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The recent Danish cohort study reported a 20% increased risk of breast cancer among current and recent hormonal contraception users. These results are largely consistent with previous studies. This study did not report on stage of disease at diagnosis, and it is not clear to what extent the apparent increased risk may be due to a small advance in the timing of diagnosis. This study did not report on the risk associated with the use of a 20-mcg ethinyl estradiol pill. They did find an increasing risk in current users of longer duration and an increased risk with use of the levonorgestrel intrauterine system-both of these potentially important findings have not been consistently found in previous studies and require further investigation. The breast cancer effects described now in multiple studies wane with time, and in the long term, hormonal contraception use has been found not to be associated with any increased total cancer risk. [ABSTRACT FROM AUTHOR]

Background: Inpatient insertion of long-acting reversible contraception and immediate postpartum tubal ligation allow women to initiate highly effective contraception before hospital discharge.Objective: We measured rates of intrauterine device and contraceptive implant initiation and tubal ligations performed during delivery hospitalizations from 2016 to 2018 from a representative sample of US hospital discharges.Study Design: We used the 2016 to 2018 National Inpatient Sample database, a 20% sample of all community hospital discharges in the United States, to identify delivery hospitalizations with concomitant intrauterine device insertion, contraceptive implant insertion, or tubal ligation. We performed weighted multivariable logistic regression to examine associations between possible predictors (age, delivery mode, payer, geographic region, and year) and odds of long-acting reversible contraception and tubal ligation, and to compare characteristics of users.Results: This sample included 2,216,638 discharges, representing 20% of 11,083,180 delivery hospitalizations across the United States. Intrauterine device insertion increased from 2.2 per 1000 deliveries (2016) to approximately 5.0 per 1000 deliveries (2018; P<.0001); implant insertion increased from 0.3 per 1000 deliveries (2016) to 2.5 per 1000 deliveries (2018; P<.0001); tubal ligation procedures decreased (64.2 to 62.1 per 1000 deliveries; P<.0001). Women who underwent a cesarean delivery had higher odds of having a tubal ligation than those who had a vaginal delivery (adjusted odds ratio, 8.83; 95% confidence interval, 8.73-8.97). Women aged <25 years had 7 times higher odds of receiving long-acting reversible contraception than of receiving tubal ligation (adjusted odds ratio, 7.38; 95% confidence interval, 6.90-7.90). Women with public insurance had almost 5 times the odds of receiving long-acting reversible contraception compared with those with commercial insurance (adjusted odds ratio, 4.83; 95% confidence interval, 4.59-5.06).Conclusion: Rates of long-acting reversible contraception insertion continue to increase while the rates of inpatient postpartum tubal ligations slowly decline. Variations in patient characteristics are associated with receiving long-acting reversible contraception or tubal ligation. [ABSTRACT FROM AUTHOR]

A self-administered anonymous waiting room survey was used to evaluate men’s preferences on testing, notification, and treatment for sexually transmitted infections (STIs) in a community clinic in Upper Manhattan in 2007. Sixty-seven percent of eligible men (n = 199) participated. Most were willing to collect a urine sample at home (71%, n = 140) or at the clinic (87%, n = 171). Respondents preferred learning of a positive STI test result by phone (67%, n = 123). However, men were willing to receive results by text (65%, n = 127) or e-mail (61%, n = 121). Most (83%, n = 162) reported they would be (very) likely to take STI medication brought to them by a partner. Twenty-one percent reported previous gonorrhea or Chlamydia infection (n = 41). Of these, 39% (n = 16) had received medication to bring their partner, and almost all (n = 14/16) reported their partner took the medicine. Multiple options for STI testing, notification, and treatment are recommended to maximize service use among men, including providing patient-delivered partner therapy [ABSTRACT FROM AUTHOR]

Signed in 2019, New York State's Reproductive Health Act enabled expansion of abortion care up to 28 weeks for any indication. This study aimed to describe how implementation of the New York State Reproductive Health Act affected abortion provision among the state's regional perinatal centers (RPCs)—tertiary referral centers for complex pregnancies that may care for patients seeking abortion later in pregnancy. A secondary objective was to identify barriers to and facilitators of expanding abortion care. From January to May 2023, we recruited clinicians from the 17 New York RPCs, including family planning specialists, maternal–fetal medicine specialists, and genetic counselors. Respondents completed an online survey. We then invited respondents to complete an in-depth interview. We calculated descriptive statistics to characterize the study population and summarize survey responses. We analyzed qualitative interview data using thematic analysis. Twenty-nine respondents completed the survey, representing 16 of 17 New York State RPCs. Seventeen respondents, representing 11 RPCs, completed an interview. All institutions provided abortion care. Twenty-three of 29 survey respondents (79%) reported barriers to providing abortion for any indication after 24 weeks from last menstrual period (LMP). Eighteen of 29 (62%) reported barriers to providing abortion after 24 weeks LMP for maternal or fetal indications. The most commonly reported barriers in the survey results were staff resistance and institutional policy. During interviews, respondents identified staff discomfort, restrictive institutional policies, and lack of clarity around policy as barriers, while highlighting advocates and collaboration within their institutions as facilitators to expansion of abortion services later in pregnancy. RPCs in New York State face barriers in providing abortion, especially after 24 weeks LMP, even though they are ideally situated to provide such care. These barriers exist despite the legality of abortion after 24 weeks in New York and policy efforts to expand access to abortion. [ABSTRACT FROM AUTHOR]

