Risks of Uterine Perforation and Expulsion Associated With Intrauterine Devices.

OBJECTIVE: The APEX-IUD (Association of Perforation and Expulsion of Intrauterine Devices) study evaluated the association of postpartum timing of intrauterine device (IUD) insertion, breastfeeding, heavy menstrual bleeding, and IUD type (levonorgestrel-releasing vs copper) with risks of uterine perforation and IUD expulsion in usual clinical practice. We summarize the clinically important findings to inform counseling and shared decision making. METHODS: APEX-IUD was a real-world (using U.S. health care data) retrospective cohort study of individuals aged 50 years and younger with IUD insertions between 2001 and 2018 and with electronic health record data. Cumulative incidences of uterine perforation and IUD expulsion were calculated. Adjusted hazard ratios (aHRs) and 95% CIs were estimated from proportional hazards models with control of confounding. RESULTS: Among the study population of 326,658, absolute risk of uterine perforation was low overall (cumulative incidence, 0.21% [95% CI 0.19-0.23%] at 1 year and 0.61% [95% CI 0.56-0.66% at 5 years]) but was elevated for IUDs inserted during time intervals within 1 year postpartum, particularly among those between 4 days and 6 weeks postpartum (aHR 6.71, 95% CI 4.80-9.38), relative to nonpostpartum insertions. Among postpartum insertions, IUD expulsion risk was greatest for insertions in the immediate postpartum period (0-3 days after delivery) compared with nonpostpartum (aHR 5.34, 95% CI 4.47-6.39). Postpartum individuals who were breastfeeding had a slightly elevated risk of perforation and lowered risk of expulsion than those not breastfeeding. Among nonpostpartum individuals, those with a heavy menstrual bleeding diagnosis were at greater risk of expulsion than those without (aHR 2.84, 95% CI 2.66-3.03); heavy menstrual bleeding also was associated with a slightly elevated perforation risk. There was a slightly elevated perforation risk and slightly lower expulsion risk associated with levonorgestrel-releasing IUDs compared with copper IUDs. CONCLUSION: Absolute risk of adverse outcomes with IUD insertion is low. Clinicians should be aware of the differences in risks of uterine perforation and expulsion associated with IUD insertion during specific postpartum time periods and with a heavy menstrual bleeding diagnosis. This information should be incorporated into counseling and decision making for patients considering IUD insertion. FUNDING SOURCE: Bayer AG. CLINICAL TRIAL REGISTRATION: EU PAS register, EUPAS33461.

Use of uterine manipulator and uterine perforation in minimally invasive endometrial cancer surgery.

OBJECTIVE: Safety of the uterine manipulator (UM) within endometrial cancer (EC) surgery is being questioned. Its use might be one of the issues for potential tumor dissemination during the procedure, especially in the case of uterine perforation (UP). No prospective data on this surgical complication, nor on the oncological consequences exist. The aim of this study was to assess the rate of UP while using UM when performing surgery for EC and the impact of UP on the choice of adjuvant treatment. METHODS: We conducted a prospective single-center cohort study from November 2018 to February 2022, considering all EC cases surgically treated by a minimally invasive approach with the help of a UM. Demographic, preoperative, postoperative and adjuvant treatment corresponding to the included patients were collected and comparatively analyzed according to the absence or presence of a UP. RESULTS: Of the 82 patients included in the study, 9 UPs (11%) occurred during surgery. There was no significant difference in demographics and disease characteristics at diagnosis that may have induced UP. The type of UM used or the approach (laparoscopic vs. robotic) did not influence the occurrence of UP (p = 0.44). No positive peritoneal cytology was found post hysterectomy. There was a statistically significantly higher rate of lymph-vascular space invasion within the perforation group, 67% vs. 25% in the no perforation group, p = 0.02. Two out of nine (22%) adjuvant therapies were changed because of UP. The median follow-up time for patients was 7.6 months (range 0.5-33.1 months). No recurrence was found in the UP group. CONCLUSION: Our study found a uterine perforation rate of 11%. This information needs to be further integrated to consider the usefulness of MU for EC surgery.

