"Maybe if we weren't in the pandemic, I would have reconsidered": Experiences of abortion care-seeking during the COVID-19 pandemic in Maryland.

OBJECTIVE: To understand the COVID-19 pandemic's impact on abortion care-seeking in Maryland, a state with Medicaid coverage for abortion, high service availability, and laws supporting abortion rights. METHODS: We conducted semi-structured telephone interviews with 15 women who had an abortion between January 2021 and March 2022 at a hospital-based clinic in a mid-sized Maryland city. We purposively recruited participants with varied pandemic financial impacts. Interview questions prompted participants to reflect on how the pandemic affected their lives, pregnancy decisions, and experiences seeking abortion care. We analyzed our data for themes. RESULTS: All participants had some insurance coverage for their abortion; over half paid using Medicaid. Many participants experienced pandemic financial hardship, with several reporting job, food, and housing insecurity as circumstances influencing their decision to have an abortion. Most women who self-reported minimal financial hardship caused by the pandemic indicated they sought an abortion for reasons unrelated to COVID-19. In contrast, women with economic hardship viewed their pregnancies as unsupportable due to COVID-19 exacerbating financial instability, even when they desired to continue the pregnancy. All participants expressed that having an abortion was the best decision for their lives. Yet, when making decisions about their pregnancy, the most financially disadvantaged women weighed their desires against the pandemic's constraints on their reproductive self-determination. CONCLUSIONS: The pandemic changed abortion care-seeking circumstances even in a setting with minimal access barriers. Financial hardship influenced some women to have an abortion for a pregnancy that-while unplanned-they may have preferred to continue.

"It's different than a doctor saying 'You're making the right choice'": A qualitative study of chaplains' experience caring for patients undergoing abortion in Washington DC, Maryland, and Virginia.

OBJECTIVES: Health care chaplains are faith providers with theological education, pastoral experience, and clinical training who provide spiritual care to patients, their families, and medical staff. This study sought to characterize chaplains' experiences providing spiritual care for patients experiencing abortion and pregnancy loss and to explore how chaplains gain competency and comfort in providing pastoral care for this patient population. STUDY DESIGN: Researchers conducted in-depth, semistructured, qualitative interviews with currently-practicing chaplains recruited via convenience sampling in the Washington DC, Maryland, and Virginia region. We analyzed interviews using directed content analysis and coded using both inductive and deductive coding. RESULTS: We interviewed 13 chaplains. The majority were Protestant and identified as Democrats. Participants often personally struggled with the acceptability of abortion but emphasized the importance of spiritual care for this patient population. They recognized that religious stigma regarding abortion prevented referrals to chaplaincy. Though desiring to contribute, chaplains reported little formal education in pregnancy support counseling. They relied on foundational pastoral care skills, like holding space, values clarification, connecting with patients' spirituality, words of comfort, ritualistic memorialization, and resource provision. All desired more training specific to abortion and pregnancy loss in chaplaincy education. CONCLUSIONS: Chaplains from varied faith backgrounds have a diverse set of skills to support patients experiencing abortion or pregnancy loss, but feel underutilized and lacking in formal training. Though not all patients require pastoral support, chaplains can be critical members of the care team, particularly for those patients experiencing spiritual distress. IMPLICATIONS: Chaplains have a paucity of training in supporting patients experiencing abortion and pregnancy loss. Chaplains want to be involved with patients experiencing abortion but feel excluded by both patients and practitioners. Standardization of pastoral care training is important to ensure adequate spiritual support for patients who desire such services.

Development and evaluation of measures to assess self-determination in peripartum contraceptive decision-making.

