Hormonal Intrauterine Devices Research Articles

Longitudinal trends in uptake of hormonal long-acting reversible contraception devices throughout the COVID-19 pandemic: an Australian population-based study

BackgroundLittle is known about the degree to which the COVID-19 pandemic, and associated restrictions and disruptions to health services, impacted the accessibility of hormonal long-acting reversible contraception (LARC) devices within...

Effects of Hormonal Contraception and the Menstrual Cycle on Fatigability and Recovery From an Anaerobic Exercise Test.

Cabre, HE, Ladan, AN, Moore, SR, Joniak, KE, Blue, MNM, Pietrosimone, BG, Hackney, AC, and Smith-Ryan, AE. Effects of hormonal contraception and the menstrual cycle on fatigability and recovery from an anaerobic exercise test. J Strength Cond Res XX(X): 000-000, 2024-This study sought to evaluate the effects of oral contraceptive (OC) and hormonal intrauterine device (H-IUD) use, compared with a eumenorrheic (EUM) cycle, on fatigability and recovery between hormone the phases. Peak power (PP), average power (AP), fatigue index (FI), blood lactate, vessel diameter, and blood flow (BF) were measured from a repeated sprint cycle test (10 × 6 seconds) in 60, healthy, active women (mean ± SD; age: 26.5 ± 7.0 years, BMI: 22.5 ± 3.7 kg·m-2) who used monophasic OC (≥6 months; n = 21), had a H-IUD (≥6 months; n = 20), or had regular naturally occurring menstrual cycle (≥3 months) or had a nonhormonal IUD (EUM; n = 19). Subjects were randomly assigned to begin in either the low-hormone phase (LHP) or high-hormone phase (HHP) and were tested once in each phase. Separate univariate analyses of covariances assessed the change from HHP to LHP between the groups, covaried for progesterone, with significance set at p ≤ 0.05. All groups demonstrated similar changes in PP, AP, FI, blood lactate, vessel diameter, and BF between the phases (p > 0.05). Although not significant, AP was higher in LHP for OC (Δ -248.2 ± 1,301.4 W) and EUM (Δ -19.5 ± 977.7 W) and higher in HHP for H-IUD (Δ 369.3 ± 1,123.0 W). Oral contraceptive group exhibited a higher FI (Δ 2.0%) and reduced blood lactate clearance (Δ 2.5%) in HHP. In recreationally active women, hormonal contraception and hormone phases may minimally impact fatigue and recovery. Individual elite female athletes may benefit from understanding hormonal contraception type as performance and recovery may slightly vary across the cycle.

Couple-Years of Protection Indicator: New Global Guidance for Updating Existing Methods and Adding New Methods.

Couple-years of protection (CYP) is an indicator that allows for monitoring and evaluating of family planning (FP) program performance through simple calculations. The CYP for each contraceptive method is calculated by multiplying the number of contraceptive commodity units distributed to clients over a 1-year period by a conversion factor that quantifies the duration of contraceptive protection provided per unit distributed. CYP calculations across methods were previously updated in 2000 and 2011, resulting in changes in methodology, factor inclusion, and specific methods. Since the 2011 update, changes and additions to the modern contraceptive method mix required new CYP conversion factors for 4 methods of contraception: Levoplant implant, progestin-only pills (POPs), Caya diaphragm, and the hormonal intrauterine device. We conducted literature reviews of both published and gray literature and consulted with experts to identify updated data on continuation rates, duration of efficacy, and method effectiveness for the 4 methods. New CYP conversion factors were calculated for the 4 methods either by using the same calculation used previously for the method considering new data or, for new methods, using calculations for similar methods. New CYP conversion factors were assigned to the 4 methods of contraception covered in this update: Levoplant, 2.5 CYP per implant inserted; POPs, 0.0833 CYP per pack (i.e., 12 cycles per CYP); Caya diaphragm, 1 CYP per device, and hormonal intrauterine device, 4.8 CYP per device inserted. CYP is an important indicator for FP programs. As new methods of contraception are developed and new evidence is generated for current methods, the indicator may need to be updated. A standard process for updating and documenting future CYP updates is recommended.