Due to the COVID-19 pandemic, the Sixth International Symposium on Intrauterine Devices and Systems for Women's Health was held as a series of seven 2-hour webinars between May 28, 2020, and June 22, 2021. This Symposium featured 48 different presenters and moderators covering a wide range of topics to highlight new IUD issues and update general IUD knowledge, just as it was done in previous symposia dating back to 1962 [1-5]. A total of 1346 people attended remotely to observe the events live. In this article, we share summaries of the presentations from the sixth symposium. These summaries, provided by the presenters, are meant to archive the symposium. This article gives the reader an overview of the topics and identifies the sessions' moderators and speakers charged with providing the content. Those interested in further detail, references, and information about the speakers can find more information on the conference website: www.iud2020.com. After the summaries, we share ideas for future IUD research and programmatic needs, as provided by Symposium's presenters and organizers. The authors' summaries are personal opinions and do not necessarily reflect the perspectives of the Symposium's organizers or the medical community at large. The Symposium was recorded and the sessions are available for viewing free of charge at the website, www.iud2020.comor on YouTube. As of July 2022, approximately 1700 visitors have viewed the recordings. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has posed challenges for medical education and patient care, which were felt acutely in obstetrics due to the essential nature of pregnancy care. The mobilization of health professions students to participate in obstetric service-learning projects has allowed for continued learning and professional identify formation while also providing a motivated, available, and skilled volunteer cohort to staff important projects for obstetric patients. [ABSTRACT FROM AUTHOR]

To evaluate ovulation risk among women enrolling in an emergency contraception (EC) study by measuring contraceptive steroids and ovarian hormones. We used standard chemiluminescent assays to evaluate endogenous hormones (estradiol, progesterone, follicle stimulating hormone, luteinizing hormone) and liquid chromatography-tandem triple quadrupole mass spectrometry to simultaneously analyze concentrations of ethinylestradiol, dienogest, norelgestromin (NGMN), norethindrone (NET), gestodene, levonorgestrel (LNG), etonogestrel (ENG), segesterone acetate, medroxyprogesterone acetate (MPA), and drospirenone in serum samples obtained at the time of enrollment in a recent study comparing oral ulipristal acetate and LNG EC in women with weight ≥80 kg reporting no recent use of hormonal contraception. We enrolled 532 and obtained a valid baseline blood sample from 520 women. Of these, 117 (22.5%) had detectable concentrations of progestin (MPA [ n = 58, 11.2%], LNG [50, 9.6%], ENG [11, 2.1%], NET [5, 0.96%], NGMN [3, 0.06%], or drospirenone [1, 0.02%]). LNG was co-detected in all three participants with samples containing NGMN. Multiple progestins were detected in eight other women: ENG/MPA (1), ENG/LNG (2), and MPA/LNG (5). Samples from 55 (10.6%) had concentrations of one or more progestin considered above the minimum level for contraceptive (MPA ≥ 0.1 ng/mL, n = 19; NGMN/LNG ≥ 0.2 ng/mL, n = 31; ENG ≥ 0.09 ng/mL, n = 8; NET ≥ 0.35 ng/mL, n = 4). We detected concentrations of serum progesterone ≥ 3 ng/mL, indicative of luteal phase (postovulation) status, in an additional 194 (37.3%) samples. More than one-third of enrolled in our clinical trial of oral EC had evidence of prior ovulation at the time of enrollment. Additionally, about 23% had evidence of recent use of hormonal contraception. These results would have decreased the expected risk of pregnancy in the study. Many participants in a recent clinical trial of oral emergency contraception did not appear to be at risk for pregnancy or would not have benefited from intervention due to cycle timing. Investigators should consider the effects of these findings on expected pregnancy rates when determining sample size in future EC clinical trials, particularly when using noninferiority designs or historical controls. [ABSTRACT FROM AUTHOR]

