Telemedicine Follow-up After Medication Management of Early Pregnancy Loss.

Objective: Our objective was to evaluate the feasibility of a new protocol for telemedicine follow-up after medication management of early pregnancy loss. Study Design: The study was designed to assess the feasibility of planned telemedicine follow-up after medication management of early pregnancy loss. We compared these follow-up rates with those after planned in-person follow-up of medication management of early pregnancy loss and planned telemedicine follow-up after medication abortion. We conducted a retrospective cohort study, including patients initiating medication management of early pregnancy loss <13w0d gestation and medication abortion ≤10w0d with a combination of mifepristone and misoprostol between April 1, 2020, and March 28, 2021. As part of a new clinical protocol, patients could opt for telemedicine follow-up one week after treatment and a home urine pregnancy test 4 weeks after treatment. Our primary outcome was completed follow-up as per clinical protocol. We also examined outcomes related to complications across telemedicine and in-person follow-up groups. Results: Of patients reviewed, 181 were eligible for inclusion; 75 had medication management of early pregnancy loss, and 106 had medication abortion. Thirty-six out of 75 patients elected for telemedicine follow-up after early pregnancy loss. Of patients scheduled for telemedicine follow-up, 29/36 (81%, 95% CI: 64-92) with early pregnancy loss and 64/69 (93%, 95% CI: 84-98) undergoing medication abortion completed follow-up as per protocol (p = 0.06). Completed follow-up was also similar among patients undergoing medication management of early pregnancy loss who planned for in-person follow-up (p = 0.135). Complications were rare and did not differ across early pregnancy loss and medication abortion groups. Conclusions: Telemedicine follow-up is a feasible alternative to in-person assessment after medication management of early pregnancy loss.

Exploring Reasons for Loss to Follow-up in Pregnancy of Unknown Location: A Mixed-Methods Study.

Objective: To quantify proportions of loss to follow-up in patients presenting with a pregnancy of unknown location and explore patients' perspectives on follow-up for pregnancy of unknown location. A pregnancy of unknown location is a scenario in which a patient has a positive pregnancy test but the pregnancy is not visualized on transvaginal ultrasound. Study Design: We conducted a retrospective cohort study of patients with pregnancy of unknown location who presented to an urban academic emergency department or complex family planning outpatient office. We sought to calculate the proportion of patients lost to follow-up, defined as inability to contact the patient within 2 weeks. We then conducted focus groups of patients diagnosed with a pregnancy of unknown location. We used thematic analysis to identify themes related to follow-up. Results: We reviewed 464 charts of patients diagnosed with pregnancy of unknown location. The median age in this cohort was 27 with most patients identifying as Black (80%, n = 370) and using public insurance (67%, n = 315). When looking at loss to follow-up rates, Black patients experienced loss to follow-up (20%, n = 72) more often than White patients (4%, n = 2; p = 0.003). Focus group participants had a mean age of 31.8+/-4.8, and the majority were of Black race (n = 16, 72.7%). Participants identified barriers to follow-up including the long duration of management, general inconvenience, and poor communication with their health care team. Participants felt a burden of responsibility to learn about their condition and to self-advocate for their follow-up and communication of results. Conclusions: These data indicate that Black patients are more likely to experience loss to follow-up compared with White patients during monitoring for pregnancy of unknown location. Patients identified many barriers to follow-up and felt that successful follow-up required substantial self-efficacy.

Early pregnancy loss medical management in clinical practice.

