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Objective: The often small number of oral contraceptive pill (OCP) cycles provided may contribute to high rates of discontinuation. We examined the effect of an increased OCP supply on 6-month continuation rates.Methods: This was a randomized trial of women initiating OCP use at an urban family-planning clinic (n=700). All participants were randomized to receive three or seven cycles of OCPs. Participants younger than age 18 years or uninsured received their entire supply as packs; those older than age 18 years with insurance were additionally randomized to receive either packs or a prescription for refills. We contacted participants by telephone 6 months after enrollment to assess OCP continuation and adverse events.Results: We obtained follow-up information from 76% of participants (260 of 342 in the three-pack group, 244 of 319 in the seven-pack group). Participants who received seven packs had higher 6-month continuation than participants who received three packs (51% compared with 35%, P<.001). The treatment effect was greater among participants younger than 18 years of age (49% compared with 12%, P<.001) than among those aged 18 years and older (52% compared with 40%, P=.018). Participants who received a prescription were less likely to continue OCP use than those who received packs (42% compared with 21%, P=.027). Adverse events in the study were rare and not associated with receiving more OCP packs.Conclusion: A greater OCP supply at the time of initiation can improve continuation rates, especially among women younger than 18 years of age.Clinical Trial Registration: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00677742.Level Of Evidence: I. [ABSTRACT FROM AUTHOR]

Background: Although oral contraception (OC) misuse is presumed to play an important role in unwanted pregnancy, research findings have often been equivocal, perhaps reflecting unaddressed inconsistencies in methodological approaches. Methods: Using established databases, we performed a systematic review of measurement methods for OC use using primary research reports published from January 1965 to December 2009. Results: Terminology used to describe OC use, which included 'continuation,' 'compliance,' and 'adherence,' differed across studies and was rarely defined. The majority of studies ( n = 27 of 38, 71%) relied solely on self-report measures of OC use. Only two reports described survey or interview questions, and reliability and validity data were seldom described. More rigorous measurement methods, such as pill counts (electronic or manual), serum and urinary biomarkers, and pharmacy records, were infrequently employed. Nineteen studies simultaneously used more than one method, but only three studies compared direct and indirect methods. Conclusions: The lack of a consistent, well-defined measurement of OC use limits our understanding of contraceptive misuse and related negative outcomes. Future research should clarify terminology, develop standardized measures, incorporate multimethod approaches with innovative methods, and publish details of measurement methods. [ABSTRACT FROM AUTHOR]

Background: Female sexual function is important for sexual well-being, general health, fertility, and relationship satisfaction. Distressing impairments in sexual function, clinically recognized as female sexual dysfunction (FSD), can manifest as issues with interest/desire, arousal, orgasm, and pain during vaginal penetration. Some evidence suggests that exposure to endocrine-disrupting chemicals may adversely affect female sexual function, but associations for per- and polyfluoroalkyl substances (PFAS) have not been previously evaluated., Objective: We investigated associations between serum PFAS concentrations and female sexual function among U.S. pregnancy planners., Methods: We used cross-sectional data from participants from Pregnancy Study Online (PRESTO), a prospective preconception cohort study. Participants reported sexual function and distress at baseline on two validated measures: a modified version of the Female Sexual Function Index-6 (FSFI-6) and the Female Sexual Distress Scale (FSDS). We quantified PFAS serum concentrations in samples collected in the preconception period (i.e., at baseline) using solid phase extraction-high performance liquid chromatography-isotope-dilution-mass spectrometry. Participants reported sociodemographic information on structured baseline questionnaires. We included 78 participants with complete PFAS and sexual function data and fit multivariable linear regression models to estimate mean differences in FSFI-6 scores (β) or percent differences (%) in FSDS scores per interquartile range (IQR) increase in PFAS concentrations, adjusting for age, annual household income, years of education, parity, and body mass index. We further investigated effect measure modification by parity (parous vs. nulliparous) in stratified models., Results: An IQR increase in perfluorohexanesulfonic acid was associated with a 1.0-point decrease (95% CI = -1.8, -0.1) in reported FSFI-6 scores, reflecting poorer sexual function. PFAS were consistently associated with lower FSFI-6 scores among parous participants. PFAS were also associated, though imprecisely, with greater sexual distress., Conclusion: Some PFAS were associated with poorer sexual function among U.S. pregnancy planners, but future studies are needed to clarify the extent to which PFAS influences female sexual health., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)

We aim to develop and formatively evaluate a brief social needs screening tool that adheres to Massachusetts Department of Public Health (MDPH) clinical service standards for sexual and reproductive health (SRH) agencies and is acceptable and feasible for use by staff during a clinical encounter. Through a multi-stage literature and expert review process, we developed an evidence-informed, two-page social needs screening tool, scoring form, and implementation guide. We piloted this tool at three SRH agencies in Massachusetts and recruited staff to provide quantitative and qualitative feedback through post-pilot test self-reported surveys and semi-structured interviews. Participants (n = 13) felt the social needs screening tool was easy to integrate into their clinical workflow and were comfortable using it with patients. All participants reported feeling comfortable administering the tool, scoring it, and referring patients to appropriate resources, if applicable. Most reported they would like to continue using the tool after the pilot implementation period, either with or without modifications. Our multi-stage tool development and formative evaluation process involving literature review, expert review, and pilot-testing in clinical settings enabled our team to create a brief, evidence-informed social needs screening tool that is acceptable to staff and feasible for use during a short clinic visit at SRH agencies in Massachusetts. Staff felt that there is value in using this tool, are comfortable using it, and are able to integrate it into their existing clinical workflows.

Background: Fertility success among mixed-sex couples often depends on frequency and timing of sexual intercourse, yet little research has evaluated the association between preconception sexual function and time-to-pregnancy., Objective: To evaluate the effects of female sexual dysfunction, distress related to sexual functioning, and painful intercourse on time-to-pregnancy., Study Design: We followed 2500 participants from Pregnancy Study Online, a prospective cohort study of self-identified females attempting pregnancy without the use of fertility treatments. Participants enrolled between 2021 and 2024. Thirty days after enrollment, participants completed a supplemental questionnaire that contained questions about sexual health, including a modified version of the 6-item Female Sexual Function Index (score range 2-30, score ≤19 defined as sexual dysfunction) and the Female Sexual Distress Scale (score range 0-48, score ≥20 defined as clinically relevant distress), which assess experiences in the previous 4 weeks. Participants completed the supplemental questionnaire no later than 6 months after initiating conception attempts. We estimated time-to-pregnancy based on self-reported pregnancy status on follow-up questionnaires completed every 8 weeks for up to 12 months. We used proportional probabilities regression to calculate fecundability ratios and 95% confidence intervals relating exposure measures with time-to-pregnancy, adjusting for a range of prespecified confounders. As an exploratory analysis, we evaluated individual domains of sexual function (ie, interest, arousal, orgasm, lubrication, and satisfaction) in relation to time-to-pregnancy., Results: The study population was primarily non-Hispanic White, high income, with college or graduate education. Exposure prevalence was 20.1% for female sexual dysfunction, 8.8% for distress, and 29.6% for any pain with intercourse. We observed no association between female sexual dysfunction and time-to-pregnancy (adjusted fecundability ratio 1.00, 95% confidence interval 0.890, 1.13) when female sexual dysfunction was defined using a clinically validated cut point, but observed that those in the first, second, and third quartile of scores had delayed conception compared to those in the fourth (highest function) (adjusted fecundability ratios 0.90, 95% confidence interval 0.76, 1.06; 0.88, 95% confidence interval 0.75, 1.04; and 0.90, 95% confidence interval 0.77, 1.04, respectively). We found 18% reduced fecundability among those with sexual distress as defined by a clinically validated cut point compared to those without (adjusted fecundability ratio 0.82, 95% confidence interval 0.69, 0.98). Participants reporting painful intercourse most or all the time had a longer time-to-pregnancy than those reporting no pain (adjusted fecundability ratio 0.81, 95% confidence interval 0.62, 1.06). In exploratory analyses, lower function in orgasm and lubrication domains, but not interest, desire, and arousal, were associated with longer time-to-pregnancy., Conclusion: Preconception sexual dysfunction, specifically distress and frequent painful intercourse, was associated with delayed conception. Preconception clinical assessment of sexual function, including discussion of individual domains of sexual function, may elucidate important modifiable issues., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Objectives: We aimed to develop and evaluate a novel model, PHI CARE, that provides a standardized framework for shared decision-making in contraceptive counseling., Methods: We developed the PHI CARE model with national experts, piloted it at three family planning clinics, and finalized it following additional patient and clinician review. We recruited pregnancy-capable people for an evaluation study via simulated contraceptive counseling and identified salient themes through inductive and deductive coding., Results: Participants (n = 12) felt that counseling with the PHI CARE model was an improvement over previous counseling experiences and led to feelings of empowerment; participants did not feel pressured to decide about method use, felt in control during the conversation, and appreciated the absence of assumptions about their desires around pregnancy. Despite the standardized format, participants felt the counseling was individualized, "values-based," and tailored to their preferences., Conclusion: PHI CARE is a model to support clinicians and counselors in operationalizing the principles of shared decision-making in contraceptive counseling. Through standardization, PHI CARE allows for a more individualized experience for patients and addresses many critiques of traditional counseling., Practice Implications: PHI CARE is a memorable, brief tool that can be used for patient-centered contraceptive counseling in any clinical encounter., (Copyright © 2024 Jacobs Institute of Women's Health, George Washington University. Published by Elsevier Inc. All rights reserved.)

