Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception.

BACKGROUND: In the United States, more intrauterine device (IUD) users select levonorgestrel IUDs than copper IUDs for long-term contraception. Currently, clinicians offer only copper IUDs for emergency contraception because data are lacking on the efficacy of the levonorgestrel IUD for this purpose. METHODS: This randomized noninferiority trial, in which participants were unaware of the group assignments, was conducted at six clinics in Utah and included women who sought emergency contraception after at least one episode of unprotected intercourse within 5 days before presentation and agreed to placement of an IUD. We randomly assigned participants in a 1:1 ratio to receive a levonorgestrel 52-mg IUD or a copper T380A IUD. The primary outcome was a positive urine pregnancy test 1 month after IUD insertion. When a 1-month urine pregnancy test was unavailable, we used survey and health record data to determine pregnancy status. The prespecified noninferiority margin was 2.5 percentage points. RESULTS: Among the 355 participants randomly assigned to receive levonorgestrel IUDs and 356 assigned to receive copper IUDs, 317 and 321, respectively, received the interventions and provided 1-month outcome data. Of these, 290 in the levonorgestrel group and 300 in the copper IUD group had a 1-month urine pregnancy test. In the modified intention-to-treat and per-protocol analyses, pregnancy rates were 1 in 317 (0.3%; 95% confidence interval [CI], 0.01 to 1.7) in the levonorgestrel group and 0 in 321 (0%; 95% CI, 0 to 1.1) in the copper IUD group; the between-group absolute difference in both analyses was 0.3 percentage points (95% CI, -0.9 to 1.8), consistent with the noninferiority of the levonorgestrel IUD to the copper IUD. Adverse events resulting in participants seeking medical care in the first month after IUD placement occurred in 5.2% of participants in the levonorgestrel IUD group and 4.9% of those in the copper IUD group. CONCLUSIONS: The levonorgestrel IUD was noninferior to the copper IUD for emergency contraception. (Supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT02175030.).

Strategies for obstetricians and gynecologists to advance reproductive autonomy in a post-Roe landscape.

The monumental reversal of Roe vs Wade dramatically impacted the landscape of reproductive healthcare access in the United States. The decision most significantly affects communities that historically have been and continue to be marginalized by systemic racism, classism, and ableism within the medical system. To minimize the harm of restrictive policies that have proliferated since the Supreme Court overturned Roe, it is incumbent on obstetrician-gynecologists to modify practice patterns to meet the pressing reproductive health needs of their patients and communities. Change will require cross-discipline advocacy focused on advancing equity and supporting the framework of reproductive justice. Now, more than ever, obstetrician-gynecologists have a critical responsibility to implement new approaches to service delivery and education that will expand access to evidence-based, respectful, and person-centered family planning and early pregnancy care regardless of their practice location or subspecialty.

Frequency of same-day contraceptive initiation, recent unprotected intercourse, and pregnancy risk: a prospective cohort study of multiple contraceptive methods.

BACKGROUND: Same-day start removes barriers to contraceptive initiation and may reduce the risk of unintended pregnancy. It may be appropriate for all contraceptive methods, but we lack data comparing methods. OBJECTIVE: This study aimed to assess the frequency of same-day start with 6 contraceptive methods among new contraceptive users and describe the efficacy of same-day start in terms of first-cycle pregnancy risk overall and by each method. STUDY DESIGN: Using prospective data from the HER Salt Lake Contraceptive Initiative, we identified and assessed outcomes for participants initiating a new method of contraception beyond the first 7 days of their menstrual cycle (same-day start). Enrolled participants at 4 family planning clinics in Salt Lake County, Utah between September 2015 and March 2017 received their method of choice regardless of their cycle day or recent unprotected intercourse. All participants self-reported last menstrual period data and unprotected intercourse events in the previous 2 weeks. We excluded participants who received care immediately after or within 2 weeks of abortion care. Clinical electronic health records provided information on contraceptive method initiation and use of oral emergency contraception. Participants reported pregnancy outcomes in 1-, 3-, and 6-month follow-up surveys with clinic verification to identify any pregnancy resulting from same-day initiation. The primary outcomes report the frequency of same-day start use and first-cycle pregnancy risk among same-day start users of all contraceptive methods. The secondary outcomes include frequency of and pregnancy risk in the first cycle of use among same-day start contraception users by method. We also report the frequency of unprotected intercourse within 5 days and 6 to 14 days of contraception initiation, frequency of concomitant receipt of oral emergency contraception with initiation of ongoing contraception, and pregnancy risk with these exposures. We analyzed pregnancy risk for each contraceptive method initiated on the same day and assessed the simultaneous use of oral emergency contraception. RESULTS: Of the 3568 individuals enrolled, we identified most as same-day start users (n=2575/3568; 72.2%), with 1 in 8 of those reporting unprotected intercourse in the previous 5 days (n=322/2575; 12.5%) and 1 in 10 reporting unprotected intercourse 6 to 14 days before contraceptive method initiation (n=254/2575; 9.9%). We identified 11 pregnancies among same-day start users (0.4%; 95% confidence interval, 0.2-0.7), as opposed to 1 (0.1%; 95% confidence interval, 0.002-0.6) among those who initiated contraception within 7 days from the last menstrual period. Users of oral hormonal contraception and vaginal hormonal methods reported the highest first-cycle pregnancy rates (1.0-1.2). Among same-day start users, 174 (6.8%) received oral emergency contraception at enrollment in conjunction with another method. Among the same-day start users who received emergency contraception at initiation, 4 (2.3%) pregnancies were reported. CONCLUSION: Same-day start is common and associated with a low pregnancy risk. Using the "any method, any-time" approach better meets contraceptive clients' needs and maintains a low risk of pregnancy.

