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To describe the clinical circumstances, surgical approach, intraoperative challenges, and outcomes of patients with two cervices undergoing uterine evacuation for spontaneous, incomplete, or induced abortion at our institution.We used diagnostic and procedure codes related to uterine anomalies and uterine evacuation to identify patients with cervical duplication who underwent uterine evacuation at Penn Medicine from January 2008 to December 2020.We identified 15 patients with cervical duplication in whom we performed uterine evacuations during 19 pregnancies. We describe in detail each patient's first pregnancy with uterine evacuation at our institution, of which providers performed 11 in the first trimester, and four in the second trimester. Ten patients had a known diagnosis of cervical duplication prior to pregnancy. Five patients did not have a diagnosis of cervical duplication prior to pregnancy and providers newly made this diagnosis intraoperatively either at our institution or referring clinics. Providers at outside institutions referred three patients to our institution for incomplete procedures. At our institution, one patient had a procedure notable for a major complication. Eight other cases were notable for surgical challenges including difficulty placing osmotic dilators, difficulty identifying the correct cervix for local anesthesia, and contralateral cervical and uterine horn instrumentation.This case series suggests surgical abortion in patients with two cervices is rare, but generally safe. The majority of patients did not have major complications, despite presenting a variety of unique procedural challenges. Surgical providers were sometimes the first to make the diagnosis of a second cervix.Uterine evacuation providers must be aware of the possibility of an undiagnosed cervical duplication, particularly when encountering surgical challenges in patients with congenital reproductive tract anomalies. Providers should consider procedures under ultrasound guidance regardless of gestational age for patients with any congenital reproductive tract anomaly or who had prior incomplete procedures.

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%.

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.

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.

Objectives This study describes the prevalence of medications for opioid use disorder (MOUD) among surgical abortion patients, evaluates long-acting reversible contraception (LARC) uptake after surgical abortion among patients on MOUD, and identifies predictors of immediate postabortion LARC uptake among individuals on MOUD. Methods We performed a secondary analysis of data from a retrospective observational cohort study of LARC uptake immediately after surgical abortion up to 210/7 weeks gestation at Planned Parenthood League of Massachusetts between October 2012 and April 2017. We estimated proportions and analyzed predictors of LARC uptake among women on MOUD using logistic regression analysis to control for possible confounders. Results During the study period, 26,858 patients had an abortion procedure; 768 (2.9%; 95% confidence interval, 2.7%–3.1%) used MOUD. In the primary study, controlling for demographic factors, MOUD was not an independent predictor of LARC uptake. In this analysis, patients on MOUD differed demographically from non-MOUD users and were significantly more likely to initiate a LARC method immediately after their procedure: 30.1% versus 25.3% (p = .002), including 22.7% who obtained an intrauterine device and 7.4% who obtained an implant. Among patients on MOUD, a prior live birth and public insurance predicted LARC uptake at the time of abortion. Conclusion Women on MOUD had higher postabortion LARC uptake compared with those not on MOUD in a setting with easy access to postabortion LARC. Public insurance coverage for abortion was associated with LARC uptake among women on MOUD.

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.

Objectives As women with cystic fibrosis (CF) live longer, healthier lives, they increasingly face decisions related to their reproductive health. This qualitative study explores their unique decision support needs and preferences to aid in the development of a CF-specific reproductive goals decision aid. Study design Women with CF age 18–44 years participated in individual, semi-structured, telephone-based interviews, and women with CF age 18 years and older participated in semi-structured focus group discussions (FGDs). Both explored experiences and attitudes surrounding parenthood, pregnancy, contraception, and preferences for reproductive health care provision. FGDs also explored the use, content, and format of a reproductive goals decision aid for women with CF. We transcribed interviews and FGDs and conducted content and thematic analyses using an inductive approach. Results Twenty women (age range 20–42 years) participated in interviews and 18 women (age range 26–63 years) participated in three FGDs. Major themes identified included: 1) CF complicates pregnancy and parenting decisions; 2) Women make contraceptive decisions within the context of their CF; 3) Women with CF prefer to receive reproductive health counseling from their CF team; 4) Women with CF desire defragmented, coordinated reproductive health care; and 5) A disease-specific reproductive goals decision aid would encourage relevant parenting, pregnancy, and contraceptive discussions. Conclusion Women with CF have unique reproductive health care needs and often face uncertainty and disjointed care when making reproductive health and contraceptive decisions. Implications This study underscores the central role of the CF team and illustrates opportunities to better support women with CF in their decisions surrounding sexual and reproductive health, including through a patient-centered, disease-specific, reproductive goals decision aid.

