable information based on real-world evidence about risk factors for intrauterine devices perforation and expulsion for clinicians.

One-year follow up on post-placental IUD insertion: A randomized clinical trial.

INTRODUCTION: Our objectives were to compare the 1-year follow-up clinical performance of the TCu380A intrauterine device (TCu380A-IUD) and levonorgestrel (LNG) 52-mg intrauterine system (IUS) inserted at post-placental period. MATERIAL AND METHODS: We conducted an open-label, parallel-group, randomized clinical trial, 1:1 with pregnant women admitted for childbirth independently of the mode of birth. Our primary outcome was expulsion up to 1 year after device placement by type of IUD and mode of delivery. During the follow up (42, 90 and 365 days (±7 days) after device placement), an ultrasound was performed to evaluate the device position. Kaplan-Meier with log-rank test was used to compare the survival curves of the TCu380A IUD and the LNG IUS. Couple-Years of Protection after insertion of both devices was calculated. RESULTS: One hundred and forty women were randomized to the TCu380A IUD (n = 70) or the LNG IUS (n = 70). By the end of the first year after device placement, 38 women experienced device expulsion (27.1%), most of them (33/38; 86.8%) within the first 42 days after delivery. The expulsions were significantly higher among users of TCu380A IUD (39.4%) than among users of the LNG IUS (22.2%; P = .039), and among those with vaginal delivery (43.8%) than among women with cesarean delivery (15%; P = .003). The 1-year cumulative continuation rate was 64.2%, significantly higher for LNG IUS (73.1%) than for TCu380A IUD (54.4%; P = .03), and among women with cesarean delivery (77.6%) than for vaginal delivery (52%; P = .00). The post-placental IUD insertion provided 356.4 Couple-Years of Protection. CONCLUSIONS: Two-thirds of women who accepted a post-placental IUD placement still used the device 1 year after childbirth. However, expulsion was the most prevalent reason for discontinuation, mainly within 42 days after device placement. The expulsion rate was significantly higher among TCu380A IUD users and among women with vaginal delivery.

Predictors for Discontinuation of Intrauterine Devices That Underwent Ultrasound-Guided Placement in a Long-term Follow-up Cohort.

OBJECTIVES: To investigate long-term outcomes of ultrasound-guided intrauterine device (IUD) insertion. The rate of and reasons for IUD discontinuation were reviewed, including the prevalence of uterine fibroids. METHODS: A retrospective cohort of patients who underwent transabdominal ultrasound (TAUS)-guided IUD insertion was reviewed. Information collected included age, body mass index, insertion date, indication for IUD use, indication for using TAUS guidance, and presence of uterine fibroids. The date of and reason for discontinuation were recorded. RESULTS: One hundred sixteen patients with successful TAUS-guided IUD placement were identified. Of these, 51 patients (43.97%) no longer had an IUD in place. An overall actual-to-expected use ratio was calculated to be 63.49%. The most common reason for IUD discontinuation was spontaneous expulsion (11.21%). The prevalence of fibroid uteri was 27.6% in our cohort. The actual-to-expected use ratio of those with a fibroid uterus was calculated to be 43.28%, which was significantly lower than that for a nonfibroid uterus (73.80%; P = .002). There were 27 of 104 patients with IUD use of less than 1 year, and fibroids were present 44.4% of the time. Comparatively, of the 77 patients that had IUD continuation of greater than 1 year, only 24.7% had fibroids (P = .022). The yearly continuation rates over 5 years were 74.04%, 55.84%, 41.67%, 35.14%, and 32.0% respectively. Of the 18 patients who received TAUS-guided insertion for a previous IUD expulsion, 33.3% had another spontaneous expulsion. CONCLUSIONS: Uterine fibroids and a previous expulsion appear to be the most likely predictors of IUD discontinuation, particularly within 1 year after insertion.

Expulsion of intrauterine devices after postpartum placement by timing of placement, delivery type, and intrauterine device type: a systematic review and meta-analysis.