One-year pregnancy and continuation rates after placement of levonorgestrel or copper intrauterine devices for emergency contraception: a randomized controlled trial.

BACKGROUND: Recent evidence demonstrates the effectiveness of the levonorgestrel 52-mg intrauterine device for emergency contraception vs the copper T380A intrauterine device. Of note, 1-year pregnancy and continuation rates after intrauterine device placement for emergency contraception remain understudied. OBJECTIVE: This study compared 1-year pregnancy and intrauterine device continuation rates and reasons for discontinuation among emergency contraception users randomized to the levonorgestrel 52-mg intrauterine device or the copper intrauterine device. STUDY DESIGN: This participant-masked, randomized noninferiority trial recruited emergency contraception individuals desiring an intrauterine device from 6 Utah family planning clinics between August 2016 and December 2019. Participants were randomized 1:1 to the levonorgestrel 52-mg intrauterine device group or the copper T380A intrauterine device group. Treatment allocation was revealed to participants at the 1-month follow-up. Trained personnel followed up the participants by phone, text, or e-mail at 5 time points in 1 year and reviewed electronic health records for pregnancy and intrauterine device continuation outcomes for both confirmation and nonresponders. We assessed the reasons for the discontinuation and used Cox proportional-hazard models, Kaplan-Meier estimates, and log-rank tests to assess differences in the continuation and pregnancy rates between the groups. RESULTS: The levonorgestrel and copper intrauterine device groups included 327 and 328 participants, respectively, receiving the respective interventions. By intention-to-treat analysis at 1 year, the pregnancy rates were similar between intrauterine device types (2.8% [9/327] in levonorgestrel 52-mg intrauterine device vs 3.0% [10/328] in copper intrauterine device; risk ratio, 0.9; 95% confidence interval, 0.4-2.2; P=.82). Most pregnancies occurred in participants after intrauterine device removal, with only 1 device failure in each group. Of note, 1-year continuation rates did not differ between groups with 204 of 327 levonorgestrel 52-mg intrauterine device users (62.4%) and 183 of 328 copper T380A intrauterine device users (55.8%) continuing intrauterine device use at 1 year (risk ratio, 1.1; 95% confidence interval, 1.0-1.2; P=.09). There were differences concerning the reasons for discontinuation between intrauterine device types, with more bleeding and cramping cited among copper intrauterine device users. CONCLUSION: The pregnancy rates were low and similar between intrauterine device types. Of note, 6 of 10 intrauterine device emergency contraception users continued use at 1 year. Moreover, 1-year continuation rates were similar between intrauterine device types.

Assessing contraceptive use as a continuum: outcomes of a qualitative assessment of the contraceptive journey.

BACKGROUND: Contraceptive use is often a multi-decade experience for people who can become pregnant, yet few studies have assessed how this ongoing process impacts contraceptive decision-making in the context of the reproductive life course. METHODS: We conducted in-depth interviews assessing the contraceptive journeys of 33 reproductive-aged people who had previously received no-cost contraception through a contraceptive initiative in Utah. We coded these interviews using modified grounded theory. RESULTS: A person's contraceptive journey occurred in four phases: identification of need, method initiation, method use, and method discontinuation. Within these phases, there were five main areas of decisional influence: physiological factors, values, experiences, circumstances, and relationships. Participant stories demonstrated the ongoing and complex process of navigating contraception across these ever-changing aspects. Individuals stressed the lack of any "right" method of contraception in decision-making and advised healthcare providers to approach contraceptive conversations and provision from positions of method neutrality and whole-person perspectives. CONCLUSIONS: Contraception is a unique health intervention that requires ongoing decision-making without a particular "right" answer. As such, change over time is normal, more method options are needed, and contraceptive counseling should account for a person's contraceptive journey.

Oral Emergency Contraception Provision in the Veterans Health Administration: a Retrospective Cohort Study.