OBJECTIVES: We aimed to adapt and validate person-centered measures to evaluate various contributors to self-determination in perinatal contraceptive decision-making. STUDY DESIGN: We developed and administered four scales adapted from existing measures in the context of Self-Determination Theory: the Treatment Self-Regulation Questionnaire (TSRQ), Perceived Competence Scale, modified Health Care Climate Questionnaire, and Important Other Climate Questionnaire. The TSRQ consists of three subscales: autonomous motivation, controlled motivation, and amotivation. We recruited a nonprobability convenience sample of 300 hospitalized postpartum patients in Baltimore, MD, between 2015 and 2016 and administered surveys in English and Spanish. We validated the scales with Cronbach's alpha coefficients, confirmatory factor analysis, and invariance analysis. We examined construct validity by testing correlations between the scales and other person-centered measures, such as satisfaction with counseling. RESULTS: Cronbach's alpha was >0.8 except for the amotivation subscale. Confirmatory factor analysis was adequate for all scales. Autonomous motivation correlated positively and significantly with perceived competence, health care provider autonomy support, important other autonomy support, and other measures of patient satisfaction. CONCLUSIONS: We found the four scales to be internally consistent and valid except for the amotivation subscale. We recommend using the autonomous motivation subscale in place of the full TSRQ. The autonomous motivation subscale, Perceived Competence Scale, modified Health Care Climate Questionnaire, and Important Other Climate Questionnaire showed adequate internal consistency, construct validity, and adherence to the expected conceptual structure of the scales. IMPLICATIONS: Autonomous decision-making is central to ethics and quality of care, especially for contraceptive methods that require a provider for initiation or discontinuation and at more vulnerable times, such as postpartum and postabortion. These scales may help tailor person-centered and autonomy-supportive interventions and programs to improve contraceptive counseling and care delivery.

Cervicovaginal mucus barrier properties during pregnancy are impacted by the vaginal microbiome.

Introduction: Mucus in the female reproductive tract acts as a barrier that traps and eliminates pathogens and foreign particles via steric and adhesive interactions. During pregnancy, mucus protects the uterine environment from ascension of pathogens and bacteria from the vagina into the uterus, a potential contributor to intrauterine inflammation and preterm birth. As recent work has demonstrated the benefit of vaginal drug delivery in treating women's health indications, we sought to define the barrier properties of human cervicovaginal mucus (CVM) during pregnancy to inform the design of vaginally delivered therapeutics during pregnancy. Methods: CVM samples were self-collected by pregnant participants over the course of pregnancy, and barrier properties were quantified using multiple particle tracking. 16S rRNA gene sequencing was performed to analyze the composition of the vaginal microbiome. Results: Participant demographics differed between term delivery and preterm delivery cohorts, with Black or African American participants being significantly more likely to delivery prematurely. We observed that vaginal microbiota is most predictive of CVM barrier properties and of timing of parturition. Lactobacillus crispatus dominated CVM samples showed increased barrier properties compared to polymicrobial CVM samples. Discussion: This work informs our understanding of how infections occur during pregnancy, and directs the engineering of targeted drug treatments for indications during pregnancy.

An exploratory study of COVID-19-related changes in abortion service availability and use in Washington, DC, Maryland, and Virginia.

OBJECTIVES: This exploratory study aimed to assess COVID-19-related changes in abortion service availability and use in Washington, DC, Maryland, and Virginia. DESIGN: Data came from a convenience sample of eight abortion clinics in this region. We implemented a cross-sectional survey and collected retrospective aggregate monthly abortion data overall and by facility type, abortion type, and patient characteristics for March 2019-August 2020. We evaluated changes in the distribution of the total number of patients for March-August in 2019 compared to March-August 2020. We also conducted segmented regression analyses and produced scatter plots of monthly abortion patients overall and by facility type, abortion type, and patient characteristics, with separate fitted regression lines from the segmented regression models for the pre- and during-COVID-19 periods. RESULTS: Five clinics reported a reduced number of appointments early in the pandemic while four reported increased call volume. There were declines in the monthly abortion trend at hospital-based clinics at the outset of the pandemic. Monthly number of medication abortions increased from March 2020 through August 2020 compared to pre-COVID-19 trends while instrumentation abortions 11 up to 19 weeks decreased. The share of abortions to Black individuals increased during the early phase of the pandemic, as did the monthly trend in abortions among this group. We also saw changes in payment type, with declines in patients paying out-of-pocket. CONCLUSIONS: Results revealed differences in abortion services, numbers, and types during the early stages of the COVID-19 pandemic in Washington, DC, Maryland, and Virginia.

