Emergency contraception for individuals weighing 80kg or greater: a randomized trial of 30 mg ulipristal acetate and 1.5 mg or 3.0 mg levonorgestrel.

OBJECTIVE: To compare the efficacy of oral emergency contraception (EC) regimens used within 72 hours of unprotected intercourse in individuals weighing >80 kg. STUDY DESIGN: We enrolled healthy women aged 18-40 years with a weight of at least 80 kg requesting EC in a multi-center, single-blind, randomized study of levonorgestrel 1.5 mg (LNG1X) and 3.0 mg (LNG2X) and ulipristal acetate 30 mg (UPA) (enrollment goal 1200). Key eligibility requirements included regular cycles, unprotected intercourse within 72 hours of enrollment, no use of hormonal contraception since last menstrual period, a negative urine pregnancy test (UPT), and willingness to abstain from intercourse until next menses. Study staff directly observed EC ingestion. To assess our primary outcome of incidence of pregnancy, participants completed home UPTs; if no menses by 2-weeks post-treatment, or a positive UPT, they returned for an in person visit with quantitative serum human chorionic gonadotropin (hCG) and ultrasound. RESULTS: We enrolled and randomized 532; 44 were not dosed or not evaluable for primary end-point, leaving an analyzable sample of 488 (173 LNG1X, 158 LNG2X, 157 UPA) with similar demographics between groups [mean age 29.6 years (5.74), BMI 37.09 kg/m2 (6.95)]. Five pregnancies occurred during the study (LNG1X n = 1, LNG2X n = 1, UPA n = 3); none occurred during the highest at-risk window relative to estimated day of ovulation (day of ovulation and the 3 days prior). We closed the study prior to achieving our enrollment goal because the low pregnancy rate in all groups established futility based on an interim blinded analysis. CONCLUSION: Although slow enrollment limited our study power, we found no differences in pregnancy rates between oral EC regimens among women weighing 80 kg or more. Our results are not able to refute or support differences between the three treatment arms. IMPLICATIONS: Women weighing 80 kg or more experienced no differences in pregnancy rates between oral EC regimens but due to several significant study limitations including sample size and the lack of a study population at high risk of pregnancy, our results are not able to determine if differences in treatment effectiveness exist.

Evaluating virtual visits for contraceptive counseling: an exploratory study using the Person-Centered Contraceptive Counseling (PCCC) scale, a patient-reported outcome measure.

OBJECTIVE(S): To describe patient-reported quality of care for virtual contraceptive counseling, using the 4-item Person-Centered Contraception Counseling (PCCC) scale. Secondary analyses evaluated PCCC scores by patient subgroups. STUDY DESIGN: From December 2021 to May 2022, we offered an anonymous web-based survey, to English and Spanish-speaking female patients 18 to 45 years old who had virtual visits through two Family Planning offices affiliated with Columbia University/New York Presbyterian Hospital in New York City. RESULTS: Among 196 respondents, 133 (68%) respondents gave the top score. The proportion who gave the top PCCC score was higher for the faculty-based practice vs. community-based practice (62% vs. 38% respectively, p=0.02), video vs. telephone (84% vs. 16% respectively, p=0.01), and English vs. Spanish (86% vs. 14% respectively, p=0.02); but did not differ for ethnicity (p=0.34). CONCLUSIONS: Patient-perceived quality of contraceptive counseling in virtual visits was high, with some disparities seen in the subgroups. IMPLICATIONS: This exploratory study about contraceptive counseling during virtual visits showed that 68% of survey respondents gave the top box PCCC score. Our work also suggests disparities in patient experiences based on several factors. Future work may expand on nuances of disparities and how these influence care.

Satisfaction with a Segesterone Acetate and Ethinyl Estradiol Contraceptive Vaginal System Among Recent Oral Contraceptive or Hormonal Contraceptive Vaginal Ring Users.

