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BACKGROUND: Family planning and abortion clinics routinely address sexual health. We sought to evaluate implementation outcomes of an HIV pre-exposure prophylaxis (PrEP) care strategy for patients seeking management of induced abortion and pregnancy loss. SETTING: Single-center, urban, academic, hospital-based family planning service METHODS: We employed a multifaceted implementation strategy directed towards family planning providers comprised of educational sessions, an electronic medical record-prompted verbal assessment of HIV risk, electronic medical record (EMR) shortcuts for PrEP prescription, and support of a PrEP navigator. We assessed penetration of the intervention by calculating the penetration of a PrEP offer, measured as the proportion of encounters in which PrEP was offered to PrEP-eligible individuals. We evaluated feasibility, acceptability, and appropriateness of the intervention using belief elicitation interviews with providers. RESULTS: From November 2018 to April 2019, the proportion of PrEP eligible patients that were offered PrEP, was 87.9% (29/33). Providers found the intervention acceptable and appropriate, but reported barriers including time constraints, and disappointment if patients did not adhere to PrEP. Providers liked that PrEP provision in abortion care settings felt innovative, and that they could contribute to HIV prevention. CONCLUSION: Family planning providers in an academic center found HIV risk assessment and PrEP provision to be feasible, acceptable, and appropriate. Further research should evaluate implementation outcomes of PrEP care strategies in additional abortion care contexts, including clinics offering reproductive health care outside of academia.

To assess whether obesity is associated with increased time to pregnancy in a cohort of participants who were stopping their contraceptive method to attempt pregnancy.We performed a secondary analysis of the FACT (Fertility After Contraceptive Termination) study. This prospective analysis included 432 participants, aged 18-35 years, who discontinued contraception to become pregnant, were sexually active with a male partner, and provided pregnancy status data within the first 12 months in the study. The primary outcome, time to pregnancy, was measured beginning with discontinuation of contraception to estimated pregnancy date. We used Cox proportional hazard models to assess associations of normal (lower than 25.0), overweight (25.0-29.9), and obese (30 or higher) body mass index (BMI) and time to pregnancy while controlling for potential confounding factors.After adjusting for confounders, participants with BMIs 30 or higher were noted to have prolonged time to pregnancy compared with those with BMIs lower than 25 (adjusted hazard ratio [aHR] 0.62; 95% CI 0.44-0.89). The median time to pregnancy for participants with normal BMIs was 5.3 months (95% CI 3.8-6.4) compared with 8.2 months (95% CI 6.8-10.8) for participants with obesity. Pregnancy rates at 1 year were 76.4% (95% CI 69.7-82.6%), 69.5% (95% CI 60.5-78.1%), and 59.1% (95% CI 51.0-67.4%) for participants with BMIs lower than 25, 25-29.9, and 30 or higher, respectively. Menstrual irregularity was also associated with decreased fertility (aHR 0.67; 95% CI 0.46-0.97).Compared with participants with normal BMIs, we observed increased time to pregnancy for participants with obesity stopping contraception with the intention to become pregnant. Understanding the reasons for this association will be helpful to inform patients and guide clinical practice.The FACT Study was funded, in part, by Bayer, CooperSurgical, and the Society of Family Planning.

To estimate the rate of requiring more than one 300-mcg Rh D immune globulin dose for fetomaternal hemorrhage (FMH) at the time of second-trimester dilation and evacuation (D + E).We performed a retrospective cohort analysis of patients at greater than 20 weeks' gestation who underwent D + E, had Rh D-negative blood type, and received FMH quantification testing.Of 25 eligible patients, 24 had negative quantification of FMH; one had positive quantification that did not meet the clinical threshold for additional dosing.The absolute risk of requiring additional Rh D immune globulin after D+E for pregnancies greater than 20 weeks' gestation was 0%.

Early pregnancy loss can be treated medically with mifepristone followed by misoprostol, with ultrasonographic confirmation of pregnancy expulsion. Alternative strategies that ascertain treatment success remotely are needed. We compared percent decline in human chorionic gonadotropin (hCG) level with treatment success or failure between patients who received mifepristone pretreatment followed by misoprostol or misoprostol alone for early pregnancy loss between 5 and 12 weeks of gestation to determine a threshold decline that might predict success. Early pregnancy loss treatment success was associated with a greater percent hCG level decline compared with treatment failure, but no threshold was able to predict success. Additional research is needed to understand hCG trends after medical management of early pregnancy loss to develop reliable protocols for remote follow-up.

ObjectivesTo compare participant-reported bleeding and pain with two medication regimens for early pregnancy loss (EPL).Study designWe performed a secondary analysis of a randomized trial in which participants took either mifepristone 200 mg orally followed by misoprostol 800 mcg vaginally 24 hours later or misoprostol alone for medical management of EPL. Participants reported bleeding and pain (Numeric Pain Rating Scale, NPRS, 0-10) with daily paper diaries and at study visits on trial days 3, 8, and 30. We used, Fisher's exact, Pearson chi-square, Wilcoxon rank sum, and Student's t-tests to compare onset, duration, and severity of bleeding and pain symptoms between trial arms after misoprostol administration.ResultsAmong 291 participants who submitted diary data, 143 received mifepristone pretreatment. A larger proportion of this group reported moderate or heavy bleeding on trial day 2, the day of misoprostol administration, compared with those who did not receive pretreatment (73% vs 47%, p < 0.01). Between days 4 and 8, more mifepristone-pretreatment participants reported mild or no bleeding, compared with the misoprostol-only arm (78% vs 61%, p < 0.01). Average pain score for trial days 2-4 was higher for the pretreatment group compared with the misoprostol-only group (6.9 vs 6.0, p=0.01), and there was a trend toward shorter total duration of pain (15 vs 19 hours, p=0.08). These differences remained after controlling for treatment success across arms.ConclusionsMifepristone pretreatment increased the severity of pain but not bleeding and resulted in a shorter trajectory of symptoms during medical management of EPL.ImplicationsMifepristone pretreatment decreases the duration of heavy bleeding and there was a trend toward decreased duration of pain during medical management of miscarriage, indicating that this medication improves the efficiency, in addition to the efficacy, of this treatment.