Background: Almost one-half of women having an abortion in the United States have had a previous procedure, which highlights a failure to provide adequate preventive care. Provision of intrauterine devices and implants, which have high upfront costs, can be uniquely challenging in the abortion care setting.Objective: We conducted a study of a clinic-wide training intervention on long-acting reversible contraception and examined the effect of the intervention, insurance coverage, and funding policies on the use of long-acting contraceptives after an abortion.Study Design: This subanalysis of a cluster, randomized trial examines data from the 648 patients who had undergone an abortion who were recruited from 17 reproductive health centers across the United States. The trial followed participants 18-25 years old who did not desire pregnancy for a year. We measured the effect of the intervention, health insurance, and funding policies on contraceptive outcomes, which included intrauterine device and implant counseling and selection at the abortion visit, with the use of logistic regression with generalized estimating equations for clustering. We used survival analysis to model the actual initiation of these methods over 1 year.Results: Women who obtained abortion care at intervention sites were more likely to report intrauterine device and implant counseling (70% vs 41%; adjusted odds ratio, 3.83; 95% confidence interval, 2.37-6.19) and the selection of these methods (36% vs 21%; adjusted odds ratio, 2.11; 95% confidence interval, 1.39-3.21). However, the actual initiation of methods was similar between study arms (22/100 woman-years each; adjusted hazard ratio, 0.88; 95% confidence interval, 0.51-1.51). Health insurance and funding policies were important for the initiation of intrauterine devices and implants. Compared with uninsured women, those women with public health insurance had a far higher initiation rate (adjusted hazard ratio, 2.18; 95% confidence interval, 1.31-3.62). Women at sites that provide state Medicaid enrollees abortion coverage also had a higher initiation rate (adjusted hazard ratio, 1.73; 95% confidence interval, 1.04-2.88), as did those at sites with state mandates for private health insurance to cover contraception (adjusted hazard ratio, 1.80; 95% confidence interval, 1.06-3.07). Few of the women with private insurance used it to pay for the abortion (28%), but those who did initiated long-acting contraceptive methods at almost twice the rate as women who paid for it themselves or with donated funds (adjusted hazard ratio, 1.94; 95% confidence interval, 1.10-3.43).Conclusions: The clinic-wide training increased long-acting reversible contraceptive counseling and selection but did not change initiation for abortion patients. Long-acting method use after abortion was associated strongly with funding. Restrictions on the coverage of abortion and contraceptives in abortion settings prevent the initiation of desired long-acting methods. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the bleeding patterns of a new combined oral contraceptive containing estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg in a 24/4-day regimen.Study Design: We pooled bleeding data from two parallel, open-label, 13-cycle phase 3 trials that enrolled participants 16 to 50 years old with body mass index (BMI) ≤35 kg/m2. Participants reported vaginal bleeding/spotting in daily diaries. For this bleeding analysis, we included participants with at least one evaluable cycle. We calculated mean frequencies of scheduled and unscheduled bleeding/spotting episodes and median duration of bleeding/spotting episodes, and assessed associations between treatment compliance, BMI and recent hormonal contraceptive use on bleeding/spotting outcomes.Results: We included 3409 participants with 33,815 cycles. Scheduled bleeding/spotting occurred in 87.2% to 90.4% of participants/cycle, with a median duration of 4 to 5 days. Unscheduled bleeding/spotting decreased from 27.1% in Cycle 1 to 20.6% in Cycle 2 to ≤17.5% from Cycle 5 onwards. Most (66.5%) unscheduled bleeding/spotting episodes were spotting-only. Between 5.8% and 7.8% of users/cycle experienced absence of any scheduled or unscheduled bleeding/spotting. Missing one or more active pills resulted in a higher occurrence of unscheduled bleeding/spotting (adjusted odds ratio [aOR] 2.13 [95% confidence interval 1.68-2.70]) and absence of scheduled bleeding/spotting (aOR 2.36 [1.82-3.07]). Participants with a BMI ≥30 kg/m2 reported more absence of scheduled bleeding/spotting (aOR 1.68 [1.37-2.05]). Switchers and starters reported similar frequencies of unscheduled bleeding/spotting (aOR 0.94 [0.83-1.07]) and absence of scheduled bleeding/spotting (aOR 1.00 [0.85-1.19]). Three percent of participants discontinued for a bleeding-related adverse event.Conclusion: E4/DRSP use results in a predictable bleeding pattern with limited unscheduled bleeding/spotting. Noncompliance and BMI affect bleeding patterns.Implications Statement: Most estetrol/drospirenone users experience a predictable and regular bleeding pattern. Providers can educate patients about the expected bleeding patterns and should advise users that they may infrequently experience no scheduled bleeding/spotting. This information may improve user acceptability and continuation of this new oral contraceptive. [ABSTRACT FROM AUTHOR]

Background: Concern regarding pelvic examinations may be more common among women experiencing intimate partner violence. Objective: We examined women's attitudes towards pelvic examination with history of intimate partner violence (pressured to have sex, or verbal, or physical abuse). Design: Secondary analysis of data from a cluster randomized trial on contraceptive access. Participants: Women aged 18–25 were recruited at 40 reproductive health centers across the USA (2011–2013). Main Measures: Delays in clinic visits for contraception and preference to avoid pelvic examinations, by history of ever experiencing pressured sex, verbal, or physical abuse from a sexual partner, reported by frequency (never, rarely, sometimes, often). We used multivariable logistic regression with generalized estimating equations for clustered data. Key Results: A total of 1490 women were included. Ever experiencing pressured sex was reported by 32.4% of participants, with 16.5% reporting it rarely, 12.1% reporting it sometimes, and 3.8% reporting it often. Ever experiencing verbal abuse was reported by 19.4% and physical abuse by 10.2% of participants. Overall, 13.2% of participants reported ever having delayed going to the clinic for contraception to avoid having a pelvic examination, and 38.2% reported a preference to avoid pelvic examinations. In multivariable analysis, women reporting that they experienced pressured sex often had significantly higher odds of delaying a clinic visit for birth control (aOR 3.10 95% CI 1.39–6.84) and for reporting a preference to avoid pelvic examinations (aOR 2.91 95% CI 1.57–5.40). We found no associations between delay of clinic visits or preferences to avoid a pelvic examination and verbal or physical abuse. Conclusions: History of pressured sex from an intimate partner is common. Among women who have experienced pressured sex, concern regarding pelvic examinations is a potential barrier to contraception. Communicating that routine pelvic examinations are no longer recommended by professional societies could potentially reduce barriers and increase preventive healthcare visits. [ABSTRACT FROM AUTHOR]