BACKGROUND: In the USA, oral emergency contraception (EC) use to prevent unintended pregnancy is increasing. Oral EC methods include levonorgestrel (LNG) and ulipristal acetate (UPA), with increased UPA efficacy over LNG in high BMI users and those beyond 3 days post intercourse. The Veterans Health Administration (VHA) provides oral EC at low or no cost, yet prescription-level Veteran data are lacking. OBJECTIVE: To describe oral EC provision in VHA, including method type and Veteran user and prescriber characteristics. DESIGN: A retrospective cohort study using VHA administrative data. PARTICIPANTS: All VHA oral EC prescriptions from January 1, 2016, to December 31, 2020. MAIN MEASURES: We linked Veteran-level sociodemographic and military characteristics and provider-level data with each prescription to identify variables associated with oral EC method. KEY RESULTS: A total of 4280 EC prescriptions (85% LNG) occurred for 3120 unique Veterans over 5 years. While prescriptions remained low annually, the proportion of UPA prescriptions increased from 12 to 19%. Compared to LNG users, UPA users were older (34% vs 25% over age 35 years, p <0.001); more likely to identify as white (57% vs 46%) and non-Hispanic (84% vs 79%) (p <0.001); and more likely to have a BMI ≥ 25 (76% vs 67%, p <0.001). UPA prescriptions originated most frequently from VA Medical Centers (87%) and women's health clinics (76%) compared to community-based or other clinic types. In multivariable regression models, race, ethnicity, BMI ≥30, and prescriber facility type of a VA Medical Center or a women's clinic location were predictive of UPA prescription. CONCLUSIONS: Oral EC provision in VHA remains low, but UPA use is increasing. LNG prescription occurs frequently in high BMI Veterans who would benefit from increased efficacy of UPA. Interventions to expand oral EC access in VHA are essential to ensure Veterans' ability to avert unwanted pregnancies.

Levonorgestrel 52 mg intrauterine system efficacy and safety through 8 years of use.

BACKGROUND: Extending hormonal intrauterine system duration will allow users to have less need for procedures to provide long-term contraception. OBJECTIVE: This study aimed to evaluate the efficacy and safety of the levonorgestrel 52 mg intrauterine system during years 7 and 8 of use. STUDY DESIGN: A total of 1751 nulliparous and multiparous participants aged 16 to 45 years enrolled in a phase 3, multicenter trial to evaluate the efficacy and safety of the use of the Liletta levonorgestrel 52 mg intrauterine system for up to 10 years. Participants aged 36 to 45 years at enrollment underwent safety evaluation only. After the first year, we evaluated participants every 6 months for intrauterine system location confirmation and urine pregnancy testing at each visit. We assessed the Pearl Indices in years 7 and 8 and the life-table analysis for cumulative pregnancy rates through 8 years of use. For the primary efficacy analyses, all participants aged 16 to 35 years at enrollment were included through year 6; years 7 and 8 included only users aged ≤39 years at the start of each use year. Safety outcomes were assessed in all participants regardless of duration of use. We assessed amenorrhea rates, defined as no bleeding or spotting in the 90 days before the end of the year. RESULTS: After intrauterine system placement, we followed 1568 participants aged 16 to 35 years and 146 participants aged 36 to 45 years. The 16- to 35-year-old participants included 986 (57.5%) nulliparous and 433 (25.3%) obese users. Overall, 569 participants started year 7, 478 completed year 7 (380 aged ≤39 years at beginning of year) and 343 completed year 8 (257 aged ≤39 years at beginning of year); 77 completed 10 years of use. Eleven pregnancies occurred over 8 years, 7 (64%) of which were ectopic. Two pregnancies occurred in year 7 (Pearl Index, 0.49; 95% confidence interval, 0.06-1.78), 1 in a participant with implantation 4 days after a desired removal; no pregnancies occurred in year 8. The cumulative life-table pregnancy rate in the primary efficacy population through year 8 was 1.32 (95% confidence interval, 0.69-2.51); without the postremoval pregnancy, the rate was 1.09 (95% confidence interval, 0.56-2.13). Two perforations (0.1%) occurred, none noted after year 1. Expulsion occurred in 71 (4.1%) participants overall, with 3 in year 7 and 2 in year 8. Pelvic infection was diagnosed in 16 (0.9%) participants during intrauterine system use, 1 each in years 7 and 8. Only 44 (2.6%) participants overall discontinued because of bleeding complaints (4 total in years 7 and 8) with rates per year of 0.1% to 0.5% for years 3 to 8. Amenorrhea rates were 39% at both years 7 and 8. CONCLUSION: The levonorgestrel 52 mg intrauterine system is highly effective over 8 years of use and has an excellent extended safety profile. This report details the longest period of efficacy and safety data for continuous use of a levonorgestrel 52 mg intrauterine system for contraception.

A prospective analysis of the relationship between sexual acceptability and contraceptive satisfaction over time.