Background: We evaluated satisfaction with use of a segesterone acetate and ethinyl estradiol (0.15/0.013 mg) contraceptive vaginal system (CVS) among women who had recently used a monthly contraceptive vaginal ring or contraceptive pills. The CVS is a ring-shaped device used in a 21-days-in/7-days-out regimen for 13 cycles. Materials and Methods: We analyzed post hoc satisfaction responses at cycle 3 and end of study (EOS) from a subset of participants with documented recent use of the monthly ring or daily pills before enrollment in a multinational, phase 3, 13-cycle trial evaluating the CVS. EOS included results from participants who had completed ≥10 cycles. Results were summarized descriptively. Results: We identified 128 recent ring and 219 recent pill users at cycle 3 (of 1033 survey participants), and 92 and 148, respectively, at EOS (of 622 survey participants); overall satisfaction with CVS use was high (≥90%). At EOS, most ring (89%) and pill (97%) users liked the CVS as much/better than any previous method. The two most-liked CVS features included ease of use and 1-year duration; the two most disliked features included ring insertion and feeling it coming out. At EOS, ≥88% of both groups reported no concern about using the same CVS for a year, and most (>80%) had recommended it to friends or family members. Conclusion: The CVS clinical trial participants who were recent ring/pill users reported high satisfaction and liked it as much/better than any previously used contraceptive; the CVS may be a good contraceptive option for switchers. Clinical trial registration NCT00263341.

Associations between contraceptive availability and rate of subsequent legal abortions in Colombia: A historical cohort analysis.

OBJECTIVE: To describe factors associated with subsequent abortions in Colombia and evaluate whether high-efficacy contraceptive availability (IUD) post-index abortion was associated with higher efficacy contraceptive initiation and fewer subsequent abortions within 2 years. METHODS: The study population comprised patients aged 15-44 years who underwent index abortion in 2017 at four clinics in Bogotá, Colombia. Using charts, we conducted a retrospective cohort study with 2-year follow-up (2017-2019) after the index abortion for outcomes of contraceptive initiation and subsequent abortion. We evaluated associations between demographic or clinical characteristics and outcomes using Pearson chi-square and multivariate logistic regression. RESULTS: Of 9175 patients with index abortion, 3409 (37.2%) initiated an intrauterine device (IUD) and 467 (5.1%) had a subsequent abortion within the study period (2017-2019). IUD availability (adjusted odds ratio [aOR], 1.64; 95% confidence interval [CI], 1.39-1.93) and insurance use (aOR, 5.03; 95% CI, 4.37-5.78) were associated with high-efficacy contraceptive initiation; medication abortion was inversely associated (aOR, 0.24; 95% CI, 0.22-0.27). Initiation of no (aOR, 4.94; 95% CI, 3.59-6.80) or moderate-efficacy (injection: aOR, 4.21 [95% CI, 3.14-5.62]; oral contraceptive pill: aOR, 4.60 [95% CI, 3.21-6.59]) methods were associated with subsequent abortion. CONCLUSION: Subsequent abortion is inversely associated with initiated postabortion contraceptive efficacy, which is modifiable on a systems level by improving access to effective postabortion contraception.

The effect of deliberate non-adherence to a norgestrel progestin-only pill: A randomized, crossover study.

OBJECTIVES: To estimate the effects on cervical mucus, ovarian activity and theoretical contraceptive protection of a 6-hour delay and of missing one norgestrel 0.075 mg progestogen-only pill. STUDY DESIGN: In a prospective, two-site, randomized, crossover study, healthy women aged 18 to 35 with BMI <32.0 kg/m² and regular ovulatory cycles completed a baseline 28-day cycle with correct daily pill use followed by two intervention cycles in which, around mid-cycle, one pill was taken 6 hours late or missed completely. We undertook ovarian ultrasonography, estradiol and progesterone measurement, and cervical mucus assessments every 3 to 4 days (daily around the time of the incorrect use) and based the theoretical contraceptive protection score on ovarian activity status, cervical mucus and their temporal relationship. RESULTS: Of 91 potential participants screened, 52 started the study and 46 provided complete data for each intervention cycle. Fourteen participants (30%) ovulated in each of the two intervention cycles, with four during the delayed pill cycle and two during the missed pill cycle having an abnormal luteal phase. Seven participants in the delayed pill cycle, and six with a missed pill had elevated cervical mucus scores temporally associated with the intervention. However only two women, one in the delayed pill cycle and one in the missed pill cycle, had cervical mucus scores in the range considered favorable for fertility. CONCLUSIONS: Delayed or missed intake of a single norgestrel 0.075 mg progestogen-only pill appears to have little effect on theoretical contraceptive efficacy. IMPLICATIONS: This biomedical study suggests that taking a norgestrel 0.075mg progestogen-only pill 6 hours late or missing one pill have little effect on ovarian activity or cervical mucus and may not jeopardize contraceptive efficacy. Correlation with typical use outcomes is necessary to confirm pregnancy risk with delayed or missed norgestrel intake.