Objectives: To measure pain and anxiety during first trimester uterine aspiration when using auricular acupressure or acupuncture as an adjunct to usual care.Methods: This randomized, double-blinded, three-arm trial enrolled patients undergoing an aspiration procedure for an induced abortion, a miscarriage, or other abnormal intrauterine pregnancy. Trial participants received auricular acupressure, auricular acupuncture, or placebo immediately prior to their procedures. The study began with 1:1:1 randomization, but later overenrolled into the acupressure group after providing retraining for greater fidelity to that intervention. All participants received ibuprofen and a paracervical block. Participants reported pain and anxiety levels via visual analog scores (0-100). Our analysis compared pain scores of those receiving acupressure versus placebo, and those receiving acupuncture versus placebo.Results: We randomized 177 participants over nine months and excluded data from four participants. We analyzed data from 70 participants who received acupressure, 51 who received acupuncture, and 52 who received placebo. The groups had similar baseline characteristics, including baseline pain and anxiety scores. For acupressure, acupuncture, and placebo groups, respectively, immediate post-procedure median pain scores were 50, 55, 47.5 (p = 0.88); maximum pain scores during the procedure were 77, 79, 79.5 (p = 0.96); postprocedure anxiety scores were 26, 28, and 21 (p = 0.47). The acupressure group results were similar before and after retraining.Conclusions: Receiving auricular acupressure or acupuncture did not result in lower pain or anxiety scores among women undergoing vacuum aspiration compared to a placebo group.Implications: The results of this trial were null, thus differing from our previous study that had shown a benefit from auricular acupuncture. Given the conflicting results, incorporating these acupuncture techniques into abortion practice would be premature. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate whether etonogestrel concentrations are reduced to a level that could potentially reduce contraceptive efficacy when the etonogestrel contraceptive implant is used concomitantly with dolutegravir-based antiretroviral therapy (ART).Study Design: We conducted a non-randomized, open-label, cross-sectional pharmacokinetic study among women using single-rod etonogestrel contraceptive implants in Botswana. We compared plasma etonogestrel concentrations, sampled at a single time-point between 3 and 12 months from implant insertion, among implant users living with HIV and receiving dolutegravir-based ART with HIV-negative implant users. We also assessed concentrations among implant users living with HIV and receiving efavirenz-based ART. We compared geometric mean etonogestrel concentrations analyzing data from 142 participants: 97 HIV-negative, 30 using dolutegravir, and 15 using efavirenz.Results: The groups were similar. Duration of implant use was between 3 and 12 months (median = 5). Geometric mean etonogestrel plasma concentrations and 90% confidence intervals of the mean were 227.5(212.4-243.8), 289.6(251.8-333.0) and 76.4(63.9-91.4) pg/mL among the HIV-negative, dolutegravir- and efavirenz-based ART groups, respectively. All women in the HIV-negative and dolutegravir-based ART groups had etonogestrel concentrations above 90 pg/mL; 9/15 women (60%) using efavirenz-based ART had concentrations below 90 pg/mL. On average, etonogestrel levels were lower among individuals who had implants inserted for longer durations.Conclusions: Implant users receiving dolutegravir-based ART had a higher mean etonogestrel concentration compared to HIV-negative women, and none had etonogestrel concentrations below the posited threshold for ovulation suppression. In contrast, women in the efavirenz-group had much lower etonogestrel concentrations. Overall, these data provide evidence that the etonogestrel implant may be effectively combined with dolutegravir-based ART regimens.Implications: The etonogestrel implant remains a highly effective contraceptive option for women living with HIV who use dolutegravir-based ART. [ABSTRACT FROM AUTHOR]

Objective: To evaluate serum estradiol (E2) concentrations during use of 90-day contraceptive vaginal rings releasing E2 75, 100, or 200 mcg/day and segesterone acetate (SA) 200 mcg/day to identify a dose that avoids hypoestrogenism.Study Design: We conducted a multicenter dose-finding study in healthy, reproductive-aged women with regular cycles with sequential enrollment to increasing E2 dose groups. We evaluated serum E2 concentrations twice weekly for the primary outcome of median E2 concentrations throughout initial 30-day use (target ≥40 pg/mL). In an optional 2-cycle extension substudy, we randomized participants to 2- or 4-day ring-free intervals per 30-day cycle to evaluate bleeding and spotting based on daily diary information.Results: Sixty-five participants enrolled in E2 75 (n = 22), 100 (n = 21), and 200 (n = 22) mcg/day groups; 35 participated in the substudy. Median serum E2 concentrations in 75 and 100 mcg/day groups were <40 pg/mL. In the 200 mcg/day group, median E2 concentrations peaked on days 4-5 of CVR use at 194 pg/mL (range 114-312 pg/mL) and remained >40 pg/mL throughout 30 days; E2 concentrations were 37 pg/mL (range 28-62 pg/mL) on days 88-90 (n = 11). Among the E2 200 mcg/day substudy participants, all had withdrawal bleeding following ring removal. The 2-day ring-free interval group reported zero median unscheduled bleeding and two (range 0-16) and three (range 0-19) unscheduled spotting days in extension cycles 1 and 2, respectively. The 4-day ring-free interval group reported zero median unscheduled bleeding or spotting days.Conclusions: Estradiol concentrations with rings releasing E2 200 mcg/day and SA 200 mcg/day avoid hypoestrogenism over 30-day use.Implications: A 90-day contraceptive vaginal ring releasing estradiol 200 mcg/day and segesterone acetate 200 mcg/day achieves estradiol concentrations that should avoid hypoestrogenism and effectively suppresses ovulation. [ABSTRACT FROM AUTHOR]