Complete perforated bladder from intrauterine devices: A case series report from a nationwide monitoring system.

AIM: Complete perforation of the bladder caused by an intrauterine device (IUD) is rare. This study examined the characteristics of patients associated with IUD-related bladder perforation and evaluated the relationship between mislocated IUDs and their potential complications. METHODS: From October 2005 to December 2021, 13 reports regarding complete perforations to the bladder by IUDs were retrieved from the National Contraceptives Adverse Reaction Monitoring System of China. The clinical features of these cases were analyzed. RESULTS: The median patient age was 30 (range, 27-46) years. There were four cases (4/13, 30.8%) with IUDs placed during lactation, one case (1/13, 7.7%) with an IUD placed after medical abortion, and eight cases (8/13, 61.5%) placed after menstruation. Seven cases (7/13, 53.9%) were first-time IUD users. The median duration of IUD placement was 47 (range, 1-145) months. Unexpected pregnancy was reported in five cases (5/13, 38.5%). Six cases (6/13, 46.2%) reported bladder stones with varying degrees of abdominal pain or urinary tract infection. Removal methods included laparotomy (four cases), cystoscopy (four cases), laparoscopy (two cases), laparoscopy combined with cystoscopy (two cases), and laparotomy after cystoscopy (one case). All IUDs were successfully removed. CONCLUSIONS: Complete perforation to the bladder by IUDs is a rare adverse event. Regular follow-up is required after the placement of IUDs. The possibility of uterine perforation should be investigated if IUD users encounter persistent lower abdominal pain or urinary tract infection.

Intrauterine device-related uterine perforation incidence and risk (APEX-IUD): a large multisite cohort study.

BACKGROUND: Reports of perforation risk related to intrauterine devices (IUDs) inserted immediately post partum and among non-post-partum individuals are scarce, and previous studies with only 12-month follow-ups underestimate the risk. Breastfeeding at IUD insertion and insertion within 36 weeks post partum have been associated with increased risk of uterine perforation. The aim of these analyses was to compare the incidence and risks of IUD-related uterine perforations by non-post-partum and post-partum intervals at IUD insertion, and among post-partum individuals, to assess the impact of breastfeeding on these outcomes. METHODS: We did a multisite cohort study in the USA, using electronic health records (EHR). Study sites were three health-care systems and a site that used data from a health-care information exchange. The study population included individuals who were aged 50 years or younger and had an IUD insertion between Jan 1, 2001, and April 30, 2018. Individuals were excluded if they had not been in the health-care system for at least 12 months before IUD insertion. The primary outcome for this analysis was any IUD-related uterine perforation diagnosis for the first IUD insertion in this time period. Both complete and partial IUD-related perforations were identified. Chart abstraction was done to validate EHR-based algorithms or confirm perforations. The crude rate and cumulative incidence of uterine perforation were evaluated by non-post-partum and post-partum intervals at IUD insertion in the full cohort, and by breastfeeding status in a subcohort of post-partum individuals. Cox models estimated crude and adjusted hazard ratios (aHRs). FINDINGS: Data from 326 658 individuals in the full cohort and 94 817 individuals in the post-partum subcohort were analysed. In the full cohort, we identified 1008 uterine perforations (51·2% complete), with the 5-year cumulative incidence being the lowest in the non-post-partum group (0·29%, 95% CI 0·26-0·34). The aHR for the post-partum interval relative to non-post partum ranged from 2·73 (95% CI 1·33-5·63; 0 to 3 days post partum) to 6·71 (4·80-9·38; 4 days to ≤6 weeks post partum). The post-partum subcohort of individuals with breastfeeding information had 673 uterine perforations (62% complete), with a 5-year cumulative incidence of 1·37% (95% CI 1·24-1·52) and an increased risk with breastfeeding (aHR 1·37, 95% CI 1·12-1·66). INTERPRETATION: Although the risk for uterine perforation with IUD insertion 4 days to 6 weeks or less post partum is nearly seven times that of insertion non-post partum, perforation remains an incredibly rare event for all clinical time points. Despite a slight increased risk of perforation with breastfeeding at IUD insertion, the benefits of breastfeeding and effective contraception generally outweigh risks and should have little clinical impact. Therefore, IUD insertion timing should be based on individual desire for IUD contraception and patient convenience to assure an IUD insertion can occur. Careful follow-up of individuals at higher risk of uterine perforation is warranted. FUNDING: Bayer AG.

