Risk of Stroke in Women Using Levonorgestrel-Releasing Intrauterine Device for Contraception.

BACKGROUND: The commonly used combined hormonal contraceptives with progestins and ethinylestradiol are associated with an increased risk of ischemic stroke (IS). Progestin-only preparations, including levonorgestrel-releasing intrauterine devices (LG-IUDs), are not associated with an increased risk, and in smaller studies, the risk is even reduced. The risk of intracerebral hemorrhage (ICH) has never been investigated. We studied the risk of IS and ICH in women using LG-IUDs compared with women not using hormonal contraceptives. METHODS: In this Danish historical cohort study (2004-2021), we followed nonpregnant women (18-49 years) registering incident IS and ICH in relation to use of LG-IUDs/nonuse of hormonal contraceptives utilizing Danish high-quality registries with nationwide coverage. Poisson regression models adjusting for age, ethnicity, education, calendar year, and medication use for risk factors were applied. RESULTS: A total of 1 681 611 nonpregnant women contributed 11 971 745 person-years (py) of observation. Mean age at inclusion was 30.0 years; mean length of follow-up was 7.1 years; 2916 women (24.4 per 100 000 py) had IS; 367 (3.1 per 100 000 py) had ICH. Of these, 364 784 were users of LG-IUD contributing 1 720 311 py to the investigation; mean age at start of usage was 34.6 years. Nonusers of hormonal contraceptives contributed 10 251 434 py; mean age at inclusion was 30.0 years. The incidence rate of IS/ICH among LG-IUD users was 19.2/3.0 and among nonusers, it was 25.2/3.1 per 100 000 py. After adjustment, incidence rate ratio for IS was 0.78 (CI, 0.70-0.88), and for ICH it was 0.94 (CI, 0.69-1.28). CONCLUSIONS: The use of LG-IUD was associated with a 22% lower incidence rate of IS without raising the incidence rate of ICH. The finding raises the question of whether levonorgestrel, in addition to its contraceptive properties, could have the potential to prevent IS.

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

BACKGROUND: International guidelines recommend placement of intrauterine devices immediately after second-trimester medical abortion, but evidence concerning the optimal time for intrauterine device placement is lacking from clinical trials. OBJECTIVE: This study aimed to investigate effectiveness, safety, and acceptability of intrauterine device placement within 48 hours, compared with placement at 2 to 4 weeks after second-trimester medical abortion. We hypothesized that intrauterine device placement within 48 hours would be superior compared with placement at 2 to 4 weeks after the abortion, in terms of the proportion of intrauterine device use after 6 months, with maintained safety and acceptability. STUDY DESIGN: In this open-label, randomized, controlled, superiority trial, we recruited participants at 8 abortion clinics in Sweden. Eligible participants were aged ≥18 years, requesting medical abortion with gestation ≥85 days, and opting for use of a postabortion intrauterine device. Participants were randomized (1:1) to intrauterine device placement either within 48 hours of complete abortion (intervention) or after 2 to 4 weeks (control). Our primary outcome was self-reported use of an intrauterine device after 6 months. Secondary outcomes included expulsion rates, pain at placement, adverse events and complications, acceptability, and subsequent pregnancies and abortions. Differences in nonnormal 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 <.05 was considered statistically significant. Group differences are presented by modified intention-to-treat and per-protocol analyses. RESULTS: Between January 2019 and June 2022, we enrolled 179 participants, of whom 90 were assigned to the intervention and 89 to the control arm. Enrollment was prematurely stopped after an interim analysis exceeded a predefined intrauterine device expulsion rate of 20%. According to modified intention-to-treat analysis, use of intrauterine device after 6 months was 50.7% (34/67) in the intervention group vs 71.6% (48/67) in the control group (proportion difference, 20.9%; 95% confidence interval, 4.4%-35.9%; P=.02). The intrauterine device expulsion rate was 30.1% (22/73) in the intervention group vs 2.9% (2/70; P<.001) in the control group. Other adverse events were rare and patient acceptability was high in both groups. CONCLUSION: Intrauterine device placement within 48 hours after second-trimester medical abortion was nonsuperior in terms of the proportion of intrauterine device use after 6 months when compared with placement after 2 to 4 weeks. Placement within 48 hours after second-trimester abortion can be used in selected individuals after counseling on expulsion risk.

Mepivacaine instillation for pain reduction during intrauterine device placement in nulliparous women: a double-blinded randomized trial.