Objectives: To describe bleeding patterns among users of the segesterone acetate (SA) and ethinyl estradiol (EE) contraceptive vaginal system (CVS), and identify factors associated with unscheduled bleeding/spotting (B/S).Study Design: We pooled results from two multicenter, single-arm, open-label, pivotal, phase 3 studies of the SA/EE CVS conducted in 17 US and 7 international sites. Participants (age 18-40 years; BMI ≤29 kg/m2) followed a 21/7-day in/out schedule of CVS use for up to 13 cycles and recorded vaginal bleeding daily in paper diaries. Scheduled and unscheduled B/S were summarized by cycle. We used multiple logistic regression to identify factors associated with unscheduled bleeding/spotting, based on the first 4 cycles only.Results: Analysis included data from 2070 participants (16,408 cycles). Ninety-eight percent documented scheduled B/S [mean (SD): 4.9 (1.1) days/cycle)]. Absence of scheduled B/S was 5-8% of women/cycle. Unscheduled B/S ranged from 13.2% to 21.7% of women per cycle. Few women (1.8%) discontinued prematurely due to unacceptable bleeding. Black women were more likely to report unscheduled B/S than White women [Adjusted odds ratio (AOR) = 1.49, 95% confidence interval (CI) = 1.14-1.94]. Women with fewer years of schooling [Conclusions: Participants using the SA/EE CVS up to 13 cycles reported good cycle control. Discontinuation due to unacceptable bleeding was very low. Further research into demographic/other differences with reported unscheduled bleeding is warranted.Implications: Since good cycle control is a key factor influencing contraceptive selection, adherence and continuation of combined hormonal contraceptives, the favorable bleeding profiles experienced by women during the SA/EE CVS clinical trials provide reassuring information for prospective users. [ABSTRACT FROM AUTHOR]

Objective(s): To describe differences in contraceptive knowledge, attitudes and use among HIV-infected and HIV-uninfected women served by an academic medical center in New York City and to describe gaps in knowledge and practice of gynecologic and HIV clinicians providing care at the same clinic sites where patients completed surveys.Study Design: We conducted a survey comparing contraceptive knowledge, attitudes, reproductive histories and long-acting reversible contraception (LARC) use in HIV-infected and -uninfected women. We also conducted a survey to elicit clinician demographic characteristics and education, contraceptive practice patterns and their knowledge of current contraceptive guidelines. We surveyed clinicians and patients at five ambulatory sites.Results: We screened 90% of patients approached. All 257 women who were eligible completed a survey. These included 107 (42%) HIV-infected women and 150 (58%) HIV-uninfected women. HIV-infected women were older, were more likely to be black/African-American, were less likely to be Latina, were more likely to receive public assistance and had lower educational attainment. HIV-infected women reported lower lifetime LARC use (12% vs. 28%) and higher recent condom use (58% vs. 25%) than HIV-uninfected women. Both groups reported similar attitudes toward intrauterine devices (IUDs) and implants. HIV clinicians were less likely to have had training in or discuss LARC methods with their patients.Conclusions: HIV-infected women were less likely to be current (last 30 days) or ever LARC users, despite having similar attitudes toward IUDs and implants, compared to HIV-uninfected women. HIV providers had lower levels of knowledge of HIV-specific contraceptive guidelines compared with gynecology practitioners.Implications: HIV-infected women and their providers share a knowledge gap regarding LARC. Increased interdisciplinary collaboration may help mitigate the resulting disparities in access to highly effective contraception in HIV-infected women. Knowledge of HIV-specific contraceptive guidelines and ability to place contraceptive implants were low among all surveyed providers, suggesting need for additional training. [ABSTRACT FROM AUTHOR]

Objectives: To assess pain-management using auricular acupuncture as an adjunct to ibuprofen and paracervical block during first trimester uterine aspiration, and to assess auricular acupuncture's effect on anxiety.Study Design: This randomized, double-blinded, three-arm trial enrolled women undergoing uterine aspiration for spontaneous or induced abortion. Study participants were randomized 1:1:1 to receive auricular acupuncture, placebo, or usual care alone. Participants in all groups received ibuprofen and paracervical block (usual care). The main outcome was maximum pain reported at the end of the procedure measured using a Visual Analog Scale; we compared those receiving auricular acupuncture to those receiving usual care alone. We also compared auricular acupuncture to placebo and placebo to usual care alone. Finally, we compared the maximum anxiety scores between participants randomized to auricular acupuncture, placebo, and usual care alone.Results: We randomized 153 women over 9 months, and analyzed 52 participants in the auricular acupuncture group, 49 in the placebo group, and 49 in the usual care group. The groups had similar baseline characteristics. After uterine aspiration, participants reported median maximum pain scores as follows: auricular acupuncture 39.5 (interquartile range (IQR) 11, 64.5), placebo 70.0 (IQR 40.5, 84), and usual care alone 71.0 (IQR 32, 91.5) (p<0.01). In pairwise comparisons, the median maximum pain score after auricular acupuncture was lower than placebo and usual-care groups (p<0.01 for both). Post-procedure median anxiety scores were 11.5, 31.0 and 44.0, respectively (p=.01).Conclusions: Women undergoing first trimester uterine aspiration assigned to auricular acupuncture reported substantially less pain and anxiety than women assigned to placebo or usual care.Implications: Auricular acupuncture may be a useful adjunct to ibuprofen and paracervical block during first trimester uterine aspiration. This approach to managing pain and anxiety could avoid the operational complexities and expenses of sedation and opioid use. [ABSTRACT FROM AUTHOR]