Abstract 2217: Associations between intrauterine device use and ovarian cancer risk among 11 population-based case-control studies

Abstract Background: Intrauterine device (IUD) use has increased while oral contraceptive (OC) use has decreased among premenopausal women. It is unknown whether IUDs offer protection against epithelial ovarian cancer (EOC), similar to OCs, or may increase risk. Therefore, we examined the association between IUD use and EOC risk. Methods: Information on contraception use was obtained through questionnaires from 11 studies participating in the Ovarian Cancer Association Consortium and African-American Cancer Epidemiology Study. Study-specific odds ratios (OR) and 95% confidence intervals (CI) were calculated using unconditional multivariable logistic regression, and heterogeneity between studies was assessed using Cochran Q and I2 statistics. There was no evidence of heterogeneity, thus data were pooled. We assessed potential effect modification by decade of birth, race, parity, and personal history of endometriosis by reporting stratum-specific estimates and tested for multiplicative interaction by comparing models with and without interaction terms via likelihood ratio test. Polytomous logistic regression was used to estimate histotype-specific associations. Results: Results were pooled for 11,033 EOC cases and 13,358 controls. There were 2,656 (19.9%) IUD users (mostly non-hormonal) and 8,923 (66.8%) OC users among controls compared to 1,933 (17.5%) IUD users and 6,318 (57.3%) OC users among cases. IUD use was associated with lower risk of endometrioid (OR: 0.73, 95% CI: 0.62-0.86) and clear cell (OR: 0.63, 95% CI: 0.48-0.80), but not high-grade serous subtypes (OR: 1.05, 95% CI: 0.98-1.14), with significant heterogeneity by histotype (p=0.0006). Among studies that collected data on IUD type, we observed a non-significant inverse association between hormonal IUD use and EOC (OR: 0.72, 95% CI: 0.51-1.03); however, only 51 cases reported hormonal IUD use. Among those who used both IUD and OCs, there was no association with the order of contraception use and EOC. There were no major differences in the associations of age at first use, duration of use, or time since last use and EOC risk. Among parous women, IUD use before first pregnancy was associated with a non-significant reduced odds of EOC (OR: 0.82, 95% CI: 0.65-1.04). We also observed a statistically significant interaction between IUD use and endometriosis with reduced odds of EOC associated with IUD use among women with endometriosis (OR: 0.77, 95% CI: 0.60-0.98) but not those without endometriosis (OR: 0.96, 95% CI: 0.90-1.03, p-interaction=0.05). Discussion: IUD use was associated with lower clear cell and endometrioid EOC risk and may be most protective among women with endometriosis. Future research should include cohorts of women with a higher prevalence of hormonal IUD use to determine the impact of changing contraceptive trends on ovarian cancer burden and identifying preventive strategies for women at high risk. Citation Format: Jennifer M. Mongiovi, Ana Babic, Naoko Sasamoto, Lauren Peres, Holly Harris, Mollie E. Barnard, Shelley S. Tworoger, Anita Koushik, Joellen M. Schildkraut, Jennifer A. Doherty, Kathryn L. Terry, the Ovarian Cancer Association Consortium & the African-American Cancer Epidemiology Study. Associations between intrauterine device use and ovarian cancer risk among 11 population-based case-control studies [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 2217.

Contraindicated use of modern contraceptives among mothers from a Pelotas Birth Cohort.

To describe the prevalence of contraindicated use of combined hormonal contraceptives, progesterone-only contraceptives, and intrauterine devices in mothers participating in the 2015 Pelotas Birth Cohort according to the WHO medical eligibility criteria. The biological mothers of children belonging to the 2015 Pelotas birth cohort who attended the 48-month follow-up were studied. The 48-month follow-up data were collected from January 1, 2019, to December 31, 2019. Contraindicated use of modern contraceptives was considered to occur when these women presented at least one of the contraindications for the use of modern contraceptives and were using these methods. The prevalence of contraindicated use was calculated according to each independent variable and their respective 95% confidence intervals (95%CI). The analyzed sample consisted of 3,053 women who used any modern contraceptive method. The prevalence of contraindicated use of modern contraceptives totaled 25.9% (95%CI: 24.4-27.5). Combined hormonal contraceptives showed the highest prevalence of contraindicated use (52.1%; 95%CI: 49.3-54.8). The prevalence of contraindicated use of modern contraceptives methods was greater in women with family income between one and three minimum wages, a 25-30 kg/m2 body mass index, indication by a gynecologist for the used method, and purchasing the contraceptive method at a pharmacy. The higher the women's education, the lower the prevalence of inappropriate use of modern contraceptives. In total, one in four women used modern contraceptives despite showing at least one contraindication. Policies regarding women's reproductive health should be strengthened.

Hormonal intrauterine devices and heat exchange during exercise.