BACKGROUND: Fear of pain associated with intrauterine device (IUD) placement has been identified as a significant barrier to the adoption of long-acting reversible contraception, contributing to lower utilization of the most effective reversible contraceptive methods. OBJECTIVE: To assess whether instillation of intrauterine mepivacaine before IUD placement alleviates pain more effectively than a placebo. STUDY DESIGN: We conducted a multicenter, double-blind, randomized, placebo-controlled trial involving nulliparous women undergoing IUD placement. An intrauterine instillation of 10 mL of 20 mg/mL mepivacaine or 0.9 mg/mL sodium chloride was administrated through a hydrosonography catheter 2 minutes prior to IUD placement. Pain scores were assessed using a 100 mm visual analog scale (VAS) at prespecified time points. Primary outcome measured the difference in VAS pain scores between the intervention group and the placebo group during IUD placement. Secondary outcomes included VAS pain scores at instillation and 10 minutes after placement, tolerability of the placement pain, as well as acceptability of the analgesia method. RESULTS: We enrolled 151 participants, with 76 assigned to the mepivacaine group and 75 to the placebo group. The mean VAS pain score during IUD placement showed a difference of 13.3 mm (95% confidence interval (CI) 5.75-20.87; P<.001): the mepivacaine group had a mean of 53.9 mm (standard deviation [SD] 22.8), while the placebo group had a mean of 67.2 mm (SD 22.4). After adjusting for each individual provider's impact, the difference in mean pain scores remained statistically significant (12.2 mm 95% CI 4.85-19.62; P<.001). A greater proportion of women in the intervention group reported tolerable pain during placement with 70/75 participants (93.3%) compared to 53/66 participants (80.3%) in the placebo group (P=.021). CONCLUSION: The intrauterine instillation of mepivacaine results in statistically significant reduction in pain score among nulliparous women during IUD placement. Although the precise clinical impact of this pain reduction method remains uncertain, the observed reduction in pain score result in a higher proportion of women reporting tolerable pain. This finding and the high acceptance as a pain reduction method thereby suggests clinical relevance. Intrauterine instillation of mepivacaine is a possible strategy to increase IUD utilization, particularly among nulliparous women who are at high risk of unintended pregnancy.

Sexual function, quality of life, anxiety, and depression in women of reproductive age using hormonal, nonhormonal, and no contraceptive methods.

BACKGROUND: Hormonal contraceptive use has been related to adverse effects, including impacts on sexual function and sexual satisfaction, although the difference in the effects on sexual function with the use of hormonal vs nonhormonal contraceptive methods remains controversial. AIM: In this study we sought to compare the prevalence of dyspareunia, sexual function, sexual satisfaction, quality of life, anxiety, and depression between women using hormonal, nonhormonal, or no contraceptive methods and to compare these outcomes between the most frequently used contraceptive methods. METHODS: This cross-sectional study included sexually active women of reproductive age who were stratified into 3 groups: women using hormonal, nonhormonal, or no contraceptive methods. Based on the use of questionnaires administered to the study participants, we compared sexual function in the 3 groups and more specifically among users of oral contraceptives, copper and hormonal intrauterine devices, and barrier methods. OUTCOMES: Participants completed 4 questionnaires to assess sexual function (Female Sexual Function Index), sexual satisfaction (Sexual Quotient-Feminine Version), quality of life (12-item Medical Outcomes Short Form Health Survey), and anxiety and depression (Hospital Anxiety and Depression Scale). RESULTS: This study included 315 women classified into 3 groups on the basis of contraceptive use: 161 in the hormonal contraceptives group (median [interquartile range] age, 24 [23-28] years), 97 in the nonhormonal contraceptives group (age 26 [23-30] years), and 57 in the no contraceptive methods group (age 28 [24-35] years). Dyspareunia prevalence showed no difference between the groups. In the quality of life domain, compared with women in the nonhormonal contraceptive group, women in the hormonal contraceptive group were younger and had lower sexual function satisfaction, reduced arousal, and heightened pain (P < .05), as well as higher anxiety and depression levels (P = .03, for both), increased pain (P = .01), and poorer overall health (P = .01). No difference was found between these groups in other quality of life domains. Regarding contraceptive methods, women using copper intrauterine devices had better sexual function, including higher rates of arousal and lower anxiety, than women using oral contraceptives (P < .05). CLINICAL IMPLICATIONS: The results of this study highlight worse sexual function and sexual satisfaction and higher levels of anxiety and depression in women using hormonal contraceptive methods than in women using nonhormonal methods. STRENGTHS AND LIMITATIONS: The findings of this study strengthen the evidence of differences in sexual function between women using oral contraceptives and those using copper intrauterine devices. Sexual function was also compared among users of oral contraceptives, copper and hormonal intrauterine devices, and barrier methods. However, less frequently used contraceptive methods, such as hormonal injections and vaginal rings, could not be compared in this sample. CONCLUSION: Women using hormonal contraceptive methods were younger, had lower sexual function and satisfaction, and experienced higher anxiety and depression levels than women using nonhormonal contraceptive methods.