OBJECTIVES: To provide updated and more detailed pooled intrauterine device expulsion rates and expulsion risk estimates among women with postpartum intrauterine device placement by timing of insertion, delivery type, and intrauterine device type to inform current intrauterine device insertion practices in the United States. DATA SOURCES: We searched PubMed, Cochrane Library, and ClinicalTrials.gov through June 2019. STUDY ELIGIBILITY CRITERIA: We included all studies, of any study design, that examined postpartum placement of Copper T380A (copper) or levonorgestrel-containing intrauterine devices that reported counts of expulsion. STUDY APPRAISAL AND SYNTHESIS METHODS: We evaluated intrauterine device expulsion among women receiving postpartum intrauterine devices in the "immediate" (within 10 minutes), "early inpatient" (>10 minutes to <72 hours), "early outpatient" (72 hours to <4 weeks), and interval (≥4 weeks) time periods after delivery. We assessed study quality using the US Preventive Services Task Force evidence grading system. We calculated pooled absolute rates of partial and complete intrauterine device expulsion separately and estimated adjusted relative risks by the timing of postpartum placement, delivery type, and intrauterine device type using log-binomial multivariable regression. RESULTS: We identified 48 level I to II-3 studies of poor to good quality that reported a total of 7661 intrauterine device placements. Complete intrauterine device expulsion rates varied by timing of placement as follows: 10.2% (range, 0.0-26.7) for immediate; 13.2% (3.5-46.7) for early inpatient; 0% for early outpatient; and 1.8% (0.0-4.8) for interval placements. Complete intrauterine device expulsion rates also varied by delivery type: 14.8% (range, 4.8-43.1) for vaginal and 3.8% (0.0-21.1) for cesarean deliveries. Among immediate postpartum vaginal placements, the expulsion rate for levonorgetrel intrauterine devices was 27.4% (range, 18.8-45.2) and 12.4% (4.8-43.1) for copper intrauterine devices. Compared with interval placement, immediate and early postpartum placements (inpatient and outpatient combined) were associated with greater risk of complete expulsion (adjusted risk ratio, 8.33; 95% confidence interval, 4.32-16.08, and adjusted risk ratio, 5.27; 95% confidence interval, 2.56-10.85, respectively). Among immediate postpartum placements, risk of expulsion was greater for placement after vaginal compared with cesarean deliveries (adjusted risk ratio, 4.57; 95% confidence interval, 3.49-5.99). Among immediate placements at the time of vaginal delivery, levonorgestrel intrauterine devices were associated with a greater risk of expulsion compared with copper intrauterine devices (adjusted risk ratio, 1.90; 95% confidence interval, 1.36-2.65). CONCLUSION: Although intrauterine device expulsion rates vary by timing of placement, type, and mode of delivery, intrauterine device insertion can take place at any time. Understanding the risk of intrauterine device expulsion at each time period will enable women to make an informed choice about when to initiate use of an intrauterine device in the postpartum period based on their own goals and preferences.

Levonorgestrel-releasing intrauterine system for endometrial hyperplasia.