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 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.

Highlights • Women living with cystic fibrosis (CF) are increasingly pursuing pregnancy. • Gestational and pregestational diabetes are highly prevalent in women with CF. • Diabetes impacts fetal outcomes, and good glycemic control reduces risk of pregnancy complications. • Diabetes during pregnancy in women with CF requires intensive endocrine and nutrition care, ideally incorporated into the CF multidisciplinary team., As cystic fibrosis transmembrane regulator (CFTR) modulator therapies offer greater longevity and improved health quality, women living with cystic fibrosis (CF) are increasingly pursuing pregnancy. Maternal risks for pregnant women with CF largely depend on a woman’s baseline pulmonary and pancreatic function, and the majority of CF pregnancies will successfully end in live births. Diabetes, either gestational or pre-existing cystic fibrosis-related diabetes (CFRD), is highly prevalent in women with CF, affecting 18 to 62% of pregnancies in recent CF center reports. In addition to the rising incidence of CFRD with age, gestational diabetes is also more common in women with CF due to lower insulin secretion, higher insulin resistance, and increased hepatic glucose production as compared to pregnant women without CF. Diabetes occurring during pregnancy has important implications for maternal and fetal health. It is well established in women without CF that glycemic control is directly associated with risks of fetal malformation, neonatal-perinatal mortality, cesarean delivery and need for neonatal intensive care. Small studies in women with CF suggest that pregnancies affected by diabetes have an increased risk of preterm delivery, lower gestational age, and lower fetal birth weight compared to those without diabetes. Women with CF preparing for pregnancy should be counseled on the risks of diabetes and should undergo routine screening for CFRD with oral glucose tolerance testing (OGTT) if not already completed in the past six months. Glycemic control in those with pre-gestational CFRD should be optimized prior to conception. Insulin is preferred for the management of diabetes in pregnant women with CF via multiple daily injections or insulin pump therapy, and continuous glucose monitors (CGM) can be useful in mitigating hypoglycemia risks. Women with CF face many unique challenges impacting diabetes care during pregnancy and would benefit from support by a multidisciplinary care team, including nutrition and endocrinology, to ensure healthy pregnancies.

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.

Women with cystic fibrosis (CF) are living longer and healthier lives, and opportunities for childbearing are increasingly promising. However, this population can also face sexual and reproductive health concerns, including menstrual irregularities, unplanned pregnancies, infertility and pregnancy complications. Additionally, more women are entering menopause and are at risk for the consequences of estrogen deficiency. The exact mechanisms involved in female reproductive health conditions in CF are not clearly understood, but are thought to include cystic fibrosis transmembrane regulator (CFTR)-mediated abnormalities, changes in female sex hormones, and other CF health-related factors. In the era of CFTR modulator therapy, new data are necessary to understand the impact of CFTR modulation on contraceptive effectiveness, fertility, and pregnancy outcomes to help guide future clinical care. This article reviews the current scientific knowledge of major reproductive health issues for women with CF.

To estimate uptake of long-acting reversible contraception (LARC) methods immediately after surgical abortion in a system that makes these methods readily available, and to determine demographic, medical, social, and visit-specific predictors of immediate post-abortion intrauterine device (IUD) and implant initiation.We performed a retrospective cohort study of LARC (levonorgestrel intrauterine system [IUS], copper IUD, and subdermal implant) initiation at the time of surgical abortion up to 21w0d gestation at Planned Parenthood League of Massachusetts from 2012 through 2017. We calculated proportions of IUD and implant initiation and used mixed effect logistic regression to estimate predictors of each outcome.Among 26,858 surgical abortion patients, 25.4% received immediate post-abortion LARC: 14.2%, 4.2%, and 7.0% received a levonorgestrel IUS, copper IUD, and implant, respectively. Compared to White women, Black women had lower odds of initiating an IUD (aOR 0.81, 95% CI 0.74-0.89). Multiparous women had greater odds than nulliparous women of initiating an IUD (aOR 1.69, 95% CI 1.57-1.82) or implant (aOR 1.36, 95% 1.20-1.53). We found age was the strongest predictor of implant initiation (18 versus≥35: aOR 3.26, 95% CI 2.26-4.71), but was not associated with IUD uptake. Gestational age was not associated with IUD or implant uptake. Implant uptake increased from 2.4% (2012) to 8.7% (2017) (aOR 3.65, 95% CI 2.36-5.65) while IUD uptake remained fairly constant.About 25% of women chose to initiate intrauterine or implantable contraception immediately after surgical abortion when these methods are readily available. Implant uptake has increased significantly in recent years. Women who initiated IUDs and implants differed in their demographic and social profiles.Women seeking surgical abortion should have same-day access to IUDs and implants. Clinicians and researchers should analyze IUD and implant initiation separately.