Objectives: To study clinician perspectives on the feasibility of incorporating family planning services within office-based addiction treatment (OBAT) clinics. We sought to understand the unique facilitators of and barriers to the integration of contraceptive services within the OBAT model with a goal to support the design and implementation of a program tailored to meet the reproductive health needs of patients with substance use disorder., Methods: After obtaining institutional review board approval, we conducted qualitative semistructured interviews with OBAT clinicians (registered nurses, advanced practice registered nurses, and physicians) at a tertiary-care safety-net hospital. Interview transcripts were analyzed using deductive codes utilizing key components of the Promoting Action on Research Implementation in Health Services and Ottawa Decision Support Frameworks., Results: We analyzed 20 interviews. Our data noted 3 major themes: (1) evidence to support integration of family planning and OBAT, (2) inherent strengths and facilitative factors of the OBAT model, and (3) barriers and challenges of the OBAT model influencing successful integration. Strengths included the destigmatizing and trust-building OBAT approach to care, common use of patient-centered counseling, and providers' nuanced understanding of substance use disorder-specific impacts on reproductive health. Barriers included time constraints, balancing urgent patient recovery needs, the desire for additional contraception provision training, and concern for potential contraceptive coercion., Conclusions: Office-based addiction treatment clinics have inherent strengths that may make it a beneficial location for integrated family planning services. Future research should elicit patient perspectives to ensure the implementation of a family planning program in OBAT that supports patients' reproductive goals while avoiding stigma or reproductive coercion., Competing Interests: The authors report no conflicts of interest., (Copyright © 2023 American Society of Addiction Medicine.)

Few studies have evaluated the association between periodontitis and spontaneous abortion (SAB), and all had limitations. We used data from the Pregnancy Study Online (PRESTO), a prospective preconception cohort study of 3,444 pregnancy planners in the United States and Canada (2019-2022), to address this question. Participants provided self-reported data on periodontitis diagnosis, treatment, and symptoms of severity (i.e., loose teeth) via the enrollment questionnaire. SAB (pregnancy loss at <20 weeks' gestation) was assessed via bimonthly follow-up questionnaires. Participants contributed person-time from the date of a positive pregnancy test to the gestational week of SAB, loss to follow-up, or 20 weeks' gestation, whichever came first. We fitted Cox regression models with weeks of gestation as the time scale to estimate adjusted hazard ratios (HRs) and 95% confidence intervals (CIs), and we used inverse probability of treatment weighting to account for differential loss to follow-up. We used probabilistic quantitative bias analysis to estimate the magnitude and direction of the effect of exposure misclassification bias on results. In weighted multivariable models, we saw no appreciable association between preconception periodontitis diagnosis (HR = 0.97, 95% CI: 0.76, 1.23) or treatment (HR = 1.01, 95% CI: 0.79, 1.27) and SAB. A history of loose teeth was positively associated with SAB (HR = 1.38, 95% CI: 0.88, 2.14). Quantitative bias analysis indicated that our findings were biased towards the null but with considerable uncertainty in the bias-adjusted results., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Postpartum contraceptive use can help prevent short-interval pregnancies, which have been associated with adverse neonatal and maternal health outcomes. Many contraceptive methods are safe for postpartum use, but patients and providers may be confused as to what impact hormonal contraception has on lactation. We performed a scoping review of the most recent U.S.-based guidelines regarding hormonal contraception on lactation to provide synthesis and recommendations to aid providers in counseling their patients. Methods: We conducted a scoping review by identifying the most recent clinical recommendations and guidelines from the Centers for Disease Control and Prevention (CDC) and three maternal and child health professional associations (American College of Obstetricians and Gynecologists [ACOG], Society for Maternal-Fetal Medicine [SMFM], and Academy of Breastfeeding Medicine [ABM]). We also reviewed the citations in these guidelines used in their development. We then conducted an updated literature review to capture studies published since the most recent systematic reviews were conducted. Results: We reviewed 1 clinical guideline from the CDC and 2 systematic reviews cited in its references, 6 professional association recommendations, and 28 publications identified through the updated literature review. Progestin-only contraceptive methods continue to demonstrate safety in breastfeeding patients, while low-quality evidence supports concerns of decreased milk supply with combined hormonal contraception. Discussion: Organizations should consider updating counseling recommendations regarding progestin-only contraceptives and lactation. Further research is needed to examine new contraceptive methods as well as the effect of hormonal contraception on lactation in the setting of preterm birth.

Background: Despite the high prevalence of female sexual dysfunction in population-based studies and the importance of sexual functioning for mixed-sex couples attempting conception, little is known about female sexual function in the preconception period., Objective: This descriptive study aimed to assess the prevalence of female sexual dysfunction, distress, and pain with intercourse in a preconception population of pregnancy planners. The study also explored the extent to which participants discussed their sex lives with a healthcare provider during a preconception visit., Study Design: We used data from Pregnancy Study Online, a web-based preconception cohort study (August 2020-October 2022). Eligible participants identified as female and were aged 21 to 45 years, residents of the United States or Canada, attempting pregnancy, and not using fertility treatments at cohort entry. At enrollment, participants completed a detailed baseline questionnaire. Thirty days after enrollment, participants were invited to complete an optional questionnaire about sexual function. Our study included 1120 participants who responded to the sexual function questionnaire within 1 year of completing their baseline questionnaire. We assessed sexual dysfunction using the 6-item Female Sexual Function Index, and sexual distress using the Female Sexual Distress Scale, which assess sexual function and distress in the previous 4 weeks, respectively. We also asked participants whether they had discussed their plans to conceive with a healthcare provider, and if so, whether they discussed their sex lives. If not, we collected information on perceived barriers., Results: Twenty-five percent of the sample met criteria for female sexual dysfunction, whereas 12.2% met the criteria for sexual distress; 8% of our sample reported both sexual dysfunction and sexual distress. Thirty percent reported at least some pain with intercourse in the past 4 weeks. Although over 80% of the sample reported discussing their conception plans with a healthcare provider, 70% of these participants did not discuss their sex lives. The most commonly reported reasons for not discussing their sex life with a provider was not experiencing a sexual health issue, the provider not asking, feeling nervous/uncomfortable/ashamed, and feeling it was not relevant to becoming pregnant or inappropriate to discuss. The percentage of participants who reported discussing their sex lives varied across provider type, with those seeing midwives having the highest percentage (39%), followed by nurse practitioners (36%) and obstetrician-gynecologists (34%)., Conclusion: Sexual dysfunction, distress, and painful intercourse are prevalent in the preconception period, but participants frequently did not discuss their sex lives when discussing plans to conceive. The provider not asking was a commonly reported barrier. Providers may consider raising the issue of sexual functioning at the time of a preconception visit to better support patients who may be dealing with a sexual function issue while attempting pregnancy. These findings may not generalize beyond a primarily non-Hispanic White, highly educated, and high-income population., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Objective: To evaluate practices among first-trimester surgical abortion facilities and providers in Canada in 2012 and examine the characteristics of the surgical abortion work force., Design: Self-administered paper or electronic survey adapted from a survey previously fielded in the United States., Setting: Canada., Participants: Facility administrators and physicians., Main Outcomes Measures: Descriptive statistics on reported first-trimester surgical abortion practice and provider demographic characteristics., Results: Eighty-three percent of identified facilities (78 of 94) and 178 physicians responded. Of the respondents, 99% of facilities and 96% of physicians provided first-trimester surgical abortions. Responding facilities provided 68,154 first-trimester surgical abortions in 2012. This represented 96% of their reported total (combined medical and surgical) first-trimester abortions. More than half (55%) of responding facilities were community based, while 45% were hospital affiliated. Most physician providers were female (68%) and were family doctors (59%). Preoperatively, 96% of physicians routinely used ultrasound and 89% gave perioperative antibiotics. Almost half (48%) used manual vacuum aspiration, but less than 35% did so beyond 9 weeks after the last menstrual period. At most facilities, most procedures were performed under combined local anesthesia and intravenous sedation (73%); only 7% indicated deep sedation or general anesthesia were used exclusively. Postoperatively, 81% of physicians performed immediate tissue examination and 96% offered postabortion contraception on the same day as the abortion. Other assessed outcomes included medication regimens and cervical preparation, with a high degree of consistency among facilities and physicians., Conclusion: First-trimester surgical abortion providers are mostly family physicians and most are female. Practices across Canada were mostly uniform and followed evidence-based guidelines. Uptake of the most recent Canadian practice guidelines may help further standardize patient care and improve routine perioperative antibiotic use and immediate tissue examination., (Copyright © 2023 the College of Family Physicians of Canada.)