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.

Complications after interval postpartum intrauterine device insertion.

BACKGROUND: In the United States, up to 57% of women report resumption of sexual activity by the 6 week postpartum visit. Effective contraception should be addressed and provided at that time, to avoid unintended pregnancies and optimize interpregnancy intervals. Long-acting reversible contraceptives are the most effective forms of reversible contraception and are increasingly popular during the postpartum period. However, timing of postpartum intrauterine device (IUD) placement varies among providers and many delay insertion due to concerns for uterine perforation or expulsion of the IUD. OBJECTIVE: This study aimed to evaluate uterine perforation and expulsion rates with IUD insertion at 4-8 weeks postpartum vs 9-36 weeks postpartum. STUDY DESIGN: We performed a retrospective cohort study using the Kaiser Permanente Southern California electronic medical record from 2010 to 2016. We calculated the proportion of perforations and expulsions with IUD insertion at 4-8 weeks vs 9-36 weeks postpartum. Our primary outcome was the perforation rate. Secondarily, we evaluated the expulsion rate. For our minimum sample size calculation, to detect a difference of 0.5% in the perforation rate, with a baseline perforation rate of 0.5% for the 9-36 week postpartum IUD placement group, 80% power, and 5% alpha error rate, we would need at least 4221 participants per group, 8442 in total. RESULTS: A total of 24,959 patients met inclusion criteria (n=13,180 in the 4-8 week group, n=11,777 in the 9-36 week group). Of 430 patients with a confirmed complication, 157 uterine perforations and 273 IUD expulsions were identified. Perforation rates were significantly higher with placement at 4-8 weeks than at 9-36 weeks (0.78% vs 0.46%; P=.001). After adjusting for race and ethnicity, breastfeeding, IUD type, provider type, parity, most recent delivery, and body mass index, the odds of perforation remained higher with placement at 4-8 weeks than at 9-36 weeks (adjusted odds ratio, 1.92; 95% confidence interval, 1.28-2.89). Our Kaplan-Meier survival curve showed that the risk of uterine perforation remained elevated until approximately 22-23 weeks postpartum. Expulsion rates were similar between the 2 groups (1.02 vs 1.17; P=.52). CONCLUSION: Uterine perforation after interval postpartum IUD insertion is greater at 4-8 weeks than at 9-36 weeks, although perforation rates remain low at <1%. Expulsion rates did not differ between the groups. Because overall rates of uterine perforation are low, women can safely be offered IUDs at any interval beyond 4 weeks with minimal concern for perforation.

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.

A phase III randomised trial of trans-abdominal ultrasound in improving application quality and dosimetry of intra-cavitary brachytherapy in locally advanced cervical cancer.