Risk factors of uterine perforation when using contraceptive intrauterine devices.

BACKGROUND: Intrauterine devices (IUDs) are one of the most popular methods of contraception, and uterine perforation has been presented among the most significant potential complications of IUD use. The aim of this study is to evaluate the risk factors of uterine perforation when using an IUD. METHODS: In this retrospective study, all 164 women who have referred to Al-Zahra hospital in Tabriz- Iran to remove the retained IUD from March 2018 to March 2021, were investigated in two groups. Patients in case group underwent surgery to remove the dislocated device and management of its complications. In control group, the devices were removed using a Novak or ring forceps with or without hysteroscopy with no uterine perforation. Data were analyzed using SPSS software, and P < 0.05 was considered statistically significant. P-Value was obtained for qualitative data via Fisher's exact test and Chi-Squared test and for quantitative data via Mann-Whitney U test and independent T-test. RESULTS: The mean age of patients in the groups with or without uterine perforation was 30.57 and 36.78 years respectively (P = 0.01). The frequency of two or more parities among patients with uterine perforation was higher than other patients (P = 0.13). Ultrasound study before (p = 0.037) and after (p = 0.007) IUD insertion was higher among patients without uterine perforation. The less inexperience of healthcare providers (P = 0.013) and lack of scheduled follow-up visits after the IUD insertion (P < 0.001), are the other important factors affecting the uterine perforation. Abdominal pain was the most common compliant of uterine perforation (P < 0.001) and laparoscopy was the most used surgery to remove the misplaced device. CONCLUSION: Uterine perforation can be effectively prevented by hiring experienced health care providers and appropriate patient selection.

Pain relief during intrauterine device placement in nulligravid women with both oral ketorolac and an analgesic: a double-blinded randomised trial.

OBJECTIVE: We assessed whether the administration of oral ketorolac with an analgesic provides effective pain relief during placement of an intrauterine device (IUD) in nulligravid women. METHODS: We conducted a double-blinded randomised trial in the Department of Obstetrics and Gynaecology, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil. We randomised participants who voluntarily agreed to participate to receive either one pill containing ketorolac 20 mg together with one pill containing dipyrone 300 mg, scopolamine 6.5 µg, hyoscyamine 104 µg, and homatropine 1 mg or placebo 60 min before IUD placement. The participants and providers were blinded to the randomisation group. The primary outcome was pain assessment (measured on a 0-10 visual analogue scale) during IUD placement. RESULTS: We enrolled participants and randomised them 1:1 between November 7, 2023, and January 31, 2024. We analysed 60 women in each group. There were no differences between the groups in the pain score during tenaculum placement, uterine sounding, and IUD placement, and in the overall perception of pain. However, the pain score was significantly lower 10 min after the procedure in women who received the treatment compared with women who received the placebo. CONCLUSION: Oral ketorolac associated with an analgesic administered 60 min before IUD placement was not significantly better than placebo during tenaculum placement, uterine sounding, and IUD insertion, and did not significantly reduce the overall pain perception. However, this treatment did significantly reduce pain 10 min after the procedure. TRIAL REGISTRATION: The trial was registered at Registro Brasileiro de Ensaios Clínicos (REBEC; in English: The Brazilian Registry of Clinical Trials) under number RBR-7phn8yv on November 6, 2023. https://ensaiosclinicos.gov.br/rg/RBR-7phn8yv.

Pain at IUD placement after one pill containing ketorolac 20 mg together with one analgesic pill given 60 min before placement were similar than placebo.

The impact of using the levonorgestrel-releasing intrauterine device on the incidence of acne in adolescents and young women.

PURPOSE: To evaluate the impact of levonorgestrel-releasing intrauterine device (LNG-IUD) use on the incidence of acne in adolescents and young women. METHODS: A narrative review was conducted in PubMed, Embase, Cochrane, and SciELO assessing the incidence of acne in adolescents and young women using LNG-IUD (13.5, or 19.5 mg, or 52 mg). Cohort, cross-sectional studies, clinical trials, and meta-analyses were included, without a date limit. Studies that didn't evaluate women in the age of interest were excluded. Only articles in English were selected. RESULTS: Nine articles were included in this narrative review. Only clinical trials, cohort studies, and cross-sectional studies were evaluated. Two cross-sectional studies evaluated the incidence of acne in women using any contraceptive methods, with the incidence of acne being 36% in women aged 17 to 47 using LNG-IUD in one study. In another study, acne incidence ranged from 2 to 8% in women using any contraceptive methods, with higher rates in younger women and LNG-IUD users. The incidence of acne varies and participants between 16 to 35 years were more likely to report new acne or worsening of pre-existing acne. In a prospective cohort study of women between 16 and 24 years, acne was a common adverse effect, with 44% in the first year. CONCLUSION: The data indicate variability in the incidence of acne among LNG-IUD users, with a higher prevalence observed in younger women. Further research should focus on the effects of LNG-IUD on acne in young populations, with rigorous study designs and consideration of previous contraceptive use.