Objective: To compare plasma etonogestrel concentrations sampled from the contralateral- versus ipsilateral-to-implant arm.Study Design: Sub-analysis of a cross-sectional study in Botswana in 33 participants who provided contralateral and ipsilateral blood samples.Results: Plasma etonogestrel concentrations in contralateral and ipsilateral specimens were highly correlated (correlation coefficient = 0.99; p < 0.0001). Bland-Altman analysis of agreement showed that etonogestrel levels were on average 5.9 pg/mL higher (2.1%) in ipsilateral compared to contralateral specimens (95% confidence interval: -4.1, 15.9 pg/mL).Conclusions: We found no meaningful differences in plasma etonogestrel concentrations between samples taken from the contralateral- versus ipsilateral-to-implant arm.Implications: Our data suggest that etonogestrel plasma concentrations are unlikely to be meaningfully different between samples drawn from the ipsilateral- versus the contralateral-to-implant arms in etonogestrel contraceptive implant users. [ABSTRACT FROM AUTHOR]

Objectives: To compare transabdominal sonography (TAS) to transvaginal sonography (TVS) in medical abortion eligibility assessment, specifically to measure how often clinicians chose to order additional testing for eligibility assessment following TAS and TVS, and to look for differences by patient and clinician characteristics. Also, to compare patient acceptability between the two modalities.Study Design: This pragmatic multisite randomized noninferiority trial compared TAS to TVS at 10 New York City and New Jersey health centers that provide medical abortion. Women seeking medical abortion were randomized 1:1 to receive TAS or TVS. Following the study ultrasound examination, clinicians determined whether participants were eligible for medical abortion based on these results or warranted further testing. All participants completed an acceptability questionnaire. We compared additional testing and acceptability between TAS and TVS.Results: Of those randomized to TAS, 63/317 (19.9%) received additional testing compared to 15/312 (4.8%) randomized to TVS. After TAS, most additional testing consisted of a same-day TVS. Other tests included β-hCG testing, scheduled repeat sonography or return visit. After TAS, 13.4% seen by physicians and 27.6% seen by advanced practice nurses (APNs) received additional testing (p<.01). Additional testing was more common in early gestational ages for both groups. We enrolled too few women with a body mass index (BMI) >35 kg/m2 to make comparisons. Participants found TAS more acceptable than TVS, and two thirds preferred TAS for future care.Conclusions: TAS provided sufficient information for clinicians to assess medical abortion eligibility without additional tests for most patients. However, the frequency of additional testing was exceedingly close to our predefined noninferiority boundary. Why APNs ordered substantially more additional testing than physicians is unclear. TAS was more acceptable to patients than TVS.Implications: TVS use requires high-level disinfection, which is resource-intensive and thus can be a barrier to care. Instead, TAS can be first-line for most women, reducing resources needed to provide medical abortion. Further research could help to establish gestational age and BMI thresholds beyond which TVS would be a more informative first test. We also need to evaluate whether additional training in using TAS would decrease additional testing. [ABSTRACT FROM AUTHOR]

Objective: This study compares the pharmacokinetics (PK) of levonorgestrel (LNG) emergency contraceptive (EC) and ulipristal acetate (UPA)-EC between normal-body mass index (BMI) and obese-BMI women.Study Design: This prospective, randomized crossover study evaluates the PK of women after single doses of LNG-EC (1.5mg) and UPA-EC (30mg). Study procedures took place during clinical research unit admissions, where participants received a standardized meal and each study drug, in random order, during two separate 24-h admissions. Study staff collected 14 blood specimens (0, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 and 48h). We evaluated serum concentrations of LNG and UPA using liquid chromatography-tandem mass spectroscopy and estimated the PK parameters of both drugs using noncompartmental analysis. The main outcome of this study was a comparison of between-group differences in AUC0-24.Results: Thirty-two women completed the study (16 in each group). Among normal-BMI and obese-BMI participants, the mean BMIs were 22.0 (range 18.8-24.6) and 34.3 (range 30.6-39.9), respectively. After LNG-EC, mean AUC0-24 and maximum concentration (Cmax) were 50% lower among obese-BMI women than among normal-BMI women (AUC0-24 100.8 vs. 208.5ng*h/mL, IQRobese-BMI 35.8, IQRnormal-BMI 74.2, p≤.01; Cmax 10.8 vs. 18.2ng/mL, p=.01). After UPA-EC, AUC0-24 and Cmax were similar between obese-BMI and normal-BMI women (AUC0-24 362.5 vs. 293.5ng*h/mL, IQRobese-BMI 263.2, IQRnormal-BMI 112.5, p=.15; Cmax 95.6 vs. 89.3ng/mL, p=.70).Conclusion: After a single dose of EC, obese-BMI women are exposed to lower concentrations of LNG and similar concentrations of UPA, when compared to normal-BMI women.Implications: Differences in LNG-EC PK by BMI group may underlie and account for the lower LNG-EC efficacy reported among obese-BMI women, but modest differences in UPA-EC PK by BMI group provide less support for variable efficacy. A pharmacodynamic study may be able to clarify whether these PK differences account for observed differences in LNG-EC and UPA-EC efficacy. [ABSTRACT FROM AUTHOR]