BackgroundExtending hormonal intrauterine system duration will allow users to have less need for procedures to provide long-term contraception.ObjectiveThis study aimed to evaluate the efficacy and safety of the levonorgestrel 52 mg intrauterine system during years 7 and 8 of use.Study designA total of 1751 nulliparous and multiparous participants aged 16 to 45 years enrolled in a phase 3, multicenter trial to evaluate the efficacy and safety of the use of the Liletta levonorgestrel 52 mg intrauterine system for up to 10 years. Participants aged 36 to 45 years at enrollment underwent safety evaluation only. After the first year, we evaluated participants every 6 months for intrauterine system location confirmation and urine pregnancy testing at each visit. We assessed the Pearl Indices in years 7 and 8 and the life-table analysis for cumulative pregnancy rates through 8 years of use. For the primary efficacy analyses, all participants aged 16 to 35 years at enrollment were included through year 6; years 7 and 8 included only users aged ≤39 years at the start of each use year. Safety outcomes were assessed in all participants regardless of duration of use. We assessed amenorrhea rates, defined as no bleeding or spotting in the 90 days before the end of the year.ResultsAfter intrauterine system placement, we followed 1568 participants aged 16 to 35 years and 146 participants aged 36 to 45 years. The 16- to 35-year-old participants included 986 (57.5%) nulliparous and 433 (25.3%) obese users. Overall, 569 participants started year 7, 478 completed year 7 (380 aged ≤39 years at beginning of year) and 343 completed year 8 (257 aged ≤39 years at beginning of year); 77 completed 10 years of use. Eleven pregnancies occurred over 8 years, 7 (64%) of which were ectopic. Two pregnancies occurred in year 7 (Pearl Index, 0.49; 95% confidence interval, 0.06-1.78), 1 in a participant with implantation 4 days after a desired removal; no pregnancies occurred in year 8. The cumulative life-table pregnancy rate in the primary efficacy population through year 8 was 1.32 (95% confidence interval, 0.69-2.51); without the postremoval pregnancy, the rate was 1.09 (95% confidence interval, 0.56-2.13). Two perforations (0.1%) occurred, none noted after year 1. Expulsion occurred in 71 (4.1%) participants overall, with 3 in year 7 and 2 in year 8. Pelvic infection was diagnosed in 16 (0.9%) participants during intrauterine system use, 1 each in years 7 and 8. Only 44 (2.6%) participants overall discontinued because of bleeding complaints (4 total in years 7 and 8) with rates per year of 0.1% to 0.5% for years 3 to 8. Amenorrhea rates were 39% at both years 7 and8.ConclusionThe levonorgestrel 52 mg intrauterine system is highly effective over 8 years of use and has an excellent extended safety profile. This report details the longest period of efficacy and safety data for continuous use of a levonorgestrel 52 mg intrauterine system for contraception.

OBJECTIVE: To assess the feasibility, functionality and acceptability of a mobile application (app), the World Health Organization (WHO) Postpartum Family Planning (PPFP) Compendium, in clinical care. METHOD: This prospective qualitative study was conducted among family planning providers routinely delivering PPFP care in Accra, Ghana. We conducted in-depth interviews at baseline and 3 months after app introduction. We elicited expected technological, psychological and environmental barriers to use, actual use in clinical settings, and feedback for app improvement. With inter-coder reliability, we analyzed the content of interview transcripts. RESULTS: Twenty providers participated in baseline interviews, and 19 participated in follow-up interviews. At baseline, providers did not have significant technological barriers to its use and felt the app was acceptable, but were concerned about the appropriateness of using an app during clinical care. At 3-month follow-up, 18 out of 19 participants reported using the app weekly, and found the app acceptable for use in clinical care. Providers recommended expanding clinical content and including similar guidance relevant to times outside the postpartum period. CONCLUSIONS: Use of a PPFP counseling app to aid family planning providers in clinical care delivery is feasible and acceptable. Providers recommended inclusion of similar guidance relevant to times outside the postpartum period.

Venous thromboembolism (VTE) affects up to 25% of individuals with sickle cell disease (SCD), but risk factors are not well characterized. We sought to measure the prevalence of VTE among SCD patients in our health system and to describe the relationship between medical history, biological sex, and VTE. We performed a retrospective chart review of SCD patients who visited an outpatient hematology clinic within Penn Medicine between June 2014 and June 2019. Demographics and medical history were compared across those with and without a history of VTE. We developed a logistic regression model to describe factors independently associated with VTE. Of 597 patients with SCD who were identified, 147 (24.6%) had a history of VTE; 100 were female and 47 were male. In the regression model, female sex was independently associated with history of VTE (odds ratio 1.91, 95% confidence interval 1.26-2.91), as were pulmonary hypertension, hydroxyurea use, and history of stroke. Among females only, 49.7% were parous and 18.8% had used oral contraceptives, and these proportions did not differ by history of VTE. One-quarter of the SCD patients in our health system had a history of VTE, confirming significantly higher rates than in the general population. Females had twice the odds of VTE compared to males, highlighting an important sex disparity in SCD disease outcomes and raising questions regarding optimal pregnancy and contraceptive care for females with SCD.

To compare the overnight maximum pain scores after osmotic dilator placement prior to a dilation and evacuation (DE) procedure in participants assigned to a prescription for ibuprofen alone or to ibuprofen plus oxycodone.We conducted a nonblinded pragmatic, randomized controlled trial to evaluate pain management among women undergoing osmotic dilator placement prior to DE. We randomly assigned 70 participants at 12 weeks 6 days to 23 weeks 6 days gestation to receive a prescription for ibuprofen alone, or ibuprofen plus oxycodone. We assessed pain using a numeric rating scale (NRS; scale 0-10) at the following time points: Baseline, dilator placement, 2 and 6 hours, and preoperatively, where we also asked participants their maximum pain score. The primary outcome was mean individual NRS pain score change from baseline to maximum pain score.Maximum mean pain score (change from baseline) was 4.7 ± 2.9 in the ibuprofen group, and 6.5 ± 2.5 in the ibuprofen plus oxycodone group (p0.01). Participants in both groups reported highest NRS pain scores 2 hours after dilator placement, 3.9 ± 2.5 and 5.3 ± 2.6 respectively (p = 0.02). Average ibuprofen use in both arms was similar, and 81% of participants used at least 1 dose of ibuprofen after dilator placement. Of those randomized to prescription to ibuprofen plus oxycodone, only 51% used a dose of oxycodone.Compared to participants randomized to receive a prescription for ibuprofen, those randomized to receive a prescription for ibuprofen plus oxycodone reported higher maximum overnight pain scores.Participants receiving a prescription for ibuprofen alone had lower maximum overnight pain scores following osmotic dilator placement. Given that opioid prescriptions did not appear to reduce overnight pain, minimizing these prescriptions would avoid opioid exposure for patients undergoing DE.