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.

Cystic fibrosis (CF) was historically a disease largely afflicting children. Due to therapeutic advancements, there are now more adults with CF than children. In the past decade, medications including Cystic Fibrosis Transmembrane conductance Regulator (CFTR) modulators became available that treat the underlying cause of CF and are dramatically improving lung function as well as quality and quantity of life for people with CF. As a result, more women with CF are becoming pregnant. We gathered a panel of experts in CF care, family planning, high risk obstetrics, nutrition, genetics and women with CF to review current literature on pregnancies and to provide care recommendations for this unique population.

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.

Cystic fibrosis (CF) was historically a disease largely afflicting children. Due to therapeutic advancement, there are now more adults with CF than children. In the past decade, medications became available that treat the underlying cause of CF and are dramatically improving lung function as well as quality and quantity of life for people with CF. As a result, more women with CF are having babies. We gathered a panel of experts in CF care, family planning, high risk obstetrics, nutrition, genetics and women with CF to review current literature on pregnancies and to provide care recommendations for this unique population.

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.

Objective To describe the prevalence of female sexual dysfunction in a well-defined polycystic ovary syndrome (PCOS) population, and to assess the impact of common PCOS treatments on sexual function. Design Secondary analysis of a randomized controlled trial, oral contraceptive pills and weight loss in PCOS. Setting Two academic medical centers. Patients Women with PCOS (N = 114) defined by the Rotterdam criteria. Interventions Continuous oral contraceptive pill (OCP) or intensive lifestyle modification (Lifestyle) or the combination (Combined) for 16 weeks. Main Outcome Measures Change in Female Sexual Function Index (FSFI) and Female Sexual Distress Scale−Revised (FSDS-R) scores after 16 weeks. Results There was no change in total FSFI or FSDS-R score in any treatment group; however, an increase in the FSFI desire domain subscore was observed in the Lifestyle and Combined treatments, indicating improved sexual desire over the 16-week period. Overall, 33 participants (28.9%) met criteria for sexual dysfunction by FSFI criteria (baseline score ≤26.55). Among this group, FSFI score improved after 16 weeks of Lifestyle and Combined treatments. There was no change in prevalence of sexual dysfunction in treatment groups at 16 weeks. Use of OCPs did not alter FSFI scores. Conclusion(s) Female sexual dysfunction is highly prevalent among women with PCOS. Our findings suggest that common treatments for PCOS, including intensive lifestyle modification and the combination of intensive lifestyle modification and OCPs, have the potential to improve sexual function in these women; the mechanism for these improvements is likely multifactorial. Clinical Trial Registration Number NCT00704912.

BACKGROUND: For persons of childbearing potential prescribed isotretinoin, the iPLEDGE program requires use of two simultaneous methods of contraception or commitment to abstinence. OBJECTIVE: To model the relative effectiveness of a variety of contraception strategies for patients taking isotretinoin including those that are acceptable according to iPLEDGE. METHODS: We performed a decision analysis modeling the estimated rate of pregnancy with various contraception strategies during a typical six-month course of isotretinoin. RESULTS: Tier 1 contraception options (e.g. subdermal hormonal implant, intrauterine devices) each had effectiveness of greater than 99.5% alone. When combined with a secondary form of contraception, Tier 2 contraception options (e.g. depot medroxyprogesterone injections, combined oral contraceptives) each had effectiveness greater than 99%. LIMITATIONS: Sensitivity analyses were conducted to evaluate the impact of uncertain parameters on the results. CONCLUSION: There may be opportunities to simplify iPLEDGE by recognizing the high effectiveness of Tier 1 contraception options and increasing use of secondary forms of contraception among those using Tier 2 contraception options as their primary form of contraception. Future studies are needed to understand the most effective strategies in clinical practice to prevent unintended pregnancy for patients taking isotretinoin to improve outcomes and provide patient-centered care.