Lactobacillus-dominance and rapid stabilization of vaginal microbiota in combined oral contraceptive pill users examined through a longitudinal cohort study with frequent vaginal sampling over two years.

BACKGROUND: Bacterial vaginosis (BV), a condition in which vaginal Lactobacillus spp. are in low abundance, is associated with vulvovaginal symptoms, obstetric outcomes and urogenital infections. Recurrent BV is difficult to manage, and emerging data indicate a reduced risk of BV with the use of hormonal contraception (HC). Despite widespread use, little longitudinal data is available on whether, and in what timeframe, combined oral contraceptive pills (COCs) may act to affect vaginal microbiota stability and Lactobacillus dominance. METHODS: We compared the vaginal microbiota of reproductive-age cisgender women during intervals on combined estrogen and progestin COCs with non-use intervals in a 2-year observational study. Vaginal microbiota were characterized by 16S rRNA gene amplicon sequencing. FINDINGS: COC users were more likely to have Lactobacillus-dominated microbiota and more stable microbiota over time. Stability increased and then plateaued four weeks after COC initiation. The associations between COCs and Lactobacillus spp. dominance, and microbiota stability, were statistically significant for White, but not African American women; however sample size was limited for African American participants. Findings were similar for other forms of HC and when excluding samples collected during menses. INTERPRETATION: Our study provides a methodologic framework to evaluate observational longitudinal microbiota data with exposure crossovers. We found COCs are associated with vaginal microbiota stability and a Lactobacillus-dominated state. COCs appear to impact stability within a month of initiation. Our findings have clinical implications for how soon benefits can be expected in (at least White) patients initiating COCs, and support the need for larger prospective trials to verify our results in ethnically diverse populations. FUNDING: R01-AI089878.

COVID-19 impacts on abortion care-seeking experiences in the Washington, DC, Maryland, and Virginia regions of the United States.

CONTEXT: Many people wanted to avoid or delay childbearing during the COVID-19 pandemic. This study sought to examine the extent COVID-19 influenced abortion care-seeking in a region that did not enact policy restricting abortion due to the pandemic, has high service availability, and few abortion-restrictive policies. METHODOLOGY: We conducted telephone surveys with adults (n=72) requesting abortion appointments between September 2020 and March 2021 at five clinics in Washington, DC, Maryland, and Virginia. We used χ2 tests to compare sociodemographic, reproductive history, service delivery characteristics, and pandemic-related life changes by whether COVID-19 influenced abortion care-seeking. RESULTS: Most respondents (93%) had an abortion at the time of the survey, 4% were awaiting their scheduled appointment, and 3% did not have an appointment scheduled. Nearly 40% of people reported COVID-19 influenced their decision to have an abortion. These individuals were significantly more likely to report "not financially prepared" (44% vs. 16%) as a reason for termination compared to people reporting no influence of COVID-19. They were also more likely to have lost or changed their health insurance due to pandemic-related employment changes (15% vs. 2%), report substantial money difficulties due to COVID-19 (59% vs. 33%), and report that paying for their abortion was "very difficult" (25% vs. 2%). CONCLUSION: COVID-19 influenced many people to have an abortion, particularly those financially disadvantaged by the pandemic. Expansion of Medicaid abortion coverage in Washington, DC and Virginia could reduce financial barriers to care and help people to better meet their reproductive needs amid future crises.

Continuation rates of two different-sized copper intrauterine devices among nulliparous women: Interim 12-month results of a single-blind, randomised, multicentre trial.

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).

An exploratory survey regarding the Maryland Contraceptive Equity Act: clinician awareness and impact on contraception provision.