Objective: To create and assess a clinic model to address the unmet need for effective contraception among women living with HIV in Botswana, where half of all pregnancies are unintended and 30% of women of reproductive age are living with HIV. Methods: We introduced family planning services into an HIV clinic in Gaborone, Botswana. Our intervention gave HIV providers brief training on contraceptive counseling plus the option of immediate referral of interested patients to an on-site contraception provider. We administered a survey to patients and providers before and after intervention. Patients were female, aged 18–45 years and using antiretrovirals. Results: At baseline, 6% of 141 patients discussed contraception with their HIV-care provider, compared with 61% of 107 post intervention (P < 0.001). At baseline, 6% of patients reported wanting to use long-acting reversible contraception (LARC). Post intervention, 45% of patients chose to meet with the contraception provider, and 29% wanted to use LARC (P < 0.001 versus baseline). All providers strongly agreed that they were better informed about contraception post intervention and were satisfied with their ability to counsel and refer women for contraception. Conclusions: Provision of on-site contraceptive services in this HIV clinic encouraged family planning discussions and increased interest in LARC. K E YWORDS Botswana, contraception, family planning, HIV, service integration

The risk for major depression is common 30 days after treatment for early pregnancy loss, especially among Black women., OBJECTIVE: To explore the relationship between race and depression symptoms among participants in an early pregnancy loss clinical trial. METHODS: We performed a planned secondary analysis of a randomized trial by comparing treatments for medical management of early pregnancy loss. We hypothesized that Black participants would have higher odds of risk for major depression (measured with the CES-D [Center for Epidemiological Studies-Depression] scale) 30 days after early pregnancy loss treatment when compared with non-Black participants. We analyzed the data as a cohort, with the primary exposure being race and secondary exposure being high adverse childhood experience scores (measured with the Adverse Childhood Experience scale). Our primary outcome was risk for major depression (score of 21 or higher on the CES-D scale) 30 days after early pregnancy loss treatment. RESULTS: Three hundred participants diagnosed with a nonviable intrauterine pregnancy from 5 to 12 weeks of gestation were randomized as part of the original trial from May 2014 to April 2017. Of 275 respondents included in this analysis, 120 [44%] self-identified as Black and 155 [56%] self-identified as non-Black. After early pregnancy loss treatment, 65 [24%] participants were at risk for major depression. Black participants had an increased risk for major depression (57%) after early pregnancy loss treatment compared with non-Black participants (43%; odds ratio [OR] 2.02; 95% CI 1.15–3.55). After adjustment for risk for baseline depression, adverse childhood experience score, and parity, the odds of risk for major depression 30 days after pregnancy loss treatment remained higher for Black participants when compared with non-Black participants (OR 2.02; 95% CI 1.15–3.55; adjusted OR 2.48; 95% CI 1.28–4.81). CONCLUSION: Overall, approximately one quarter of women who experience an early pregnancy loss are at an increased risk for major depression 30 days after treatment. This risk is about twice as high for Black women compared with non-Black women. There is a need for appropriate mental health resources for women undergoing early pregnancy loss care. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02012491.

Objective To determine college health centers’ referral patterns for students seeking induced abortion. Study design We conducted a cross-sectional simulated patient study at 4-year colleges in Pennsylvania between June 2017 and May 2018. A researcher posing as a student seeking abortion referral contacted student health centers twice during the course of the study using a structured script, once as a minor (under 18 years), and once as an adult. The primary outcome was “direct referral”, defined as a referral to an abortion provider. We measured proportions of student health centers who provided no referral, “indirect referral” (referral to a non-specific provider), and “inappropriate referral” (referral to a non-abortion provider). We analyzed the relationship between the proportion of direct referrals and minor status of the caller as well as college characteristics (religious affiliation, location, student body mean income, and size). We included variables found to be significant as covariates in a generalized linear model that accounted for the cluster of multiple calls to each institution. Results We attempted contact with 115 institutions, once as a minor and once as an adult, resulting in 202 successful contacts. Direct referral was the most common outcome (49.5%), followed by inappropriate referral (33.7%) and no referral (21.8%). The proportion of direct referrals given to minors was similar when compared to adults (48.0% vs 52.0%, OR 0.82, 95% CI 0.47–1.42). Religiously affiliated institutions were less likely to provide a direct referral than non-religiously affiliated schools (aOR 0.47, 95% CI 0.30–0.75). With each increase in students’ household income tertile, health centers were more likely to provide a direct referral (aOR 1.22, 95% CI 1.05–1.42). Conclusions Half of college student health centers in Pennsylvania do not provide direct abortion referrals, and many provide inappropriate referrals. Student health centers at religiously affiliated institutions and those with poorer students are less likely to provide direct abortion referrals. Implications Student health providers should inform themselves about fake health clinics and local abortion providers. Colleges should train staff, create accurate resources and define clear policies around referral. Professional and policymaking organizations should affirm the duty of all college health centers, regardless of religious affiliation, to provide abortion referrals.

Objectives To calculate the minimum fetal red blood cell concentration required to cause maternal Rh sensitization; validate the use of a flow cytometry protocol below that concentration; preliminarily assess the concentrations of fetal red blood cells in pregnant women before and after uterine aspiration. Study design Using pre-existing literature, we calculated the lowest concentration of fetal red blood cells found to cause sensitization within adult female circulation. We validated a two-color flow cytometry protocol using fluorescently labeled antibodies to Hemoglobin F (expressed by fetal red blood cells and adult F cells) and Carbonic Anhydrase (expressed in red blood cells during the third trimester and postnatally) by titrating second trimester cord blood into non-pregnant adult blood. We applied this flow cytometry protocol in a prospective cohort study of 42 pregnant women at 5–12 weeks gestational age undergoing uterine aspiration for induced or spontaneous abortion. Results The calculated threshold for causing Rh sensitization was 250 fetal red blood cells per 10 million total red blood cells. We showed a linear relationship between observed and expected fetal red blood cell fractions in titrated samples. Fetal red blood cell counts were more reliable when samples acquired by flow cytometry contained at least 1 million red blood cells. All 37 subjects with evaluable paired samples demonstrated fetal red blood cell concentrations below the calculated threshold for Rh sensitization both pre- and post-procedure. The fetal RBC concentrations increased from a mean of 4.5 (median 0, range 0–57) fetal RBCS pre- to a mean of 8.6 (median 2, range 0–32) fetal RBCs post- per 10 million total RBCs (p Conclusions Flow cytometry was capable of separately quantifying fetal red blood cells and maternal F cells to very dilute concentrations. Fetal red blood cell exposure in the first trimester was well below the calculated threshold for maternal Rh sensitization in our cohort. Larger studies are warranted to confirm our pilot study findings, fill this evidence gap and inform universal guidelines for administering Rh immunoglobulin after first trimester uterine aspiration. Implications Fetal red blood cell exposure following first trimester uterine aspiration is well below the calculated threshold for maternal Rh sensitization in our cohort.