Objective To systematically review the literature to determine if extended use of intrauterine devices including the copper or levonorgestrel intrauterine device beyond approved durations is effective and safe for preventing pregnancy. Data sources We searched PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and Global Index Medicus from inception through June 2019. Study eligibility criteria We considered primary studies of women using the T380A Copper or currently available levonorgestrel intrauterine devices past their approved duration (extended use). The primary outcome was pregnancy. Safety outcomes included adverse events and side effects that led to discontinuation. Study appraisal and synthesis methods We abstracted study data into evidence tables and assessed study quality as related to the risk of bias, precision, and external validity. For each intrauterine device type, we calculated a pooled pregnancy rate during the first two years of extended use using the Poisson inverse variance method. Results Of 4,068 studies identified by our search, four good to poor quality studies of the 52 mg levonorgestrel intrauterine device (approved for five years) with a total of 2098 women starting extended use, and two good to fair quality studies of the T380A copper intrauterine device (approved for 10 years) with 245 women starting extended use met inclusion criteria. For the levonorgestrel intrauterine device, the pooled pregnancy rate was 0.02 per 100 person-years (95% confidence interval 0.00-0.45) in year six, 0.03 per 100 person-years (95% confidence interval 0.00-0.71) in year 7, and 0.02 per 100 person-years (95% confidence interval 0.00-0.29) in years six and seven combined. During this same time, annual rates of adverse events or discontinuation due to side effects ranged from 0-3.7 per 100 participants. For the copper intrauterine device, the pooled pregnancy rate for years 11 and 12 was 0.0 per 100 person-years (95% confidence interval 0.0-0.8), and annual rates of adverse events and discontinuation due to side effects during extended use ranged from 0-4.6 per 100 participants. Conclusion The available evidence suggests that rates of pregnancy, adverse events, and discontinuation due to side effects during the first two years of extended use of the 52 mg levonorgestrel intrauterine device and the T380A copper intrauterine device are low and comparable to rates during approved duration of use. Data were limited in quantity and quality, and may not be generalizable to all intrauterine device users.

All women of reproductive age with psychiatric and neurologic disease should be screened for contraceptive need, and offered counseling on options compatible with their medications and medical conditions. While non-hormonal methods are appropriate for all patients, hormonal contraception may interact with some medications used by women in treatment of epilepsy, multiple sclerosis and mood disorders. Women at risk for or with a history of stroke should avoid estrogen-containing options; similarly, women who report migraine with aura are also discouraged from use of any estrogen-based contraception due to the potential increase in risk of stroke. Fortunately, the highly effective reversible contraceptive options that include intrauterine devices (IUDs) and the progestin-only implant are appropriate for almost all these women. This chapter provides evidence and guidance for selection of appropriate, safe contraceptive options in women with migraine disease, epilepsy, stroke, multiple sclerosis and psychiatric disease.

These recommendations present an evidence-based assessment of provision of contraceptives at the time of surgical abortion. Most methods of contraception, including the intrauterine devices (IUD), implant, depot medroxyprogesterone injection, oral contraceptive pill, contraceptive patch, monthly vaginal ring, barrier methods and some permanent methods, can be safely initiated immediately after first- or second-trimester surgical abortion. Provision of postabortion contraceptives, particularly IUDs and implants, substantially reduces subsequent unintended pregnancy. IUD insertion immediately following uterine aspiration is safe. While this may be associated with a higher risk of device expulsion than with interval placement, expulsion rates remain low, and this risk must be weighed against the fact that patients often do not receive their desired IUD at an interval insertion and therefore experience higher rates of subsequent unintended pregnancy. Many patients experience barriers that prevent access to the full spectrum of postabortion contraceptive options, particularly IUDs and implants. Advancements in health-systems-based point-of-care provision and policies are needed to improve comprehensive contraceptive availability following surgical abortion. These recommendations will address clinical considerations for postabortion contraceptive provision and recommend interventions to improve contraceptive access following uterine evacuation.