INTRODUCTION: Intra-cavitary brachytherapy (ICB) remains an integral part of radiotherapy treatment in cervical cancer. Two-dimensional X ray point-based planning remains common and blind insertion leads to uterine perforations and higher toxicity. We conducted a randomised controlled trial of using trans-abdominal ultrasound in performing ICB to reduce perforation and organ at risk doses. PATIENT AND METHODS: The present study is a phase III open label randomised controlled trial of ultrasound guided ICB conducted on invasive cervical cancer patients. Patients were randomised by a simple computer-generated randomization chart into Arm A (No Ultrasound guidance) and Arm B (ICB with ultrasound guidance). The uterine perforation rates, tandem length change rates, bladder doses, rectal dose and procedure times were compared. Fischer exact test was used to compare the arms and p value <0.05 considered significant. RESULTS: A total of 160 patients were randomised. With US assistance, the uterine perforation rate was 1.25% (n = 1). In the non-US assistance arm the perforation rate was 12.5% (n = 10) (p = 0.005). Mean time to complete the entire procedure was significantly shortened from 26 min to 19 min favouring the US arm (p = 0.001). Dosimetric assessment between the two groups showed significant decrease in dose received by the various organs at risk with US assistance. CONCLUSION: The present study confirms significant improvement in application quality as well as dosimetry with reduction in procedure time. Trans-Abdominal US should be routinely used for ICB procedures, particularly in resource limited settings.

Migración de dispositivo intrauterino a vejiga / Intrauterine device migration to bladder

Introducción: La litiasis vesical secundaria se forma en el reservorio vesical y requiere la existencia de condiciones patológicas previas como lo son los cuerpos extraños. Objetivo: Describir dos casos clínicos de litiasis vesical secundaria a migración de un dispositivo intrauterino. Caso clínico: Se presentan dos casos de migración intravesical de dispositivo intrauterino con litiasis vesical secundaria. Se diagnosticaron años después de su inserción, ante la aparición de dolor pélvico, cistitis a repetición y hematuria. La laparoscopia no fue útil para su diagnóstico. En consulta de Urología la ultrasonografía y la radiografía de pelvis fueron herramientas diagnósticas útiles ante la sospecha inicial de esta patología. Presentaron buena evolución y regresión total de los síntomas tras cistolitotomía suprapúbica. Conclusión: Se debe pensar en la posibilidad de migración de un dispositivo intrauterino a vejiga ante la cronicidad de síntomas urinarios irritativos bajos en toda mujer que emplee este método anticonceptivo y desconozca su paradero(AU)

Introduction: Secondary bladder lithiasis is formed in the bladder reservoir and requires the existence of previous pathological conditions such as foreign bodies. Objective: To describe two clinical cases of bladder lithiasis secondary to intrauterine device migration. Clinical case report: Two cases of intravesical migration of an intrauterine device with secondary bladder stones are reported. They were diagnosed years after insertion, due to the appearance of pelvic pain, recurrent cystitis and hematuria. Laparoscopy was not helpful for its diagnosis. In Urology consultation, ultrasound and pelvic radiography were useful diagnostic tools in the event of the initial suspicion of this pathology. They showed good evolution and total regression of symptoms after suprapubic cystolithotomy. Conclusion: The possibility of an intrauterine device migration to the bladder should be considered when chronicity of irritative low urinary symptoms in every woman who uses this contraceptive method and which locations are unknown(AU)

Homelessness, housing instability, and abortion outcomes at an urban abortion clinic in the United States.

BACKGROUND: Adverse reproductive health outcomes are well documented among people experiencing homelessness or housing instability. Little is known about abortion outcomes among this population. OBJECTIVE: This study aimed to investigate the relationship between housing status and abortion outcomes and whether gestational age mediates this relationship. STUDY DESIGN: Our sample comprised 1903 individuals who had abortions at an urban clinic in San Francisco, CA, from 2015 to 2017. We defined homelessness or housing instability as a binary exposure, which included staying outside, with friends and/or family, or in a tent, vehicle, shelter, transitional program, or hotel. We evaluated gestational duration of ≥20 weeks as a mediator variable. Our primary outcome was any abortion complication. Logistic regression models were adjusted for age, race, substance use, mental health diagnoses, and previous vaginal and cesarean deliveries. RESULTS: Approximately 19% (n=356) of abortions were among people experiencing homelessness or housing instability. Compared with those with stable housing, people experiencing homelessness or housing instability presented later in pregnancy (mean gestational duration, 13.3 vs 9.5 weeks; P<.001) and had more frequent complications (6.5% vs 2.8%; P<.001; odds ratio, 2.2; 95% confidence interval, 1.2-3.9). Adjusting for race, substance use, mental health diagnoses, and previous cesarean deliveries, individuals experiencing homelessness or housing instability were more likely to have abortion complications (odds ratio, 2.3; 95% confidence interval, 1.3-4.0). However, the relationship was attenuated after adjusting for gestational duration (odds ratio, 1.4; 95% confidence interval, 0.7-2.6), suggesting that gestational duration mediates the relationship between housing status and abortion complications. CONCLUSION: Patients experiencing homelessness or housing instability presented later in gestation, which seems to contribute to the increased frequency of abortion complications.