OBJECTIVE: The Maryland Contraceptive Equity Act took effect in January 2018 with the goal of reducing insurance barriers to contraception. We sought to assess the Act's impact on contraceptive provision. STUDY DESIGN: From March-August 2019, we emailed an exploratory survey to clinicians providing contraception in Maryland that queried awareness of the Act and changing practices. RESULTS: The survey had a 13% response rate (164/1256 clinicians). Fifty (31%) were aware of the Act. Clinicians rated the Act was somewhat likely to change prescribing practices (3.5/5 point Likert Scale, SD 1.3). CONCLUSION: The majority of clinicians providing contraception in Maryland are not aware of the Act. If aware of the Act, clinicians may change their contraceptive prescribing practices.

Contraceptive values and preferences of pregnant women, postpartum women, women seeking emergency contraceptives, and women seeking abortion services: A systematic review.

OBJECTIVE: We sought to systematically review the literature on contraceptive values and preferences of pregnant women, postpartum women, women seeking emergency contraception, and women seeking abortion services, globally. STUDY DESIGN: We searched ten electronic databases for articles from January 1, 2005 through July 27, 2020 regarding users' values and preferences for contraception. Results were divided into four sub-groups. RESULTS: Twenty-three studies from 10 countries met the inclusion criteria. Values and preferences across all four sub-groups were influenced by method effectiveness, access, availability, convenience, cost, side effects, previous experience, partner approval, and societal norms. Similarities and differences were evident across sub-groups, especially concerning contraceptive benefits and side effects. No contraceptive method had all the features users deemed important. Many studies emphasized values and preferences surrounding long-acting reversible contraception (LARC), including convenience of accessing LARCs and concerns about side effect profiles. DISCUSSION: Individuals must have access to a full range of safe and effective modern contraceptive options, allowing people to make decisions based on evolving contraceptive preferences over time. Future contraception guideline development, policy, and programmatic implementation should continue considering the added influence of these specific reproductive experiences on contraceptive values and preferences of users to improve access, counseling, and method choice.

Women with sickle cell disease report low knowledge and use of long acting reversible contraception.

BACKGROUND: High rates of unplanned pregnancy and low rates of contraception use are reported among women with sickle cell disease (SCD). Pregnancy in women with SCD is high risk and unintended pregnancies limit opportunities to provide indicated preconception care and counseling. Contraceptive use in women with SCD is complicated by a lack of disease-specific data about treatment risks and benefits. The purpose of this study was to describe, for the first time in the U.S. context, contraceptive use, knowledge and preferences in adult cohort of women with SCD. MATERIALS AND METHODS: A single-center survey study of women with SCD of reproductive age from our Center's adult and pediatric sickle cell centers. RESULTS: Seventy-eight women ages 28-65 years (median 33.5 years, IQR 16) completed surveys. Seventy-three percent of respondents had an average of 2.5 pregnancies (S.D. 1.22) and of these, 58% reported being pregnant when they did not want to be pregnant at least once. The most common forms of contraception used were condoms (87%), birth control pills (46%), medroxyprogesterone (44%) and withdrawal (44%). Twenty-two percent of subjects reported using a long-acting reversible form of contraception and 21% reported a tubal ligation or partner vasectomy. Respondents demonstrated low knowledge of the efficacy of contraceptive options and over-estimated the risk of pregnancy with the IUD, implant. Contraceptive priorities included pregnancy prevention, decreasing HIV transmission and effects on SCD symptoms. CONCLUSIONS: Women with SCD have high rates of unintended pregnancy, low knowledge of contraceptive efficacy and low use of long-acting reversible contraception.

Association of Vaginal Microbiota With Signs and Symptoms of the Genitourinary Syndrome of Menopause Across Reproductive Stages.