BACKGROUND: In the absence of treatment, endometrial hyperplasia (EH) can progress to endometrial cancer, particularly in the presence of histologic nuclear atypia. The development of EH results from exposure of the endometrium to oestrogen unopposed by progesterone. Oral progestogens have been used as treatment for EH without atypia, and in some cases of EH with atypia in women who wish to preserve fertility or who cannot tolerate surgery. EH without atypia is associated with a low risk of progression to atypia and cancer; EH with atypia is where the cells are structurally abnormal, and has a higher risk of developing cancer. Oral progestogen is not always effective at reversing the hyperplasia, can be associated with side effects, and depends on patient adherence. The levonorgestrel-intrauterine system (LNG-IUS) is an alternative method of administration of progestogen and may have some advantages over non-intrauterine progestogens. OBJECTIVES: To evaluate the effectiveness and safety of the levonorgestrel intrauterine system (LNG-IUS) in women with endometrial hyperplasia (EH) with or without atypia compared to medical treatment with non-intrauterine progestogens, placebo, surgery or no treatment. SEARCH METHODS: We searched the following databases: the Cochrane Gynaecology and Fertility Group (CGF) Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and PsycINFO, and conference proceedings of 10 relevant organisations. We handsearched references in relevant published studies. We also searched ongoing trials in ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry, and other trial registries. We performed the final search in May 2020. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cross-over trials of women with a histological diagnosis of endometrial hyperplasia with or without atypia comparing LNG-IUS with non-intrauterine progestogens, placebo, surgery or no treatment. DATA COLLECTION AND ANALYSIS: Two review authors independently performed study selection, risk of bias assessment and data extraction. Our primary outcome measures were regression of EH and adverse effects associated with the LNG-IUS device (such as pelvic inflammatory disease, device expulsion, uterine perforation) when compared to treatment with non-intrauterine progestogens, placebo, surgery or no treatment. Secondary outcomes included hysterectomy, hormone-related adverse effects (such as bleeding/spotting, pelvic pain, breast tenderness, ovarian cysts, weight gain, acne), withdrawal from treatment due to adverse effects, satisfaction with treatment, and cost or resource use. We rated the overall quality of evidence using GRADE methods. MAIN RESULTS: Thirteen RCTs (1657 women aged 22 to 75 years) met the inclusion criteria. Two studies had insufficient data for meta-analysis, thus the quantitative analysis included 11 RCTs. All trials evaluated treatment duration of six months or less. The evidence ranged from very low to moderate quality: the main limitations were risk of bias (associated with lack of blinding and poor reporting of study methods), inconsistency and imprecision. LNG-IUS versus non-intrauterine progestogens Primary outcomes Regression of endometrial hyperplasia The LNG-IUS probably improves regression of EH compared with non-intrauterine progestogens at short-term follow-up (up to six months) (OR 2.94, 95% CI 2.10 to 4.13; I² = 0%; 10 RCTs, 1108 participants; moderate-quality evidence). This suggests that if regression of EH following treatment with a non-intrauterine progestogen is assumed to be 72%, regression of EH following treatment with LNG-IUS would be between 85% and 92%. Regression of EH may be improved by LNG-IUS compared with non-intrauterine progestogens at long-term follow-up (12 months) (OR 3.80, 95% CI 1.75 to 8.23; 1 RCT, 138 participants; low-quality evidence), Adverse effects associated with LNG-IUS There was insufficient evidence to determine device-related adverse effects; only one study reported on expulsion with insufficient data for analysis. Secondary outcomes The LNG-IUS may be associated with fewer hysterectomies (OR 0.26, 95% CI 0.15 to 0.46; I² = 19%; 4 RCTs, 452 participants; low-quality evidence), fewer withdrawals from treatment due to hormone-related adverse effects (OR 0.41, 95% CI 0.12 to 1.35; I² = 0%; 4 RCTs, 360 participants; low-quality evidence) and improved patient satisfaction with treatment (OR 5.28, 95% CI 2.51 to 11.10; I² = 0%; 2 RCTs, 202 participants; very low-quality evidence) compared to non-intrauterine progestogens. The LNG-IUS may be associated with more bleeding/spotting (OR 2.13, 95% CI 1.33 to 3.43; I² = 78%; 3 RCTs, 428 participants) and less nausea (OR 0.52, 95% CI 0.28 to 0.95; I² = 0%; 3 RCTs, 428 participants) compared to non-intrauterine progestogens. Data from single trials for mood swings and fatigue had a similar direction of effect as for bleeding/spotting, nausea and weight gain. There was insufficient evidence to determine cost or resource use. LNG-IUS versus no treatment Regression of endometrial hyperplasia One study demonstrated that the LNG-IUS is associated with regression of EH without atypia (OR 78.41, 95% CI 22.86 to 268.97; I² = 0%; 1 RCT, 190 participants; moderate-quality evidence) compared with no treatment. This study did not report on any other review outcome. AUTHORS' CONCLUSIONS: There is moderate-quality evidence that treatment with LNG-IUS used for three to six months is probably more effective than non-intrauterine progestogens at reversing EH in the short term (up to six months) and long term (up to two years). Adverse effects (device-related and hormone-related) were poorly and incompletely reported across studies. Very low quality to low-quality evidence suggests the LNG-IUS may reduce the risk of hysterectomy, and may be associated with more bleeding/spotting, less nausea, less withdrawal from treatment due to adverse effects, and increased satisfaction with treatment, compared to non-intrauterine progestogens. There was insufficient evidence to reach conclusions regarding device-related adverse effects, or cost or resource use.