Impact of suboptimal tandem implantation on local control and complications in intracavitary brachytherapy for cervix cancer.

PURPOSE: Correct tandem implantation for cervix cancer intracavitary brachytherapy may be challenging. We investigated whether suboptimal implantation can be related to patient and disease characteristics and may result in subsequent underutilization of brachytherapy in cervical cancer. METHODS AND MATERIALS: Consecutive cervix cancer patients referred for intracavitary brachytherapy after external beam radiation therapy performed in several general hospitals from 2013 to 2017 were included. RESULTS: In 172 patients having 301 procedures, 95 implantations were suboptimal (15% inadequate tandem insertions, 10% subserosal insertion, and 6% uterine perforation on postimplant CT scan). Risk factors were age, myometrium invasion, and uterine retroversion. Median followup was 21 months. Three-year local control and survival rates were 72% and 85%, respectively. Forty-seven patients (27%) failed to receive brachytherapy. Failure to perform brachytherapy was associated with poorer local control (OR = 0.34 [0.17-0.67], p = 0.001). By contrast, suboptimal implantation did not increase local failure or toxicity rates in patients undergoing brachytherapy. No peritoneal carcinomatosis occurred after uterine perforation in our cohort. CONCLUSIONS: Suboptimal implantation was frequent. In the absence of image guidance during implantation, conversion to other treatment modalities (including external beam radiation therapy) due to insertion difficulties resulted in worse local control. With optimization, however, suboptimal brachytherapy implantation did not result in suboptimal dose coverage or poorer local control. Failure to perform a brachytherapy boost correlates with increased local failure risk in patients with cervix cancer, whereas tandem malposition does not. Real-time intraoperative ultrasound guidance may be useful to reduce uterine perforation rates and thus increase brachytherapy use.

Safety of levonorgestrel 52 mg intrauterine system compared to copper intrauterine device: a population-based cohort study.

OBJECTIVE: To compare the risk of all-cause death, hospitalizations (any cause), ectopic pregnancy, pelvic inflammatory disease or infection, uterine perforation, device removal, neuro-psychiatric drugs initiation, or new psychiatric visit(s) between levonorgestrel (LNG) 52 mg intrauterine system (IUS) and copper intrauterine device (IUD) users in France. STUDY DESIGN: We identified a historical cohort of women aged 20-55 years with a first dispensing of either LNG 52 mg IUS or copper-IUD between January 1, 2010, and December 31, 2014, in the French National Claims database, SNDS. We used propensity score matching to balance the two groups on baseline sociodemographic and clinical characteristics to minimize confounding. We estimated Cox proportional hazards models to compare health outcomes between LNG 52 mg IUS and copper-IUDs users. RESULTS: We matched 9318 LNG 52 mg IUS users (mean age 36.2±6.8 years) to 10,185 copper-IUD users (mean age 35.4±7.1 years). After matching and age-adjustment, LNG 52 mg IUS users had a slightly higher risk of anxiolytic drugs initiation (HR 1.08, 95%CI 1.01-1.15) and device removal (HR 1.05, 95%CI 1.01-1.10) compared to copper-IUD users, with no differences for other studied outcomes. CONCLUSION: French IUS users report slightly more anxiolytic treatment initiation and IUD removal compared to copper-IUD users. These results are consistent with a potential pharmacovigilance signal of anxiety-related disorders in LNG 52 mg IUS users. IMPLICATIONS STATEMENT: In French LNG 52 mg IUS users, there was slightly more anxiolytic treatment initiation and IUD removal compared to copper-IUD users. No risk difference was found for all-cause death, hospitalizations, ectopic pregnancy, pelvic disorders, and uterine perforation. We cannot exclude that the associations are related to differences in characteristics of women who chose each type of type of IUD.