The genitourinary syndrome of menopause (GSM) describes signs and symptoms resulting from effects of estrogen deficiency on the female genitourinary tract, including the vagina, labia, urethra, and bladder. Signs/symptoms associated with GSM may occur during any reproductive stage from multiple etiologies but are most common during menopause due to low estrogen. Vaginal microbiota, particularly Lactobacillus spp., are beneficial to the female genital tract; however, their abundance declines during menopause. We aimed to longitudinally assess vaginal microbiota characterized by 16S rRNA gene amplicon sequencing and GSM-associated endpoints across reproductive stages. In a 2-year cohort study of 750 women aged 35-60 years at enrollment and 2 111 semiannual person-visits, low-Lactobacillus vaginal microbiota communities were observed at 21.2% (169/798), 22.9% (137/597), and 49.7% (356/716) of person-visits among pre-, peri-, and postmenopausal women, respectively (p < .001). Compared to communities that have high Gardnerella vaginalis relative abundance and diverse anaerobes, the following communities were associated with a lower covariate-adjusted odds of vaginal atrophy: L crispatus-dominated communities among postmenopausal women (odds ratio [OR] = 0.25; 95% confidence interval [CI]: 0.08, 0.81), L gasseri/L jensenii (OR = 0.21; 95% CI: 0.05, 0.94) and L iners (OR = 0.21; 95% CI: 0.05, 0.85) among perimenopausal women, and L iners-dominated communities (OR = 0.18; 95% CI: 0.04, 0.76) among premenopausal women. Postmenopausal women with L gasseri/L jensenii-dominated communities had the lowest odds of vaginal dryness (OR = 0.36; 95% CI: 0.12, 1.06) and low libido (OR = 0.28; 95% CI: 0.10, 0.74). Findings for urinary incontinence were inconsistent. Associations of vaginal microbiota with GSM signs/symptoms are most evident after menopause, suggesting an avenue for treatment and prevention.

Oral sedation for pain with cervical dilator placement: a randomized controlled trial.

OBJECTIVE: Assess oral sedation versus placebo for pain control with cervical dilator placement. STUDY DESIGN: We randomized participants presenting for dilation and evacuation to lorazepam 1 mg/oxycodone 5 mg or placebo 45 min before cervical dilator placement. Our primary outcome was median visual analog scale (VAS) pain score after dilator placement using a 100-mm VAS. We used our outcome data to calculate median pain score changes from baseline to better reflect pain score differences between study groups. Planned sample size was 30 participants per group, for a total of 60. RESULTS: We randomized 27 participants; 9 received sedation and 11 placebo. Median pain score increase from baseline to last dilator placement was 20 [interquartile range (IQR) 8-29] and 31 (IQR 15-81) in the oral sedation and placebo groups, p = .16. CONCLUSION: We were unable to enroll our desired sample size, and our sample is underpowered to make any conclusions. Our results suggest that oral sedation may provide some benefit for pain relief with dilator insertion and indicate that further research might be worthwhile especially in settings that do not routinely provide these analgesics. IMPLICATIONS: We had difficulty with study recruitment because many patients desired oral sedation for pain management for cervical dilator placement and declined randomization. Randomized trials of pain management with a placebo arm may find recruitment challenging especially if default clinical care already includes a pain management option that patients would have to opt out of.

Rates of New Human Papillomavirus Detection and Loss of Detection in Middle-aged Women by Recent and Past Sexual Behavior.

BACKGROUND: Understanding the source of newly detected human papillomavirus (HPV) in middle-aged women is important to inform preventive strategies, such as screening and HPV vaccination. METHODS: We conducted a prospective cohort study in Baltimore, Maryland. Women aged 35-60 years underwent HPV testing and completed health and sexual behavior questionnaires every 6 months over a 2-year period. New detection/loss of detection rates were calculated and adjusted hazard ratios were used to identify risk factors for new detection. RESULTS: The new and loss of detection analyses included 731 women, and 104 positive for high-risk HPV. The rate of new high-risk HPV detection was 5.0 per 1000 woman-months. Reporting a new sex partner was associated with higher detection rates (adjusted hazard ratio, 8.1; 95% confidence interval, 3.5-18.6), but accounted only for 19.4% of all new detections. Among monogamous and sexually abstinent women, new detection was higher in women reporting ≥5 lifetime sexual partners than in those reporting <5 (adjusted hazard ratio, 2.2; 95% confidence interval, 1.2-4.2). CONCLUSION: Although women remain at risk of HPV acquisition from new sex partners as they age, our results suggest that most new detections in middle-aged women reflect recurrence of previously acquired HPV.