OBJECTIVES: This study aimed to review clinical practice outcomes of early pregnancy loss (EPL) medical management using mifepristone and misoprostol outside of a clinical trial setting. STUDY DESIGN: In this retrospective cohort study, we reviewed a deidentified database of patients who received mifepristone-misoprostol for EPL from May 2018 to May 2021 at our academic center-based clinic, which was a study site for a multicenter mifepristone-misoprostol EPL trial completed in March 2018. All patients received mifepristone 200 mg orally and misoprostol 800 mcg vaginally or buccally, with clinic follow-up typically scheduled within 1 week. The primary outcome was successful medical management, defined as management without the need for aspiration, and the secondary outcomes included additional interventions and indications, follow-up ultrasonography findings, and adverse events requiring treatment. RESULTS: We treated 90 patients with a median ultrasound-measured gestational size of 49 (range 30-80) days and median time from mifepristone to misoprostol of 24 (range 8-66) hours. Follow-up was completed in clinic by 80 (88.9%), completed remotely by five (5.6%), and not completed by five (5.6%) patients. Overall, 76 (95% CI 82.9%-96.0%) of 85 patients (89.4%) with follow-up were successfully managed without uterine aspiration. Eighty patients had initial follow-up ultrasonography interpreted as gestational sac expulsion; seven (8.8%) of these ultimately underwent aspiration, including one patient who had a previously undiagnosed cesarean scar ectopic pregnancy. Two patients had significant safety outcomes: one pelvic infection and one blood transfusion during aspiration in the patient with a cesarean scar ectopic pregnancy. CONCLUSIONS: Outside of a clinical trial setting, medical management of EPL with mifepristone and misoprostol remains effective and safe. IMPLICATIONS: Medical management of EPL with mifepristone and misoprostol is effective and safe outside of a clinical trial setting. A standardized protocol based on the best available clinical trial evidence can be used in clinical practice for the medical management of EPL.

Evaluation of a decision aid for early pregnancy loss: A pilot randomized controlled trial in Philadelphia, Pennsylvania.

OBJECTIVES: To evaluate the effect of a decision aid on decisional conflict scale in patients choosing management for early pregnancy loss. STUDY DESIGN: We conducted a pilot randomized control trial to assess the effect of the Healthwise patient decision aid on decisional conflict scale in patients with early pregnancy loss as compared with a control website. Patients 18years and older were eligible if they had an early pregnancy loss between 5 and 12 completed weeks of gestation. Participants completed surveys at baseline, poststudy intervention, after consultation, and 1week postconsultation. Surveys assessed participant scores on the decisional conflict scale (scale 0-100), knowledge, assessment of shared decision-making, satisfaction, and decision regret. Our primary outcome was the poststudy-intervention decisional conflict scale score. RESULTS: From July 2020 through March 2021 we randomized 60 participants. After the intervention, the median decisional conflict scale score for the control group was 10 [0-30] and 0 [0-20] for the intervention group (p = 0.17). When assessing the decisional conflict scale subscales postintervention, the informed subscale for the control group was 16.7 [0-33.3] as opposed to 0 [0] for the patient decision aid group (p = 0.003). Knowledge remained significantly higher in the experimental arm from the postintervention to the 1-week follow-up. We found no differences between groups when assessing our other metrics. CONCLUSIONS: Use of a validated decision aid did not result in statistically significant differences in the total decisional conflict scale scores as compared with the control. Participants allocated to the intervention were more informed postintervention and had consistently higher knowledge scores. IMPLICATIONS: Use of a validated decision aid prior to early pregnancy loss management consultation did not affect overall decisional conflict but resulted in improved knowledge.

Patient attitudes and preferences for the management of pregnancy of unknown location.

Objective: To understand patient attitudes and preferences when faced with the uncertainty of pregnancy of unknown location (PUL). Design: Qualitative, interview-based study. Setting: University Hosptial. Patients: Patients aged >18 years sampled from the emergency department and a subspecialty fertility practice of a university hospital system. Interventions: Six to 8 weeks after resolution of a PUL, with an ultimate clinical outcome of either an intrauterine pregnancy, spontaneous abortion, or ectopic pregnancy. Participants underwent either surgical, medical, or expectant management. Main Outcome Measures: Thematic analysis of the virtual, semistructured interviews (45-60 minutes in length) conducted with participants to identify commonly expressed priorities was performed. Results: Interviews were completed from October 2020 to March 2021 until thematic saturation was achieved (n = 15). Resolution diagnoses included intrauterine pregnancy (26.7%, n = 4), ectopic pregnancy (40.0%, (n = 6), and spontaneous abortion (33.3%, n = 5). Moreover, 66.7% (n = 10) of the patients presented to the emergency department, whereas 33.3% (n = 5) presented to a subspecialty fertility clinic. All had desired pregnancies. Thematic analyses revealed 4 related priorities around PUL management: health of pregnancy; health of self; future fertility; and diagnostic prediction and diagnostic certainty. The relative balance of these priorities was dynamic and evolved throughout the course of management with different outcomes. A second set of themes related to logistical preferences included mental health support, clarity of treatment and next steps, and continuity of care. Interrater reliability was validated with a pooled κ of >0.8. Limitations include that all participants had desired pregnancies, and the experiences of those who experienced different pregnancy outcomes may have been affected by recall bias. Conclusions: These data demonstrate novel themes around related priorities in patients with desired pregnancies diagnosed with a PUL previously underappreciated by clinicians. The balance of these priorities evolved throughout management with increasing information and clarity. Continually reevaluating relevant patient priorities and preferences is essential to the comprehensive management of PUL.