Effectiveness of Hysteroscopic Techniques for Endometrial Polyp Removal: The Italian Multicenter Trial.

STUDY OBJECTIVE: To compare the effectiveness and safety of different techniques of hysteroscopic polypectomy. DESIGN: Multicenter, prospective observational trial (Canadian Task Force classification II-2). SETTING: Nineteen Italian gynecologic departments (university-affiliated or public hospitals). PATIENTS: Consecutive patients suffering from endometrial polyps (EPs). INTERVENTIONS: Hysteroscopic polypectomy, as performed through different techniques. MEASUREMENTS AND MAIN RESULTS: Included in the study were 1404 patients (with 1825 EPs). The setting was an ambulatory care unit in 40.38% of the cases (567 women), of whom 97.7% (554) did not require analgesia/anesthesia. In the remaining 59.62% of women (837 women), the procedures were performed in an operating room under mild sedation, local or general anesthesia. Minor complications occurred in 32 patients (2.27%), without significant differences between the techniques used (p = ns). Uterine perforation occurred in 14 cases, all performed in the operating room with some kind of anesthesia, only 1 with a vaginoscopic technique and the remaining during blind dilatation (odds ratio [OR], 19.98; 95% confidence interval [CI], 1.19-335.79; p = .04). An incomplete removal of EPs was documented in 39 patients. Logistic regression analysis showed that a higher risk of residual EPs was associated with the use of a fiber-based 3.5-mm hysteroscope (OR, 6.78; 95% CI, 2.97-15.52; p <.001), the outpatient setting (OR, 2.17; 95% CI, 1.14-4.14; p = .019), and EPs located at the tubal corner (OR, 1.98; 95% CI, 1.03-2.79; p = .039). No association between incomplete EP removal and EP size or number was recorded (p = ns), as well as with the other variables evaluated. CONCLUSION: Outpatient polypectomy was associated with a minimal but significantly higher risk of residual EPs in comparison with inpatient polypectomy. Conversely, inpatient polypectomy was associated with a considerably higher risk of uterine perforation and penetration in comparison with office hysteroscopy. Because of lower intraoperative risks and higher cost-effectiveness, office hysteroscopy may be considered, whenever possible, as the gold standard technique for removing EPs.

IUD use among parous women and risk of uterine perforation: a secondary analysis.

OBJECTIVE: The objective of the study was to determine if delivery and lactation are risk factors for complete intrauterine device perforations. STUDY DESIGN: We performed a reanalysis of the European Active Surveillance Study on Intra-Uterine Devices data set using complete penetration of the myometrium as the definition for perforation. RESULTS: Of the 61,448 women enrolled (70% levonorgestrel, 30% copper devices), we identified 58 complete perforations, 30 of which occurred in lactating women. Incidence per 1000 insertions was 4.5 (95% confidence interval [CI]: 3.0-6.4) for lactating and 0.6 (95% CI: 0.4-0.9) for nonlactating women. Time since delivery was also associated with perforation risk. CONCLUSIONS: Lactation and delivery are independent cofactors for perforation. Results do not differ when restricting the definition of perforation.

Perforation risk and intra-uterine devices: results of the EURAS-IUD 5-year extension study.