Synthetic progestins in oral contraceptives are thought to blunt heat dissipation by reducing skin blood flow and sweating. However, whether progestin-releasing intrauterine devices (IUDs) modulate heat loss during exercise-heat stress is unknown. We used direct calorimetry to measure whole-body total (dry + evaporative) heat loss in young, physically active women (mean (SD); aged 24(4)years, 39.3(5.3) ml/kg/min) with (IUD; n=19) and without (Control; n=17) IUDs in the follicular and luteal phases of the menstrual cycle during light- and moderate-intensity exercise at fixed rates of heat production (∼175 and ∼275W/m2 ) in 30°C, ∼21% relative humidity. Between-group and -phase differences were evaluated using traditional hypothesis testing and statistical equivalence testing within pre-determined bounds (±11W/m2 ; difference required to elicit a ±0.3°C difference in core temperature over 1h) in each exercise bout. Whole-body total heat loss was statistically equivalent between groups within ±11Wm-2 (IUD-Control [90% CIs]; Light: -2 [-8, 5] W/m2 , P=0.007; Moderate: 0 [-6, 6] W/m2 , P=0.002), as were dry and evaporative heat loss (P ≤ 0.023), except for evaporative heat loss during moderate-intensity exercise (equivalence: P=0.063, difference: P=0.647). Whole-body total and evaporative heat loss were not different between phases (P≥0.267), but dry heat loss was 3 [95% CIs: 1, 5] W/m2 greater in the luteal phase (P≤0.022). Despite this, all whole-body heat loss outcomes were equivalent between phases (P≤0.003). These findings expand our understanding of the factors that modulate heat exchange in women and provide valuable mechanistic insight of the role of endogenous and exogenous female sex hormones in thermoregulation. KEY POINTS: Progestin released by hormonal intrauterine devices (IUDs) may negatively impact heat dissipation during exercise by blunting skin blood flow and sweating. However, the influence of IUDs on thermoregulation has not previously been assessed. We used direct calorimetry to show that IUD users and non-users display statistically equivalent whole-body dry and evaporative heat loss, body heat storage and oesophageal temperature during moderate- and high-intensity exercise in a warm, dry environment, indicating that IUDs do not appear to compromise exercise thermoregulation. However, within IUD users and non-users, dry heat loss was increased and body heat storage and oesophageal temperature were reduced in the luteal compared to the follicular phase of the menstrual cycle, though these effects were small and unlikely to be practically meaningful. Together, these findings expand our understanding of the factors that modulate heat exchange in women and have important practical implications for the design of future studies of exercise thermoregulation.

Contraceptive Recommendations for Women with Immune-Mediated Inflammatory Diseases: A Delphi Consensus.

Immune-mediated inflammatory diseases (IMID) are a group of disorders characterized by chronic inflammation caused by an altered immune regulation in targeted organs or systems. IMID itself could have an implied increased risk of venous thromboembolism (VTE) and this risk varies throughout the course of the disease as well as with some contraceptive methods and treatments. The aim of this study was to present some key considerations in relation to contraception in women with IMID. This was an exploratory study conducted in Spain following the online modified Delphi methodology with two rounds of participation. Four questionnaires were designed for each medical specialty: gastroenterology, rheumatology, dermatology, and gynecology. Each questionnaire was divided in three domains: general recommendations about IMID, specific recommendations, and contraceptive methods for patients with IMID. A 5-point Likert scale measured agreement with each statement, with an 80% agreement threshold. Following the first round, the percentage of each response was calculated for every item. Subsequently, a second round was conducted to reach a consensus on the items for which discrepancies were observed. A total of 52 and 50 experts participated in the first and second round, respectively. Participants agreed on the existence of a higher risk of VTE in inflammatory bowel diseases, psoriasis, and rheumatoid arthritis diseases. Regarding recommendations for contraceptive methods in patients with IMID, experts considered the hormonal intrauterine device (IUD) as a first-line contraceptive (80.0%) and low doses of progesterone-only pills if the latter is not recommended (88.0%). Most of the interviewees concurred on the importance of the patients' contraceptive needs during the disease course (98.1%). Raising awareness and promoting a multidisciplinary relationship among the physicians involved in the therapeutic decisions by considering all the risk factors when prescribing a contraceptive method is important to prevent VTE in women with IMID.

Gene expression associated with vaginal bleeding in women using the 52-mg levonorgestrel hormonal intrauterine device: A prospective study.