BACKGROUND: Contraceptives are used to prevent unwanted pregnancies and treat certain gynecologic conditions, but many women report non-use or inconsistent use because of method dissatisfaction. The sexual acceptability of contraception-how birth control methods affect users' sexual well-being-is likely an important component of contraceptive satisfaction but has yet to be systematically examined. OBJECTIVE: This study aimed to assess contraceptive satisfaction among new-start contraceptive users and examine whether sexual acceptability measures predict contraceptive satisfaction at 3 months while controlling for more commonly measured contraceptive side effects. STUDY DESIGN: This analysis used data derived from the baseline, 1-month, and 3-month surveys of the HER Salt Lake Contraceptive Initiative, a prospective cohort study of new contraceptive clients. From March 2016 to March 2017, enrolled participants received their desired contraceptive method at no cost and could switch or discontinue at any time (up to 3 years). This analysis included individuals who continued their new contraceptive method for at least 1 month and completed all relevant survey measures. We used ordered logistic regression modeling to predict contraceptive satisfaction at 3 months. Primary predictor variables included changes in sexual functioning (6-item Female Sexual Function Index), sexual satisfaction (New Sexual Satisfaction Scale), and perceived impact of the contraceptive method on sex life at 1 month. Covariates included vaginal bleeding changes, physical side effects, and mood-related side effects. RESULTS: Our analytical sample included 1879 individuals. At 3 months, 52.1% of participants were "completely satisfied" with their contraceptive method, 30.7% were "somewhat satisfied," 4.2% were "neither satisfied nor dissatisfied," 6.9% were "somewhat dissatisfied," and 6.2% were "completely dissatisfied." Compared with patients who said their contraceptive method made their sex life "a lot" worse at 1 month, patients whose method improved their sex life "a lot" had a 7.7 times increased odds of greater satisfaction at 3 months (95% confidence interval, 4.02-14.60; P<.0001) and patients whose method improved their sex life a "little" had a 5.88 times increased odds of greater satisfaction (confidence interval, 3.12-11.11; P<.001). To a much lesser degree, experiencing less or no bleeding was significantly associated with increased satisfaction, whereas worsening of physical side effects was linked to decreased satisfaction. The only other factors significantly associated with satisfaction were changes in bleeding and physical side effects. CONCLUSION: Our findings suggest that patients' sexual experiences of their contraceptive methods are important correlates of satisfaction. Clinicians may wish to underscore that sexual experiences of birth control methods matter and encourage patients to find a contraceptive method that works for them sexually.

Implementation and Monitoring of the Family Planning Elevated Contraceptive Access Program, Utah, 2018‒2019.

Family Planning Elevated (FPE) is a contraceptive access initiative in Utah. FPE designed and utilized a comprehensive monitoring system to identify and respond to challenges implementing our initiative as they arose. Here, we describe the components of our monitoring system, and highlight how FPE's monitoring system successfully identified that Utah's Medicaid expansion was not widely adopted by eligible individuals. We then describe how FPE adapted to this challenge. (Am J Public Health. 2022;112(S5):S528-S531. https://doi.org/10.2105/AJPH.2022.306935).

Measuring the Sexual Acceptability of Contraception: Psychometric Examination and Development of a Valid and Reliable Prospective Instrument.

BACKGROUND: People's sexual experiences have a strong association with contraceptive satisfaction and continuation, but no measures exist to specifically assess contraceptive-related sexual acceptability. AIM: This study developed and examined the psychometric properties of reliability, separation, and item fit of a new Contraceptive Sexual Acceptability (CSA) instrument. METHODS: Enrolled participants initiating a new contraceptive method from the HER Salt Lake longitudinal cohort study contributed baseline survey responses for scale development. The study included the Female Sexual Function Index, the New Sexual Satisfaction Scale, measures of physical and mood-related side effects, and self-reported perceptions of contraception's sexual impacts. Items from these measures' served as the basis for analyses. We analyzed responses using descriptive techniques and modeled using exploratory factor (EFA) and bifactor analyses (BFA). The Masters' Partial Credit Rasch method modeled reliability, separation, and item fit statistics. Here we evaluate (i) the reproducibility of relative measure location on the modeled linear latent variable, (ii) the number of statistically unique performance levels that can be distinguished by the measure, and (iii) the discrepancy between item responses and expectations of the model. Psychometric findings and theoretical models informed item reduction and final scale development. OUTCOMES: We developed a 10-item Contraceptive Sexual Acceptability scale that exceeded the thresholds and sufficiently covered domains for use in contraceptive research and clinical settings. RESULTS: Starting with data on 39-items from 4,387 individuals, we identified 10-items that best measured the CSA latent construct. The Rasch model included a total of 5 calibrations. We reduced items based on bifactor analysis and surpassed unidimensionality thresholds (OH = 0.84, ECV = 0.74) set a priori. The final items included questions with scaled responses about pleasure and orgasm (orgasm quality, orgasm frequency, giving partner pleasure), physical (arousal and function) and psychological (emotional connection, surrender) components, general questions of satisfaction and frequency, and a measure of perceived impact of contraception on sexual experiences in the previous 4 weeks. CLINICAL IMPLICATIONS: The 10-item CSA instrument covers physical and psychological aspects of contraceptive sexual acceptability and can be used in clinical settings. STRENGTHS & LIMITATIONS: The unidimensional CSA instrument offers a brief, yet comprehensive assessment of sexual acceptability. Given the limited diversity of the sample, implementation of this scale in contraceptive research and clinical interactions should be evaluated and validated in more diverse settings. CONCLUSION: Attuning to sexual acceptability could ultimately help contraceptive clients find methods that better meet their needs and preferences. Sanders JN, Kean J, Zhang C, et al. Measuring the Sexual Acceptability of Contraception: Psychometric Examination and Development of a Valid and Reliable Prospective Instrument. J Sex Med 2022;19:507-520.

Does access to no-cost contraception change method selection among individuals who report difficulty paying for health-related care?