Uterine dimensions and intrauterine device malposition: can ultrasound predict displacement or expulsion before it happens?

OBJECTIVE: Intrauterine devices (IUDs) are the most commonly used method of long-acting reversible contraception. IUD malpositions are described as expulsion, embedding, displacement, and perforation, which may cause contraception failure, organ injury, hemorrhage, and infection. The aim of the study was to evaluate the relationship between displacement and IUD positioning in the uterus, and uterine dimensions as measured using transvaginal ultrasonography. MATERIALS AND METHODS: Three-hundred and eighty-four patients who had TCu380A devices inserted at a tertiary hospital were evaluated at insertion and at 1 month, 3 months, and 6 months after insertion. At the insertion visit, demographic characteristics, history of menorrhagia, dysmenorrhea, previous IUD displacement, and obstetric history were recorded. Transvaginal ultrasonographic measurement of the uterine cavity, uterine length, uterine width, cervix length, cervix width, transverse diameter of the uterine cavity, the distance between the tip of the IUD and the fundus, and endometrium were measured to evaluate IUD displacement. RESULTS: Sixteen of 384 patients had displacement. There were significant differences in times between last pregnancy outcomes and IUD insertion and dysmenorrhea history (p = 0.004 and p = 0.028, respectively). Among TCu380A users, women with 7.5 mm IUD endometrium distances had a higher risk for displacement with a sensitivity of 81% and specificity of 37.5% (AUC: 0.607, 95% CI 0.51-0.70). Women with uterus width less than 41.5 mm were more likely to have displacement with a sensitivity of 53.8% and a specificity of 75% (AUC: 0.673, 95% CI 0.60-0.75). CONCLUSION: IUD endometrium distance and uterus width are important parameters for displacement for TCu380A.

Post-placental intrauterine device insertion vs puerperal insertion in women undergoing caesarean delivery in Egypt: a 1 year randomised controlled trial.

OBJECTIVE: The aim of the study was to compare 6 month expulsion rates of the copper-bearing intrauterine device (IUD) inserted after delivery of the placenta or at the 6 week postpartum visit in women undergoing caesarean section. METHODS: A parallel-group randomised trial was conducted in an Egyptian university hospital between February 2016 and December 2018. Participants were randomised to either post-placental IUD insertion or IUD insertion at the 6 week postpartum visit. Participants were followed for 12 months. Primary outcomes were IUD expulsion and the proportion of women using an IUD at 6 months. A secondary outcome was the cumulative pregnancy rate at 12 months. RESULTS: Five hundred participants were enrolled in each group. At 6 months the total expulsions were 58/416 (13.9%) in the post-placental group and 4/214 (1.9%) in the puerperal group; IUD use at 6 months was 416/478 (87.0%) in the post-placental group and 214/232 (92.2%) in the puerperal group. Data collected by phone at 12 months showed a higher cumulative pregnancy rate in the puerperal group (84/500, 16.8%) vs the post-placental group (22/500, 4.4%). IUD continuation at 12 months was higher in the post-placental group. CONCLUSION: Participants in the post-placental group had a higher expulsion rate at 6 months, but more IUDs were placed in this group and fewer pregnancies had occurred at 12 months compared with the puerperal group. TRIAL REGISTRATION: Clinicaltrials.gov NCT02679820.

Follow-up visits to check strings after intrauterine contraceptive placement cannot predict or prevent future expulsion.