Purpose of the Article: Cesarean rates and maternal morbidity increase with the duration of the second stage of labor. We studied the effect of hourly evaluation and documentation during the second stage of labor on maternal and fetal outcomes., Materials and Methods: We performed a retrospective cohort study of all women who delivered at our urban, tertiary care hospital and underwent a second stage of greater than 60 min between 1 June 2016 and 31 May 2019. There were 1498 patients with complete data. Four hundred forty patients had hourly evaluation and documentation throughout the second stage and 1058 did not. We performed t -tests, Chi-squared, and regression analyses to compare cesarean delivery rate, second-stage duration, quantitative blood loss, hemorrhage and blood transfusion rates, and fetal outcomes. We performed regression analyses to evaluate for independent effect of this intervention on each outcome., Results: Patients with hourly evaluation and documentation had a decreased likelihood of cesarean delivery (8.2% vs. 20.3%, p  < .001), shorter second-stage of labor (98.1 min vs. 177.5 min, p  < .001), decreased quantitative blood loss (514.4 mL vs. 667.7 mL, p  < .001), and hemorrhage rate (12.5% vs. 19.9%, p  < .001). Hourly evaluation was associated with decreased transfusion rates (3.2% vs. 5.6%, p  = .05) but was not related to the number of units transfused. Regression analyses confirmed the impact of hourly documentation when potential confounders were included. These differences in outcomes were also noted when evaluation was performed and documented within every 75 min. Hourly second-stage evaluation and documentation did not affect other maternal or infant morbidities., Conclusion: Hourly evaluation and documentation in the second stage was associated with decreased cesarean delivery rate, second-stage duration, quantitative blood loss, hemorrhage, and transfusion.

Placentas of obese women have low mitochondrial β-oxidation of fatty acids (FA) and accumulate lipids in late pregnancy. This creates a lipotoxic environment, impairing placental efficiency. We hypothesized that placental FA metabolism is impaired in women with obesity from early pregnancy. We assessed expression of key regulators of FA metabolism in first trimester placentas of lean and obese women. Maternal fasting triglyceride and insulin levels were measured in plasma collected at the time of procedure. Expression of genes associated with FA oxidation (FAO; ACOX1, CPT2, AMPKα), FA uptake (LPL, LIPG, MFSD2A), FA synthesis (ACACA) and storage (PLIN2) were significantly reduced in placentas of obese compared to lean women. This effect was exacerbated in placentas of male fetuses. Placental ACOX1 protein was higher in women with obesity and correlated with maternal circulating triglycerides. The PPARα pathway was enriched for placental genes impacted by obesity, and PPARα antagonism significantly reduced 3 H-palmitate oxidation in 1 st trimester placental explants. These results demonstrate that obesity and hyperlipidemia impact placental FA metabolism as early as 7 weeks of pregnancy., (© 2022. The Author(s).)

Background: Refusal to participate in studies related to sexual health can compromise the internal and external validity of findings. Research examining non-response to sexual health studies has primarily focused on predictors such as specific sexual attitudes and behaviors., Aim: Evaluate predictors of non-response to a supplemental sexual health survey added to a web-based cohort study, focusing on predictors that may be important in epidemiologic studies of sexual health., Methods: In March 2021, we added the "Sexual Health and Wellbeing Questionnaire" (SQ), an optional supplemental sexual health survey, to the protocol for Pregnancy Study Online , a web-based North American prospective cohort study. Eligible participants identified as female and were aged 21-45 years, actively trying to conceive, and in a relationship with a male partner. Participants completed a baseline questionnaire at enrollment and follow-up questionnaires every 8 weeks. Participants were invited to complete the SQ 30 days after baseline questionnaire completion. The analytic sample included all Pregnancy Study Online participants who enrolled between March 2021 and December 2021 and was divided into 3 mutually-exclusive groups: (i) those who completed the baseline questionnaire only (ie, did not complete a follow-up questionnaire or the SQ), (ii) those who completed at least 1 follow-up questionnaire but not the SQ, and (iii) participants who completed the SQ (with or without a follow-up questionnaire). We compared sociodemographic, medical, lifestyle, and reproductive factors across these groups., Results: Of the 1,491 enrolled participants, 302 (20.3%) completed the baseline questionnaire only, 259 (17.4%) completed a follow-up questionnaire but not the SQ, and 930 (62.4%) completed the SQ. Strong predictors of non-response (absolute difference in response >10% comparing SQ responders to baseline-only responders) included longer pregnancy attempt time at study entry, a history of infertility, and lower income and education. Compared with response to the follow-up questionnaire only, SQ response was lower among Hispanic/Latina participants and participants aged <25 years., Clinical Translation: The addition of sexual health surveys to established cohort studies may be an effective way to expand epidemiologic sex research efforts., Strengths & Limitations: Study strengths include the prospective design, geographic heterogeneity of the cohort, and use of online methods. Our findings may not generalize to clinic-based sex research., Conclusion: We report that in an established North American cohort study, response to the SQ exceeded 60%. We observed few strong predictors for SQ non-response among engaged participants. Bond JC, Abrams J, Wesselink AK, et al. Predictors of Non-Response to a Sexual Health Survey in a North American Preconception Cohort Study. J Sex Med 2022;19:1707-1715., (Copyright © 2022 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)