BACKGROUND: Out-of-pocket costs continue to be a barrier to accessing necessary healthcare services, including contraception. We explored how eliminating out-of-pocket cost affects contraceptive method choice among people reporting difficulty paying for healthcare in the previous year, and whether method satisfaction differed by method choice. METHODS: We used data from the HER Salt Lake Contraceptive Initiative. This prospective cohort study provided participants with no-cost contraception (April 2016-March 2017) following a control period that provided no reduction in cost for the contraceptive implant, a reduced price for the hormonal IUD, and a sliding scale that decreased to no-cost for the copper IUD (September 2015-March 2016). We restricted the study population to those who reported difficulty paying for healthcare in the past 12 months. For our primary outcome assessing changes in method selection between intervention and control periods, we ran simultaneous multivariable logistic regression models for each method, applying test corrections for multiple comparisons. Among participants who continued their method for 1 year, we explored differences in method satisfaction using multivariable logistic regression. RESULTS: Of the 1,029 participants reporting difficulty paying for healthcare and controlling for other factors, participants more frequently selected the implant (aOR 6.0, 95% CI 2.7, 13.2) and the hormonal IUD (aOR 3.2, 95% CI 1.7, 5.9) during the intervention than control period. Comparing the same periods, participants less frequently chose the injection (aOR 0.5, 95% CI 0.3, 0.8) and the pill (aOR 0.4, 95% CI 0.3, 0.6). We did not observe a difference in uptake of the copper IUD (aOR 2.0, 95% CI 1.0, 4.1).Contraceptive satisfaction scores differed minimally by contraceptive method used among contraceptive continuers (n = 534). Those who selected LNG IUDs were less likely to report low satisfaction with their method (aOR 0.5, 95% CI 0.3, 0.97). CONCLUSION: With costs removed, participants who reported difficulty paying for healthcare were more likely to select hormonal IUDs and implants and less likely to select the injectable or contraceptive pills. Among continuers, there were few differences in method satisfaction. CLINICALTRIALS: gov Identifier NCT02734199.

Intrauterine device use, sexually transmitted infections, and fertility: a prospective cohort study.

BACKGROUND: In the 1970s, numerous medical reports, media coverage, and litigation around the Dalkon Shield intrauterine device led to a perception that all intrauterine devices cause upper genital tract infection and infertility. OBJECTIVE: This study aimed to assess the association between intrauterine device use and time to conception. STUDY DESIGN: The Fertility After Contraceptive Termination Study is a multicenter, prospective cohort study of women stopping their contraceptive method to attempt conception. We recruited participants between 2011 and 2017. Participants were a convenience sample of women recruited from academic centers in Philadelphia, PA; Los Angeles, CA; St. Louis, MO; Indianapolis, IN; Aurora, CO; and Salt Lake City, UT. Women were eligible if they stopped their contraceptive method within the past 120 days before enrollment, were between 18 and 35 years of age, had no history of infertility or sterilization, and had at least 6 months of follow-up. Baseline data included demographic and reproductive characteristics, past contraceptive use, nucleic acid amplification testing for sexually transmitted infections, and serology for past infection with Chlamydia trachomatis, Trichomonas vaginalis, and Mycoplasma genitalium. The primary exposure was intrauterine device use (ever); the primary outcome was time to conception. All participants were observed longitudinally for up to 24 months. We used piecewise exponential proportional hazards models with multiple imputation to provide hazard ratios and their respective 95% confidence intervals. RESULTS: Of the 461 participants, mean age was 28.2 years, 178 (38.7%) were Black, 157 (34.1%) were considered as low socioeconomic status, and 275 (59.7%) had a history of intrauterine device use. Without adjusting for any covariates, the median time to conception was shorter for participants who had a history of intrauterine device use (5.1 months) than participants who never used an intrauterine device (7.5 months). After controlling for potential confounders, the association of past intrauterine device use with time to conception was not statistically significant (adjusted hazard ratio, 1.25; 95% confidence interval, 0.99-1.58). In our multivariable model, age, nulligravidity, Black race, low socioeconomic status, and past Mycoplasma genitalium infection were associated with longer times to conception (hazard ratio, 0.76; 95% confidence interval, 0.58-0.99). Conception by 12 months was lower in participants with past Mycoplasma genitalium infection (68% vs 80% without past infection; P=.019). CONCLUSION: We found no impairment of fertility with ever use of an intrauterine device. Serologic evidence of past Mycoplasma genitalium infection was associated with longer times to conception and higher rates of infertility. Mycoplasma genitalium infection is a potential modifiable cause of infertility.

Ex-vivo forces associated with intrauterine device placement and perforation: a biomechanical evaluation of hysterectomy specimens.

BACKGROUND: This biomechanical analysis of hysterectomy specimens assesses the forces associated with intrauterine device placement. These include compressive forces required to cause uterine perforation with two commonly available commercial intrauterine device placement instruments and a metal uterine sound. METHODS: We obtained hysterectomy specimens at a single academic center. All specimens resulted from excision for benign conditions in premenopausal women by any operative method. Within one hour of excision, we stabilized uterine specimens in an apparatus specifically designed for this analysis. A single, experienced clinician performed all experimental maneuvers and measured forces with a Wagner FDIX-25 force gauge. The investigator applied traction on a tenaculum to approximate force used during an intrauterine device placement. The maximum compressive force to the uterine fundus was determined by using manufacturers' placement instruments for two commercially available products and a metal sound. RESULTS: Sixteen individuals provided hysterectomy specimens. No complete perforations occurred while using loaded intrauterine devices; in a single observation the LNG IUS entered the myometrium. The plastic intrauterine device placement rod bowed in all attempts and did not perforate the uterine serosa at the fundus. A metal uterine sound created a complete perforation in all specimens (p < .001). The lowest mean maximum force generated occurred with the levonorgestrel intrauterine system placement instrument 12.3 N (SD ± 3.8 N), followed by the copper T380A intrauterine device placement instrument 14.1 N (SD ± 4.0 N), and highest for the metal sound 17.9 N (SD ± 7.6 N) (p < 0.01). CONCLUSIONS: In this ex-vivo model, metal uterine sounds caused complete perforation and intrauterine device placement instruments did not. This study received Institutional Review Board (IRB0059096) approval.