BackgroundWith advance notice about the availability and effectiveness of contraceptive methods, abortion patients have more time and information for decision-making. We assessed the impact of an informational telephone call prior to the surgical abortion visit on patient contraceptive knowledge.MethodsThis was a pilot randomised controlled trial. Prior to their abortion visit, participants were randomised to the intervention message, a standardised notification about the availability, effectiveness and safety of long-acting (LARC) and short-acting reversible contraception (SARC) on the day of the abortion, or to the control message, a reiteration of appointment logistics without information about contraception. At the visit, participants completed a pre-procedure survey to assess contraceptive knowledge and usefulness of the intervention. The primary outcome was knowledge of LARC availability immediately after surgical abortion. A secondary outcome was contraceptive method uptake.ResultsWe enrolled 234 subjects. The pre-visit telephone notification improved knowledge that LARC is available immediately after surgical abortion (71.3% vs 50.9%, PConclusionsAdvance notice about contraception was acceptable to surgical abortion patients and improved their contraceptive knowledge.Trial registration numberNCT02836561.

To prevent subsequent unintended pregnancy, contraception should be initiated soon after surgical and medical abortion. Evidence regarding the safety of postabortion contraception, especially for longacting reversible methods, has accumulated in recent years.This review seeks to provide up-to-date recommendations about the provision and timing of contraception after surgical and medical abortion.Recommendations are based on the US Medical Eligibility Criteria (MEC) or on the authors' review of the current literature for topics that the MEC does not address.Contraceptive counseling at the time of abortion should be collaborative. All reversible contraceptive methods are safe to begin immediately after surgical abortion, barring concern for surgical complications or underlying medical contraindications. After medical abortion, the implant may be initiated immediately, combined hormonal contraception may be initiated shortly thereafter, and the intrauterine device may be placed once the abortion is complete. Further research is needed to determine the optimal timing of depot medroxyprogesterone acetate initiation after medical abortion.Abortion is an important opportunity for contraceptive counseling and provision. Clinic policies and insurance coverage should maximize access to all contraceptive methods, including long-acting reversible methods.

To use the Androgen Excess-PCOS Society (AE-PCOS) criteria in adolescents to diagnose polycystic ovary syndrome (PCOS) and identify the prevalence of metabolic risk factors.Retrospective chart review of adolescents (2 years postmenarche) presenting at a specialty clinic from 2008 through 2010 with complete evaluation for PCOS and metabolic risk were reviewed. Metabolic risk in adolescents with PCOS was compared with those with ≤ 1 AE-PCOS criteria.Of the 205 adolescents evaluated, 66% were found to have PCOS based on the AE-PCOS criteria. The most common presenting symptom was menstrual irregularity, followed by acne, hirsutism, and weight gain. Adolescents with PCOS had a significantly higher prevalence of obesity, hypertension, and low level of high-density lipoprotein cholesterol. Subjects with PCOS had ≥ 1 metabolic risk factor compared with the subjects without PCOS (63.6% vs 33.3%, P = .002). More adolescents with PCOS had ≥ 2 abnormal metabolic risk factors excluding body mass index compared with those without PCOS (P.02). The prevalence of metabolic syndrome (≥ 3 risk factors) was 10.8% in adolescents with PCOS compared with 1.7% in those without PCOS (P.04).Adolescents diagnosed with PCOS based on the AE-PCOS criteria are at a significantly increased risk of ≥ 1 metabolic abnormality. Our data underscore the need to accurately diagnose PCOS in the adolescent population instead of delaying the diagnosis to adulthood. Further, using similar criteria for the diagnosis of PCOS in adolescents (2 years postmenarche) and adults will be more convenient for the clinician.

The objective of this study was to determine the clinical pregnancy rate with 2 inseminations compared to a single intrauterine insemination (IUI) in a given cycle using frozen-thawed donor sperm. This was a retrospective study at a university practice; patients were women using donor sperm. We conducted a comparison of single IUI, intracervical insemination (ICI) followed by an IUI on the next day, and double IUI (2 consecutive days); clinical pregnancy rate was the main outcome measure. The cycle-specific and total pregnancy rates were not significantly different between the 3 protocol groups (306 cycles). The average pregnancy rate over 3 cycles was 10.2% for IUI, 15.3% for ICI/IUI, and 13.7% for IUI/IUI (P = .47). After controlling for repeated measures per subject and age, gravidity, and use of Clomid, there was no significant difference between protocols. The ICI/IUI (odds ratio [OR] = 1.70; 95% confidence interval [CI], 0.83-3.51) and IUI/IUI (OR = 1.5; 95% CI, 0.52-4.33) protocols appeared more likely to result in a clinical pregnancy than the single IUI protocol. Current information on the optimal number of inseminations per cycle using donor sperm is limited. Our large study using 3 protocols found an increase in pregnancy rate with the addition of either an ICI or IUI to a single IUI protocol in a natural or Clomid cycle but did not meet statistical significance. Additional prospective studies are needed to better counsel patients using donor sperm.