OBJECTIVES: The objective of this analysis was to identify intra-uterine devices (IUD) perforations detected from 12 to 60 months following IUD insertion, and to combine this information with (our previously published) data about perforations detected in the first 12 months to calculate cumulative perforation rates. METHODS AND MATERIALS: Prospective, non-interventional cohort study with new users of levonorgestrel-releasing intra-uterine systems (LNG-IUS) and copper-IUD. The original cohort included 61,448 women followed for 12 months. Of these, we had sufficient resources to perform an additional follow-up and analysis at 60 months in 39,009 women. Inclusion criteria for this analysis was insertion prior to 31 July 2010. All potential cases were validated via the health care professional or medical records. Crude and adjusted relative risks were calculated using a logistic regression model. RESULTS: We identified 23 additional perforations (19 LNG-IUS and 4 copper-IUD) more than 12 months after insertion. Added to perforations detected at 12 months, the overall perforation rate was 2.1 per 1000 insertions (95% CI: 1.6-2.8) for LNG-IUS users (40 + 19 perforations/27,630 insertions) and 1.6 per 1000 insertions (95% CI: 0.9-2.5) for copper-IUD users (14 + 4 perforations/11,379 insertions). LNG-IUS users had a borderline higher risk of perforation compared with copper-IUD users (ORadj 1.7; 95% CI: 1.0-2.8). Forty-five (58%) of the 77 perforations were associated with suspected risk factors. Breastfeeding (RR 4.9, 95% CI: 3.0-7.8) and time since delivery (RR 3.0, CI: 1.5-5.4) remained significant risk factors in perforations detected after 12 months. No perforations resulted in serious injury to intra-abdominal or pelvic structures. CONCLUSIONS: The incidence of uterine perforations in this study was low, although higher than the commonly reported rate. Approximately one third of perforations are detected 12 months after insertion. Clinical sequalae of perforations are generally mild and associated with a very low risk of injury to intra-abdominal and pelvic structures. Implications Uterine perforation is a rare risk associated with intra-uterine device use. Late diagnosed perforations can occur, although women can be reassured that the morbidity associated with detection and removal is low.

Ultrasound guidance during hysteroscopic myomectomy in G1 and G2 Submucous Myomas: for a safer one step surgery.

OBJECTIVE: Hysteroscopic myomectomy is the gold standard method for treatment of submucous fibroids. Hysteroscopic myomectomy techniques for removal of submucous fibroids still have controversies. In this study we aimed to describe usefulness of ultrasound guidance in hysteroscopic myomectomy for a safe and effective removal of submucous G1 and G2 fibroids. STUDY DESIGN: This is a multicentre study. 64 symptomatic patients with submucous fibroid underwent ultrasound guided hysteroscopic myomectomy. First we excised intrauterine dome of fibroid until reaching the level of cavity wall by the method of resectoscopic (electrosurgical resection using a loop electrode) slicing. Next remnant intramural node was squeezed by uterine contractions induced. After we had excised the intrauterine dome of fibroid by slicing method, we formed cavitation for the intramural part (newly raised myoma dome). The cavity was filled with distension solution and we evaluated the margins of the uterus and the margins of the myoma by sonographically. Then the myoma was excised under ultrasonographic guidance by transabdominal probe. We obtained a regular uterine cavity. RESULTS: Mean operation time was 42±7min. Mean Mannitol volume was 4.3±1.7l and the mean intraoperational fluid deficit was 500ml. Not in any case uterine perforation was occurred. All fibroids removed totally. In 8 (19%) cases intrauterine synechiae detected and all these synechiaes were incised by a scissor during hysteroscopy. CONCLUSION: There is still no single technique proven to be unequivocally superior to the others for treating fibroids with intramural development (G1-G2). Ultrasound guided hysteroscopy seems to be an effective and safe method for resection of G1 and G2 fibroids.

Facility-based treatment for medical complications resulting from unsafe pregnancy termination in the developing world, 2012: a review of evidence from 26 countries.