Update on medication abortion follow-up options: many sizes to fit all.

PURPOSE OF REVIEW: To assess the efficacy, benefits, and limitations of available and emerging follow-up options for medication abortion. RECENT FINDINGS: Medication abortion follow-up does not have to be a 'one size fits all' protocol. From most to least invasive, follow-up options include facility-based ultrasound, laboratory-based repeat serum beta-human chorionic gonadotropin (hCG) testing, urine hCG testing (high sensitivity, low sensitivity, and multilevel pregnancy tests), self-assessment with symptom evaluation, and no intervention. Provider or facility-dependent follow-up, including ultrasound and serum testing are effective, but have several limitations, including needing to return to a facility and cost. Remote, client-led follow-up options, such as urine pregnancy testing and symptoms evaluation, are well tolerated and effective for ruling out the rare outcome of ongoing pregnancy after medication abortion and have several advantages. Advantages include being inexpensive and flexible. However, it is important to note that low-sensitivity and multilevel pregnancy tests are not available in all settings. In studies evaluating client-led follow-up with urine pregnancy tests, ongoing pregnancies were identified over half the time with symptoms alone. SUMMARY: Guidelines from several professional organizations have aligned with the evidence and no longer recommend routine office-based follow-up. To ensure care is person-centered, providers should offer follow-up options that align with the comfort, logistical ability, and values of the client.

Utility and Limitations of Human Chorionic Gonadotropin Levels for Remote Follow-up After Medical Management of Early Pregnancy Loss.

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.

Fetomaternal hemorrhage assessment in Rh-negative patients undergoing dilation and evacuation between 20 and 24 weeks' gestational age: A retrospective cohort study.

OBJECTIVE: 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). STUDY DESIGN: 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. RESULTS: Of 25 eligible patients, 24 had negative quantification of FMH; one had positive quantification that did not meet the clinical threshold for additional dosing. CONCLUSIONS: The absolute risk of requiring additional Rh D immune globulin after D+E for pregnancies greater than 20 weeks' gestation was 0%.

Medical management of ectopic pregnancy in a family planning clinic: A case series.

OBJECTIVE: To evaluate safety of medical management of ectopic pregnancy in a free-standing family planning clinic setting. STUDY DESIGN: We retrospectively reviewed cases of ectopic pregnancy between January 2014 and December 2018 which were identified using a "Beta Board" tracking system. Planned Parenthood of Orange and San Bernardino Counties staff added patients the "Beta Board" if they had a positive urine pregnancy test without definitive ultrasound diagnosis of intrauterine pregnancy and/or symptoms suggestive of ectopic pregnancy, such as vaginal bleeding, and cramping. Patients were included in the study if they had received a final diagnosis of ectopic pregnancy. RESULTS: Of 5083 patients tracked via the Beta Board, 260 patients presented to a Planned Parenthood free-standing, family planning clinic with ectopic pregnancy. Ninety-five patients were treated with methotrexate entirely at the clinic. There were no deaths. Four ectopic pregnancies ruptured and 8 required surgery. CONCLUSION: Treatment of ectopic pregnancy with methotrexate in the family planning clinic setting can be safe and effective with reassuring outcomes that are similar to the hospital setting.

The Role of Subcutaneous Depot Medroxyprogesterone Acetate in Equitable Contraceptive Care: A Lesson From the Coronavirus Disease 2019 (COVID-19) Pandemic.

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.

The effect of mifepristone pretreatment on bleeding and pain during medical management of early pregnancy loss.

OBJECTIVES: To compare participant-reported bleeding and pain with two medication regimens for early pregnancy loss (EPL). STUDY DESIGN: We 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. RESULTS: Among 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. CONCLUSIONS: Mifepristone pretreatment increased the severity of pain but not bleeding and resulted in a shorter trajectory of symptoms during medical management of EPL. IMPLICATIONS: Mifepristone 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.

Timing and efficacy of mifepristone pretreatment for medical management of early pregnancy loss.