To evaluate gene expression associated with vaginal bleeding in the 52-mg hormonal intrauterine device (IUD) users. We conducted a prospective study involving 100 women seeking to use the 52-mg hormonal IUD for contraception. We excluded women with a history or current condition of abnormal uterine bleeding and who were unable to attend a 1-year follow up. Women who expelled the device, removed it for reasons unrelated to vaginal bleeding, or were lost to follow up were discontinued. We collected endometrial biopsies immediately before IUD placement and assessed 20 selected genes using reverse transcription quantitative polymerase chain reaction. Users maintained a uterine bleeding diary for 12 months following IUD insertion. For statistical analysis, participants were categorized into groups with or without vaginal bleeding at 3 and 12 months. Women with elevated CXCL9 expression had an 8.15-fold higher likelihood of experiencing vaginal bleeding at 3 months (odds ratio [OR] 8.15, 95% confidence interval [CI] 2.24-29.61, P = 0.001). At 12 months of follow up, women with increased TIMP1 expression had a 2.74-fold higher chance of experiencing vaginal bleeding (OR 2.74, 95% CI 1.08-6.95, P = 0.033). CXCL9 ≥ 1.5 and IL17A ≥ 0.68 were associated with a higher probability of vaginal bleeding at 3 months, while TIMP1 levels ≥0.943 were linked to an increased risk of bleeding at 12 months. Users of the 52-mg hormonal IUD with elevated relative CXCL9 expression face an increased risk of vaginal bleeding at 3-month follow up, whereas those with heightened TIMP1 expression are more likely to experience vaginal bleeding at 12 months.

The levonorgestrel-releasing intrauterine device is related to early emotional reactivity: An ERP study

Despite the evidence of altered emotion processing in oral contraceptive (OC) users, the impact of hormonal intrauterine devices (IUD) on emotional processing remains unexplored. Our study aimed to investigate how behavioural performance and event-related potentials (ERPs) linked with emotion reactivity and its regulation are associated with hormonal profiles of women using different types of hormonal contraception and naturally cycling women. Women using OCs (n = 25), hormonal IUDs (n = 33), and naturally cycling women in their early follicular (NCF, n = 33) or mid-luteal (NCL, n = 28) phase of the menstrual cycle were instructed to view emotional pictures (neutral, low and high negativity) and use cognitive reappraisal to up- or down-regulate negative emotions, while their electroencephalogram was recorded. Participants rated perceived negativity after each picture and their emotional arousal throughout the task. Saliva samples were collected to assess levels of 17β-estradiol, progesterone, and testosterone. As expected, emotional arousal increased throughout the task and correlated positively with perceived negativity. Perceived negativity and the amplitudes of the middle (N2/P3) and later (LPP) latency ERP components increased with increasing stimuli negativity. Emotion regulation modulated perceived negativity and the amplitudes of very late ERP components (parietal and frontal LPP). Moreover, IUD-users showed a higher negative amplitude of the frontal N2 in comparison to all three other groups, with the most consistent differences during up-regulation. Finally, testosterone correlated positively with the N2 peak in IUD-users and NCL women. Overall, our findings suggest that IUD-use and testosterone might be related to altered preconscious processing during the emotion regulation task requiring attention to the stimulus. The study underscores the need for additional research into how different hormonal contraceptives are linked to socio-emotional functioning.

Knowledge, Attitude and Use of Contraceptives Among Women of Reproductive Age in a Nigerian Rural Community

BACKGROUND: The use of contraception, encompassing various methods such as hormonal pills, condoms, intrauterine devices, and natural techniques like abstinence, plays a pivotal role in family planning and reproductive health. Despite its importance, the utilization of contraceptives, particularly in low-resource nations like Nigeria, has remained notably low. This is concerning, considering the positive impact of contraception on maternal and child health and its contribution to national development by curbing population growth. In Nigeria, awareness of contraception is relatively high, but the adoption of modern contraceptive methods is alarmingly low, with only 10% of females utilizing them. This rate is notably insufficient given the high levels of sexual activity, especially among adolescents and young adults. Furthermore, regional disparities exist within Nigeria, with the south-south geopolitical zone exhibiting a higher prevalence of modern contraceptive use at 15.5%. Factors influencing contraceptive usage include education, religious beliefs, and awareness of available methods. In Yenagoa, Bayelsa state, the prevalence of modern contraceptives was notably higher at 36.8% in 2017, underscoring the impact of education and knowledge of contraceptive options. Increasing contraceptive use is crucial for Nigeria, a lower-middle-income country, as it not only aids in averting unplanned pregnancies and maternal mortality but also in controlling population growth. AIM: The study aimed to shed light on contraceptives' profound health advantages to both women and families. By investigating the knowledge, attitude, and use of contraceptives within the context of the study community, it sought to contribute to the promotion and enhancement of contraceptive use among women of reproductive age in the rural community of Sagbama, South-south Nigeria. METHODS: A descriptive cross-sectional study was conducted among women of reproductive age, over a period of 3 months in Sagbama Community, Bayelsa state. Multi-stage sampling was employed. Data was obtained using interviewer-administered semi-structured 31-item questionnaire and analyzed using IBM SPSS version 26. Bivariate analysis with p-value <0.05 was significant. RESULTS: Among the 314 respondents, the mean age was 29.96 years. Nearly half were married (48.4%), with varying numbers of children. The majority had some form of education, with 46.8% having secondary education. Most respondents (95.9%) had heard of contraceptives, primarily from friends (76.4%) and hospitals (58%). The most well-known contraceptive methods were male condoms (95.9%), contraceptive pills (79.9%), and implants (72.3%). Positive attitudes toward contraceptive use were observed in 83.4% of respondents, driven by the desire to prevent unwanted pregnancies and space births (80.9%). Of sexually active women (81.4%), 53.3% used contraceptives, with male condoms (44%) and pills (15.7%) being the most common methods. Reasons for non-use included a perceived lack of need (28.6%) and fear of side effects (26.5%). CONCLUSION: Despite high knowledge levels, the use of contraceptives among women of reproductive age in the community was poor. Education and addressing misconceptions are essential to promote effective contraceptive use. Comprehensive health and sex education involving both men and women should be provided to dispel misconceptions and encourage correct contraceptive use.