Background: The most widely used copper intrauterine device (IUD) in the world (the TCu380A), and the only product available in many countries, causes side effects and early removals for many users. These problems are exacerbated in nulliparous women, who have smaller uterine cavities compared to parous women. We compared first-year continuation rates and reasons/probabilities for early removal of the TCu380A versus a smaller Belgian copper IUD among nulliparous users., Methods: This 12-month interim report is derived from a pre-planned interim analysis of a sub population and focused on key secondary comparative endpoints. In this participant-blinded trial at 16 centres in the USA, we randomised participants aged 17-40 in a 4:1 ratio to the NT380-Mini or the TCu380A. In the first year, participants had follow-up visits at 6-weeks and 3, 6, and 12-months, and a phone contact at 9 months; we documented continued use, expulsions, and reasons for removal. Among participants with successful IUD placement, we compared probabilities of IUD continuation and specific reasons for discontinuation using log-rank tests. This trial is registered with ClinicalTrials.gov number NCT03124160 and is closed to recruitment., Findings: Between June 1, 2017, and February 25, 2019, we assigned 927 nulliparous women to either the NT380-Mini ( n  = 744) or the TCu380A ( n  = 183); the analysis population was 732 (NT380-Mini) and 176 (TCu380A). Participants using the NT380-Mini, compared to the TCu380A, had higher 12-month continuation rates (78·7% [95% CI: 72·9-84·5%] vs. 70·2% [95% CI: 59·7-80·7], p  = 0·014), lower rates of removal for bleeding and/or pain (8·1% vs. 16·2%, p  = 0·003) and lower IUD expulsion rates (4·8% vs. 8·9%, p  = 0·023), respectively., Interpretation: The NT380-Mini offers important benefits for a nulliparous population compared to the TCu380A in the first twelve months, when pivotal experiences typically occur. Higher continuation rates with the NT380-Mini may avert disruptions in contraceptive use and help users avoid unintended pregnancy., Funding: Bill & Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Mona Lisa, N.V. (Belgium)., Competing Interests: DH, PLC, and KN's institution (FHI 360) received funding from Bill & Melinda Gates Foundation and Mona Lisa, N.V. to conduct this study. The following investigators’ institutions received contract funding from FHI 360 (with funds originating from Bill & Melinda Gates Foundation) to help conduct this study: CAS, ID, BAC, ABG, CD, ALN. The following investigators’ institutions received contract funding from Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to help conduct this study: DKT, JTJ, MDC, KOW, SBT, JLK, CD, MAT, DFA, PMC, AEB. These two employees of the NIH were supported by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to help conduct this study: DLB and JEB. No author received personal financial payments for this work. No author has financial relationships with Mona Lisa, N.V. DH reports board membership on Society of Family Planning. CAS reports contracts or grants to institution from Bayer Pharma, Sebela Pharma, and Danco Pharma; royalties to self and institution from Atheneum Pharma; payment for expert testimony from Center for Reproductive Rights, Planned Parenthood Federation and ACLU; a U.S. Provisional Patent Application No. 62/777,369; honoraria from American Board of Obstetrics & Gynecology. DKT reports contracts or grants to institution from The Laura and John Arnold Foundation, Society of Family Planning Research Fund, the William and Flora Hewlett Foundation, the Willard L. Eccles Foundation, the Intermountain Community Care Foundation, Bayer Women's Health, Organon, Cooper Surgical, Medicines360, Sebela Pharmaceuticals and anonymous foundation. MCD reports contracts to institution from Chemo Research SL, Evofem, HRA Pharma, Medicines360, Merck, Sebela; consulting fees from Estetra SRL, FHI360, Libbs, Mayne, Medicines360; speaking honorarium from Gedeon Richter, Mayne; payment/reimbursement of expenses for travel to meetings to present research from Medicines360; payment/reimbursement of expenses for travel to meetings to present research or attend Advisory Board from Estetra SRL; payment/reimbursement of expenses for travel to attend Advisory Board from TherapeuticsMD; Advisory Board meetings with honorarium from Evofem, Fuji Pharma, Mayne, Merck, Searchlight and TherapeuticsMD; honorarium for duties as Deputy Editor of the journal Contraception. KOW reports grants or contracts to institution from Bayer Pharmaceuticals and honoraria for a remote consultancy from Bayer Pharmaceuticals. SBT reports contracts to institution from Sebela, Medicines 360, Bayer Healthcare, Chemo Research, S.L., Merck & Co.; DSMB for Merck & Co.; Advisory Board for Bayer Healthcare; Society of Family Planning board member; American Board of Obstetrics & Gynecology (Complex Family Planning Division Member). BAC reports contracts or grants to institution from Medicines360, Sebela, and Mylan; member of American College of Obstetrics and Gynecology working group. ABG reports grants or contracts to institution from Merck; royalties from Uptodate; consulting fees from Society of Family Planning; board member of Society of Family Planning. ALN reports contracts or grants to institution from Merck, Mylan, Myovant, Sagami Rubber Industries, Sebela; consulting fees from Agile Therapeutics, Bayer HealthCare, Mayne Pharma, Pfizer, TherapeuticsMD; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Agile Pharma, Bayer HealthCare, Myovant Sciences, Merck, TherapeuticsMD; support for attending meetings and/or travel from Agile Pharma, Bayer HealthCare, Myovant Sciences, Merck, Pfizer, TherapeuticsMD. MAT reports Board member of American Society for Reproductive Medicine. DFA reports grants or contracts to institution from Bayer Healthcare, Dare Biosciences, Estetra, Myovant, and ObsEva; consulting fees from Bayer Healthcare, Exeltis, Mithra, Lupin, ObsEva, Mithra; honoraria for lecture from Exeltis; DSMB member; Board of directors for Diczfalusy Foundation; stock ownership in InnovaGyn, Inc.; stock options with Agile Therapeutics. PMC reports consulting fees from Bayer to provide remote IUD consultative support to clinicians; payments to institution from Bayer for clinical research. AEB reports grants or contracts to institution from Merck & Co, Inc (USA) and Scope/Chemo (Spain); honorarium and travel to meetings from TherapeuticsMD; support for related work and travel as associate editor for ACOG Clinical Updates; support for travel/honorarium from American Board of Obstetrics & Gynecology. BK reports grants or contracts to institution from Contramed Pharmaceuticals (Sebela), Evofem Biosciences, Gynuity Health Projects; royalties from Uptodate; consulting fees from Merck. The remaining authors do not have any related relationships to disclose: JTJ, KN, ID, PLC, JLK, CD, JEB, DLB., (© 2022 The Author(s).)

Background: Chronic vulvar pain is a prevalent but often misdiagnosed and undertreated condition that adversely impacts quality of life. A large proportion of women report not seeking care for chronic vulvar pain, but little is known about the factors that underlie care-seeking decisions. Materials and Methods: We used a large, population-based survey of women aged 18-40 years to assess a history of chronic vulvar burning, pain on contact, or itching that had lasted ≥3 months. The survey also captured demographic characteristics and comorbidities. Women were asked if they had ever sought care for their chronic vulvar condition. Demographic characteristics and comorbidities were evaluated across pain categories and by care-seeking behaviors. Results: A higher proportion of women who described their pain as burning only and both burning and pain on contact had sought care for their pain (69.2% and 85.2%, respectively) compared with pain on contact only (41.8%). Women who described their pain as pain on contact only were also less likely to see multiple providers and to have ever received treatment for their pain. Care seekers were more likely to be married, have a college education, have a normal body mass index, and have multiple gynecologic comorbidities. Conclusions: Our study suggests that care-seeking behavior varies by pain type. Less than half of women who characterized their pain as pain on contact had sought medical care. Those who did seek care reported seeing fewer providers than those who experienced burning. Providers may wish to proactively ask patients about pain on contact.

Several common adverse pregnancy outcomes can reveal subclinical or latent cardiovascular disease (CVD) risk, transiently exposed through the physiologic stress of pregnancy. The year after pregnancy may be a singular opportunity to identify and initiate treatment for CVD risk, even before the onset of traditional CVD risk factors. However, clinical guidance regarding CVD risk management after adverse pregnancy outcomes is lacking. We therefore conducted a systematic review of US clinical practice guidelines and professional society recommendations to inform primary care-based CVD risk management after adverse pregnancy outcomes. We identified 13 relevant publications. While most recommendations were based on limited or weak evidence, we identified several areas of consensus. First, individuals with an adverse pregnancy outcome associated with future CVD are likely to benefit from CVD risk assessment-accompanied by education, counseling, and support for lifestyle modification-beginning within the first postpartum year. Second, among clinicians, clear and consistent documentation about adverse pregnancy outcomes and recommended follow-up is important to coordinate care after pregnancy. In addition, patients need to be informed about their pregnancy complications and associated CVD risks, so that they can make informed health care and lifestyle decisions. Finally, in general, CVD prevention in the year after an adverse pregnancy outcome focuses on lifestyle modification, reserving pharmacotherapy for the highest-risk patients and those with traditional CVD risk factors. While postpartum lifestyle interventions show promise for reducing CVD risk after adverse pregnancy outcomes, continued research to determine the optimal content, timing, and long-term effects of such interventions is needed., (© 2021. Society of General Internal Medicine.)