The levonorgestrel-releasing intrauterine device (LNG-IUD) is an important tool in the prevention of unplanned pregnancies in adolescents and young women. Acne is a possible adverse effect that could lead to discontinuation of the method.

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.

The effect of a combined indomethacin and levonorgestrel-releasing intrauterine system on short-term postplacement bleeding profile: a randomized proof-of-concept trial.

BACKGROUND: Long-acting reversible contraceptives, including hormonal levonorgestrel-releasing intrauterine systems, are the most effective methods of reversible contraception. However, unfavorable bleeding, particularly during the first months of use, is one of the most important reasons for discontinuation or avoidance. Minimizing this as early as possible would be highly beneficial. Nonsteroidal anti-inflammatory drugs inhibiting prostaglandin synthesis are known to reduce bleeding and pain at time of menses. A levonorgestrel-releasing intrauterine system has been developed with an additional reservoir containing indomethacin, designed to be released during the initial postplacement period. OBJECTIVE: This proof-of-concept study aimed to establish whether the addition of indomethacin to the currently available levonorgestrel-releasing intrauterine system (average in vivo levonorgestrel release rate of 8 µg/24 h during the first year of use) reduces the number of bleeding and spotting days during the first 90 days of use compared with the unmodified system. The dose-finding analysis included 3 doses of indomethacin-low (6.5 mg), middle (12.5 mg), and high (15.4 mg)-to determine the ideal dose of indomethacin to reduce bleeding and spotting days with minimal side-effects. STUDY DESIGN: This was a multicenter, single-blinded, randomized, controlled phase II trial conducted between June 2018 and June 2019 at 6 centers in Europe. Three indomethacin dose-ranging treatment groups (low-, middle-, and high-dose indomethacin/levonorgestrel-releasing intrauterine system) were compared with the unmodified levonorgestrel-releasing intrauterine system group, with participants randomized in a 1:1:1:1 ratio. The primary outcome was the number of uterine bleeding and spotting days over a 90-day reference (treatment) period. Secondary outcomes were the number of women showing endometrial histology expected for intrauterine levonorgestrel application and the frequency of treatment-emergent adverse events. Point estimates and 2-sided 90% credible intervals were calculated for mean and median differences between treatment groups and the levonorgestrel-releasing intrauterine system without indomethacin. Point and interval estimates were determined using a Bayesian analysis. RESULTS: A total of 174 healthy, premenopausal women, aged 18 to 45 years, were randomized, with 160 women eligible for the per-protocol analysis set. Fewer bleeding and spotting days were observed in the 90-day reference period for the 3 indomethacin/levonorgestrel-releasing intrauterine system dose groups than for the levonorgestrel-releasing intrauterine system without indomethacin group. The largest reduction in bleeding and spotting days was achieved with low-dose indomethacin/levonorgestrel-releasing intrauterine system, which demonstrated a point estimate difference of -32% (90% credible interval, -45% to -19%) compared with levonorgestrel-releasing intrauterine system without indomethacin. Differences for high- and middle-dose indomethacin/levonorgestrel-releasing intrauterine system groups relative to levonorgestrel-releasing intrauterine system without indomethacin were -19% and -16%, respectively. Overall, 97 women (58.1%) experienced a treatment-emergent adverse event considered related to the study drug, with similar incidence across all treatment groups including the unmodified levonorgestrel-releasing intrauterine system. These were all mild or moderate in intensity, with 6 leading to discontinuation. Endometrial biopsy findings were consistent with effects expected for the levonorgestrel-releasing intrauterine system. CONCLUSION: All 3 doses of indomethacin substantially reduced the number of bleeding and spotting days in the first 90 days after placement of the levonorgestrel-releasing intrauterine system, thus providing proof of concept. Adding indomethacin to the levonorgestrel-releasing intrauterine system can reduce the number of bleeding and spotting days in the initial 90 days postplacement, without affecting the safety profile, and potentially improving patient acceptability and satisfaction.

One-year follow up of contraceptive use and pregnancy rates after early medical abortion: Secondary outcomes from a randomized controlled trial of immediate post-abortion placement of intrauterine devices.