Clinical Assessment of 3 Intrauterine Devices in Adolescent Girls: A Randomized Clinical Trial

Study ObjectiveTo assess clinical performance, bleeding pattern, dysmenorrhea, and satisfaction up to 1 year after placement of 3 types of intrauterine devices (IUDs) (TCu380A, levonorgestrel 52 mg, and levonorgestrel 19.5 mg) in adolescents MethodsThe study was a randomized trial with 318 adolescents allocated to the 3 IUDs. We assessed reasons for removal, continuation, menstrual patterns, dysmenorrhea, and satisfaction. ResultsParticipants aged (mean ± SD) 17.9 ± 1.4 years, with 80.8% being nulligravidae. After 1 year, 265 (83.3%) continued using the IUD; however, the continuation rate of TCu380A (75.4 ± 4.2) was lower than that of both the levonorgestrel 52-mg (88.6 ± 3.1) and 19.5-mg IUDs (86.8 ± 3.3), and bleeding/pain and expulsion were the main reasons for removal of the TCu380A IUD. The duration of menstruation was longer among the TCu380A IUD users (6.0 ± 2.0 days) than those using the levonorgestrel 52 mg (2.5 ± 3.9) and 19.5 mg (3.2 ± 3.2) devices, P < .001. Amenorrhea was reported by 49.5% and 37.8% users of the levonorgestrel 52-mg and 19.5-mg devices, respectively, P < .001. Dysmenorrhea was reported in 68.5% of all participants at the baseline; this was 67.9% of the TCu380A group and 33.3% and 36.0% of the levonorgestrel 52-mg and 19.5-mg IUD groups, respectively, P < .001. Satisfaction ranged from 80.7% in the TCu380A group to 97.8% in the levonorgestrel 52-mg group (P = .03). ConclusionThe 3 IUDs are suitable for adolescents, with high contraceptive efficacies and rates of continuation within 1 year of use and high degrees of satisfaction. Users of the hormonal IUDs reported lower expulsion rates, more favorable menstrual patterns, and less dysmenorrhea compared with the TCu380A IUD.

Nanostrategy of Targeting at Embryonic Trophoblast Cells Using CuO Nanoparticles for Female Contraception.

Effective contraceptives have been comprehensively adopted by women to prevent the negative consequences of unintended pregnancy for women, families, and societies. With great contributions of traditional hormonal drugs and intrauterine devices (IUDs) to effective female contraception by inhibiting ovulation and deactivating sperm, their long-standing side effects on hormonal homeostasis and reproductive organs for females remain concerns. Herein, we proposed a nanostrategy for female contraceptives, inducing embryonic trophoblast cell death using nanoparticles to prevent embryo implantation. Cupric oxide nanoparticles (CuO NPs) were adopted in this work to verify the feasibility of the nanostrategy and its contraceptive efficacy. We carried out the in vitro assessment on the interaction of CuO NPs with trophoblast cells using the HTR8/SVneo cell line. The results showed that the CuO NPs were able to be preferably uptaken into cells and induced cell damage via a variety of pathways including oxidative stress, mitochondrial damage, DNA damage, and cell cycle arrest to induce cell death of apoptosis, ferroptosis, and cuproptosis. Moreover, the key regulatory processes and the key genes for cell damage and cell death caused by CuO NPs were revealed by RNA-Seq. We also conducted in vivo experiments using a rat model to examine the contraceptive efficacy of both the bare CuO NPs and the CuO/thermosensitive hydrogel nanocomposite. The results demonstrated that the CuO NPs were highly effective for contraception. There was no sign of disrupting the homeostasis of copper and hormone, or causing inflammation and organ damage in vivo. In all, this nanostrategy exhibited huge potential for contraceptive development with high biosafety, efficacy, clinical translation, nonhormonal style, and on-demand for women.

Descriptive study of the real-world, long-term cost estimates and duration of use for hormonal and nonhormonal intrauterine devices using US commercial insurance claims.