Using transvaginal ultrasounds for the identification of follicle-like structures ≥10 mm in a multi-center randomized contraceptive clinical trial of three 84-day oral ulipristal acetate regimens.

PURPOSE: We examine the use of transvaginal sonography in imaging ovarian follicles among non-pregnant reproductive-aged women enrolled in a contraceptive clinical trial. METHODS: Ten sites conducted a clinical trial comparing three oral ulipristal acetate regimens for ovulation inhibition. Enrollees underwent twice weekly transvaginal sonography and hormonal blood testing throughout treatment and until the second menses post-treatment. The primary outcome of the present analysis was success in identifying follicles ≥10 mm in a subgroup of sonograms performed at times of likely follicular activity (estradiol <100 pg/ml and progesterone >3 ng/ml). Secondarily, an overall analysis assessed all sonograms regardless of timing. RESULTS: At times of likely follicular activity, 135 women underwent 969 sonograms. The proportion of sonograms without follicles ≥10 mm ranged from 8.3% to 46.3% when stratified by site (p = .01). The odds of no follicle among higher-body mass index (BMI) women were 1.91 times those among lower-BMI women after controlling for site and treatment arm (95% CI: 1.13, 3.22). Results were similar for the overall population. CONCLUSION: Sonographers were less likely to identify follicles for higher-BMI women and results varied by site. Machine quality slightly impacted sonogram results, but did not sufficiently explain site differences.

Pooled analysis of two phase 3 trials evaluating the effects of a novel combined oral contraceptive containing estetrol/drospirenone on bleeding patterns in healthy women.

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

Recap of the sixth international symposium on intrauterine devices and systems for women's health.

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

Designing illustrative social media stories to promote adolescent peer support and healthy sexual behaviors.

Objective: Adolescent females in the United States continue to have unmet sexual and reproductive healthcare needs. Research shows that interventions incorporating peer support can augment perceived self-efficacy and reinforce healthy behaviors. Yet, few user-centered digital sexual health interventions incorporate peer support, and aim to change perceptions of peer norms and model social skills. The objective of this study was to design and demonstrate the receptivity of adolescent females to illustrated digital social media stories that promote healthy sexual behaviors and peer social support. Methods: We conducted a three-phase study approved by our Institutional Review Board. In Phase 1, we presented sexually active adolescent female emergency department patients aged 14-19 with eight sexual health scenarios via a survey study. Participants wrote three text messages addressed to the protagonist of each scenario which motivated and encouraged her to consider the use of contraceptives. Messages were scored based on the construct of peer support (emotional, tangible, informational, and belonging). In Phase 2, we worked with a professional artist and screenwriter to design digital sexual health comics using the gathered messages. In Phase 3, we gathered feedback on the comics from adolescent female emergency department patients. Results: Females (n = 22) provided 352 messages. Using top rated messages, we designed five digital visualizations in a running story called Mari tells it like it is. Each story incorporated 5-12 peer-authored quotes. We inserted the final images into Instagram®. Additional females (n = 39) found the images "relatable," "super-realistic," and "educational." Conclusion: Collecting peer-authored texts from our local adolescent community led to the creation of well-received sexual health visualizations. This novel method of design incorporated adolescent voices to promote peer support and healthy behaviors.

Update on incidence of inpatient tubal ligation and long-acting reversible contraception in the United States.

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

Recommendations for standardization of bleeding data analyses in contraceptive studies.

To address limitations that exist with existing definitions of menstrual bleeding changes that occur with contraceptive methods, we assembled a panel to develop new recommendations for standardization of bleeding data analyses associated with contraceptive use to better inform users, clinicians, investigators, pharmaceutical companies, and regulatory agencies. We propose three criteria for assessing bleeding outcomes: pattern, flow, and duration. The descriptors within each criterion depend on whether the contraceptive is designed to result in a predictable or unpredictable bleeding pattern. Predictable pattern outcomes quantify days of scheduled, unscheduled and no bleeding, while unpredictable pattern outcomes assess frequency. Flow is quantified based on patient comparisons to their typical flow when not using contraception, with spotting representing no menstrual products use. Duration of a prolonged bleeding and/or spotting episode is more than 7 days. Studies should assess bleeding characteristics for a minimum of 12 months for 21/7, 24/4, extended cycle or continuous regimens, two years for injectables, and the full duration of use for long-acting contraceptives. Describing pattern, flow and duration as independent categories allows a fuller understanding of the bleeding outcomes and better future assessments of acceptability and continuation. Standardization of outcomes permits better comparison between studies and data synthesis; standardization will also improve the ability of clinicians and patients to understand differences between products.