INTRODUCTION: Intrauterine devices (IUDs) effectively prevent unwanted pregnancies. Little is known about long-term outcomes of women choosing an IUD after early medical abortion. MATERIAL AND METHODS: We present secondary outcome data of continuation rates, factors associated with continuation and discontinuation, choice of IUD type, women's satisfaction with IUD, and IUD expulsions, subsequent pregnancies, and abortions within 1 year post-abortion in a randomized, controlled, multicenter trial on IUD placement within 48 hours compared with placement 2-4 weeks after medical abortion up to 63 days' gestation (ClinicalTrials.gov NCT03603145). RESULTS: Of the 240 women studied, 112/120 (93.3%) in the intervention group vs 113/120 (94.2%) in the control group completed the 12-month follow-up. The rate of IUD use at 12 months was 84/112 (75%) in the intervention group vs 75/113 (66.4%) in the control group (P = 0.19). Attendance at the IUD placement visit was the only predictor of long-term IUD use (relative risk [RR] = 5.7, 95% confidence interval [CI] 2.03-16.0; P = 0.001). The main reason for choosing an IUD was high contraceptive effectiveness. The most common reasons for IUD discontinuation were bleeding problems and abdominal pain. IUD expulsion was rare and did not differ between groups. Satisfaction among IUD users at 1 year was high (>94%) and the majority of all participants would recommend IUD to a friend (65.8%). Use of no contraception and experience of unprotected intercourse were less common in the intervention group (11/112 [9.8%] vs 25/113 [22.1%], P = 0.02 and 17/112 [15.2%] vs 32/113 [28.3%], P = 0.02, respectively). There was no difference in the rate of subsequent pregnancies and abortions (pregnancies 14/112, 12.5% in the intervention group vs 8/113, 7.1% in the control group, P = 0.19; abortions 5/112, 4.5% vs 3/113, 2.7%, P = 0.5). CONCLUSIONS: IUD placement after medical abortion led to high continuation and satisfaction rates with no difference between groups. We found no difference in IUD expulsions after immediate compared with later placement. Unprotected intercourse was significantly less common in the immediate group. In clinical practice, immediate placement of IUDs available free of charge at the abortion clinic is likely to increase attendance to the placement visit and continued use of IUDs after abortion.

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.

Acceptance rate of post-placental plac ement of intrauterine devices during the SARS-CoV-2 (COVID-19) pandemic.

OBJECTIVE: To evaluate the acceptance rate of post-placental intrauterine device (PPIUD) placement during the SARS-CoV-2 (COVID-19) pandemic and to to assess factors associated with PPIUD acceptance. METHODS: A cross-sectional study was conducted between August 2020 and August 2021. PPIUDs were offered to women scheduled for caesarean delivery or admitted in labour at the Women's Hospital of the University of Campinas. The study compared women according to whether they accepted or did not accept the IUD placement. The factors associated with PPIUD acceptance were analysed through bivariate and multiple logistic regression analyses. RESULTS: We enrolled 299 women (15.9% of the deliveries that occurred during study period), aged 26.8 ± 6.5 years; 41.8% were White, almost one third were primiparous, and 155/299 (51.8%) had a vaginal delivery. The PPIUD acceptance rate was 65.6%. The principal reason for refusal was the desire for another contraceptive (41.8%). Women with the highest likelihood of accepting a PPIUD were younger (<30 years old has 1.7 more likely or 74% greater), those without a partner (3.4 times more likely) and those after vaginal delivery (1.7 times more likely or 69% greater). CONCLUSION: The COVID-19 does not affected the PPIUD placement. PPIUD is a viable alternative during crisis in which women has difficult to access health services. Younger women, those without a partner and after vaginal delivery were more likely to accept a PPIUD during the COVID-19 pandemic.

Post-placental IUDs are an alternative during periods of crisis like the COVID-19 pandemic. Younger women, those without a partner and after vaginal delivery were more likely to accept a PPIUD during the COVID-19 pandemic.

Assessment of pain and ease of intrauterine device placement according to type of device, parity, and mode of delivery.