OBJECTIVES: In some settings women are advised to return to the clinic after intrauterine contraceptive (IUC) placement, for a follow-up visit to check the strings and identify any expulsions. Our objective was to evaluate whether the number of follow-up visits to check the strings at the external cervical os after IUC placement predicts or prevents future expulsions. METHODS: This was a retrospective study conducted at the University of Campinas Medical School, Brazil. We reviewed the medical records of all women who used an IUC between January 1980 and December 2017, to identify women who had experienced IUC expulsion (N = 1974). We excluded women whose IUC was expelled more than once (n = 331) or after 10 years of use (n = 31). We fitted a generalised linear model of the time between IUC placement and expulsion, adjusting for several variables at expulsion. Significance was established at p < .05. RESULTS: Most expulsions (843/1612; 52.3%) occurred within the first 6 months after IUC placement and 691/1612 (42.9%) were within the first three months after placement. The adjusted model showed that the number of visits, the woman's age, and complaints of pain and bleeding during use were not significantly associated with and had no influence on expulsion. CONCLUSIONS: Our results indicate that after IUC insertion more than one follow-up visit within the first four to six months after placement is not necessary, as additional visits to check for IUC strings do not appear to reduce or predict future expulsion.

Do menstrual cups increase risk of IUD expulsion? A survey of self-reported IUD and menstrual hygiene product use in the United States.

Purpose: To gather preliminary data about menstrual hygiene product use and associated risk of intrauterine device (IUD) expulsion. Materials and methods: We conducted an Internet-based survey using the Amazon Mechanical Turk (MTurk) platform and Researchmatch.org. Eligible participants were women at least 18 years old and self-identified as current or previous IUD users. Results: Of 902 survey responses, 71% reported current or previous IUD use and 19.7% reported menstrual cup use. IUD users were significantly more likely than non-IUD users to use a menstrual cup or tampons. Among all IUD users, 56 individuals reported experiencing at least one expulsion (8.8%). We found a positive association between concurrent menstrual cup use and IUD expulsion (OR: 2.75, 95% CI: 1.40-5.42, p = .002), but no association with concurrent tampon or pad use. Of concurrent IUD and cup users who experienced an expulsion, one reported it occurring 'while using a menstrual cup', with others reporting the expulsion during other events. Conclusions: Menstrual cup use may be higher than previously reported, particularly in IUD users. Concurrent menstrual cup use may increase the risk of IUD expulsion. Prospective research is necessary to fully explore the relationship between menstrual hygiene product use and IUD expulsions.

Real-world experience with the IUB Ballerine MIDI copper IUD: an observational study in the French-speaking region of Switzerland.

Objective: The aim of the study was to assess the acceptability of the intrauterine ball IUB Ballerine MIDI copper intrauterine device (IUD), using real-world data collected from users and physicians. Methods: In this retrospective, observational study, conducted in the French-speaking region of Switzerland, healthy women (n= 207) who had had an IUB Ballerine MIDI inserted ≥12 months before enrolment, and their physicians completed questionnaires relating to device insertion, user experience and outcome. Questions relating to current menstrual patterns, physical comfort and product satisfaction were only posed to women still using the device. Results: The mean age at insertion was 30.8 ± 7.2 years, with an average 14.2 ± 2.9 month lapse from time of insertion until study commencement. At the time of the study, 140 (67.6%) women were still using the device. The expulsion rate was 5.3% (n= 11) and the pregnancy rate was 1.4% (n= 3). Most of the women still using the device reported no to moderate pain or cramps (80.7%). The majority of women reported moderate to high (65.7%) satisfaction with the device, with 81.4% claiming they would recommend it to friends and relatives. Over 84.8% of physicians reported that the device was easy to insert, with no difficulties encountered during the procedure. Conclusions: The IUB Ballerine MIDI was demonstrated to be safe and acceptable in different clinical settings and risk groups among a socioeconomically and demographically diverse study population.

Six-month expulsion of postplacental copper intrauterine devices placed after vaginal delivery.