Evaluation of ovulation and safety outcomes in a multi-center randomized trial of three 84 day ulipristal acetate regimens.

OBJECTIVES: To describe ovulation inhibition and safety of daily oral ulipristal acetate (UPA) over 84 days. STUDY DESIGN: This multi-center phase 1 and/or 2 trial randomized participants to use oral ulipristal 10 mg or 5 mg daily or a 3 cycle regimen of 5 mg for 24 days followed by four placebo days. We stratified randomization by body mass index (BMI) <32 or 32-40 kg/m2. To estimate ovulation inhibition, the primary outcome, participants underwent transvaginal ultrasound and blood sampling twice weekly; we analyzed compliant participants who completed the 84 day study. Safety endpoints included 3 endometrial biopsies and liver chemistry tests. RESULTS: We enrolled 180 participants and included 137 in the ovulation inhibition analyses. Progesterone values that remained below 3ng/mL throughout treatment suggested consistent ovulation inhibition in 52 of 137 (38%) participants; 25 of 47(53%), 20 of 44(45%), and 7 of 46(15%) among participants randomized to the 10 mg, 5 mg, and cyclic treatments, respectively (p < 0.01). Progesterone values consistently <3 ng/mL were more frequent in participants with a BMI > 32kg/m2 (25/50(50%) vs 27/87(31%), p = 0.01). Average ulipristal concentrations were higher among participants with low progesterone concentrations (p < 0.01). Endometrial biopsies during treatment showed progesterone-receptor-modulator-associated endometrial changes in 52 of 164 participants (32%); 22 of 49(40%), 16 of 48(29%), and 14 of 51(26%) in women randomized to the 10 mg, 5 mg, and the cyclic treatments, respectively (p = 0.07, test-for-trend); these changes resolved after treatment cessation. Liver transaminase changes were rare. CONCLUSIONS: Oral ulipristal acetate over 12 weeks did not reliably suppress ovulation, particularly in the 5 mg cyclic-dose group. Ovulation inhibition and endometrial changes were dose dependent. Reversible endometrial changes occurred during treatment. IMPLICATIONS: Progesterone-receptor modulators have been suggested for daily oral contraception. Since progesterone concentrations suggest that ovulation occurred during treatment, further studies would be necessary to assess whether these were functional ovulations and to evaluate other possible mechanisms of contraception.

Mechanism of action of norgestrel 0.075 mg a progestogen-only pill. I. Effect on ovarian activity.

OBJECTIVE: To explore the effect on ovarian activity and ovulation of 28 days of correct daily use of a progestogen-only pill containing norgestrel 0.075 mg. STUDY DESIGN: We performed a prospective, randomized, crossover study at 2 US sites, recruiting healthy women of reproductive age to use norgestrel 0.075 mg daily for three 28-day treatment cycles. We monitored ovarian activity every 3 to 4 days with reproductive hormone measurements and ovarian ultrasonography. Participants recorded pill use in daily diaries. An adjudication committee independent of the research sites assessed ovarian activity using a modified Hoogland score combining hormone concentrations and follicle diameter and appearance (quiescence 1-3, ovarian activity without ovulation 4-5, and ovulatory/postovulatory 6-7). RESULTS: We report here the findings of the initial 28-day treatment cycle in which 51 of 52 recruited participants provided data sufficient for analysis. Two thirds of subjects had no evidence of ovulation (34/51, 66.6%); eight of these (15.7%) had quiescent ovaries (follicle <13 mm diameter) and 26 (51%) had follicular development (follicle >13 mm diameter) without ovulation. Seventeen participants ovulated, of whom 12 (23.5%) had a normal, and 5 (9.8%) an abnormal luteal phase. Persistent ovarian follicles were common among women who had ovarian activity without ovulation, 17 of 26 participants (65.4%) had a large follicle which persisted beyond 28 days. CONCLUSION: During 28 days of exposure to a norgestrel 0.075 mg progestogen-only pill, most women had no evidence of ovulation. IMPLICATIONS: Ovulation inhibition and follicle growth disturbance are important in the mechanism of action of a progestogen-only pill containing norgestrel 0.075 mg.

Female permanent contraception trends and updates.