Intrauterine devices (IUDs) have comparable efficacy to permanent surgical contraceptive methods; however, long-term costs are infrequently considered. Existing estimates inconsistently account for costs outside of IUD insertion or removal, actual duration of use, or differences between hormonal and nonhormonal IUDs. To describe health care resource utilization and commercial payer costs that arise throughout hormonal and nonhormonal IUD use. In this retrospective cohort study, paid claims data (Merative, MarketScan) from a large US commercial claims database were evaluated between 2013 and 2019. Claims were included from individuals aged 12 to 45 years who had an IUD inserted in 2014, continuous insurance coverage for 1 year prior to insertion and throughout follow-up, and no insertion, removal, or reinsertion in the previous year. Procedures and services that could be IUD-related were identified using Current Procedural Terminology and International Classification of Diseases, Ninth and Tenth Edition codes. Duration of IUD use was evaluated by Kaplan-Meier analysis of time to IUD removal. Event rates were determined for identified procedures and services; costs were calculated as the sum of payer reimbursements per enrolled individual. All IUD types available during the study period were described: 2 hormonal IUDs (52-mg and 13.5-mg levonorgestrel-releasing [LNG]) and the nonhormonal (380-mm2 copper) IUD. Of 195,009 individuals meeting the age requirement and receiving an IUD in 2014, 63,386 met the inclusion criteria and 53,744 had their IUD type on record-42,777 (67.5%) 52-mg LNG, 2,932 (4.6%) 13.5-mg LNG, and 8,035 (12.7%) nonhormonal IUD users. Despite differences in their indicated duration (13.5-mg LNG, 3 years; 52-mg LNG, 5 years; and nonhormonal, 10 years), most individuals had their IUD removed before its indicated full duration of use (13.5-mg LNG, 56.1%; 52-mg LNG, 61.3%; nonhormonal [at 5 years], 54.6%). The event rate per 100 individuals during the follow-up period was highest for abnormal uterine bleeding (16.2), ovarian cysts (9.3), and surgical management of uterine perforations (4.5). IUD insertion costs (mean ± SE) per enrolled individual for the 13.5-mg LNG, 52-mg LNG, and nonhormonal IUDs were $931 ± $9, $1,107 ± $4, and $897 ± $6, respectively. Cumulative mean ± SE 5-year postinsertion costs for the 13.5-mg LNG, 52-mg LNG, and nonhormonal IUDs were $2,892 ± $232, $1,514 ± $31, and $1,389 ± $97, respectively, among the remaining enrolled individuals. In this descriptive study of commercially insured IUD users, at least half had their IUD removed before its indicated duration. IUD improvements that reduce the frequency of abnormal uterine bleeding, ovarian cysts, and uterine perforations may help reduce long-term IUD costs.

Use of a hybrid digital training approach for hormonal IUD providers in Nigeria: results from a mixed method study

BackgroundIn Nigeria, in-service trainings for new family planning (FP) methods have typically been conducted using a combination of classroom-based learning, skills labs, and supervised practicums. This mixed-methods study evaluated the feasibility, acceptability, provider competency, and costs associated with a hybrid digital and in-person training model for the hormonal intrauterine device (IUD).MethodsThe study was conducted in Enugu, Kano, and Oyo states, Nigeria, and enrolled FP providers previously trained on non-hormonal IUDs. Participants completed a digital didactic training, an in-person model-based practicum with an Objective Structured Clinical Examination (OSCE), followed by supervised provision of service to clients. Provider knowledge gains and clinical competency were assessed and described descriptively. Data on the feasibility, acceptability, and scalability of the approach were gathered from participating providers, clinical supervisors, and key stakeholders. Training costs were captured using an activity-based approach and used to calculate a cost per provider trained. All analyses were descriptive.ResultsSixty-two providers took the hybrid digital training, of whom 60 (91%) were included in the study (n = 36 from public sector, n = 15 from private sector, and n = 9 both public/private). The average knowledge score increased from 62 to 86% pre- and post-training. Clinical competency was overall very high (mean: 94%), and all providers achieved certification. Providers liked that the digital training could be done at the time/place of their choosing (84%), was self-paced (79%), and reduced risk of COVID-19 exposure (75%). Clinical supervisors and Ministry of Health stakeholders also had positive impressions of the training and its scalability. The hybrid training package cost $316 per provider trained.ConclusionsWe found that a hybrid digital training approach to hormonal IUD service provision in Nigeria was acceptable and feasible. Providers demonstrated increases in knowledge following the training and achieved high levels of clinical competency. Both providers and clinical supervisors felt that the digital training content was of high quality and an acceptable (sometimes preferable) alternative to classroom-based, in-person training. This study provided insights into a hybrid digital training model for a long-acting contraceptive, relevant to scale-up in Nigeria and similar settings.

