Depot medroxyprogesterone acetate concentrations in patients with and without the use of antiseizure medications.

OBJECTIVES: To measure plasma concentrations of medroxyprogesterone acetate (MPA) in users with epilepsy treated with antiseizure medications and compare these to MPA concentrations in those without epilepsy. STUDY DESIGN: For this multisite cross-sectional study, we obtained a single blood sample from those with epilepsy treated with various antiseizure medications (n = 18) within the week before their next depot medroxyprogesterone injection. Among the participants without epilepsy (n = 20), 10 similarly were scheduled within the week prior to the next injection, and 10 were scheduled at earlier intervals to attempt to balance the time intervals between groups. MPA concentrations were determined by a validated assay. RESULTS: MPA concentrations were similar among those with epilepsy and controls and between groups with and without the use of enzyme-inducing medications. The lowest MPA concentrations, under 0.07 ng/mL, were observed among two of eight using enzyme-inducing antiseizure medications, one of 10 using noninducing medications, and one of 19 controls had concentrations below 0.2 ng/mL. CONCLUSIONS: In this exploratory study, lower MPA concentrations in some participants using enzyme-inducing antiseizure medications suggest a potential interaction that could reduce depot medroxyprogesterone efficacy.

Society of Family Planning Clinical Recommendation: Management of hemorrhage at the time of abortion.

Hemorrhage after abortion is rare, occurring in fewer than 1% of abortions, but associated morbidity may be significant. Although medication abortion is associated with more bleeding than procedural abortion, overall bleeding for the two methods is minimal and not clinically different. Hemorrhage can be caused by atony, coagulopathy, and abnormal placentation, as well as by such procedure complications as perforation, cervical laceration, and retained tissue. Evidence for practices around postabortion hemorrhage is extremely limited. The Society of Family Planning recommends preoperative identification of individuals at high risk of hemorrhage as well as development of an organized approach to treatment. Specifically, individuals with a uterine scar and complete placenta previa seeking abortion at gestations after the first trimester should be evaluated for placenta accreta spectrum. For those at high risk of hemorrhage, referral to a higher-acuity center should be considered. We propose an algorithm for treating postabortion hemorrhage as follows: (1) assessment and examination, (2) uterine massage and medical therapy, (3) resuscitative measures with laboratory evaluation and possible reaspiration or balloon tamponade, and (4) interventions such as embolization and surgery. Evidence supports the use of oxytocin as prophylaxis for bleeding with dilation and evacuation; methylergonovine prophylaxis, however, is associated with more bleeding at the time of dilation and evacuation. Future research is needed on tranexamic acid as prophylaxis and treatment and misoprostol as prophylaxis. Structural inequities contribute to bleeding risk. Acknowledging how our policies hinder or remedy health inequities is essential when developing new guidelines and approaches to clinical services.

Self-managed Medication Abortion in the United States.

Self-managed abortion (SMA) is ending a pregnancy without medical supervision, either by obtaining medications (known as self-managed medication abortion) or through other means. Many factors influence a person's decision to pursue self-managed abortion, such as time constraints, financial considerations, and local availability of abortion services. We present on the prevalence, methods and best practices for clinicians in the United States who may interface with individuals undergoing self-managed medication abortion at any point in the process through a harm reduction approach.

Avoiding unintended pregnancy during transition from copper intrauterine device to etonogestrel contraceptive implant: A case report.

We present a patient who experienced an unintended pregnancy after transitioning from the copper intrauterine device to the etonogestrel subdermal implant. When switching from contraceptive methods that do not reliably suppress ovulation, clinicians should consider backup contraception and additional counseling, depending on the specific timing of removal.

Breaking the Binary: How Clinicians Can Ensure Everyone Receives High Quality Reproductive Health Services.