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

The progesterone-receptor modulator, ulipristal acetate, drastically lowers breast cell proliferation.

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

A multi-media digital intervention to improve the sexual and reproductive health of female adolescent emergency department patients.

BACKGROUND: Adolescent females presenting to emergency departments (EDs) inconsistently use contraceptives. We aimed to assess implementation outcomes and potential efficacy of a user-informed, theory-based digital health intervention developed to improve sexual and reproductive health for adolescent females in the ED. METHODS: We conducted a pilot-randomized controlled trial of sexually active female ED patients age 14-19 years. Participants were randomized to the intervention Dr. Erica (Emergency Room Interventions to improve the Care of Adolescents) or usual care. Dr. Erica consists of an ED-based digital intervention along with 3 months of personalized and interactive multimedia messaging. We assessed the feasibility, adoption, and fidelity of Dr. Erica among adolescent female users. Initiation of highly effective contraception was the primary efficacy outcome. RESULTS: We enrolled 146 patients; mean (±SD) age was 17.7 (±1.27) years and 87% were Hispanic. Dr. Erica demonstrated feasibility, with high rates of consent (84.4%) and follow-up (82.9%). Intervention participants found Dr. Erica acceptable, liking (98.0%, on Likert scale) and recommending (83.7%) the program. A total of 87.5% adopted the program, responding to at least one text; a total of 289 weblinks were clicked. Dr. Erica demonstrated fidelity; few participants opted out (6.9%) and failed to receive texts (1.4%). Contraception was initiated by 24.6% (14/57) in the intervention and 21.9% (14/64) in the control arms (absolute risk difference [ARD] = 2.7%, 95% confidence interval [CI] = -12.4% to 17.8%). Participants receiving Dr. Erica were more likely to choose a method to start in the future (65.9% [27/41]) than controls (30.0% [15/50]); ARD = 35.9%, 95% CI = 16.6% to 55.1%). CONCLUSIONS: A personalized, interactive digital intervention was feasible to implement, acceptable to female ED patients and demonstrated high fidelity and adoption. This ED-based intervention shows potential to improve contraception decision making.

Estetrol-drospirenone combination oral contraceptive: North American phase 3 efficacy and safety results.

OBJECTIVE: To assess efficacy, cycle control, and safety of an oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg. STUDY DESIGN: Women aged 16 to 50 years with a body mass index ≤35 kg/m2 enrolled in this multicenter, open-label, 13-cycle, phase 3 trial evaluating E4/DRSP in a 24-active/4-placebo regimen. Follow-up was scheduled at Cycles 2, 4, 7, and 10 and within 3 weeks of completing Cycle 13. Participants used daily diaries to record pill use and vaginal bleeding. We evaluated efficacy outcomes in women 16 to 35 years and bleeding patterns and safety (adverse events [AEs]) in all participants. We assessed overall and method-failure pregnancy rates using the Pearl index (PI) and life-table analysis. Scheduled bleeding included spotting or bleeding starting during the 4-day placebo period or first 3 days of the next cycle. RESULTS: We enrolled 1864 women of whom 1674 were 16 to 35 years. Women 16 to 35 years had a PI of 2.65 (95% CI 1.73-3.88), method-failure PI of 1.43 (95% CI 0.7-2.39) and 13-cycle life-table pregnancy rate of 2.1%. Scheduled bleeding occurred in 82.9% to 87.0% of women per cycle; median duration was 4.5 days. Unscheduled bleeding decreased from 30.3% in Cycle 1 to 21.3% to 22.1% during Cycles 2 to 4 and remained stable (15.5% to 19.2%) thereafter. The most frequently reported AEs were headache (5.0%) and metrorrhagia (4.6%). One-hundred thirty-two (7.1%) women discontinued the study early for an AE, most commonly for metrorrhagia (0.9%) and menorrhagia (0.8%). No thromboembolic events occurred. CONCLUSION: E4/DRSP is an effective oral contraceptive with a predictable bleeding pattern for most women and low AE rates. IMPLICATIONS STATEMENT: A new oral contraceptive with a novel estrogen, estetrol, combined with drospirenone has efficacy and safety within the range of other available oral contraceptives. Large phase 4 studies will be needed to confirm if this combination is associated with an improved adverse event profile or lower thrombosis risk.

Auricular acupressure and auricular acupuncture as an adjunct for pain management during first trimester aspiration abortion: A randomized, double-blinded, three-arm trial.

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