Objective To identify factors associated with contraceptive uptake among participants in a miscarriage management clinical trial. Study design We performed a secondary analysis of a multi-center, randomized controlled trial of medical management regimens for miscarriage between 5 and 12 completed weeks. Pregnancy intention was measured by patient report after miscarriage diagnosis. Participants were offered contraception in accordance with standard clinical care once their miscarriage was completed. We analyzed participants as a cohort and fit a multivariable model to describe demographic characteristics and pregnancy intentions independently associated with contraceptive uptake. Results Of 244 participants with available contraceptive outcomes, 121 (50%) stated that this pregnancy was planned, and 218 (90%) stated that they had planned to continue the pregnancy to term. Ninety-seven participants (40%) initiated contraception: 33 (14%) selected a long-acting reversible method, 44 (18%) a short-acting reversible method, and 20 (8%) condoms or emergency contraception, while 147 (60%) declined contraception after miscarriage completion. In the multivariable model, unplanned pregnancy (aRR 2.13, 95% CI: 1.45–3.13) and lack of intention to continue the pregnancy (aRR 1.61, 95% CI: 1.18–2.20) were independently associated with contraceptive uptake. Of participants who declined contraception, 85 (57%) did so in order to conceive again. Nearly one-quarter of participants who declined contraception described the index pregnancy as unplanned, but after miscarriage planned to conceive a new pregnancy. Conclusion Patients with unplanned pregnancy who miscarried were twice as likely to initiate contraception as those with planned pregnancy, however pregnancy intentions sometimes changed after miscarriage. Implications Miscarriage management represents an important opportunity to clarify pregnancy goals and provide contraceptive counseling. Although unplanned pregnancy correlates with contraceptive uptake, we do not recommend using this clinically to predict contraceptive need. Future research should examine how best to measure pregnancy intention and its relationship to the experience of miscarriage.

To provide an update on advances in medical management of early pregnancy loss, including the addition of mifepristone pretreatment to existing regimens. The utilization of misoprostol for medical management of early pregnancy loss has been studied extensively and is established as a safe and effective treatment. Two recent randomized controlled trials have demonstrated that the addition of mifepristone pretreatment significantly increases the effectiveness of misoprostol and a large body of data demonstrate the excellent safety profile of mifepristone. However, the Food and Drug Administration Risk Evaluation and Mitigation Strategy restrictions impose a major barrier to mifepristone use. The addition of mifepristone to existing misoprostol regimens has significantly improved the effectiveness and patient-centered benefits of medical management of early pregnancy loss. Mifepristone restrictions need to be removed in order to decrease the barriers to women obtaining evidence-based care.

Continuing to 36 months, the phase 2 study of a low-dose copper intrauterine device with a nitinol frame showed high efficacy and safety., OBJECTIVE: To assess in parous and nulliparous women, the efficacy, safety, and tolerability of a new, low-dose copper (175 mm2) intrauterine contraceptive with a flexible nitinol frame provided in a preloaded applicator. METHODS: Institutional review boards at 12 U.S. sites approved this commercially funded project. Patients met standard inclusion and exclusion criteria for a copper-based intrauterine device (IUD), generally consistent with the Centers for Disease Control and Prevention's U.S. Medical Eligibility Criteria for Contraceptive Use, 2016. Intrauterine device placement occurred at any day in the eligible patient's menstrual cycle after assuring she was not pregnant. The primary outcome measure assessed efficacy (measured by the Pearl Index) in this 1-year study with a 2-year extension. Secondary outcomes included placement success, ease of placement, safety as measured by adverse events, and tolerability assessed by discontinuation rate and bleeding and spotting patterns. RESULTS: A total of 286 women provided 5,640 cycles evaluable for pregnancy. Patients averaged 27.1 years of age. Nulliparous women represented 60.8% of the patients. Over 36 months of observation, we identified two pregnancies (Pearl Index 0.46 [95% CI 0.06–1.67]) and 10 serious adverse events; none were study-related. Successful placement occurred in 283 participants (99.0%). Median (range) continuation times were 2.7 years (0–3.4). We identified five expulsions (1.8%), zero uterine perforations, and one report of pelvic inflammatory disease. Adverse events prompted 30 women (10.6%) to discontinue early in the first year of use with 23 (8.1%) discontinuing for issues of bleeding, pain, or both. Altogether, 107 (37.8%) completed 36 months of device use. Mean bleeding days per cycle decreased from 7.6 in cycle 1 to 5.2 in cycle 13. CONCLUSION: The novel, low-dose copper and nitinol IUD demonstrated high efficacy and safety in this phase 2 U.S. Food and Drug Administration trial and warrants further expanded study in a phase 3 clinical trial. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02446821. FUNDING SOURCE: Sebela Pharmaceuticals, Inc.

This Viewpoint discusses potential consequences that the US Supreme Court ruling in Dobbs v Jackson Women’s Health Organization may have for patient outcomes, public health, training and legal challenges for health care professionals, and the patient-practitioner relationship.

Early pregnancy loss, also referred to as miscarriage, is common, affecting approximately 1 million people in the United States annually. Early pregnancy loss can be treated with expectant management, medications, or surgical procedures-strategies that differ in patient experience, effectiveness, and cost. One of the medications used for early pregnancy loss treatment, mifepristone, is uniquely regulated by the Food and Drug Administration.This study aimed to compare the cost-effectiveness from the healthcare sector perspective of medical management of early pregnancy loss, using the standard of care medication regimen of mifepristone and misoprostol, with that of office uterine aspiration.We developed a decision analytical model to compare the cost-effectiveness of early pregnancy loss treatment with medical management with that of office uterine aspiration. Data on medical management came from the Pregnancy Failure Regimens randomized clinical trial, and data on uterine aspiration came from the published literature. The analysis was from the healthcare sector perspective with a 30-day time horizon. Costs were in 2018 US dollars. Effectiveness was measured in quality-adjust life-years gained and the rate of complete gestational sac expulsion with no additional interventions. Our primary outcome was the incremental cost per quality-adjust life-year gained. Sensitivity analysis was performed to identify the key uncertainties.Mean per-person costs were higher for uterine aspiration than for medical management ($828 [95% confidence interval, $789-$868] vs $661 [95% confidence interval, $556-$766]; P=.004). Uterine aspiration more frequently led to complete gestational sac expulsion than medical management (97.3% vs 83.8%; P=.0001); however, estimated quality-adjust life-years were higher for medical management than for uterine aspiration (0.082 [95% confidence interval, 0.8148-0.08248] vs 0.079 [95% confidence interval, 0.0789-0.0791]; P.0001). Medical management dominated uterine aspiration, with lower costs and higher confidence interval. The probability that medical management is cost-effective relative to uterine aspiration is 97.5% for all willingness-to-pay values of ≥$5600/quality-adjust life-year. Sensitivity analysis did not identify any thresholds that would substantially change outcomes.Although office-based uterine aspiration more often results in treatment completion without further intervention, medical management with mifepristone pretreatment costs less and yields similar quality-adjust life-years, making it an attractive alternative. Our findings provided evidence that increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care.