The gender binary has historically defined the study and practice of reproductive and sexual healthcare. However, the male and female binary categorization of sex does not adequately define patients seeking reproductive and sexual health. Comprehensive sexual healthcare should consider diverse gender identity and non-heteronormative sexual practices, family planning, sexually transmitted infections, cancer prevention, and sexual function. Recent research suggests clinicians do not feel prepared to provide care for sexual and gender minority (SGM) patients. In this narrative review, we focus on reproductive and sexual health within the scope of obstetric and gynecologic (OB/GYN) clinical practice. We used traditional medical subject headings to summarize data from publications in peer-reviewed journals published in the last 10 years and identified barriers, facilitators and best practices for de-gendering reproductive healthcare. Following a roughly chronological care path across the lifespan, we categorized findings into the following topics: Early Care for SGM, Sexual Health, Family Planning, and Care Later in Life for SGM. We include recommendations for creating a welcoming environment, SGM inclusive training for clinicians and staff, and best practices for individualized counseling. We review suggested practices related to service delivery and clinical considerations in the provision of sexual and reproductive health care for gender and sexual minority patients.

Abortion Care in the United States - Current Evidence and Future Directions.

Abortion Care in the United StatesAbortion services are a vital component of reproductive health care. Jung and colleagues review medication abortion and procedural abortion as well as implications of increasing restrictions on access in the United States.

Funic potassium chloride injection during intact dilation and evacuation.

OBJECTIVE: To describe effectiveness of funic potassium chloride (KCl) injection for fetal demise during intact dilation and evacuation (D&E). STUDY DESIGN: We abstracted medical records of patients who underwent standard or intact D&E to identify those who had intact D&E from 20 weeks 0 days through 23 weeks 6 days from February 2016 to August 2017 at one academic center. We extracted data on time to asystole following KCl injection, as well as incidents including hemorrhage, infection, uterine perforation, and unplanned admissions for up to 6 months following each procedure. RESULTS: Of 57 procedures, 32 (56%) were intact. Median time from KCl injection to fetal asystole was 48 seconds (interquartile range [IQR] 34-100). Median time to asystole at weeks 20 and 21 (46 seconds [IQR 34-60 seconds]) did not differ significantly from weeks 22 and 23 (85 seconds [IQR 34-200 seconds]), p = 0.15. Asystole occurred in less than four minutes in all cases but one. No adverse events occurred with either the funic KCl injections or the intact D&E procedures. CONCLUSION: Funic KCl injection for intact D&E usually causes fetal asystole in less than 4 minutes. IMPLICATIONS: Funic KCl injection under direct visualization is a feasible method to induce fetal asystole at the time of intact dilation and evacuation.

Examining the impact of federal regulations on abortion research in the United States: An exploratory, qualitative study.

OBJECTIVES: We aimed to identify and characterize barriers faced by researchers studying abortion in academic medical centers in the United States. We specifically focused on regulatory restrictions on abortion research related to institutional review board (IRB) or research ethics committee interpretations of Subpart B of the 2001 Code of Federal Regulations, which states that researchers cannot take part in decisions involving the timing, method, or procedures used to terminate a pregnancy. We aimed to document investigators' experiences obtaining approval from their IRBs and to identify obstacles that prevent investigators from generating evidence related to abortion care. STUDY DESIGN: We conducted semistructured telephone interviews with family planning researchers at 15 US academic institutions across the country. We coded transcripts using an iterative process, and analyzed the data for content and themes. RESULTS: Interviewees reported significant variations in the way that IRBs at their institutions applied federal regulations to abortion research. At several institutions, the regulations represented barriers to conducting abortion research and discouraged some investigators from conducting such research altogether. At other institutions, interviewees did not face significant barriers related to their IRB's interpretation of Subpart B. Many interviewees discussed creating and maintaining positive professional relationships with members of their IRB as a way to overcome barriers and successfully conduct abortion research. CONCLUSIONS: Our study suggests that IRBs interpret Subpart B in varying ways. At some institutions, this creates barriers to conducting abortion research. However, abortion researchers have also found ways to navigate these challenges successfully. IMPLICATIONS: This exploratory study identified barriers that may constrain the generation of evidence in abortion care at some academic institutions, and can inform future endeavors to overcome limitations to abortion research.

Long-term effects of teamwork training on communication and teamwork climate in ambulatory reproductive health care.