Objective: To explore Black women's lived experiences of racism and the associated effects on reproductive health decisions and the reproductive health care experience., Methods: We recruited participants through social media and community outreach. We conducted semi-structured individual interviews focusing on Black women's lived experiences of racism and their effects on reproductive health. We coded and analyzed interview transcripts using process coding methodology., Results: Participants (N=21) were 21-45 years old and from Boston, Chicago, and Atlanta. Our primary themes were: 1) reproductive health racism across the life course, 2) anti-Black racism in the reproductive health care system, and 3) self-protective actions when interacting with the reproductive health care system. Reproductive racism across the life course included subthemes of early sexualization of Black women, heightened awareness of reproductive health inequities, and knowledge of reproductive oppression. Anti-Black racism in the reproductive health care system included subthemes of absence of shared decision making; vicarious reproductive health experiences; stereotyping, invalidation, and dismissal by reproductive health professionals; and medical mistrust. Participants guarded themselves against racism within reproductive health care by engaging in a variety of self-protective actions including seeking a health care professional of color, overpreparing for their appointments, enlisting advocates, seeking care only when desperate, and heightening symptoms to be heard., Conclusion: Personal, vicarious, and historical experiences of racism within reproductive health care triggered participants to perform self-protective actions when interacting with the reproductive health care system. These actions served to promote safety, autonomy and rehumanization within a system that has historically and contemporarily devalued Black reproductive health., Competing Interests: Financial Disclosure: Dr. Katherine O. White receives institutional research support from Bayer, Merck, and Evofem. The other authors did not report any potential conflicts of interest., (Copyright © 2022 by the American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: To assess sedation medication dosage differences between patients with and without opioid use disorder at the time of surgical abortion., Study Design: We performed a retrospective cohort study, identifying patients obtaining a surgical abortion in our ambulatory procedure unit between 2012 and 2017. We identified 64 patients with documented opioid use disorder at the time of their procedure and assigned 64 patients without opioid use disorder to a control cohort. We reviewed patient characteristics and calculated total doses of midazolam and fentanyl administered to patients. We used multivariate linear regression modelling to model the amount of medication administered to each group while controlling for confounders., Results: The exposed and unexposed cohorts were similar in terms of baseline characteristics except for race. The cohort of patients with opioid use disorder was predominantly White (n = 55, 86%) and completely English speaking (n = 64, 100%), whereas the control cohort was majority Black (n = 39, 61%) and mostly English speaking (n = 44, 69%) On average, patients with opioid use disorder received 22 mcg more fentanyl (110 mcg vs 88 mcg, p < 0.001) and 0.4 mg more midazolam (2.7 mg vs 2.3 mg, p = 0.001) than patients without opioid use disorder. After adjusting for prior abortions, parity, English speaking status, psychiatric conditions, and education, we found smaller differences in both fentanyl (15 mcg, 95% CI 1.7, 28.2 mg) and midazolam dosages (0.3 mg, 95% CI -0.01, 0.6) between groups., Conclusions: Patients with and without opioid use disorder received similar doses of midazolam and fentanyl for moderate sedation for surgical abortion., Implications: This study suggests that standard medication titration protocols utilized with moderate sedation for surgical abortions need not be changed for patients with opioid use disorder. Moderate sedation can be a helpful option for pain control for this vulnerable population., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Objective: To explore contraceptive decision making among recently pregnant patients with a history of opioid use disorder., Study Design: We conducted semi-structured qualitative interviews, based on principles of the Ottawa Decision Support Framework, with 20 recently pregnant individuals diagnosed with opioid use disorder at a tertiary care medical center in Massachusetts. We audio-recorded the interviews and they were transcribed verbatim. We analyzed our interview data using inductive and deductive coding., Results: Participants value the availability of barrier methods as a means of preventing both sexually transmitted infections and pregnancy. For some participants, housing instability makes storing contraceptive methods and managing personal hygiene related to bleeding patterns difficult. For others, housing instability impacts their overall fertility goals. Side effects including weight gain, interactions with mood stabilizing medications, concern regarding post-operative opioids, or intrinsic aspects of a method that serve as reminders of opioid use may be unacceptable given the risk of relapse. The relapsing and remitting arc of recovery make remembering important aspects of both short- and long-acting contraceptive method use difficult, yet participants offer strategies to aid in doing so., Conclusion: When choosing a contraceptive method participants in our study exhibit similarities to individuals with other chronic medical conditions as well as motivations specific to opioid use disorder. Their contraceptive decisions are grounded in integrating a method into a chaotic life, preventing relapse, and protecting future fertility., Implications: Our data highlight how lived experiences at the intersection of active opioid use disorder and recovery fundamentally shape the lens through which pregnancy-capable individuals with opioid use disorder view their contraceptive decisions., (Copyright © 2021. Published by Elsevier Inc.)

Background: Short interpregnancy interval (IPI) is associated with risk of adverse pregnancy outcomes; however, few studies have evaluated the role of depression as a risk factor for short IPI. Puerto Rican women in the United States experience disparities in adverse birth outcomes and have the highest birth rates. Methods: We analyzed the association between prenatal depressive symptoms and IPI in Proyecto Buena Salud, a prospective cohort of predominantly Puerto Rican women in Western Massachusetts (2006-2011). Depression was measured using the Edinburgh Postnatal Depression Scale (EPDS) in early, mid, and late pregnancy. We calculated follow-up time as the difference between the date of delivery of the index pregnancy and the last menstrual period of the subsequent pregnancy using medical records and billing data. We defined short IPI as ≤18 months. Results: Of 1262 eligible women, 35% ( n  = 440) had at least probable minor depression (EPDS scores ≥13) and 25% ( n  = 315) had probable major depression (EPDS scores ≥15). Participants were followed for a median of 3.7 years (interquartile range = 1.4-6.0 years) and 240 (20.6%) participants experienced a short IPI. After adjusting for risk factors, women with probable minor depression (adjusted odds ratio [aOR] = 1.39, 95% confidence interval [CI] = 1.02-1.88) and probable major depression (aOR = 1.42, 95% CI = 1.02-1.97) during pregnancy had increased odds of short IPI. Conclusions: Prenatal depressive symptoms were common in this Puerto Rican population and were associated with a modest increase in odds of short IPI. Further examination of the pathways through which mental health may affect IPI in vulnerable populations is warranted.

Background: Contraception screening and referral occur infrequently in cancer care for young women of reproductive age. Barriers to contraception screening and referral in this setting have not been thoroughly identified. Objectives: We sought to understand oncology clinicians' current practices and perceptions of barriers to screening and referring young women for adequate contraception during cancer treatment. Methods: We conducted individual semi-structured interviews with 19 oncology clinicians whom we recruited from an urban, northeast medical center. Participants included physicians, advanced practice clinicians, and nurses in surgical and medical oncology. The interview guide addressed core components of the Promoting Action on Research Implementation in Health Services framework, and subsequent directed content analysis identified themes indicative of barriers to contraception screening and referral. Findings: Participants varied significantly in their current contraception screening practices; many conflated early pregnancy diagnosis or pregnancy avoidance counseling with contraception, whereas others described inaccurate contraceptive recommendations for specific clinical scenarios. Participants also lacked clarity of roles and responsibilities within the oncologic care team for contraception and assumed that another team member had addressed contraception. Participants perceived themselves to lack adequate education about contraception, which precluded contraception discussions. Conclusion: We recommend cancer centers consider these possible barriers to contraception screening and referral by promoting development of institutional guidelines to standardize contraception screening and referral, clarifying roles and responsibilities for contraception discussions within the care team, and expanding oncology clinician education on contraception. National professional organizations should work to expand guidelines to inform and support this process in clinical practice.