Characteristics and hormonal contraception use patterns of levonorgestrel 13.5 mg intrauterine device users in Sweden 2014–2016

ObjectivesThe levonorgestrel-releasing intrauterine device containing 13.5 mg of levonorgestrel (LNG 13.5 mg IUD), Jaydess, was approved for contraception by the European Medicines Agency in 2013. We aimed to describe the characteristics of new users of LNG 13.5 mg IUD in Sweden within the first 3 years after approval (2014–2016). Study designWe conducted an observational, population-based study using data from the Swedish national registers. Women with the first pharmacy dispensation of LNG 13.5 mg IUD between 2014 and 2016 were followed until December 31, 2020. Descriptive analyses included demographic characteristics, duration of the use of first-time LNG 13.5 mg IUD, and contraceptive switching patterns. ResultsWe included 38,327 women, with mean age at first-time LNG 13.5 mg IUD use of 26 (SD: 7) years. Over 80% were prescribed LNG 13.5 mg IUD by a midwife. The most common comorbidities in the year prior to LNG 13.5 mg IUD use (2%–3% prevalence) were depression, anxiety, premenstrual syndrome, and menorrhagia. The median duration of first-time LNG 13.5 mg IUD use was 2.6 years, and after use, more than 50% of women opted to continue using a hormonal intrauterine device. ConclusionsIn this postmarketing drug utilization study, there were over 38,000 first-time LNG 13.5 mg IUD users in Sweden between 2014 and 2016, with an estimated median duration of use of 2.6 years. First-time LNG 13.5 mg IUD users consisted mostly of young, healthy individuals with a history of hormonal contraceptive use. Over half of the women continued using a hormonal IUD after the first LNG 13.5 mg IUD. ImplicationsThe median duration of LNG 13.5 mg IUD use was 2.6 years, approaching the 3-year indicated use limit. The majority of users continued with another hormonal intrauterine device after LNG 13.5 mg IUD use.

Continuation rates of hormonal intrauterine devices in adolescents and young adults when placed for contraceptive and non-contraceptive indications

ObjectiveThis study aimed to estimate and compare continuation rates of hormonal intrauterine devices (IUDs) when placed for contraceptive or menstrual management indications in adolescents and young adults. Study DesignWe conducted a secondary analysis of a prospectively collected database of all hormonal IUD insertions from January 1, 2017 through December 31, 2020, with at least 1-year follow-up, across four Adolescent Medicine practices. IUD insertions without known indication were excluded. ResultsA total of 936 IUD insertions were attempted, 45% for contraception only, 18% for menstrual management only, and 37% for both indications. Insertion was successful in 868 (93%) attempts, and success did not differ by indication (p = 0.74). The mean age at insertion was 18.9 years (SD = 2.4 years), with no difference by indication. Of the completed insertions, 650 (75%) had at least one follow-up during the data analysis period. Excluding those without follow-up, the overall continuation rates were 77% at 1 year, 66% at 2 years, and 54% at 3 years. While continuation rates did not differ by indication at 1 year, at 3 years, continuation was highest among those who sought the device for menstrual management only (contraception = 53%, menstrual = 57%, both = 53%, p < 0.01) Malposition was rare (4.0%), as was device expulsion (2.5%), and these did not differ by indication. ConclusionIUD continuation rates were high among adolescents and young adults and did not significantly differ when placed for contraceptive or non-contraceptive indication in the first year of use. ImplicationsAdolescents and young adults may seek the hormonal IUD for contraception and/or menstrual management. Our study found that IUD continuation rates were high at 1 year regardless of the indication for utilization.

Use of Objective Structured Clinical Examination (OSCE) in a hybrid digital / in-person training for hormonal IUD in Nigeria: findings and applications of the approach.

Background: The hormonal intrauterine device, a long-acting reversible contraceptive method, is being introduced to pilot sites in the private and public sector in Nigeria by the Nigerian Federal Ministry of Health since 2019. To inform training of health care providers, a study was conducted on a hybrid digital and in-person training which utilized Objective Structured Clinical Examination (OSCE) to assess competency of provider trainees. This study represents one of few documented experiences using OSCE to assess the effectiveness of a digital training. Methods: From September - October 2021, in Enugu, Kano and Oyo states of Nigeria, 62 health care providers from public and private sector health facilities were trained in hormonal IUD service provision using a hybrid digital / in-person training approach. Providers, who were skilled in provision of copper IUD, underwent a didactic component using digital modules, followed by an in-person practicum, and finally supervised service provision in the provider trainee's workplace. Skills were assessed using OSCE during the one-day practicum. Results: Use of the OSCE to assess skills provided valuable information to study team. The performance of provider trainees was high (average 94% correct completion of steps in the OSCE). Conclusions: OSCE was used as a research methodology as part of this pilot study; to date, OSCE has not been integrated into the training approach to be scaled up by FMOH. Uniformly high performance of provider trainees was seen on the OSCE, unsurprising since provider trainees were experienced in providing copper IUD. If and when training is rolled out to providers inexperienced with copper IUD, OSCE may have a more important role to assess skills before service provision. The role of OSCE in design of hybrid digital / in-person training approaches should be further explored in rollout of hormonal IUD and other contraceptive technologies.