BACKGROUND: We previously reported an association between team training in the ambulatory setting and improvements in team climate at 6 and 12 months, but it is unknown whether improvements persist at 2 years. STUDY DESIGN: From 2014 to 2015, we enrolled 20 organizations, each operating a varying number of health centers, into a teamwork training initiative. We evaluated teamwork outcomes at baseline and 2 years using a communication behaviors assessment, the TeamSTEPPS® Teamwork Perceptions Questionnaire (T-TPQ), and the Patients' Insights and Views of Teamwork (PIVOT) survey. RESULTS: At 2 years, use of TeamSTEPPS® tools and strategies remained increased compared to baseline at many health centers; results ranged from 32% of centers reporting increased use of pauses to identify the patient to 91% reporting increased use of standardized language. Staff T-TPQ responses indicated that TeamSTEPPS® implementation was associated with improved perceptions of teamwork in approximately half (49%) of statements at 2 years. Significant improvements occurred in over half of PIVOT survey statements, and patient satisfaction was significantly greater at 2 years compared to baseline. CONCLUSIONS: Patient and staff views of teamwork were significantly improved 2 years after TeamSTEPPS® implementation in ambulatory reproductive health care centers, demonstrating positive long-term effects of teamwork training.

Best practices for collecting repeated measures data using text messages.

BACKGROUND: Researchers and clinicians use text messages to collect data with the advantage of real time capture when compared with standard data collection methods. This article reviews project setup and management for successfully collecting patient-reported data through text messages. METHODS: We review our experience enrolling over 2600 participants in six clinical trials that used text messages to relay information or collect data. We also reviewed the literature on text messages used for repeated data collection. We classify recommendations according to common themes: the text message, the data submitted and the phone used. RESULTS: We present lessons learned and discuss how to create text message content, select a data collection platform with practical features, manage the data thoughtfully and consistently, and work with patients, participants and their phones to protect privacy. Researchers and clinicians should design text messages to include short, simple prompts and answer choices. They should decide whether and when to send reminders if participants do not respond and set parameters regarding when and how often to contact patients for missing data. Data collection platforms send, receive, and store messages. They can validate responses and send error messages. Researchers should develop a protocol to append and correct data in order to improve consistency with data handling. At the time of enrollment, researchers should ensure that participants can receive and respond to messages. Researchers should address privacy concerns and plan for service interruptions by obtaining alternate participant contact information and providing participants with a backup data collection method. CONCLUSIONS: Careful planning and execution can reward clinicians and investigators with complete, timely and accurate data sets.

Impact of teamwork improvement training on communication and teamwork climate in ambulatory reproductive health care.

BACKGROUND: While team training is associated with improved hospital-based team climate, less is known about effects in the ambulatory setting. STUDY DESIGN: In 2014 and 2015, we enrolled 20 organizations, each operating various health centers, into this ongoing study. Evaluation tools include a communication behaviors assessment (CBA) and Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS® ) Teamwork Perceptions Questionnaire (T-TPQ), which staff completes at baseline, 6 months, and 1 year, and the Patients' Insights and Views of Teamwork (PIVOT) survey, which patients complete at baseline and 1 year. We also assessed patient satisfaction. We analyzed T-TPQs paired at the individual level and CBAs and PIVOTs paired at the health center level. We also conducted key informant interviews with the first cohort. RESULTS: CBAs showed that TeamSTEPPS tools and strategies were utilized, with 50% or more of centers reporting increases in all behaviors at 1 year; key informant interviews confirmed this. T-TPQ findings indicated that TeamSTEPPS implementation was associated with improved staff perceptions of teamwork at 6 months; lesser improvements were seen at 1 year. The PIVOT survey demonstrated significant improvements in select patient ratings of teamwork. Patient satisfaction improved at 1 year. CONCLUSIONS: TeamSTEPPS has positive effects in the ambulatory reproductive health care environment. Improvements persisted at 1 year.

Quality of Information Available Online for Abortion Self-Referral.