The HER Salt Lake media campaign: comparing characteristics and outcomes of clients who make appointments online versus standard scheduling.

BACKGROUND: Little research has examined how media outreach strategies affect the outcomes of contraceptive initiatives. Thus, this paper assesses the potential impact of an online media campaign introduced during the last six months of a contraceptive initiative study based in Salt Lake City, UT (USA). METHODS: During the last six months of the HER Salt Lake Contraceptive Initiative (September 2016-March 2017), we introduced an online media campaign designed to connect potential clients to information about the initiative and a brief (9-item) appointment request form (via HERsaltlake.org). Using linked data from the online form and electronic medical records, we examine differences in demographics, appointment show rates, and contraceptive choices between "online requester" clients who made clinical appointments through the online form (n = 356) and "standard requester" clients who made appointments using standard scheduling (n = 3,051). We used summary statistics and multivariable regression to compare groups. RESULTS: The campaign logged 1.7 million impressions and 15,765 clicks on advertisements leading to the campaign website (HERSaltLake.org). Compared to standard requesters, online requesters less frequently reported a past pregnancy and were more likely to be younger, white, and to enroll in the survey arm of the study. Relative to standard requesters and holding covariates constant, online requesters were more likely to select copper IUDs (RRR: 8.14), hormonal IUDs (RRR: 12.36), and implants (RRR: 10.75) over combined hormonal contraceptives (the contraceptive pill, patch, and ring). Uptake of the contraceptive injectable, condoms, and emergency contraception did not differ between groups. CONCLUSION: Clients demonstrating engagement with the media campaign had different demographic characteristics and outcomes than those using standard scheduling to arrange care. Online media campaigns can be useful for connecting clients with advertised contraceptive methods and initiatives. However, depending on design strategy, the use of media campaigns might shift the demographics and characteristics of clients who participate in contraceptive initiatives. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT02734199, Registered 12 April 2016-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT02734199 .

Comparison of levonorgestrel level and creamatocrit in milk following immediate versus delayed postpartum placement of the levonorgestrel IUD.

BACKGROUND: Breastfeeding and postpartum contraception critically influence infant and maternal health outcomes. In this pilot study, we explore the effects of timing and duration of postpartum levonorgestrel exposure on milk lipid and levonorgestrel content to establish baseline data for future research. METHODS: This sub-study recruited a balanced convenience sample from 259 participants enrolled in a parent randomized controlled trial comparing immediate to delayed (4-8 weeks) postpartum levonorgestrel IUD placement. All planned to breastfeed, self-selected for sub-study participation, and provided the first sample at 4-8 weeks postpartum (before IUD placement for the delayed group) and the second four weeks later. We used the Wilcoxon rank sum (inter-group) and signed rank (intra-group) tests to compare milk lipid content (creamatocrit) and levonorgestrel levels between groups and time points. RESULTS: We recruited 15 participants from the immediate group and 17 from the delayed group with 10 and 12, respectively, providing both early and late samples. Initially, median levonorgestrel concentration of the immediate group (n = 10) (32.5 pg/mL, IQR: 24.8, 59.4) exceeded that of the delayed group (n = 12) (17.5 pg/mL, IQR: 0.0, 25.8) (p = 0.01). Four weeks later, the values aligned: 26.2 pg/mL (IQR: 20.3, 37.3) vs. 28.0 pg/mL (IQR: 25.2, 40.8). Creamatocrits were similar between both groups and timepoints. CONCLUSIONS: Immediate postpartum levonorgestrel IUD placement results in steady, low levels of levonorgestrel in milk without apparent effects on lipid content. These findings provide initial support for the safety of immediate postpartum levonorgestrel IUD initiation, though the study was not powered to detect noninferiority between groups. TRIAL REGISTRATION: This randomized controlled trial was registered with ClinicalTrials.gov (Registry No. NCT01990703) on November 21, 2013.

Determining the impact of the Zika pandemic on primary care providers' contraceptive counseling of non-pregnant patients in the US: a mixed methods study.