BACKGROUND: Family planning clinical encounters are important opportunities for HIV prevention. Our objectives were 1) to estimate the proportion of patients seeking induced abortion and early pregnancy loss management eligible for HIV pre-exposure prophylaxis (PrEP), and 2) to compare PrEP eligibility and uptake between patients with unintended and intended pregnancy. METHODS: We conducted a cross-sectional survey and a nested prospective cohort study of patients seeking induced abortion and early pregnancy loss management. We assessed pregnancy intendedness, PrEP awareness, HIV risk and risk perception, desire for same-day PrEP start, and PrEP continuation at 30 days. We used chi-square and Fisher’s exact tests to assess differences between the participants with intended and unintended pregnancy. We had 80% power to detect a 14% difference in PrEP eligibility between the groups. RESULTS: We enrolled 250 women. Fifty-six percent (139) had an unintended pregnancy and 44% (110) had an intended pregnancy. PrEP eligibility did not differ significantly between the patients with intended and unintended pregnancy (16% vs 10%, p=0.18). More than half (54%, 135/250) were unaware of PrEP prior to their study visit, and 93%, 232/250 considered themselves unlikely to acquire HIV. Of 33 women who were PrEP-eligible, 11 accepted same-day start, and 1 continued PrEP at 30 days. CONCLUSIONS: Intendedness of pregnancy was unrelated to PrEP eligibility in women seeking induced abortion and early pregnancy loss management. Most patients seeking these services are unaware of PrEP. Integrating PrEP into family planning care is likely to increase awareness and uptake of PrEP in women.

To assess the prevalence of Critical or Emergent patient classification among pregnant patients presenting to the Emergency Department (ED) and to identify characteristics that discriminate between patients requiring Emergency care from those who can be safely triaged to the ambulatory setting.In this cross-sectional study conducted in 3 urban EDs, patients under 16 weeks gestation who presented with bleeding and/or cramping completed a 7-item questionnaire. We compared baseline clinical variables and survey responses among patients classified as Critical or Emergent per the American Board of Emergency Medicine's patient acuity definitions with those classified as Lower Acuity to identify independent risk factors for outcomes.Of 484 participants, 21 (4.3%) were classified as Critical or Emergent and required interventions. While no demographic characteristics differentiated Critical patients from Lower Acuity patients, survey questions associated with a higher likelihood of emergency intervention included history of prior ectopic pregnancy (OR 8.7, 95% CI 3.2-23.5) heavy bleeding in the past two hours (OR 11.8, 95% CI 3.8-36.1), as well as having made a prior ED visit in the current pregnancy (OR 1.9, 95% CI 0.7-5.1). Joint consideration of these risk factors in a multivariable model performed well at discriminating between Critical and Lower Acuity patients with an area under the ROC curve of 0.82 (95% CI 0.71-0.93).Patients with a history of ectopic pregnancy, heavy bleeding in the past two hours, and/or prior presentation to the ED in the current pregnancy had the highest risk of needing emergency-level care. The vast majority of patients presenting to the ED with early pregnancy complaints were discharged without intervention.

Clinically stable miscarriage patients presenting to the emergency department have baseline socioeconomic disadvantages and are less satisfied than those presenting to ambulatory clinics., OBJECTIVE: To quantitatively and qualitatively describe the patient experience for clinically stable patients presenting with miscarriage to the emergency department (ED) or ambulatory clinics. METHODS: We present a subanalysis of a mixed-methods study from 2016 on factors that influence miscarriage treatment decision-making among clinically stable patients. Fifty-four patients were evaluated based on location of miscarriage care (ED or ambulatory-only), and novel parameters were assessed including timeline (days) from presentation to miscarriage resolution, number of health system interactions, and number of specialty-based provider care teams seen. We explored themes around patient satisfaction through in-depth narrative interviews. RESULTS: Median time to miscarriage resolution was 11 days (range 5–57) (ED) and 8 days (range 0–47) (ambulatory-only). We recorded a mean of 4.4±1.4 (ED) and 3.0±1.2 (ambulatory-only) separate care teams and a median of 13 (range 8–20) (ED) and 19 (range 8–22) (ambulatory-only) health system interactions. Patients seeking care in the ED were younger (28.3 vs 34.0, odds ratio [OR] 5.8, 95% CI 1.8–18.7), more likely to be of black race (28.3 vs 34.0, OR 3.3, 95% CI 1.1–10.0), uninsured or insured through Medicaid (16 vs 6, OR 6.8, 95% CI 2.1–22.5), and more likely to meet criteria for posttraumatic stress disorder when compared with ambulatory-only patients (10 vs 3, OR 6.0, 95% CI 1.5–23.4). Patients valued diagnostic clarity, timeliness, and individualized care. We found that ED patients reported a lack of clarity surrounding their diagnosis, inefficient care, and a mixed experience with health care provider sensitivity. In contrast, ambulatory-only patients described a streamlined and sensitive care experience. CONCLUSION: Patients seeking miscarriage care in the ED were more likely to be socioeconomically and psychosocially vulnerable and were less satisfied with their care compared with those seen in the ambulatory setting alone. Expedited evaluation of early pregnancy problems, with attention to clear communication and emotional sensitivity, may optimize the patient experience.

Objective Our objective was to explore knowledge, attitudes and beliefs about pregnancy and contraceptive decision-making among reproductive-aged women with cystic fibrosis. Study design In this qualitative study, we used purposive sampling of reproductive age women enrolled in the Adult Cystic Fibrosis program at Penn Medicine. We conducted semistructured one-on-one interviews lasting 30–60 min. Interviews were audio-recorded and transcribed verbatim. Data were analyzed using thematic analysis. Results We interviewed 24 women. Participants described shortened life span, personal health status and impact of cystic fibrosis on a potential child as three factors that were central to family planning. Future pregnancy intentions, perception of fertility including misconceptions and provider counseling influenced related contraception utilization. Conclusions Women with cystic fibrosis described thoughtful considerations about desired pregnancies to be planned during times of optimal health. Gaps in knowledge may limit a woman’s ability to make the most informed family planning decisions. Implications Having cystic fibrosis directly affects women’s decisions around pregnancy and family planning. Understanding what motivates women with cystic fibrosis to use or not to use contraception can improve family planning care delivery to this population.