BACKGROUND: Immediate placement of an intrauterine device after vaginal delivery is safe and convenient, but longitudinal data describing clinical outcomes have been limited. OBJECTIVE: We sought to determine the proportion of TCu380A (copper) intrauterine devices expelled, partially expelled, malpositioned, and retained, as well as contraceptive use by 6 months postpartum, and determine risk factors for expulsion and partial expulsion. STUDY DESIGN: In this prospective, observational study, women who received a postplacental TCu380A intrauterine device at vaginal delivery were enrolled postpartum. Participants returned for clinical follow-up at 6 weeks, and for a research visit with a pelvic exam and ultrasound at 6 months. We recorded intrauterine device outcomes and 6-month contraceptive use. Partial expulsion was defined as an intrauterine device protruding from the external cervical os, or a transvaginal ultrasound showing the distal end of the intrauterine device below the internal os of the cervix. Multinomial logistic regression models identified risk factors associated with expulsion and partial expulsion by 6 months. The area under the receiver operating characteristics curve was used to assess the ability of a string check to predict the correct placement of a postplacental intrauterine device. The primary outcome was the proportion of intrauterine devices expelled at 6 months. RESULTS: We enrolled 200 women. Of 162 participants with follow-up data at 6 months, 13 (8.0%; 95% confidence interval, 4.7-13.4%) experienced complete expulsion and 26 (16.0%; 95% confidence interval, 11.1-22.6%) partial expulsion. Of 25 malpositioned intrauterine devices (15.4%; 95% confidence interval, 10.2-21.9%), 14 were not at the fundus (8.6%; 95% confidence interval, 5.2-14.1%) and 11 were rotated within the uterus (6.8%; 95% confidence interval, 3.8-11.9%). Multinomial logistic regression modeling indicated that higher parity (odds ratio, 2.05; 95% confidence interval, 1.21-3.50; P = .008) was associated with expulsion. Provider specialty (obstetrics vs family medicine; odds ratio, 5.31; 95% confidence interval, 1.20-23.59; P = .03) and gestational weight gain (normal vs excess; odds ratio, 9.12; 95% confidence interval, 1.90-43.82; P = .004) were associated with partial expulsion. Long-acting reversible contraceptive method use at 6 months was 80.9% (95% confidence interval, 74.0-86.6%). At 6 weeks postpartum, 35 of 149 (23.5%; 95% confidence interval, 16.9-31.1%) participants had no intrauterine device strings visible. Sensitivity of a string check to detect an incorrectly positioned intrauterine device was 36.2%, and specificity of the string check to predict a correctly positioned intrauterine device was 84.5%. This corresponds to an area under the receiver operating characteristics curve of 0.5. CONCLUSION: This prospective assessment of postplacental TCu380A intrauterine device placement, with ultrasound to confirm device position, finds a complete intrauterine device expulsion proportion of 8.0% at 6 months. The association of increasing parity with expulsion is consistent with prior research. The clinical significance of covariates associated with partial expulsion (provider specialty and gestational weight gain) is unclear. Due to the observational study design, any associations cannot imply causality. The proportion of partially expelled and malpositioned intrauterine devices was high, and the area under the receiver operating characteristics curve of 0.5 indicates that a string check is a poor test for assessing device position. Women considering a postplacental intrauterine device should be counseled about the risk of position abnormalities, as well as the possibility of nonvisible strings, which may complicate clinical follow-up. The clinical significance of intrauterine device position abnormalities is unknown; future research should evaluate the influence of malposition and partial expulsion on contraceptive effectiveness and side effects.

Postpartum intrauterine devices: clinical and programmatic review.

The immediate postpartum period is a critical moment for contraceptive access and an opportunity to initiate long-acting reversible contraception, which includes the insertion of an intrauterine device. The use of the intrauterine device in the postpartum period is a safe practice with few contraindications and many benefits. Although an intrauterine device placed during the postpartum period is more likely to expel compared with one placed at the postpartum visit, women who initiate intrauterine devices at the time of delivery are also more likely to continue to use an intrauterine device compared with women who plan to follow up for an interval intrauterine device insertion. This review will focus on the most recent clinical and programmatic updates on postpartum intrauterine device practice. We discuss postpartum intrauterine device expulsion and continuation, eligibility criteria and contraindications, safety in regards to breastfeeding, and barriers to access. Our aim is to summarize evidence related to postpartum intrauterine devices and encourage those involved in the healthcare system to remove barriers to this worthwhile practice.