BACKGROUND: Global pandemics like Zika (ZIKV) factor into pregnancy planning and avoidance, yet little is known about how primary care providers (PCPs) incorporate public health guidance into contraceptive counseling. Study objectives include: 1) determining the impact of the ZIKV pandemic on contraceptive counseling changes; and 2) assessing PCP knowledge and practice regarding contraception, ZIKV, and CDC ZIKV guidelines. METHODS: Study components included: (1) a retrospective review of electronic health records of non-pregnant, reproductive age women presenting for preventive health visits between 2014 and 2017 assessed using interrupted time series analyses (ITSA) to identify changes in documentation of ZIKV risk assessment and contraceptive counseling; and (2) a sequential, cross-sectional study with quantitative surveys and qualitative, semi-structured interviews of PCPs providing preventive care to non-pregnant patients at eight federally qualified health centers in Utah. We performed descriptive analyses on survey data and analyzed qualitative data for dominant themes using a modified Health Belief Model. RESULTS: We conducted 6634 chart reviews yielding 9840 visits. The ITSA did not reveal changes in ZIKV risk assessment or contraceptive counseling. Twenty-two out of 40 (55%) eligible providers participated in the provider component. Participants averaged 69 and 81% correct on contraceptive and ZIKV knowledge questions, respectively. Sixty-five percent reported counseling consistent with CDC ZIKV guidelines. Qualitative analysis found providers unlikely to prioritize ZIKV risk assessment in contraceptive counseling for non-pregnant patients. CONCLUSIONS: PCPs who care for non-pregnant women are knowledgeable about contraception and ZIKV; however, there was no change in ZIKV risk assessment or contraceptive counseling. This stresses the importance of developing strategies to improve guideline uptake.

Multi-morbidity and Highly Effective Contraception in Reproductive-Age Women in the US Intermountain West: a Retrospective Cohort Study.

BACKGROUND: Women with chronic health conditions benefit from reproductive planning and access to highly effective contraception. OBJECTIVE: To determine the prevalence of and relationship between chronic health conditions and use of highly effective contraception among reproductive-age women. DESIGN: Retrospective cohort study using electronic health records. PARTICIPANTS: We identified all women 16-49 years who accessed care in the two largest health systems in the US Intermountain West between January 2010 and December 2014. MAIN MEASURES: We employed administrative codes to identify highly effective contraception and flag chronic health conditions listed in the US Medical Eligibility Criteria for Contraceptive Use (US MEC) and known to increase risk of adverse pregnancy outcomes. We described use of highly effective contraception by demographics and chronic conditions. We used multinomial logistic regression to relate demographic and disease status to contraceptive use. KEY RESULTS: Of 741,612 women assessed, 32.4% had at least one chronic health condition and 7.3% had two or more chronic conditions. Overall, 7.6% of women with a chronic health condition used highly effective contraception vs. 5.1% of women without a chronic condition. Women with chronic conditions were more likely to rely on public health insurance. The proportion of women using long-acting reversible contraception did not increase with chronic condition number (5.8% with 1 condition vs. 3.2% with 5 or more). In regression models adjusted for age, race, ethnicity, and payer, women with chronic conditions were more likely than those without chronic conditions to use highly effective contraception (aRR 1.4; 95% CI 1.4-1.5). Public insurance coverage was associated with both use of long-acting reversible contraception (aRR 2.2; 95% CI 2.1-2.3) and permanent contraception (aRR 2.9; 95% CI 2.7-3.1). CONCLUSIONS: Nearly a third of reproductive-age women in a regional health system have one or more chronic health condition. Public insurance increases the likelihood that women with a chronic health condition use highly effective contraception.

Bleeding changes after levonorgestrel 52-mg intrauterine system insertion for contraception in women with self-reported heavy menstrual bleeding.

BACKGROUND: The levonorgestrel 52-mg intrauterine system has proven efficacy for heavy menstrual bleeding treatment in clinical trials, but few data exist to demonstrate how rapidly the effects occur and the effects in women with self-reported heavy bleeding, as seen commonly in clinical practice. OBJECTIVE: Evaluate changes in bleeding patterns in women with self-reported heavy menstrual bleeding before levonorgestrel 52-mg intrauterine system insertion. STUDY DESIGN: A total of 1714 women aged 16-45 years old received a levonorgestrel 52-mg intrauterine system in a multicenter trial evaluating contraceptive efficacy and safety for up to 10 years. At screening, participants described their baseline menstrual bleeding patterns for the previous 3 months. Participants completed daily diaries with subjective evaluation of bleeding information for the first 2 years. For this analysis, we included women with at least 1 complete 28-day cycle of intrauterine system use and excluded women using a hormonal or copper intrauterine contraception in the month prior to study enrollment. We evaluated changes in menstrual bleeding and discontinuation for bleeding complaints per 28-day cycle over 26 cycles (2 years) in women who self-reported their baseline pattern as heavy. We also compared rates of amenorrhea, defined as no bleeding or spotting, within the entire study population in women with subjective heavy menstrual bleeding at baseline compared with those who did not complain of heavy menstrual bleeding. RESULTS: Of the 1513 women in this analysis, 150 (9.9%) reported baseline heavy menstrual bleeding. The majority of women reported no longer experiencing heavy menstrual bleeding by the end of cycle 1 (112/150, 74.7%) with even greater rates by cycle 2 (124/148, 83.8%). At the end of cycles 6, 13, and 26, 129 of 140 (92.1%; 95% confidence interval, 87.7%-96.6%), 114 of 123 (92.7%; 95% confidence interval, 88.1%-97.3%), and 100 of 103 (97.1%; 95% confidence interval, 93.8%-100%) women reported no heavy menstrual bleeding, respectively. After cycles 13 and 26, 63 of 123 (51.2%; 95% confidence interval, 42.4%-60.1%) and 66 of 103 (64.1%; 95% confidence interval, 54.8%-73.3%), respectively, reported their bleeding as amenorrhea or spotting only. A lower proportion of women with baseline self-reported heavy menstrual bleeding reported amenorrhea as compared with women in the overall study cohort without heavy menstrual bleeding at the end of 6 cycles (319 [25.5%] vs 21 [15.0%], P=.005) and 13 cycles (382 [34.4%] vs 26 [21.1%], P=.003); differences were not significant after 19 cycles (367 [37.2%] vs 36 [31.0%], P=.022) and 26 cycles (383 [43.5%] vs 38 [36.9%], P=.21). Only 4 (2.7%) women with baseline heavy menstrual bleeding discontinued for bleeding complaints (2 for heavy menstrual bleeding and 2 for irregular bleeding), all within the first year. CONCLUSION: Most women who self-report heavy menstrual bleeding experience significant improvement quickly after levonorgestrel 52-mg intrauterine system insertion. Discontinuation for bleeding complaints among women with baseline heavy menstrual bleeding is very low.