Preconception contraceptive use and miscarriage: prospective cohort study

ObjectivesTo evaluate the association between preconception contraceptive use and miscarriage.DesignProspective cohort study.SettingResidents of the United States of America or Canada, recruited from 2013 until the end of 2022.Participants13 460 female...

Influence of menstrual cycle and hormonal contraceptive use on MS symptom fluctuations: A pilot study.

In clinical practice, females with MS often report menstrually-related symptom fluctuations. Hypothetically, use of oral contraceptives (OCs) could reduce these fluctuations, particularly continuous OCs (11+ weeks of consistent exogenous hormones followed by 1 week placebo). To prospectively capture (1) whether neurologic and generalized symptoms vary with menstrual cycle phase and (2) whether type of contraception impacts symptom fluctuations. In this two-center pilot study, females with MS and a regular menstrual cycle prospectively tracked their menstrual cycles and completed symptom surveys for up to 6 months. Participants were categorized as 1) users of oral contraceptives, either a) cyclic or b) continuous, or 2) endogenously cycling, either c) hormonal intrauterine device (IUD) users or d) "none users" (e.g. no hormonal contraception; included condoms, copper IUD, tubal ligation, "fertility awareness methods"). There was no correction for multiple analyses. Altogether, 47/70 participants (67%) provided >4 weeks of data and were included in the analyses. Mean (SD) age was 35.0 (0.9) years, median (IQR) EDSS was 1.5 (1-2) and mean (SD) SymptoMScreen score was 10.4 (9.6). For endogenously cycling patients (IUD and none users), fatigue (MFIS) was lower in the perimenstrual period than in the luteal period (p<0.05). For continuous OC users, variability in symptoms was lower than for endogenously cycling females (MFIS: p<0.01; Daily Hassles, from Uplift & Hassles Survey: p<0.05) or cyclic OC users (MFIS: p<0.001). In this pilot study, symptom severity did not definitively fluctuate in relationship to the menstrual cycle in endogenously cycling participants. However, fatigue and daily hassles were less variable for participants using continuous OC than for cyclic OC users or no-OC users. Future confirmatory studies are warranted to further examine whether contraceptive choice can be leveraged to manage symptom fluctuation in cycling females with MS. Such studies could enroll larger cohorts over fewer cycles or employ incentivization and hormonal measurements to enhance participant retention and statistical power.

Sociodemographic and Behavioral Predictors of Recurrent Bacterial Vaginosis Among Sexual Health Clinic Patients in New York City From 2014 to 2018.

Bacterial vaginosis (BV) is associated with adverse reproductive outcomes, and recurrence is common. We examined factors associated with BV recurrence using electronic medical record data for patients attending New York City Department of Health and Mental Hygiene sexual health clinics from 2014 to 2018. Clinician-diagnosed BV was defined using a clinical BV diagnosis code based on Amsel criteria. Recurrent BV was defined as any BV diagnosis occurring more than 30 days after the previous diagnosis. Adjusted hazard ratios (AHRs) for the relationship between potential risk factors and recurrent BV were estimated using conditional gap-time models. The data set contained 14,858 patients with at least one BV diagnosis. Of these, 46.3% (n = 6882) had at least 1 follow-up visit to a sexual health clinic between January 2014 and December 2018. Of those with a follow-up visit, 53.9% (n = 3707) had ≥1 recurrent BV episode, with 33.7% (n = 2317) experiencing recurrence within 3 months. In the multivariable model, using a hormonal intrauterine device (IUD; AHR, 1.31; 95% confidence interval [CI], 1.14-1.49) or copper IUD (AHR, 1.17; 95% CI, 1.01-1.37), having a history of trichomonas (AHR, 1.23; 95% CI, 1.12-1.36), and being non-Hispanic Black (AHR, 1.11; 95% CI, 1.04-1.18) were associated with a higher risk of BV recurrence, whereas using non-IUD hormonal contraception was associated with reduced risk (AHR, 0.88; 95% CI, 0.80-0.98). Risk of BV recurrence was increased among patients using an IUD, whereas it was reduced in patients using non-IUD hormonal contraception.