Genetic studies of schizophrenia focus increasingly on putative endophenotypes because their genetic etiology may be simpler than clinical diagnosis. The Consortium on the Genetics of Schizophrenia (COGS), a multisite family study, aims to identify the genetic basis of several endophenotypes including verbal declarative memory (VDM), a neurocognitive function that shows robust impairment in schizophrenia. We present data on one type of measure of VDM, the California Verbal Learning Test, Second Edition (CVLT-II), in schizophrenia probands (n=305), their full biological siblings (n=449) and parents (n=232), and in community comparison subjects (CCS; n=509) across seven sites. Probands performed more poorly on each of five CVLT-II measures compared to related sibling and parent groups and CCS. Siblings and parents performed significantly worse than CCS on one measure (Discriminability), but with smaller effect sizes and less impairment than observed previously. The results raise questions about the homogeneity of VDM as an endophenotype, about methodological issues related to sampling, and about psychometric issues that impact the utility of the CVLT for detecting VDM deficits in nonpsychotic relatives of persons with schizophrenia.

INTRODUCTION: As the median age of survival of women with cystic fibrosis rises reproductive health has become increasingly important in this population. We sought to characterize contraceptive preferences and use among adult females with cystic fibrosis (CF). METHODS: We used questions from previously validated surveys to build an instrument that assessed reproductive health and contraceptive variables. Female participants ages 17-45 years were recruited through the electronic mailing list of the Penn Adult CF Program. RESULTS: Fifty-three of 100 adult female patients with CF have responded to date. Eighty-three percent are sexually active and 31% have been pregnant. Twenty-two percent of reported pregnancies resulted in abortion secondary to either unplanned pregnancy or suboptimal health status. Forty-nine percent of participants use contraception. Condoms (35%) and oral contraceptive pills (27%) are most commonly used. Respondents prioritize effectiveness and ease of use in their contraceptive method; they want to avoid side effects medication interactions and diminished sexual enjoyment. CONCLUSION: Our CF population is sexually active but contraceptive use is low and unplanned and mistimed pregnancies are common. Uptake of contraceptive methods that fit these womens preferences is low. There is significant unmet need for contraception in this population.

Women with polycystic ovary syndrome (PCOS) have a high prevalence of cardiovascular disease (CVD) risk factors including dyslipidemia. Lipoproteins are heterogeneous, and measurement of serum lipids provides only the size of the pool and does not predict their function or composition. Recently, high-density lipoprotein cholesterol (HDL-C) function, as determined by cholesterol efflux capacity from macrophages, has been shown to be an independent predictor of subclinical CVD.The aim of the study was to comprehensively evaluate lipoprotein profile including lipid particle size and number and cholesterol efflux capacity in PCOS to better define CVD risk.A case control study was performed at an academic PCOS center.Women with PCOS (n = 124) and geographically matched controls (n = 67) were included in the study.The primary outcome was to measure HDL-C efflux capacity by an ex vivo system involving the incubation of macrophages with apolipoprotein (Apo) B-depleted serum from subjects, and the secondary outcome was to measure lipid particle size and number using nuclear magnetic resonance spectroscopy.Women with PCOS had significantly higher body mass index and blood pressure but similar HDL-C and low-density lipoprotein cholesterol levels compared to controls. The mean ApoA1 levels were lower, and the ApoB/ApoA1 ratio was higher in PCOS subjects compared to controls (P.01). There were no differences in ApoB levels. Women with PCOS had an 7% decrease in normalized cholesterol efflux capacity compared to controls (P.003). Cholesterol efflux capacity in PCOS correlated with body mass index, ApoA1, HDL-C, and the presence of metabolic syndrome. In a multivariable regression model, PCOS was significantly associated with diminished cholesterol efflux. PCOS was also associated with an atherogenic profile including an increase in large very low-density lipoprotein particles, very low-density lipoprotein (VLDL) size, and small low-density lipoprotein cholesterol particles (P.01).Our novel findings of decreased cholesterol efflux and an atherogenic lipid particle number and size pattern in women with PCOS, independent of obesity, further substantiate the increased risk of CVD in this population.