OBJECTIVES: To determine the time interval between mifepristone and misoprostol administration associated with the most efficacious early pregnancy loss (EPL) management. STUDY DESIGN: We performed a secondary analysis of a randomized trial. Participants with EPL were instructed to take 200 mg oral mifepristone followed by 800 mcg vaginal misoprostol 24 hours later. The primary outcome was gestational sac expulsion at the first follow-up visit (1-4 days after misoprostol use) after a single dose of misoprostol and no additional intervention within 30 days after treatment. Despite specification of drug timing, participants used the medication over a range of time. We graphed sliding average estimates of success and assessed the proportion of treatment successes over time to define timing interval cohorts for analysis. We used multivariable generalized linear regression to assess the association between time interval and success. RESULTS: Of 139 eligible participants, 70 (50.4%) self-administered misoprostol before 24 hours, and 69 (49.6%) at or after 24 hours. We defined the following time intervals: 0 to 6 hours (n = 22); 7 to 20 hours (n = 29); and 21 to 48 hours (n = 88). Success occurred in 96.6% of the 7- to 20-hour cohort compared to 54.6% and 87.5% of the cohorts self-administering misoprostol earlier or later, respectively. When adjusting for race, gestational age, diagnosis, bleeding at presentation, insurance status, and enrollment site, participants administering misoprostol between 0 and 6 hours (adjusted risk ratio 0.58, 95% CI 0.40-0.85) and 21 to 48 hours (adjusted risk ratio 0.91, 95% CI 0.72-0.99) had a lower risk of success when compared to participants administering 7 to 20 hours after mifepristone. CONCLUSIONS: These data suggest that medical management of EPL has the highest likelihood of success when misoprostol is self-administered 7 to 20 hours after mifepristone. IMPLICATIONS: These preliminary data suggest that patients have the highest likelihood of success when misoprostol is taken between 7 and 20 hours after mifepristone. In contrast with medical abortion, simultaneous medication administration may not be as effective as delayed. Future research is needed to confirm the optimal medication time interval.

Prioritizing Desiredness in Pregnancy of Unknown Location: An Algorithm for Patient-Centered Care.

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.

Patient Satisfaction of Surgical Treatment of Clitoral Phimosis and Labial Adhesions Caused by Lichen Sclerosus.

INTRODUCTION: Lichen sclerosus (LS) is a chronic inflammatory dermatosis, usually affecting the anogenital skin in women. This chronic inflammation can cause scarring of genitalia including narrowing of the introitus and phimosis of the clitoris. These architectural changes can lead to recurrent tearing during intercourse (vulvar granuloma fissuratum) and decreased clitoral sensation. Surgical correction of vulvar granuloma fissuratum (VGF) and clitoral phimosis can be performed, but there is little data on the patient satisfaction and complications following these surgical procedures. AIM: To evaluate patient experience and outcomes in women undergoing surgical correction of scarring caused by anogenital LS. METHODS: A retrospective chart review of patients at a vulvar disorders clinic was performed to identify women who had undergone surgical correction of clitoral phimosis or lysis of vulvar adhesions for VGF due to LS. Twenty-eight women were contacted via telephone between 4 and 130 months postoperatively. An eight-question survey was used to determine patient experience and outcomes. MAIN OUTCOME MEASURES: All participants completed an eight-question survey to evaluate patient satisfaction with the surgery, effects on clitoral sensation, orgasm and pain with intercourse, postoperative symptoms or complications, and the presence of recurrent vulvar scarring. RESULTS: Participants reported that they were either very satisfied (44%) or satisfied (40%) with the procedure. Of the women who experienced decreased clitoral sensation prior to surgery, 75% endorsed increased clitoral sensitivity postoperatively. Of the women who had dyspareunia prior to surgery, the majority of women reported having pain-free sex (33%) or improved but not completely pain-free sex (58%) after surgery. There were no complications or symptoms made worse by the surgical procedures. CONCLUSIONS: This study shows high patient satisfaction and low complication risk associated with surgical correction of clitoral phimosis and lysis of vulvar adhesions for VGF caused by LS. Patients reported improvement in clitoral sensation and ability to achieve orgasm, as well as decreased dyspareunia. Surgical correction of vulvar scarring is a viable option to restore vulvar anatomy and sexual function in appropriate candidates with anogenital LS. Flynn AN, King M, Rieff M, Krapf J, and Goldstein AT. Patient satisfaction of surgical treatment of clitoral phimosis and labial adhesions caused by lichen sclerosus. Sex Med 2015;3:251-255.