Sex education and contraceptive use of adolescent and young adult females in the United States: an analysis of the National Survey of Family Growth 2011-2017.

OBJECTIVES: The effects of the comprehensiveness of sex education on sexual health measures have not been well-studied. We compared trends in comprehensive sex education and its relation to contraceptive use at first intercourse and current contraceptive use for women ages 15-24 in the United States between 2011 and 2017. STUDY DESIGN: Analyses included females ages 15-24 from the 2011-2017 National Survey of Family Growth. We defined comprehensive sex education as including 6 topics queried in the NSFG (how to say no to sex, birth control methods, where to get birth control, how to use condoms, sexually transmitted infections, HIV/AIDS), and non-comprehensive sex education as including less than 6 topics. Multivariable regression models investigated associations with contraceptive indicators. RESULTS: Among 5445 respondents, percentages of women receiving comprehensive sex education in 2011-2013, 2013-2015, and 2015-2017 were 35%, 40%, and 34%. Across all periods, respondents reporting comprehensive sex education before first sex were less likely to report first sexual intercourse before age 15 (aOR 0.55; 95% CI: 0.40-0.74) and non-volitional first intercourse (aOR 0.42, 95% CI: 0.26-0.72) compared to those with non-comprehensive sex education. At first intercourse, those with comprehensive sex education were more likely to have used any (aOR = 1.63; 95% CI: 1.18-2.25) and very effective (aOR = 1.35; 95% CI: 1.04-1.75) contraception. Comprehensive sex education was unrelated to current contraceptive use (aOR = 0.87; 95% CI: 0.63-1.21). CONCLUSIONS: Comprehensive sex education was associated with increased odds of contraceptive use at first intercourse, but not current contraceptive use. IMPLICATIONS: Programs that promote comprehensive sex education may have a positive impact on preventive behaviors at sexual debut.

A 1-year prospective, open-label, single-arm, multicenter, phase 3 trial of the contraceptive efficacy and safety of the oral progestin-only pill drospirenone 4 mg using a 24/4-day regimen.

OBJECTIVES: To evaluate contraceptive effectiveness and safety of oral drospirenone 4 mg 24/4-day regimen in the United States. STUDY DESIGN: We performed a prospective, single-arm, multicenter phase 3 trial in sexually active women for up to thirteen 28-day treatment cycles. Primary outcome was the Pearl index, calculated using confirmed on-drug pregnancies and evaluable cycles in nonbreastfeeding women aged ≤ 35 years. We assessed adverse events (AEs), including hyperkalemia and venous thromboembolism. RESULTS: Of 1006 women who received at least one dose of drospirenone, 352 women (35.0%) completed the trial and 654 (65.0%) women discontinued before trial end. Most participants (92.2%) were ≤ 35 years; one third had a body mass index (BMI) ≥ 30 kg/m2. Among nonbreastfeeding women aged ≤ 35 years, there were 17 pregnancies (Pearl index: 4.0; 95% confidence interval [CI], 2.3-6.4; n = 953), of which three were unconfirmed and two were from sites excluded from the main analysis for major breaches of Food and Drug Administration regulations. The Pearl index was 2.9 (95% CI: 1.5-5.1) for confirmed pregnancies among 915 nonbreastfeeding women aged ≤ 35 years from sites with no protocol violations. Nearly all (95.4%) treatment-emergent AEs were mild or moderate in intensity. No cases of venous thromboembolism were reported. The frequency of hyperkalemia was 0.5%. Women with baseline systolic/diastolic blood pressure ≥ 130/85 mmHg had a mean reduction from baseline in blood pressure at exit visit (- 8.5/- 4.9 mmHg; n = 119). No other clinically relevant changes were observed. Participant satisfaction was high. CONCLUSION: Drospirenone 4 mg 24/4 regimen provides effective contraception with a good safety/tolerability profile in a broad group of women, including overweight or obese women. IMPLICATIONS: This new progestin-only contraceptive, drospirenone 4 mg in a 24/4 regimen, provides a contraceptive option for the majority of women regardless of blood pressure or BMI.