Early pregnancy loss is the most common complication in pregnancy. Management options for miscarriage include expectant management, medical intervention, or surgical aspiration. Non-surgical and surgical management are all safe and acceptable options for medically uncomplicated patients. Patient and provider preferences contribute profoundly to clinical decisions about miscarriage management. Shared-decision making and evidence based counseling have been shown to significantly improve patient satisfaction with early pregnancy loss care. This review article will discuss the epidemiology and risk factors of early pregnancy loss, current evidence and clinical practice guidelines around management options, and provider and patient preferences for early pregnancy loss management.

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

Increasing subcutaneous depot medroxyprogesterone acetate availability and prescribing has the potential to improve contraceptive access, expand patient autonomy, and decrease racial health disparities., Since the beginning of the coronavirus disease 2019 (COVID-19) pandemic, health care professionals have made swift accommodations to provide consistent and safe care, including emphasizing remote access to allow physical distancing. Depot medroxyprogesterone acetate intramuscular injection (DMPA-IM) prescription is typically administered by a health care professional, whereas DMPA-subcutaneous has the potential to be safely self-injected by patients, avoiding contact with a health care professional. However, DMPA-subcutaneous is rarely prescribed despite its U.S. Food and Drug Administration approval in 2004 and widespread coverage by both state Medicaid providers and many private insurers. Depot medroxyprogesterone acetate users are disproportionately non-White, and thus the restriction in DMPA-subcutaneous prescribing may both stem from and contribute to systemic racial health disparities. We review evidence on acceptability, safety, and continuation rates of DMPA-subcutaneous, consider sources of implicit bias that may impede prescription of this contraceptive method, and provide recommendations for implementing DMPA-subcutaneous prescribing.

Introduction Females with sickle cell disease now have a life expectancy that extends well into and beyond their reproductive years. Pregnancy and childbirth are accompanied by high morbidity and mortality in this population, rendering contraception a critical part of their health care. Methods We approached adult female patients of the Hospital of the University of Pennsylvania hematology clinic who were of reproductive age (ages 18–45) and carried a diagnosis of sickle cell disease. We evaluated contraceptive method uptake and method characteristic preferences, as well as other reproductive history, and compared contraceptive uptake rates to that from female respondent data from the National Survey of Family Growth (2017–2019). Results Of 95 eligible patients, we completed surveys with 48 participants (response rate of 51%). Over half (n = 27, 56%) of participants were not currently using any form of contraception—double the rate of the general United States population (25%). The most common contraceptives currently used were the depot medroxyprogesterone (DMPA) injection (n = 6, 13%) and the progestin intrauterine device (IUD) (n = 6, 13%). DMPA uptake was significantly higher, and permanent contraceptive and oral contraceptive pill uptake significantly lower, among these participants with sickle cell disease compared to the general United States population. Participants’ preferred contraceptive characteristics included effectiveness (n = 39, 81%), control over when to use the contraceptive (n = 39, 81%), and lack of side effects (n = 38, 79%). Conclusions Contraceptive uptake was significantly lower and method mix different among females with sickle cell disease compared to the general United States population. Further research is needed on contraceptive safety, non-contraceptive benefits, and contraceptive decision-making for females with sickle cell disease. Implications This study sheds light on the contraceptive choices and preferences of females with sickle cell disease, who are at disproportionate risk for pregnancy complications. In order to maximize the reproductive health of females with sickle cell disease, we must consider how their disease interacts with contraception and better understand how they approach contraceptive decision-making.

Germanium quantum dots are very interesting for applications such as solar cells, photodetectors, and light emitters because their small bandgap can be tuned over a wide energy range by changing the particle size. One obstacle to applications is the presence of defects, both in the interior and at the surface of the nanoparticles. The defects function as nonradiative recombination centers or trap charge carriers, which will hinder further optical performance. Introducing hydrogen, as employed in a-Si:H solar cells, has proven to be a good method to counter such detrimental defect effects. In this work, germanium quantum dots were fabricated by an ultraclean, vacuum-based nanoparticle reactor in which hydrogen was supplied during growth. Optical spectroscopy of the a-Ge:H quantum dots, together with Raman and X-ray photoelectron spectroscopy, revealed a direct bandgap and that the presence of hydrogen resulted in amorphous Ge:H quantum dots. These a-Ge:H quantum dots are a step forward toward reducing charge carrier recombination in quantum dot solar cells.

Patient-centered care is one of the six aims for improvement in health care quality outlined by the National Academy of Medicine (previously known as the Institute of Medicine). We propose an algorithm for patients who are presenting with a pregnancy of unknown location that emphasizes pregnancy desiredness to improve patient-centered care. Health care professionals should assess pregnancy desiredness at a patient's initial consultation for evaluation of pregnancy of unknown location; desiredness, along with other clinical criteria, should guide management. For women with an undesired pregnancy, health care professionals should offer expedient active management. Uterine aspiration will allow for quick clinical diagnosis and resolution of the pregnancy. Alternatively, for women with a desired pregnancy or for those who are ambivalent, we recommend careful conservative management. Adopting this algorithm will recenter the patient in the complex management of pregnancy of unknown location.

To document the terminology patients hear during the treatment course for a nonviable pregnancy and to ask patients their perceived clarity and preference of terminology to identify a patient-centered lexicon.We performed a preplanned substudy survey of English-speaking participants in New York, Pennsylvania, and California at the time of enrollment in a randomized multisite trial of medical management of first-trimester early pregnancy loss. The six-item survey, administered on paper or an electronic tablet, was developed and piloted for internal and external validity. We used a visual analog scale and quantified tests of associations between participant characteristics and survey responses using risk ratios.We approached 155 English-speaking participants in the parent study, of whom 145 (93.5%) participated. In the process of receiving their diagnosis from a clinician, participants reported hearing the terms "miscarriage" (n=109 [75.2%]) and "early pregnancy loss" (n=73 [50.3%]) more than "early pregnancy failure" (n=31 [21.3%]) and "spontaneous abortion" (n=21 [14.4%]). The majority selected "miscarriage" (n=79 [54.5%]) followed by "early pregnancy loss" (n=49 [33.8%]) as their preferred term. In multivariable models controlling for study site, ethnicity, race, history of induced abortion, and whether the current pregnancy was planned, women indicated that "spontaneous abortion" and "early pregnancy failure" were significantly less clear than "early pregnancy loss" (53/145, adjusted risk ratio 0.12, 95% CI 0.07-0.19 and 92/145, adjusted risk ratio 0.38, 95% CI 0.24-0.61, respectively, as compared with 118/145 for "early pregnancy loss"). "Miscarriage" scored similarly to "early pregnancy loss" in clarity (119/145, adjusted risk ratio 1.05, 95% CI 0.62-1.77).The terminology used to communicate "nonviable pregnancy in the first trimester" is highly variable. In this cohort of women, most preferred the term "miscarriage" and classified both "miscarriage" and "early pregnancy loss" as clear labels for a nonviable pregnancy. Health care providers can use these terms to enhance patient-clinician communication.ClinicalTrials.gov, NCT02012491.