OBJECTIVE: We compared pain and the ease of insertion of two different types of intrauterine devices (IUDs; the levonorgestrel intrauterine systems 52 mg (LNG-IUS 52 mg) and the copper-bearing IUD [TCu380A]) among nulligravidas and parous women with and without caesarean delivery. METHODS: A cross-sectional study assessed pain referred by women and ease of insertion of the two IUDs models. We applied a visual analogue scale (VAS) to assess pain, while the ease of insertion was defined by healthcare professionals. RESULTS: We assessed 1076 women, including 334 nulligravidas and 566 parous women who had had at least one caesarean delivery and 176 women with history of only vaginal delivery. Regarding pain at IUD placement, 26 (2.5%) women reported no pain, 167 (16.4%) light pain, 319 (31.3%) moderate and 506 (49.7%) intense pain. The highest scores for pain were reported by nulligravidas (67.2%, p = 0.001), while the mean pain score was higher in the LNG-IUS 52 mg group. Difficulties reported by healthcare providers were more frequent in the nulligravidas (21.2%) and women with previous caesarean delivery (16.9%). CONCLUSIONS: Our findings suggested differences between the two IUDs tested, with higher pain associated with the LNG-IUS 52 mg, and highlights the need for pain management, mainly among nulligravida and women with history of caesarean delivery.SHORT CONDENSATIONIntense pain at insertion was more related to nulligravida than parous women and more pain with placement of LNG-IUS 52 mg IUDs than TCu380A IUDs. Nevertheless, our results confirmed that ease of IUD placement was between 80% to 90% of all insertions, being more common in parous women without previous caesarean delivery.

Metabolomics profile of 5649 users and nonusers of hormonal intrauterine devices in Finland.

BACKGROUND: Use of hormonal intrauterine devices has grown during the last decades. Although hormonal intrauterine devices act mostly via local effects on the uterus, measurable concentrations of levonorgestrel are absorbed into the systemic circulation. The possible metabolic changes and large-scale biomarker profiles associated with hormonal intrauterine devices have not yet been studied in detail. OBJECTIVE: To examine through the metabolomics approach the metabolic profile of patients using hormonal intrauterine devices and how this metabolic profile is affected by duration and discontinuation of use. STUDY DESIGN: The study consisted of cross-sectional analyses of 5 population-based surveys (FINRISK and FinHealth studies), spanning from 1997 to 2017. All fertile-aged participants (18-49 years) in the surveys with available information on hormonal contraceptive use and metabolomics data (n=5649) were included in the study. Altogether, 211 metabolic measures of users of hormonal intrauterine devices (n=1006) were compared with those of nonusers of hormonal contraception (n=4643) via multivariable linear regression models. To allow comparison across multiple measures, association magnitudes were reported in standard deviation units of difference in biomarker concentration compared with the reference group. RESULTS: After adjustment for covariates, levels of 141 metabolites differed in current users of hormonal intrauterine devices compared with nonusers of hormonal contraception (median difference in biomarker concentration, 0.09 standard deviation): lower levels of particle concentration of larger lipoprotein subclasses, triglycerides, cholesterol and derivatives, apolipoproteins A and B, fatty acids, glycoprotein acetyls, and aromatic amino acids. The metabolic pattern of hormonal intrauterine device use did not change according to duration of use. When comparing previous users and never-users of hormonal intrauterine devices, no significant metabolic differences were observed. CONCLUSION: The use of hormonal intrauterine devices was associated with several moderate metabolic changes previously associated with reduced arterial cardiometabolic risk. The metabolic effects were independent of duration of use of the hormonal intrauterine devices. Moreover, the metabolic profiles were similar after discontinuation of hormonal intrauterine device use and in never-users.

Reasons for low utilization of intrauterine device utilisation amongst short term contraceptive users in Hossana town, Southern Ethiopia: a qualitative study.

BACKGROUND: Intrauterine devices (IUDs) are one of the long-acting, safe and effective methods of contraception in women across the world. However, this method is underutilised in many countries, including Ethiopia. Several quantitative studies have been used to address this problem and generated a list of factors associated with this problem. However, this list lacks detailed and local contexts that are necessary to inform local solutions. The current study uses a qualitative method to explore determinants of IUDs underutilization among short term modern contraceptive users from the maternal health services in the study setting. The use of a qualitative study design is necessary to obtain and rich contextual details that can inform the development of locally appropriate strategies to increase the IUDs uptake in the study area and improve women's reproductive health outcomes. METHOD: A qualitative study was conducted in Hossana town public health facilities, Southern Ethiopia from November 1-30, 2019. A total of thirteen in-depth interviews were conducted including with: 11 short term contraceptive users, one health centre head and one health extension worker. The interview guide comprised semi-structured questions. Interviews were audio recorded, transcribed and collected data analysed thematically. RESULT: The main key determinants of IUDs service underutilisation were identified from participants' narratives, including: (1) poor knowledge about the benefits of IUDs, (2) insufficient counselling and ineffective delivery of health information to aid women in decision making, (3) the absence of trained health personals, and shortage of supplies. CONCLUSION: Results indicate that the poor utilisation of IUDs services is determined by both the service provider and the consumer related factors. Poor knowledge of short term users of contraception is a critical factor because without knowledge, clients may not use the available services effectively. The shortage of necessary supplies, poor provider-client relationships, and poor counselling by service providers are also service factors that act as barriers to uptake of IUDs. Efforts should be made to increase IUDs utilization by focusing on educating women about the importance of IUDs, improving counselling of mothers and strengthening the health systems, including allocating more resources to increase access to IUDs among the service users.