"In Africa, There Was No Family Planning. Every Year You Just Give Birth": Family Planning Knowledge, Attitudes, and Practices Among Somali and Congolese Refugee Women After Resettlement to the United States.

It is crucial for refugee service providers to understand the family planning knowledge, attitudes, and practices of refugee women following third country resettlement. Using an ethnographic approach rooted in Reproductive Justice, we conducted six focus groups that included 66 resettled Somali and Congolese women in a western United States (US) metropolitan area. We analyzed data using modified grounded theory. Three themes emerged within the family planning domain: (a) concepts of family, (b) fertility management, and (c) unintended pregnancy. We contextualized these themes within existing frameworks for refugee cultural transition under the analytic paradigms of "pronatalism and stable versus evolving family structure" and "active versus passive engagement with family planning." Provision of just and equitable family planning care to resettled refugee women requires understanding cultural relativism, social determinants of health, and how lived experiences influence family planning conceptualization. We suggest a counseling approach and provider practice recommendations based on our study findings.

Predictors of contraceptive switching and discontinuation within the first 6 months of use among Highly Effective Reversible Contraceptive Initiative Salt Lake study participants.

BACKGROUND: Nearly half of women will switch or discontinue using their selected contraceptive method in the first year. Research on early switching or discontinuation provides important clinical and public health insights, although few studies have assessed associated factors, particularly among longitudinal cohorts. OBJECTIVE: The current study explores attributes associated with early contraceptive method switching or discontinuation (<6 months of initiation) among participants enrolled in the intervention cohorts of the Highly Effective Reversible Contraceptive Initiative Salt Lake Contraceptive Initiative (Utah, United States). MATERIALS AND METHODS: Highly Effective Reversible Contraceptive Initiative Salt Lake participants have access to no-cost contraception for 3 years. This includes both the initial selection and the ability to switch or to discontinue methods without cost. Methods available included the following: nonhormonal behavioral methods (male/female condoms, withdrawal, diaphragms, cervical caps, and fertility awareness); short-acting methods (pill, patch, ring, and injectable); and long-acting methods (intrauterine devices and contraceptive implants). Participants completed surveys at baseline and at 1, 3, and 6 months. We collected data on participant demographics, contraceptive continuation, switching, and discontinuation, as well as factors associated with these changes, including established measures of pregnancy intention and ambivalence and reasons for switching or discontinuing. We conducted descriptive statistics, univariable, and multivariable Poisson regression analyses to assess predictors of both discontinuation and switching. We also conducted χ2 analyses to compare reported reasons for stopping between switchers and discontinuers. RESULTS: At 6 months, 2,583 women (70.0%) reported continuation of their baseline method, 367 (10%) reported at least 1 period of discontinuation, 459 (12.4%) reported switching to a different method, and 279 (7.6%) did not provide 6-month follow-up. Factors associated with discontinuation included selection of a short-acting method (incidence rate ratio [IRR], 2.49; 95% confidence interval [CI], 1.97, 3.12), report of Hispanic ethnicity (IRR, 1.45; 95% CI, 1.12, 1.89) and nonwhite race (IRR, 1.48; 95% CI, 1.08, 2.02), and having any future pregnancy plans, even years out. Participants with some college education were less likely to report discontinuation (IRR, 0.73; 95% CI, 0.57, 0.94). Selecting a short-acting method at baseline was also associated with increased likelihood of method switching (IRR, 2.29, 95% CI, 1.87, 2.80), as was having 2 or more children (IRR, 1.37; 95% CI, 1.08, 1.74). Women were less likely to switch if they were on their parents' insurance (IRR, 0.74; 95% CI, 0.56, 0.99). Among participants who switched methods, 36.9% switched to a long-acting reversible method, 31.7% switched to a short-acting hormonal method, and 31.1% switched to a nonhormonal behavioral method, such as condom use. Of participants providing a reason for stopping, 454 women (73.2%) reported side effects as 1 reason for switching or discontinuing their initial method. CONCLUSION: Early contraceptive method switching and discontinuation are frequent outcomes of contraceptive use. These changes are common even with removal of contraceptive access barriers.