Background: Although the levonorgestrel 52 mg intrauterine device is locally active and has low systemic hormone exposure, hormonal intrauterine device users sometimes report hormone-related side effects., Objective: Evaluate hormone-related adverse event rates among all participants and compare these among those who used combined hormonal or no hormonal contraception in the month before enrollment., Study Design: A total of 1714 women aged 16 to 45 years old received a levonorgestrel 52 mg intrauterine device in a multicenter phase 3 trial to evaluate contraceptive efficacy and safety for up to 10 years. This analysis evaluated a subset of participants who used combined hormonal or no hormonal contraception in the month prior to device placement. We assessed all nonexpulsion, nonbleeding-related events with ≥1% incidence at 180 days with a plan to include weight increase regardless of incidence; we excluded events considered nonhormonal. We computed 180-day side effect frequency rates based on the number of days a side effect was reported during the study period. We created a multivariable model for side effect incidence at 180 days based on age, race, ethnicity, body mass index at enrollment, parity, and contraception use in the month before enrollment. For those side effects with a P value <.2 on univariate comparison between combined hormonal and no hormonal contraception users, we secondarily evaluated 360-day event rates., Results: Overall, 644 participants used combined hormonal contraception (primarily oral [n=499, 77.5%]) and 855 used no hormonal method before intrauterine device placement. Individual side effect rates over the first 180 days did not differ between prior combined hormonal and no hormonal contraception users except for acne (84 [13.0%] vs 73 [8.5%], respectively), P=.006, odds ratio 1.61 (95% confidence interval 1.15-2.24). However, this association was weaker after adjustment for age, race, ethnicity, obesity status, and parity (adjusted odds ratio 1.40, 95% confidence interval 0.99-1.98) At 360 days, prior combined hormonal contraception users were more likely to report acne (101 [15.7%] vs 91 [10.6%], respectively, P=.005) and orgasm/libido problems (20 [3.1%] vs 12 [1.4%], respectively, P=.03). Over the first 180 days, all side effects other than acne were reported in less than 3% of days; acne was reported an average of 13 days (7.4%) per prior combined hormonal contraception user and 9 days (5.0%) per prior nonhormonal contraception user (P<.0001). Discontinuation for evaluated side effects occurred in 83 (5.5%) participants with no difference between those who used combined hormonal (36 [5.6%]) or no hormonal contraception (47 [5.5%], P=1.0) before study entry., Conclusion: Using combined hormonal contraception prior to levonorgestrel 52 mg intrauterine device placement is weakly associated with reporting hormonally related side effects like acne. Only a small percentage of levonorgestrel 52 mg intrauterine device users experienced potentially hormone-related side effects during the initial 6 months of use that resulted in discontinuation., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: To describe patient-reported quality of care for virtual contraceptive counseling, using the four-item Person-Centered Contraception Counseling (PCCC) scale. Secondary analyses evaluated PCCC scores by patient subgroups., Study Design: From December 2021 to May 2022, we offered an anonymous web-based survey, to English and Spanish-speaking female patients 18 to 45 years old who had virtual visits through two Family Planning offices affiliated with Columbia University/New York Presbyterian Hospital in New York City., Results: Among 196 respondents, 133 (68%) respondents gave the top score. The proportion who gave the top PCCC score was higher for the faculty-based practice vs. community-based practice (62% vs. 38% respectively, p = 0.02), video vs. telephone (84% vs. 16% respectively, p = 0.01), and English vs. Spanish (86% vs. 14% respectively, p = 0.02); but did not differ for ethnicity (p = 0.34)., Conclusions: Patient-perceived quality of contraceptive counseling in virtual visits was high, with some disparities seen in the subgroups., Implications: This exploratory study about contraceptive counseling during virtual visits showed that 68% of survey respondents gave the top box PCCC score. Our work also suggests disparities in patient experiences based on several factors. Future work may expand on nuances of disparities and how these influence care., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: To describe ovulation inhibition and safety of daily oral ulipristal acetate (UPA) over 84 days., Study Design: This multi-center phase 1 and/or 2 trial randomized participants to use oral ulipristal 10 mg or 5 mg daily or a 3 cycle regimen of 5 mg for 24 days followed by four placebo days. We stratified randomization by body mass index (BMI) <32 or 32-40 kg/m 2 . To estimate ovulation inhibition, the primary outcome, participants underwent transvaginal ultrasound and blood sampling twice weekly; we analyzed compliant participants who completed the 84 day study. Safety endpoints included 3 endometrial biopsies and liver chemistry tests., Results: We enrolled 180 participants and included 137 in the ovulation inhibition analyses. Progesterone values that remained below 3ng/mL throughout treatment suggested consistent ovulation inhibition in 52 of 137 (38%) participants; 25 of 47(53%), 20 of 44(45%), and 7 of 46(15%) among participants randomized to the 10 mg, 5 mg, and cyclic treatments, respectively (p < 0.01). Progesterone values consistently <3 ng/mL were more frequent in participants with a BMI > 32kg/m 2 (25/50(50%) vs 27/87(31%), p = 0.01). Average ulipristal concentrations were higher among participants with low progesterone concentrations (p < 0.01). Endometrial biopsies during treatment showed progesterone-receptor-modulator-associated endometrial changes in 52 of 164 participants (32%); 22 of 49(40%), 16 of 48(29%), and 14 of 51(26%) in women randomized to the 10 mg, 5 mg, and the cyclic treatments, respectively (p = 0.07, test-for-trend); these changes resolved after treatment cessation. Liver transaminase changes were rare., Conclusions: Oral ulipristal acetate over 12 weeks did not reliably suppress ovulation, particularly in the 5 mg cyclic-dose group. Ovulation inhibition and endometrial changes were dose dependent. Reversible endometrial changes occurred during treatment., Implications: Progesterone-receptor modulators have been suggested for daily oral contraception. Since progesterone concentrations suggest that ovulation occurred during treatment, further studies would be necessary to assess whether these were functional ovulations and to evaluate other possible mechanisms of contraception., (Copyright © 2022. Published by Elsevier Inc.)