OBJECTIVE: To assess the quality of information available online for abortion self-referral and to determine whether quality varies by region or distance to an abortion provider. METHODS: This was a cross-sectional study. We used a standard protocol to perform internet searches from August 2016 to June 2017 for abortion services in the 25 most populous U.S. cities and the 43 state capitals that were not one of the 25 most populous cities. We classified the first 10 webpage results and the first five map results and advertisements as facilitating abortion referral (local independent abortion provider, local Planned Parenthood facility, national abortion provider or organization, prochoice website, or abortion directory), not facilitating abortion referral (nonproviding physician office, nonmedical website, abortion provider greater than 50 miles from the location, news article, general directory, other), or hindering abortion referral (crisis pregnancy center or antichoice website). We used U.S. Census Bureau subregions to examine geographic differences. We made comparisons using a χ test. RESULTS: Overall, from 612 searches from 68 cities, 52.9% of webpage results, 67.3% of map results, and 34.4% of advertisements facilitated abortion referral, whereas 12.9%, 21.7%, and 29.9%, respectively, hindered abortion referral. The content of the searches differed significantly based on U.S. Census Bureau subregion (all P≤.001) and distance to an abortion provider (all P≤.02). CONCLUSION: Two thirds of map results facilitated abortion self-referral, whereas only half of webpage results did so. Advertisements were the least likely to facilitate and the most likely to hinder self-referral. Quality was lowest in areas that were farthest from abortion providers.

Randomized trial of high- and low-fidelity simulation to teach intrauterine contraception placement.

BACKGROUND: High-fidelity simulation creates conditions that resemble real circumstances, and can help teach procedures such as intrauterine contraception placement. Its impact on skill retention has not been studied. OBJECTIVE: We sought to evaluate novice learners' skills, attitudes, and knowledge on placement of intrauterine contraception when trained using a high-fidelity commercially available simulator compared with a low-fidelity simulator. STUDY DESIGN: We recruited senior nurse practitioner students and interns in obstetrics and gynecology and family medicine inexperienced with intrauterine contraception placement. In this unblinded, randomized controlled trial, participants were assigned to practice within a high-fidelity simulator group or a coasterlike model group. We evaluated intrauterine contraception placement skills, self-perceived comfort and competence, and knowledge before and after simulation, as well as at 3 months. Our primary outcome was the change in scores for intrauterine contraception placement skills before and after practice. Assuming a standard deviation of 15 points, we needed 10 participants per group to detect a 20-point difference in scores with 80% power. RESULTS: From June through July 2014, 60 participants enrolled; 59 completed the initial study visit and 1 withdrew. In all, 48 (80%) completed the second study visit at 3 months. Demographic characteristics were similar for the randomization groups. We observed an improvement in intrauterine contraception placement skills for both groups following practice on simulators (P < .01); the proportion that improved was similar (20% for the high-fidelity simulator group and 15% for the coaster group, P = .55). Increases in self-perceived comfort and competence with placing copper, levonorgestrel 52-mg, and levonorgestrel 13.5-mg devices were similar (all P ≥ .11). Knowledge assessment scores were comparable between the 2 groups postsimulation (73% for the high-fidelity simulator group and 80% for the coaster group, P = .29) and at 3 months (87% for both groups, P = 1.0). CONCLUSION: Trainees' knowledge, intrauterine contraception placement skills, and self-perceived comfort and competence were comparable whether they used high- or low-fidelity simulators.

A randomized controlled trial of daily text messages versus monthly paper diaries to collect bleeding data after intrauterine device insertion.

OBJECTIVE: Bleeding data in contraceptive trials are often collected using daily diaries, but data quality may vary due to compliance and recall bias. Text messaging is a widespread and promising modality for data collection. STUDY DESIGN: This trial randomized participants 1:1 to use text messages or paper diaries to report on bleeding experienced during the 90 days after intrauterine device (IUD) insertion. Participants chose either the copper T380A or the 52-mg levonorgestrel IUD. Our primary outcome was number of days of reported bleeding data. We hypothesized that data gathered with daily text messages would have fewer missing values than paper diaries. Intention to treat analyses used the rank-sum test to compare medians. RESULTS: Two hundred thirty women enrolled, and randomization yielded groups similar in baseline characteristics. Twenty percent of participants provided no bleeding data; of these, 77% were assigned to paper diaries. With 90 days of reporting, approximately 20% in each group provided complete bleeding data. The text group reported a median of 82 days [interquartile range (IQR) 40-89] and the paper group reported a median of 36 days (IQR 0-88) (p≤.001). The number of responses received decreased gradually over the 90-day period but was always higher in the text group. Women who had attained higher levels of education did well regardless of data collection modality, while response rates of text messages were greater among those with a high school education or less (p<.01). CONCLUSIONS: Participants reporting bleeding via text messages provided more complete data than women using paper diaries. IMPLICATIONS: Depending on resources and population of interest, text messages may be a useful modality to improve data collection for patient-reported outcomes.