BackgroundEarly pregnancy loss is a common event in the first trimester, occurring in 15%-20% of confirmed pregnancies. A common evidence-based medical regimen for early pregnancy loss uses misoprostol, a prostaglandin E1 analog, with a dosage of 800 μg, self-administered vaginally. The clinical utility of this regimen is limited by suboptimal effectiveness in patients with a closed cervical os, with 29% of patients experiencing early pregnancy loss requiring a second dose after 3 days and 16% of patients eventually requiring a uterine aspiration procedure.ObjectiveThis study aimed to evaluate clinical predictors associated with treatment success in patients receiving medical management with mifepristone-misoprostol or misoprostol alone for early pregnancy loss.Study designWe performed a planned secondary analysis of a randomized trial comparing mifepristone-misoprostol with misoprostol alone for management of early pregnancy loss. The published prediction model for treatment success of single-dose misoprostol administered vaginally included the following variables: active bleeding, type of early pregnancy loss (anembryonic pregnancy or embryonic and/or fetal demise), parity, gestational age, and treatment site; previous significant predictors were vaginal bleeding within the past 24 hours and parity of 0 or 1 vs >1. To determine if these characteristics predicted differential proportions of patients with treatment success or failure, we performed bivariate analyses; given the small proportion of treatment failures in the combined treatment arm, both arms were combined for analysis. Thereafter, we performed a logistic regression analysis to assess the effect of these predictors collectively in each of the 2 treatment groups separately as well as in the full cohort as a proxy for the combined treatment arm. Finally, by using receiver operating characteristic curves, we tested the ability of these predictors in association with misoprostol treatment success to discriminate between treatment success and treatment failure. To quantify the ability of the score to discriminate between treatment success and treatment failure in each treatment arm as well as in the entire cohort, we calculated the area under the curve. Using multivariable logistic regression, we then assessed our study population for other predictors of treatment success in both treatment groups, with and without mifepristone pretreatment.ResultsOverall, 297 evaluable participants were included in the primary study, with 148 in the mifepristone-misoprostol combined treatment group and 149 in the misoprostol-alone treatment group. Among patients who had vaginal bleeding at the time of treatment, 15 of 17 (88%) in the mifepristone-misoprostol combined treatment group and 12 of 17 (71%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. Among patients with a parity of 0 or 1, 94 of 108 (87%) in the mifepristone-misoprostol treatment group and 66 of 95 (69%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. These clinical characteristics did not predict treatment success in the combined cohort alone (area under the curve=0.56; 95% confidence interval, 0.48-0.64). No other baseline clinical factors predicted treatment success in the misoprostol-alone treatment arm or mifepristone pretreatment arm. In the full cohort, the significant predictors of treatment success were pretreatment with mifepristone (adjusted odds ratio=2.51; 95% confidence interval, 1.43-4.43) and smoking (adjusted odds ratio=2.15; 95% confidence interval, 1.03-4.49).ConclusionNo baseline clinical factors predicted treatment success in women receiving medical management with misoprostol for early pregnancy loss. Adding mifepristone to the medical management regimen of early pregnancy loss improved treatment success; thus, mifepristone treatment should be considered for management of early pregnancy loss regardless of baseline clinical factors.

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

IMPORTANCE: Early pregnancy loss (EPL) is the most common complication of pregnancy. A multicenter randomized clinical trial compared 2 strategies for medical management and found that mifepristone pretreatment is 25% more effective than the standard of care, misoprostol alone. The cost of mifepristone may be a barrier to implementation of the regimen. OBJECTIVE: To assess the cost-effectiveness of medical management of EPL with mifepristone pretreatment plus misoprostol vs misoprostol alone in the United States. DESIGN, SETTING, AND PARTICIPANTS: This preplanned. prospective economic evaluation was performed concurrently with a randomized clinical trial in 3 US sites from May 1, 2014, through April 30, 2017. Participants included 300 women with anembryonic gestation or embryonic or fetal demise. Cost-effectiveness was computed from the health care sector and societal perspectives, with a 30-day time horizon. Data were analyzed from July 1, 2018, to July 3, 2019. INTERVENTIONS: Mifepristone pretreatment plus misoprostol administration vs misoprostol alone. MAIN OUTCOMES AND MEASURES: Costs in 2018 US dollars, effectiveness in quality-adjusted life-years (QALYs), and treatment efficacy. Incremental cost-effectiveness ratios (ICERs) of mifepristone and misoprostol vs misoprostol alone were calculated, and cost-effectiveness acceptability curves were generated. RESULTS: Among the 300 women included in the randomized clinical trial (mean [SD] age, 30.4 [6.2] years), mean costs were similar for groups receiving mifepristone pretreatment and misoprostol alone from the health care sector perspective ($696.75 [95% CI, $591.88-$801.62] vs $690.88 [95% CI, $562.38-$819.38]; P = .94) and the societal perspective ($3846.30 [95% CI, $2783.01-$4909.58] vs $4845.62 [95% CI, $3186.84-$6504.41]; P = .32). The mifepristone pretreatment group had higher QALYs (0.0820 [95% CI, 0.0815–0.0825] vs 0.0806 [95% CI, 0.0800–0.0812]; P = .001) and a higher completion rate after first treatment (83.8% vs 67.1%; P < .001) than the group receiving misoprostol alone. From the health care sector perspective, mifepristone pretreatment was cost-effective relative to misoprostol alone with an ICER of $4225.43 (95% CI, −$195 053.30 to $367 625.10) per QALY gained. From the societal perspective, mifepristone pretreatment dominated misoprostol alone (95% CI, −$5 111 629 to $1 801 384). The probabilities that mifepristone pretreatment was cost-effective compared with misoprostol alone at a willingnessto-pay of $150 000 per QALY gained from the health care sector and societal perspectives were approximately 90% and 80%, respectively. CONCLUSIONS AND RELEVANCE: This study found that medical management of EPL with mifepristone pretreatment was cost-effective when compared with misoprostol alone. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02012491