Female sexual function in women using LARC methods.

OBJECTIVE: This study aims to assess sexual function (SF) and quality of life (QoL) among women using copper intrauterine devices (Cu-IUD), levonorgestrel-releasing intrauterine system (LNG-IUS) or etonogestrel(ENG)-releasing subdermal implant. METHODS: This is a cross-sectional study involving 213 women who are sexually active, using Cu-IUD, LNG-IUS or ENG implant for at least one year. SF assessment was carried out through the Female Sexual Function Index (FSFI) and QoL was made through The Short Form Health Research. RESULTS: Frequency of sexual dysfunction score in Cu-IUD users was 33.8%; 47.2% in LNG-IUS users and 47.8% in ENG-implant users, without difference between groups. Desire domain had higher score in Cu-IUD users (Cu-IUD:4.20 ± 1.15 × LNG-IUS:3.76 ± 1.17 × ENG-implant:3.63 ± 1.15; p = .009). Between Cu-IUD and LNG-IUS users there was no difference in FSFI score. Total FSFI score was higher in Cu-IUD group when compared only to ENG-implant (Cu-IUD:27.48 ± 6.14 × Implant:25.07 ± 6.89; p = .029). Regarding the QoL score, difference was found only in general health domain (Cu-IUD:65.22 ± 14.91 × LNG-IUS:62.61 ± 19.04 × Implant:58.33 ± 16.46; p = .034), with lower score for implant group. CONCLUSION: There was no difference in the SF total score between the users of Cu-IUD, LNG-IUS and ENG implant. However, the score of the FSFI desire domain and general health status were higher among users of the Cu-IUD.

Effect of modified levonorgestrel-releasing intrauterine system in human adenomyosis with heavy menstrual bleeding.

AIM: The levonorgestrel-releasing intrauterine (LNG-IUS) system is an effective primary treatment for adenomyosis; however, it has high expulsion rates. We aimed to modify the system-allowing affixion to the myometrium-and evaluate the expulsion rate, effectiveness, and side effects in patients with adenomyosis and heavy menstrual bleeding. METHODS: This study included patients with adenomyosis and heavy menstrual bleeding who underwent implantation of: a modified LNG-IUS (experimental group, n = 47); and the original system after gonadotropin-releasing hormone agonist treatment (control group, n = 47), between January 2014 and April 2016. RESULTS: In the experimental group, two device expulsions occurred 12-18 months postimplantation. In the remaining 45 patients, the system was safely removed after the 60-month validity period, and no extrauterine device movement or infection occurred. In the control group, downward displacement and expulsion of the device occurred in eight (17%) patients within 60 months. The 5-year total expulsion rates were 4.3% and 17.0% in the experimental and control groups, respectively (p = 0.045). There were significant changes in the pretreatment severity of dysmenorrhea, menstrual volume, uterine volume (cm3 ), and hemoglobin level in each group compared with after 1 year (p < 0.01 in all groups). The severity of dysmenorrhea, menstrual volume, uterine volume, and hemoglobin level after 1 year were similar between the two groups (p > 0.05 in all groups). CONCLUSIONS: Use of the modified LNG-IUS is a safe, cost-effective, and simple method for reducing the downward movement and expulsion rate in patients with adenomyosis and heavy menstrual bleeding.

Trends in oral contraceptive and intrauterine device use among reproductive-aged women in the US from 1999 to 2017.

PURPOSE: Since the 1960s, increasing oral contraceptive (OC) use has mirrored decreasing ovarian cancer incidence. The impact of intrauterine devices (IUDs) on cancer risk is less well established. With improved access and increased options, we must consider how changing usage can affect cancer risks. METHODS: Nationally representative data from the National Health and Nutrition Examination Survey (NHANES, 1999-2016) and the National Survey for Family Growth (NSFG, 2006-2017) were used to evaluate contraceptive use over time in premenopausal women (NHANES n = 13,179; NSFG n = 26,262). Trends were assessed overall and by race, age, pregnancy history, education, and body mass index. RESULTS: The average annual absolute increase in self-reported IUD use was 0.81% (NSFG), while OC use decreased 0.49% in NSFG and 0.47% in NHANES. This represents a significant decrease in OC use in NSFG [annual percent change (APC) - 2.2% (95% CI - 3.4, - 1.0%), p < 0.01]. Trends in OC use varied somewhat by pregnancy history in NHANES (p-interaction = 0.054). In contrast, IUD use increased 6.2% annually [(1.4, 11.2%), p = 0.03] and varied significantly by pregnancy history (p-interaction < 0.01). Nulligravid women increased IUD use 11.0% annually [(2.6, 20.1%), p = 0.02] compared to women with prior pregnancy at 5.2% [(0.4, 10.2%), p = 0.04]. In 2015-2017, IUD use was 76.5% hormonal (71.1, 81.8%) and 22.9% copper (17.4, 28.3%) with greater hormonal IUD use in obese women [89.4%, (82.9, 95.9%)]. CONCLUSION: Increasing IUD use outpaced declining OC use in premenopausal US women. There may be a resulting decreased gynecologic cancer risk as more women gain access to potentially risk-reducing contraceptives.