Objectives: To assess whether first-trimester aspiration abortion practices of US providers agree with evidence-based policy guidelines., Study Design: We sent surveys by mail or electronically to all abortion facilities in the United States identified via professional networks and websites from June through December 2013. Administrators reported on the volume of procedures performed at their site(s) through 13 weeks 6 days' gestation and on clinic services. Clinicians reported on personal demographic characteristics and abortion practices. We reviewed guidelines from key US professional organizations to determine how well reported practices aligned with available recommendations and the extent to which guidelines have changed since the time of the survey., Results: We identified 703 clinical sites in the United States; 383 (54%) sites responded, 256 of which offer first-trimester aspiration abortions. Most providers identified as obstetrician-gynecologists (74%) and female (64%); 52% were less than 50 years old compared to 36% in 2002. Overall, reported practices follow evidence-based guidelines, including routine administration of periprocedure antibiotics (85%), use of misoprostol for cervical ripening in the late first trimester (94%), pain management practices, and same-day contraception provision (98%) including long-acting devices (76%). Less evidence-based practices include routine preprocedure ultrasound (99%), not providing abortion before 5 weeks' gestation (66%), restrictive fasting policies, and prolonged and postprocedure antibiotic provision., Conclusion: Overall, the first-trimester aspiration abortion practices revealed in our survey agree with professional evidence-based policy guidelines, though some related to preprocedure ultrasound use, very early abortion provision, preanesthesia fasting protocols, and antibiotic regimens deserve attention., Implications: In this third cross-sectional survey of US abortion practices (prior surveys 1997 and 2002), first-trimester aspiration abortion providers are younger than before, reflecting an improvement in the "graying" of the abortion provider workforce. Research and education are needed to further improve evidence-based practice in abortion care., (Copyright © 2018 Elsevier Inc. All rights reserved.)

The magnetic, thermal, and optical properties of single-crystalline CoTa 2 O 6 and FeTa 2 O 6 are reported. Optical dichroism was observed in CoTa 2 O 6 . Magnetic susceptibility χ(T) measurements reveal long-range antiferromagnetic order with Néel temperatures [Formula: see text] K and 8.11(5) K, respectively, and anisotropy in χ. The thermal expansion coefficients exhibit significant anisotropy and the influence of the magnetic ions and long-range order. A structural phase transition to orthorhombic occurs below T N for FeTa 2 O 6 . Magnetic field H lowers T N with its affect largest when H is directed along either [1 1 0] or [1 [Formula: see text] 0], and smallest when directed along [0 0 1]. This leads to an anisotropic magnetocaloric effect that is investigated through measurements of the specific heat and magnetization in applied magnetic field.

Objective: To assess whether second-trimester surgical abortion practices of U.S. providers agree with evidence-based policy guidelines., Study Design: We conducted a cross-sectional survey of abortion facilities in the U.S. identified via publicly available resources and professional networks from June through December 2013., Results: Of 703 identified facilities, 383 (54%) participated, including 172 clinicians providing second-trimester surgical abortions (dilation and evacuations [D&Es]). The majority of clinicians were obstetrician-gynecologists (87%), female (67%), and less than 50 years old (62%). Most clinicians (93%) ever use misoprostol as a cervical preparation agent, including in the setting of a uterine scar (87%). Some clinicians refer to a hospital-based provider if the patient has a placenta previa and a history of cesarean section (31%) or a complete previa alone (17%). Many clinicians have weight or body mass index restrictions for cases performed under iv moderate sedation (32/97, 33%) or deep sedation (23/50, 46%). Most clinicians (69%) who report performing D&Es at 18 weeks last menstrual period or greater do not routinely induce fetal demise preoperatively. Clinicians employ routine intraoperative ultrasound (79%) more commonly than routine postoperative ultrasound (47%), with no difference by years of provider experience. Most clinicians routinely use prophylactic uterotonic agents, most often postoperatively. Most clinicians (80%) routinely give perioperative antibiotics, most often doxycycline (75%)., Conclusion: Overall, the second-trimester surgical abortion practices revealed in our survey agree with professional evidence-based policy guidelines. Wider variability was reported for practices lacking a strong evidence base., Implications: In this third cross-sectional survey of U.S. abortion practices (prior 1997 and 2002), second-trimester surgical abortion providers are younger than before, reflecting an improvement in the "graying" of the abortion provider workforce. Facility restrictions on gestational age along with hospital restrictions on referrals pose barriers to outpatient abortion access., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objective: To explore patient experiences of contraceptive coercion by healthcare providers at time of abortion., Study Design: We conducted a qualitative study of English-speaking women seeking abortion services at a hospital-based clinic. We used the Integrated Behavioral Model and the Reproductive Autonomy Scale to inform our semi-structured interview guide; the Scale provides a framework of reproductive coercion as a lack of autonomy or power to decide about and control decisions relating to reproduction. We enrolled participants until thematic saturation was achieved. Two coders used modified grounded theory to analyze transcribed interviews with Nvivo 11.0 (Κ=0.81)., Results: The 31 women we interviewed from June 2016 to March 2017 were all in the first trimester, and predominantly young (mean age 27±5 years), non-Hispanic Black (52%) and Medicaid-insured (68%). Some participants (42%) reported feeling "pressured" into choosing some form of contraception. A subset of participants (26%) voiced that providers seemed to prefer LARC methods or were "pushing" a specific method. Several participants perceived pressure to choose any method due to providers' preference to prevent repeat abortions. Conversely, participants who were offered a range of methods through the use of decision aids and who were given time to deliberate demonstrated more reproductive autonomy., Conclusions: Almost half of participants perceived a form of coercion around their contraceptive counseling. Coercion manifested in perceived provider preference for specific methods or immediate initiation of a method. Participant narratives involving decision aids to offer a range of methods and time for deliberation demonstrated greater reproductive autonomy and less coercion. Abortion stigma may mediate potentially coercive interactions between patients and providers., Implications: This qualitative study explored contraceptive coercion at the time of abortion. Findings highlighted provider pressure to initiate contraception, LARC preference, and abortion stigma. Offering many methods and opportunity for deliberation supported autonomy and satisfaction. Findings inform ongoing efforts to improve contraceptive counseling and promote reproductive autonomy, while addressing unintended pregnancies., (Published by Elsevier Inc.)

Objective: To compare obstetric outcomes after failed hysteroscopic and laparoscopic sterilization., Methods: This retrospective cohort study examined pregnancy outcomes including live birth, preterm birth, stillbirth, spontaneous abortion, therapeutic abortion, ectopic pregnancies, and gestational trophoblastic disease using a commercial claims administrative database for the years 2007-2013. We used a Z-test to compare pregnancy outcomes per 100 person-years based on type of sterilization. Cox proportional hazard models controlled for patient age, geographic region, urbanicity, comorbidities, and insurance type., Results: We evaluated 997 pregnancy outcomes among 817 women from a total of 70,115 women with a history of either hysteroscopic sterilization (n=387 pregnancies/27,724 cases) or laparoscopic sterilization (n=610 pregnancies/42,391 cases). Women undergoing hysteroscopic sterilization were slightly older than, but otherwise similar to, women undergoing laparoscopic sterilization. The most common outcome was live birth, which was more likely after hysteroscopic sterilization compared with laparoscopic sterilization (adjusted hazard ratio 1.32, 95% CI 1.09-1.60). The rate of spontaneous abortion was not statistically significantly different between the two groups. Therapeutic abortion occurred more often after hysteroscopic sterilization (adjusted hazard ratio 1.49, 95% CI 1.10-2.01), whereas ectopic pregnancies occurred less often (adjusted hazard ratio 0.12, 95% CI 0.05-0.29) compared with laparoscopic sterilization., Conclusion: Hysteroscopic sterilization is associated with higher rates of live birth and lower rates of ectopic pregnancy compared with laparoscopic sterilization. Spontaneous abortion and preterm birth rates were similar in both groups. These data do not support an adverse effect of hysteroscopic sterilization on subsequent pregnancy outcomes.