OBJECTIVE To compare, using decision analysis methodology, the 1-year probability of pregnancy after intended postplacental intrauterine device (IUD) insertion with intended delayed insertion at an outpatient postpartum visit (delayed postpartum placement). METHODS We developed an evidence-based decision model with the primary outcome of 1-year probability of pregnancy. We compared 1-year probability of pregnancy after intended postplacental or intended delayed postpartum IUD placement. We obtained estimates from the literature for the proportions of the following: mode of delivery, successful IUD placement, IUD type, postpartum visit attendance, IUD expulsion, IUD discontinuation, and contraceptive use, choice, and efficacy after IUD discontinuation. We performed sensitivity analyses and a Monte Carlo simulation to account for variations in proportion estimates. RESULTS One-year probabilities of pregnancy among a theoretical cohort of 2,500,000 women intending to receive a postplacental IUD after vaginal birth and 1,250,000 women intending to receive a postplacental IUD after cesarean birth were 17.3% and 11.2%, respectively; the 1-year probability of pregnancy among a theoretical cohort of 2,500,000 women intending to receive a delayed postpartum IUD was 24.6%. For delayed postpartum IUD placement to have effectiveness equal to postplacental placement, 91.4% of women delivering vaginally and 99.7% of women delivering by cesarean would need to attend postpartum care. Once placed, the effectiveness of postplacental IUDs was lower than that of delayed postpartum IUDs: 1-year probabilities of pregnancy after IUD placement at a vaginal birth, cesarean birth, and an outpatient postpartum visit were 15.4%, 6.6%, and 3.9%, respectively. CONCLUSION After accounting for factors that affect successful IUD placement and retention, this decision model indicates that intended postplacental IUD insertion results in a lower 1-year probability of pregnancy as compared with intended delayed postpartum IUD insertion.

To evaluate satisfaction with intrauterine device (IUD) insertion procedures among adolescent and young adult women.This secondary analysis of data from a multisite, single-blind, sham-controlled randomized trial of women having a levonorgestrel 13.5-mg IUD inserted enrolled participants from March 2015 through July 2016 at three family planning clinics in Philadelphia, Pennsylvania. Eligible participants were 14-22 years of age, nulliparous, not pregnant, and English-speaking. Randomization was computer-generated allocation in block sizes of four to a 1% lidocaine paracervical or sham block. Only patients were blinded. Satisfaction was measured with three items that assessed overall satisfaction with the procedure, whether participants would recommend the IUD to a friend, and the perception that the IUD was worth the discomfort. Predictors included demographics, sexual and reproductive history, pain after IUD insertion, and treatment group.Ninety-five women enrolled; 93 (97.9%) were included in the analysis. Forty-five (47.4%) were white, 34 (36.0%) were black, 62 (66.0%) were privately insured, and 75 (79.0%) had used contraception previously. Most (n=73 [76.8%]) reported high overall satisfaction with the procedure, 64 (67.4%) would recommend an IUD to a friend, and 79 (83.2%) perceived the IUD was worth the discomfort. The odds of reporting high overall satisfaction were lower among adolescents compared with young adults (odds ratio [OR] 0.07, 95% CI 0.008-0.68); those who never had a gynecologic examination compared with those who had (OR 0.26, 95% CI 0.07-0.99); and decreased as pain score increased (OR 0.96, 95% CI 0.94-0.99). Higher pain scores were negatively correlated with the odds of recommending an IUD to a friend and perceiving the IUD was worth the discomfort.Adolescent and young adult women report high levels of satisfaction after the IUD insertion procedure. Young age, lack of experience with gynecologic examinations, and high pain were inversely related to satisfaction.ClinicalTrials.gov, NCT02352714.

We sought to evaluate the 6-week clinical outcomes (intrauterine device [IUD] retention, recognized expulsions, ability to visualize or palpate strings, and need for ultrasound evaluation) in women who received a TCu380A postplacental IUD (PPIUD) after vaginal (VD) or cesarean delivery (CD).We conducted a retrospective cohort study to examine the 6-week retention of TCu380A IUDs placed within 10 min of placental delivery in VD (n=137) and CD (n=73). We used Student's t test and Wilcoxon rank sum tests for continuous data and Pearson χOf the 169 women who had follow-up, 151 (89.3%) retained their IUD at 6 weeks (95% CI 84.7%-93.9%). All women who underwent CD retained their IUD at 6 weeks postpartum (56/56), whereas 95/113 (84% [95% CI 76.0%-90.3%]) who underwent VD retained their original IUD (p.01). Strings were detected more frequently in women who had a VD (93.1% [95% CI 85.6-97.4]) compared to those who delivered by CD (44.2% [95% CI 30.5-58.7]; p.01). Women who underwent CD had an ultrasound to evaluate IUD location more frequently (42.9% [95% CI 29.7-56.8]) compared to women who underwent VD (13.7% [95% CI 7.5-22.3]; p.01).Women are more likely to retain a PPIUD after CD compared to a VD (p.01); however, women who have a PPIUD placed after CD are more likely to have nonvisible strings with a pelvic exam (p.01) and undergo pelvic ultrasound evaluation (p.01) compared to a PPIUD placed at the time of a VD.

To estimate the effect of a 1% lidocaine paracervical nerve block on pain during intrauterine device (IUD) insertion compared with a sham block in adolescents and young women.We conducted a multisite, single-blind, sham-controlled randomized trial in adolescents and young women having a 13.5-mg levonorgestrel IUD inserted. Enrollment occurred at three family planning clinics in Philadelphia, Pennsylvania. Eligible adolescents and young women were aged 14-22 years, nulliparous, not currently or recently pregnant, and English-speaking. Participants were randomized using computer-generated allocation in block sizes of four to receive a 10-mL 1% lidocaine paracervical block or a sham block (1 cm depression of the vaginal epithelium at paracervical block sites with a wooden cotton-tipped applicator). Only patients were blinded. The primary outcome was pain after IUD insertion measured with a 100-mm visual analog scale. Using a two-sided t test and assuming a 20-mm difference in visual analog scale scores, a SD of 28 mm, an α of 0.05, and 90% power, a sample of 43 participants per group was estimated.Between March 2015 and July 2016, 95 participants enrolled (47 lidocaine block group; 48 sham block group). All were included in the analysis. Forty-four percent were white, 36% black, 65% privately insured, and 79% previously used contraception. The median visual analog scale score after IUD insertion was 30.0 (95% CI 20.0-58.0) in the lidocaine block group and 71.5 (95% CI 66.0-82.0) in the sham block (P.001).A 10-mL 1% lidocaine paracervical nerve block reduces pain during IUD insertion in adolescents and young women compared with a sham block with pressure on the vaginal epithelium.ClinicalTrials.gov, NCT02352714.