Training of healthcare providers and use of long-acting reversible contraception in low- and middle-income countries: A systematic review.

INTRODUCTION: Unintended pregnancy, a major global health issue resulting in unsafe terminations of pregnancy and maternal deaths in low- and middle-income countries, could be significantly reduced through increased use of modern contraception, including long-acting reversible contraceptives (LARC). Training of healthcare providers to administer such contraceptives may improve uptake. We conducted a systematic review to collate the end-user uptake data following training of healthcare providers in low- and middle-income countries. MATERIAL AND METHODS: We searched PubMed, Embase, the Global Health Library and the Cochrane Library up to 23 May 2020. The review was restricted to low- and middle-income countries and focused on healthcare providers who had received training in LARC. Studies that reported contraceptive uptake among women, preference of LARC among healthcare workers and/or women, and unplanned pregnancies within 12 months of LARC initiation were included. All included studies underwent quality assessment using either the Cochrane Risk of Bias Tool or the Newcastle-Ottawa Scale. PROSPERO registration number CRD42020185291. RESULTS: A total of 28 studies (end-users n = 6 112 544) were included (27 cohort studies and one randomized trial). Nineteen studies were set in Africa, five in Asia, one in Central America and four were multi-country studies. Twenty-eight studies reported LARC use among women, and 25 studies found an increase in uptake of LARC by women using short-acting methods switching to longer-acting methods or by recruiting new users of LARC. The randomized controlled trial was assessed as high quality and reported positive findings; however, there was great heterogeneity in the type of intervention and of how outcomes were measured among the other included studies. Further, the quality of these studies varied, although it should be noted that the poor-quality studies reflected the trends of those of higher quality. CONCLUSIONS: Despite heterogeneity, current evidence indicates that training of healthcare providers in LARC may increase the uptake among women in low- and middle-income countries. More robust studies are warranted to inform policy.

Acceptability of immediate postpartum and post-abortion long-acting reversible contraception provision to adolescents: A systematic review.

INTRODUCTION: Long-acting reversible contraception (LARC) methods are safe for adolescents and provide the greatest assurance against rapid repeated pregnancy when inserted during the immediate postpartum (IPP) and immediate post-abortion (IPA) period. Despite increasing enthusiasm for IPP/IPA LARC insertion, adolescents' preferences and experiences have seldom been examined. The objective of this review was to examine the attitudes of adolescents (aged 10-19 years) towards IPP/IPA LARC, their experiences and perceptions around having an LARC device fitted IPP/IPA and the factors involved in decision-making to use, not use or discontinue IPP/IPA LARC. MATERIAL AND METHODS: In January 2021, we searched seven bibliographic databases for original research articles published in English, from the year 2000. Studies of any design focused on IPP/IPA LARC were eligible for inclusion. Three of the authors assessed articles for eligibility and extracted data relevant to the outcomes of the review. Joanna Briggs Institute Critical Appraisal Tools were used to assess methodological quality. Key themes emerging from the data were synthesized and reported narratively. RESULTS: We identified 10 relevant articles, four of which were entirely adolescent-focused. Only three addressed IPA LARC. IPP availability was important for ensuring access to LARC postpartum. Attitudes towards LARC IPP were associated with adolescents' sociodemographic characteristics and positive perceptions related to the long duration of action. Determinants of discontinuation and nonuse included poor-quality contraceptive counseling, intolerable side effects and subsequent distress, misconceptions about LARC safety IPP and the influence of partners and community on autonomy. No factors involved in IPA LARC decision-making were available. Limited evidence demonstrated that adolescents may favor contraceptive implants over intrauterine devices, and in certain contexts may face greater barriers to IPA LARC access than adult women do. CONCLUSIONS: Immediate insertion of LARC postpartum appears acceptable to adolescents who do not experience side effects and those with the opportunity to make autonomous contraception decisions. This important topic has been addressed in few studies involving an entirely adolescent population. Very limited evidence is available on IPA LARC. Further research on adolescents' lived experiences of IPP/IPA LARC access and use is necessary to inform the provision of person-centered care when assisting adolescents' contraceptive choice following pregnancy.