Background: Pediatric practices' scores on healthcare quality measures are increasingly available to the public. However, patients from low-income and racial/ethnic minority populations rarely use these data. We sought to understand potential barriers to using quality data by assessing what factors mattered to women when choosing a pediatric practice., Methods: As part of a randomized trial to overcome barriers to using quality data, we recruited women from a prenatal clinic serving an underserved population. Women reported how much 12 factors mattered when they chose a pediatric practice (5-point Likert scale), what other factors mattered to them, and which factors mattered the most. We assessed whether factor importance varied with selected participant characteristics and qualitatively analyzed the "other" factors named., Results: Participants' (n = 367) median age was 23 years, and they were largely Hispanic (60.4%), white (21.2%), or black (16.9%). Insurance acceptance "mattered a lot" to the highest percentage of women (93.2%), while online information about what other parents think of a practice "mattered a lot" to the fewest (7.4%). Major themes from our qualitative analysis of "other" factors that mattered included physicians' interpersonal skills and pediatrician-specific traits. Factors related to access "mattered the most" to the majority of women., Conclusions: Pediatrician characteristics and factors related to access to care may be more important to low-income and racial/ethnic minority women than more commonly reported quality metrics. Aligning both the content and delivery of publicly reported quality data with women's interests may increase use of pediatric quality data., Clinical Trial Registration: Clinicaltrials.gov NCT01784575.

Objectives: We sought to assess the change in serum ethinyl estradiol (EE2) and norelgestromin (NGMN) levels over 12 weeks of continuous contraceptive patch use., Study Design: We asked participants (n=30) to apply consecutive patches to be worn continuously (without a patch-free interval) for 12 weeks. We collected blood samples at the end of each patch week and two times during weeks 4, 8, and 12 (with the additional blood draw occurring mid-week). Liquid chromatography-tandem triple quadrupole mass spectrometry (LC-MS/MS) was utilized to assess EE2 and NGMN levels., Results: Twenty-seven women completed the study; 26 were compliant with patch use. Ethinyl estradiol levels ranged from 0 to 193 pg/mL over the period. We observed an accumulation over the 12-week time at an estimated rate of 2.15 pg/mL per week (95% confidence interval 0.95-3.35, p<.001). The change in NGMN levels ranged from 0 to 2.52 ng/mL over the 12 weeks (95% confidence interval 0.021-0.019, p=.915). The most common side effects reported were vaginal spotting, breast tenderness and abdominal pain/cramping. There were no serious adverse events reported., Conclusion: While the range of weekly EE2 values was quite wide, the absolute values remain low and generally within the expected range described in product labeling. Providers may consider prescribing continuous use of the patch, but given the slow accumulation of EE2 over time, 12 weeks should not be exceeded in the absence of safety data., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: Racial/ethnic minority patients are often underrepresented in clinical trials. Efforts to address barriers to participation may improve representation, thus enhancing our understanding of how research findings apply to more diverse populations., Methods: The IDEAS (Information, Description, Education, Assistance, and Support) for a Healthy Baby study was a randomized controlled trial (RCT) of an intervention to reduce barriers to using publicly reported quality data for low-income, racial/ethnic minority women. We used strategies grounded in a health equity framework to address barriers to recruitment and retention in three domains: preparation, process, and patient-centeredness. "Preparation" included teaching study staff about health inequities, role-playing skills to develop rapport and trust, and partnering with clinic staff. "Processes" included use of electronic registration systems to pre-screen potential candidates and determine when eligible participants were in clinic and an electronic database to track patients through the study. Use of a flexible protocol, stipends, and consideration of literacy levels promoted "patient-centeredness.", Results: We anticipated needing to recruit 800 women over 18 months to achieve a completion goal of 650. Using the recruitment and retention strategies outlined above, we recruited 746 women in 15 months, achieving higher recruitment (87.1 %) and retention rates (97.3 %) than we had anticipated., Discussion: These successful recruitment and retention strategies used for a large RCT promoted inclusivity and accessibility. Researchers seeking to recruit racial and ethnic minority pregnant women in similar settings may find the preparation, process, and patient-centered strategies used in this study applicable for their own studies., Trial Registration: ClinicalTrials.gov NCT01784575 , 1R21HS021864-01., Competing Interests: Sarah Goff declares that she has no conflict of interest. Yara Youssef declares that she has no conflict of interest. Kathleen Mazor declares that she has no conflict of interest. Penelope Pekow declares that she has no conflict of interest. Katharine White consults for Actavis. Peter Lindenauer declares that he has no conflict of interest. The authors have no conflicts to disclose. The study involved human subjects. Approval was obtained from the Baystate Medical Center Institutional Review Board and participants completed informed written consent.

Objective: To compare the effectiveness of 1.0 mg intra-fetal or intra-amniotic digoxin to achieve fetal asystole before second-trimester surgical pregnancy termination., Methods: In a randomized trial, women received 1.0 mg transabdominal intra-fetal or intra-amniotic digoxin on the day of laminaria placement before dilation and evacuation between 20 and 24 weeks of gestation. The primary outcome was incidence of fetal asystole, documented immediately before dilation and evacuation. We planned to analyze the primary outcome by original group assignment as well as by as-treated and per-protocol populations. A sample size of 270 was needed to detect an 8% difference in failure rates between groups. Prespecified secondary outcomes included the incidence of adverse events, side effects, and procedural differences., Results: Between January 2012 and January 2013, we screened 381 women and randomized 270 women to receive intra-fetal (n=136) or intra-amniotic (n=134) digoxin. Characteristics were similar across groups; the mean gestational age was 21.6 weeks (standard deviation 1.2). The proportion of fetal asystole was higher in the intra-fetal group (128/135 [94.8%]) than the intra-amniotic group (107/130, 82.3%; relative risk of failure to achieve asystole 3.41, 95% confidence interval 1.52-7.68). Results were similar in the as-treated and per-protocol populations. There were no significant differences in adverse events or side effects and no differences in injection duration, operative time, or estimated blood loss., Conclusion: Administration of intra-fetal injection of digoxin led to a higher proportion of participants achieving fetal asystole within 24 hours than intra-amniotic injection., Clinical Trial Registration: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01047748.

Background: Consumers rarely use publicly reported health care quality data. Despite known barriers to use, few studies have explored the effectiveness of strategies to overcome barriers in vulnerable populations., Methods: This randomized controlled trial tested the impact of a patient navigator intervention to increase consumer use of publicly reported quality data. Patients attending an urban prenatal clinic serving a vulnerable population enrolled between May 2013 and January 2015. The intervention consisted of 2 in-person sessions in which women learned about quality performance and viewed scores for local practices on the Massachusetts Health Quality Partners Web site. Women in both the intervention and control arms received a pamphlet about health care quality. Primary study outcomes were mean clinical quality and patient experience scores of the practices women selected (range 1-4 stars)., Results: Nearly all (726/746; 97.3%) women completed the study, 59.7% were Hispanic, and 65.1% had a high school education or less. In both unadjusted and adjusted models, women in the intervention group chose practices with modestly higher mean clinical quality (3.2 vs 3.0 stars; P = .001) and patient experience (3.0 vs 2.9 stars; P = .05) scores. When asked to rate what factors mattered the most in their decision, few cited quality scores., Conclusions: An intervention to reduce barriers to using publicly reported health care quality data had a modest effect on patient choice. These findings suggest that factors other than performance on common publicly reported quality metrics have a stronger influence on which pediatric practices women choose., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2016 by the American Academy of Pediatrics.)

Objective: To determine the location of Canadian abortion services relative to where reproductive-age women reside, and the characteristics of abortion facilities and providers., Design: An international survey was adapted for Canadian relevance. Public sources and professional networks were used to identify facilities. The bilingual survey was distributed by mail and e-mail from July to November 2013., Setting: Canada., Participants: A total of 94 abortion facilities were identified., Main Outcome Measures: The number and location of services were compared with the distribution of reproductive-age women by location of residence., Results: We identified 94 Canadian facilities providing abortion in 2012, with 48.9% in Quebec. The response rate was 83.0% (78 of 94). Facilities in every jurisdiction with services responded. In Quebec and British Columbia abortion services are nearly equally present in large urban centres and rural locations throughout the provinces; in other Canadian provinces services are chiefly located in large urban areas. No abortion services were identified in Prince Edward Island. Respondents reported provision of 75 650 abortions in 2012 (including 4.0% by medical abortion). Canadian facilities reported minimal or no harassment, in stark contrast to American facilities that responded to the same survey., Conclusion: Access to abortion services varies by region across Canada. Services are not equitably distributed in relation to the regions where reproductive-age women reside. British Columbia and Quebec have demonstrated effective strategies to address disparities. Health policy and service improvements have the potential to address current abortion access inequity in Canada. These measures include improved access to mifepristone for medical abortion; provincial policies to support abortion services; routine abortion training within family medicine residency programs; and increasing the scope of practice for nurses and midwives to include abortion provision., (Copyright© the College of Family Physicians of Canada.)