Permanent contraception remains one of the most popular methods of contraception worldwide. This article has reviewed recent literature related to demographic characteristics of users, prevalence of use and trends over time, surgical techniques, and barriers to obtain the procedure. We have emphasized the patient's perspective as a key element of choosing permanent contraception. This review has incorporated sections on salpingectomy, hysteroscopy, unmet need, impact of policies at religiously affiliated institutions, and reproductive coercion., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: The proliferation of breast epithelial cells increases during the luteal phase of the menstrual cycle, when they are exposed to progesterone, suggesting that ulipristal acetate, a selective progestin-receptor modulator (SPRM), may reduce breast cell proliferation with potential use in breast cancer chemoprevention., Methods: Women aged 18-39 were randomized 1:1 to ulipristal 10-mg daily or to a combination oral contraceptive (COC) for 84 days. Participants underwent a breast biopsy and breast MRI at baseline and at end of study treatment. Proliferation of breast TDLU cells was evaluated by Ki67 immunohistochemical stain. We evaluated the breast MRIs for background parenchymal enhancement (BPE). All slides and images were masked for outcome evaluation., Results: Twenty-eight treatment-compliant participants completed the study; 25 of whom had evaluable Ki67 results at baseline and on-treatment. From baseline to end of treatment, Ki67 % positivity (Ki67%+) decreased a median of 84% in the ulipristal group (N = 13; 2-sided p (2p) = 0.040) versus a median increase of 8% in the COC group (N = 12; 2p = 0.85). Median BPE scores decreased from 3 to 1 in the ulipristal group (p = 0.008) and did not decrease in the COC group., Conclusion: Ulipristal was associated with a major decrease in Ki67%+ and BPE. Ulipristal would warrant further investigation for breast cancer chemoprevention were it not for concerns about its liver toxicity. Novel SPRMs without liver toxicity could provide a new approach to breast cancer chemoprevention., Trial Registration: NCT02922127, 4 October 2016., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Objective: To assess efficacy, cycle control, and safety of an oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg., Study Design: Women aged 16 to 50 years with a body mass index ≤35 kg/m 2 enrolled in this multicenter, open-label, 13-cycle, phase 3 trial evaluating E4/DRSP in a 24-active/4-placebo regimen. Follow-up was scheduled at Cycles 2, 4, 7, and 10 and within 3 weeks of completing Cycle 13. Participants used daily diaries to record pill use and vaginal bleeding. We evaluated efficacy outcomes in women 16 to 35 years and bleeding patterns and safety (adverse events [AEs]) in all participants. We assessed overall and method-failure pregnancy rates using the Pearl index (PI) and life-table analysis. Scheduled bleeding included spotting or bleeding starting during the 4-day placebo period or first 3 days of the next cycle., Results: We enrolled 1864 women of whom 1674 were 16 to 35 years. Women 16 to 35 years had a PI of 2.65 (95% CI 1.73-3.88), method-failure PI of 1.43 (95% CI 0.7-2.39) and 13-cycle life-table pregnancy rate of 2.1%. Scheduled bleeding occurred in 82.9% to 87.0% of women per cycle; median duration was 4.5 days. Unscheduled bleeding decreased from 30.3% in Cycle 1 to 21.3% to 22.1% during Cycles 2 to 4 and remained stable (15.5% to 19.2%) thereafter. The most frequently reported AEs were headache (5.0%) and metrorrhagia (4.6%). One-hundred thirty-two (7.1%) women discontinued the study early for an AE, most commonly for metrorrhagia (0.9%) and menorrhagia (0.8%). No thromboembolic events occurred., Conclusion: E4/DRSP is an effective oral contraceptive with a predictable bleeding pattern for most women and low AE rates., Implications Statement: A new oral contraceptive with a novel estrogen, estetrol, combined with drospirenone has efficacy and safety within the range of other available oral contraceptives. Large phase 4 studies will be needed to confirm if this combination is associated with an improved adverse event profile or lower thrombosis risk., (Copyright © 2021. Published by Elsevier Inc.)