Integration of a Comprehensive Contraception Education Program Into Clinical Practice in a Family Planning Clinic.

OBJECTIVE: To improve rates of contraception adherence by implementing a comprehensive contraception educational program for women receiving care at a family planning clinic. DESIGN: Quasi-experimental cohort study in which we evaluated women presenting before (control group) and after program implementation (intervention group) and compared the proportion of women returning for contraceptive method change and/or for unintended pregnancy. SETTING: Family planning clinic of a large academic medical center. PARTICIPANTS: English-speaking women ages 12 to 50 years who presented to the clinic for pregnancy termination or initiation of a new contraceptive method from May 2012 to May 2014. INTERVENTION: A provider-facilitated, patient-centered educational intervention was implemented to foster patient knowledge and choice about contraception. RESULTS: We conducted chart review to identify any clinic visit that occurred in the 12 months after the index visit. Pearson's chi-square test was used to compare results for women in both groups. The intervention group included 201 women, and the control group included 162 women. In the control group, 28% (n = 46/162) returned within the year for unintended pregnancy and/or contraceptive method change, whereas only 17% (n = 35/201) returned in the study group. This difference was statistically significant (p < .05). CONCLUSION: Initiation of a comprehensive contraception educational program was associated with a decrease in rates of return visits for unintended pregnancy and contraceptive method changes. This implies an improvement in adherence to the initially chosen contraceptive method. Such interventions hold promise for improving contraceptive adherence and decreasing unintended pregnancy. Improving contraceptive adherence is a critical first step to decreasing unintended pregnancies.

Bleeding profile associated with 1-year use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system: pooled analysis from Phase 3 trials.

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 [

Segesterone acetate/ethinyl estradiol 12-month contraceptive vaginal system safety evaluation.

OBJECTIVES: To evaluate safety outcomes from clinical studies of a 12-month contraceptive vaginal system (CVS) releasing an average of segesterone acetate (SA) 150 mcg and ethinyl estradiol (EE) 13 mcg daily. STUDY DESIGN: We integrated clinical safety data from nine studies in which women used the CVS for 21 consecutive days and removed it for 7 days of each 28-day cycle. Four studies used the final manufactured CVS, including a 1-year pharmacokinetic study, two 1-year phase 3 trials and a second-year treatment extension study. We assessed safety by evaluating adverse events women reported in a daily diary. We also included data from focused safety studies evaluating endometrial biopsies, vaginal microbiology and liver proteins from one of the phase 3 studies. RESULTS: The combined studies included 3052 women; 2308 women [mean age 26.7±5.1 years; mean body mass index (BMI) 24.1±3.7 kg/m2] received the final manufactured CVS, of whom 999 (43.3%) completed 13 cycles of use. Women using the final CVS most commonly reported adverse events of headache (n=601, 26%), nausea (n=420, 18%), vaginal discharge/vulvovaginal mycotic infection (n=242, 10%) and abdominal pain (n=225, 10%). Few (<1.5%) women discontinued for these complaints. Four (0.2%) women experienced venous thromboembolism (VTE), three of whom had risk factors for thrombosis [Factor V Leiden mutation (n=1); BMI>29 kg/m2 (n=2)]. During 21,482 treatment cycles in the phase 3 studies evaluable for expulsion, women reported partial expulsions in 4259 (19.5%) cycles and complete expulsions in 1509 (7%) cycles, most frequently in the initial cycle [499/2050 (24.3%) and 190/2050 (9.3%), respectively]. Safety-focused studies revealed no safety concerns. CONCLUSION: The 1-year SA/EE CVS has an acceptable safety profile. Additional studies are warranted in obese women at higher risk of VTE. IMPLICATIONS: This 1-year contraceptive vaginal system represents a new long-term, user-controlled and procedure-free option with a safety profile similar to other combination hormonal contraceptives. The same precautions currently used for combination hormonal contraceptive prescriptions apply to this new contraceptive vaginal system.