Objective: To understand the current availability and practice of first-trimester medical abortion (MA) in Canada., Design: Using public sources and professional networks, abortion facilities across Canada were identified for a cross-sectional survey on medical and surgical abortion. English and French surveys were distributed by surface or electronic mail between July and November 2013., Setting: Canada., Participants: A total of 94 abortion facilities were identified., Main Outcome Measures: Descriptive statistics on MA practice and facility and provider characteristics, as well as comparisons of MA practice by facility and provider characteristics using χ 2 and t tests., Results: A total of 78 of 94 (83.0%) facilities responded. Medical abortion represented 3.8% of first-trimester abortions reported (2706 of 70 860) in 2012. Among the facilities offering MA, 45.0% performed fewer than 500 first-trimester abortions a year, while 35.0% performed more than 1000. More MAs were performed in private offices or ambulatory health centres than in hospitals. Sixty-two physicians from 28 of 78 facilities reported providing first-trimester MA; 87.1% also provided surgical abortion. More than three-quarters of MA physicians were female and 56.5% were family physicians. A preponderance (85.2%) of providers offered methotrexate with misoprostol. Nearly all physicians (90.3%) required patients to have an ultrasound before MA, and 72.6% assessed the completion of the abortion with ultrasonography. Most physicians (74.2%) offered MA through 49 days after the onset of the last menstrual period, and 21.0% offered MA through 50 to 56 days; 37.1% reported providing MA to patients who lived more than 2 hours away. Four physicians from 1 site provided MA via telemedicine., Conclusion: In Canada, MA provision using methotrexate and misoprostol is consistent with best-practice guidelines, but MA is rare and its availability is unevenly distributed., (Copyright© the College of Family Physicians of Canada.)

Objectives: To evaluate feasibility, acceptability, continuation, and trough serum levels following self-administration of subcutaneous (sc) depot medroxyprogesterone acetate (DMPA)., Study Design: Women presenting to a family planning clinic to initiate, restart or continue DMPA were offered study entry. Participants were randomized in a 2:1 ratio to self- or clinician administered sc DMPA 104 mg. Those randomized to self-administration were taught to self-inject and were supervised in performing the initial injection; they received printed instructions and a supply of contraceptive injections for home use. Participants randomized to clinician administration received usual care. Continued DMPA use was assessed by self-report and trough medroxyprogesterone acetate levels at 6 and 12 months., Results: Two hundred fifty women were invited to participate, and 137 (55%) enrolled. Of these, 91 were allocated to self-administration, and 90/91 were able to correctly self-administer sc DMPA. Eighty-seven percent completed follow-up. DMPA use at 1 year was 71% for the self-administration group and 63% for the clinic group (p=0.47). Uninterrupted DMPA use was 47% and 48% for the self and clinic administration groups at 1 year (p=0.70), respectively. Serum analyses confirmed similar mean DMPA levels in both groups and therapeutic trough levels in all participants., Conclusions: Sixty-three percent of women approached were interested in trying self-administration of DMPA, even in the context of a randomized trial, and nearly all eligible for enrollment were successful at doing so. Self-administration and clinic administration resulted in similar continuation rates and similar DMPA serum levels. Self-administration of sc DMPA is feasible and may be an attractive alternative for many women., Implications: Self-administration of sc DMPA is a feasible and attractive option for many women. Benefits include increased control over contraceptive measures and less time spent on contracepting behaviors. Globally, self-administration has the potential to revolutionize contraceptive uptake by increasing the number of women with access to DMPA., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Publicly reported performance on quality measures is intended to enable patients to make more informed choices. Despite the growing availability of these reports, patients' use remains limited and disparities exist. Low health literacy and numeracy are two barriers that may contribute to these disparities. Patient navigators have helped patients overcome barriers such as these in other areas, such as cancer care and may prove useful for overcoming barriers to using publicly reported quality data., Methods/design: The goals of this study are: to determine the efficacy of a patient navigator intervention to assist low-income pregnant women in the use of publicly available information about quality of care when choosing a pediatrician; to evaluate the relative importance of factors influencing women's choice of pediatric practices; to evaluate the effect of the intervention on patient engagement in management of their own and their child's health care; and to assess variation in efficacy of the intervention for sub-groups based on parity, age, and race/ethnicity. English speaking women ages 16 to 50 attending a prenatal clinic at a large urban medical center will be randomized to receive an in-person navigator intervention or an informational pamphlet control between 20 to 34 weeks of gestation. The intervention will include in-person guided use of the Massachusetts Health Quality Partners website, which reports pediatric practices' performance on quality measures and patient experience. The primary study outcomes will be the mean scores on a) clinical quality and b) patient experience measures., Discussion: Successful completion of the study aims will yield important new knowledge about the value of guided website navigation as a strategy to increase the impact of publicly reported quality data and to reduce disparities in use of these data., Trial Registration: ClinicalTrials.gov #NCT01784575.

Oral contraceptives are commonly chosen methods whose contraceptive effectiveness is very user-dependent. Approaches to significantly improving oral contraceptive continuation have been largely unsuccessful. Long-acting reversible methods are the most highly effective reversible contraceptives, with the highest continuation rates, and should be the first-line methods offered to reproductive-aged women.

Purpose: To explore associations between eating-disordered (ED) symptoms, perceived oral contraceptive (OC)-related weight changes, and OC discontinuation among young minority women., Methods: We conducted a prospective substudy of a randomized controlled trial evaluating the impact of a pill pack supply (3 vs. 7 months) on OC continuation among young urban women presenting to a university-affiliated community-based family planning clinic for OC management. Participants (n = 354) were adolescent (n = 173) and young adult (n = 181) women aged 13-24 years, predominantly underinsured and largely Hispanic (92%). We conducted a structured baseline interview that included an ED screening instrument. At the 6-month follow-up, we conducted a telephone interview to determine OC continuation and dimensions of perceived OC-related weight changes during the study period., Results: At baseline, 24% of the subjects fulfilled the moderate/severe ED symptom screen criteria (n = 60). By 6 months, 57% of the subjects (n = 200) reported weight changes and 62% (n = 218) had discontinued OC use. Unadjusted discontinuation rates were similar across age- and ED symptom groups. In multivariate analysis, both ED symptoms (odds ratio = .49, 95% confidence interval = .25-.96, p = .04) and perceived weight changes (odds ratio = .60, 95% confidence interval = .38-.94, p = .03) were negatively associated with OC continuation., Conclusions: ED symptoms and perceived weight changes were associated with an increased likelihood of OC discontinuation among these young women. Reproductive health practitioners should consider psychological symptoms when managing OC., (Copyright © 2013 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)

Background: We examined the influence of depressed mood and psychological stress on oral contraceptive (OC) side effects and discontinuation., Study Design: We administered standard psychological instruments to 354 young women (13-24 years old) beginning a 6-month OC continuation intervention trial and questions on OC side effects and use at 6 months. Logisitic regression determined the relationships between psychological conditions, perceived OC side effects and continuation rates., Results: Baseline depressed mood (21%) and stress (19%) and 6-month mood (25%) and weight changes (57%) were relatively common. Only 38% continued OCs at 6 months. Depressed mood [odds ratio (OR) 2.27, confidence interval (CI) 1.25-4.15, p=.007] and stress (OR 2.07, CI 1.12-3.82, p=.02) were associated with perceived OC-related moodiness; depressed mood was associated with perceived weight loss (OR 1.89, CI 1.01-3.55, p=.05). Depressed mood (OR 0.54, CI 0.29-0.99, p=.04), stress (OR 0.48, CI 0.25-0.91, p=.03) and perceived weight change (OR 0.60, CI 0.38-0.94, p=.03) all reduced the likelihood of OC continuation., Conclusion: Young women with adverse psychological symptoms are at risk for perceived OC side effects and discontinuation., (Copyright © 2012 Elsevier Inc. All rights reserved.)