UNLABELLED: With changing conditions affecting receipt of postabortion care, an updated estimate of the incidence of treatment for complications from unsafe pregnancy termination is needed to inform policies and programmes. National estimates of facility-based treatment for complications in 26 countries form the basis for estimating treatment rates in the developing world. An estimated seven million women were treated in the developing world for complications from unsafe pregnancy termination in 2012, a rate of 6.9 per 1000 women aged 15-44 years. Regionally, rates ranged from 5.3 in Latin America and the Caribbean to 8.2 in Asia. Results inform policies to improve women's health. TWEETABLE ABSTRACT: An estimated 7 million women were treated in the developing world for complications of unsafe TOP in 2012.

Use of Oral Misoprostol for Cervical Priming before Hysteroscopy: A Randomized Comparison of Two Dosages.

OBJECTIVE: The study aims to compare the safety and effectiveness of 200 and 400 µg of oral misoprostol for cervical priming before hysteroscopy. METHODS: A double-blinded randomized study included 70 patients scheduled for hysteroscopy in a Lebanese University Hospital. Two dosages of oral misoprostol (200 or 400 µg) were randomly distributed to these patients 1 h before surgery under general anesthesia. Subjective assessment of the ease of dilatation, size of the first used Hegar, cervical injuries, bleeding or uterine perforation, duration of the procedure and misoprostol adverse effect were all noted and compared. RESULTS: The difficulty of dilation until a Hegar 10 was similar for both treatment groups. Operative time was not reduced with a higher misoprostol dosage. We found 2 uterine perforations within the 200 µg group (6.7%), and none within the 400 µg group. Cervical lacerations and bleeding were similar (20%) for both treatment groups. A 2-fold increase in side effects (nausea, vomiting and cramps) is reported among the 400 µg group. CONCLUSIONS: Increasing the dose of misoprostol from 200 to 400 mg doubled the rate of side effects while no clinical benefit was noted. Larger trials are needed to assess rates of uterine perforation with the 200 µg dosage.

Complications from first-trimester aspiration abortion: a systematic review of the literature.

OBJECTIVE: We conducted a systematic review to examine the prevalence of minor and major complications following first-trimester aspiration abortion requiring medical or surgical intervention. STUDY DESIGN: We searched PubMed, Cumulative Index to Nursing and Allied Health Literature, Scopus and the Cochrane Library for articles published between 1980 and April 2015 that reported on repeat aspiration, hemorrhage, infection, cervical/vaginal trauma, uterine perforation, abdominal surgery, hospitalization, anesthesia-related complications and death. We limited our review to studies that included ≥100 abortions performed by physicians in North America, Western Europe, Scandinavia and Australia/New Zealand. We compared the prevalence of complications that required additional interventions for abortions performed in office-based clinics and surgical center or hospital clinic settings. RESULTS: From 11,369 articles retrieved, 57 studies met our inclusion criteria. Evidence from 36 studies suggests that ≤3.0% of procedures performed in any setting necessitates repeat aspiration. Hemorrhage not requiring transfusion occurred in 0-4.7% of office-based procedures and 0-4.1% of hospital-based procedures but was ≤1.0% in 23 studies. Major complications requiring intervention, including hemorrhage requiring transfusion and uterine perforation needing repair, occurred in ≤0.1% of procedures, and hospitalization was necessary in ≤0.5% of cases in most studies. Anesthesia-related complications occurred in ≤0.2% of procedures in six office-based studies and ≤0.5% of procedures performed in surgical centers or hospital-based clinics. No abortion-related deaths were reported. CONCLUSIONS: The percentage of first-trimester aspiration abortions that required interventions for minor and major complications was very low. Overall, the prevalence of major complications was similar across clinic contexts, indicating that this procedure can be safely performed in an office setting. IMPLICATIONS: Laws requiring abortion providers to have hospital admitting privileges or facilities to meet ambulatory surgical center standards would be unlikely to improve the safety of first-trimester aspiration abortion in office settings.