Estimating the cost of Rh testing and prophylaxis in early pregnancy: A time-driven activity-based costing study.

OBJECTIVE: To estimate the cost of Rhesus (Rh) testing and prophylaxis for first-trimester vaginal bleeding in the ambulatory setting. STUDY DESIGN: We used time-driven, activity-based costing to analyze tasks associated with Rh testing and prophylaxis of first-trimester vaginal bleeding at one hospital-based outpatient and two independent reproductive health clinics. At each site, we observed 10 patients undergoing Rh-typing and two patients undergoing Rh prophylaxis. We computed the costs of blood Rh-typing by both fingerstick and phlebotomy, cost of locating previous blood type in the electronic health record (available for 69.8% of hospital-based patients), and costs associated with Rh immune globulin prophylaxis. All costs are reported in 2021 US dollars. RESULTS: The hospital-based clinic reviewed the electronic health record to confirm Rh-status (cost, $26.18 per patient) and performed a phlebotomy, at $47.11 per patient, if none was recorded. The independent clinics typed blood by fingerstick, at a per-patient cost of $4.07. Rh-immune globulin administration costs, including the medication, were similar across facilities, at a mean of $145.66 per patient. Projected yearly costs for testing and prophylaxis were $55,831 for the hospital-based clinic, which was the lowest-volume site, $47,941 for Clinic A, which saw 150 patients/month, and $185,654 for Clinic B, which saw 600 patients/month. CONCLUSIONS: Rh testing and prophylaxis for first-trimester vaginal bleeding generates considerable costs for outpatient facilities, even for Rh-positive patients with a prior blood type on record. IMPLICATIONS: Rh testing and prophylaxis for first-trimester bleeding generate considerable costs even for Rh-positive patients and those with a previously known blood type. These findings highlight the need to reconsider this practice, which is no longer supported by evidence and already safely waived in multiple medical settings in the United States and around the world.

Medical management of early pregnancy loss is cost-effective compared with office uterine aspiration.

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

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%.

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.

Ultrasound assessment of postplacental copper intrauterine device position 6 months after placement during cesarean delivery.

OBJECTIVE: The objective was to describe the sonographic position of copper intrauterine devices (IUDs) 6 months after insertion during cesarean delivery. STUDY DESIGN: This prospective, observational study followed participants who received a copper IUD during cesarean delivery. We performed pelvic examination at 6 weeks and 6 months and sonography at 6 months to determine IUD position. Patients had additional examinations as needed to address complications. RESULTS: Sixty-nine participants provided outcomes through 6 months: 41 (59%) had correctly positioned IUDs, 21 (30%) had malpositioned intrauterine IUDs, 5 experienced expulsion (3 partial, 2 complete), and 2 had elective removal; 52 (75%) had missing strings. Missing strings at 6 weeks predicted an incorrect IUD position in 22 of 52 participants (positive predictive value 42%), and visible or palpable strings predicted a correct IUD position in 7 of 12 participants (negative predictive value 58%). CONCLUSION: Although 59% of copper IUDs placed during cesarean were correctly positioned at 6 months, nearly one third were malpositioned. IMPLICATIONS: Ultrasound may be indicated for patients receiving a copper IUD during cesarean delivery as checking IUD strings alone does not assure correct placement. Providers offering postpartum IUDs should ensure that appropriate processes for the evaluation and management of devices with missing strings or abnormal position are available to all patients regardless of insurance status.

Cost-effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy: Secondary Analysis of a Randomized Clinical Trial.

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

Pregnancy intentions and contraceptive uptake after miscarriage.

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.

Patient Experiences With Miscarriage Management in the Emergency and Ambulatory Settings.

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.

A Decision Analysis Model of 1-Year Effectiveness of Intended Postplacental Compared With Intended Delayed Postpartum Intrauterine Device Insertion.

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

Validity of self-reported history of Chlamydia trachomatis infection.

BACKGROUND: Chlamydia trachomatis infection is common and largely asymptomatic in women. If untreated, it can lead to sequelae such as pelvic inflammatory disease and infertility. It is unknown whether a patient's self-reported history of Chlamydia trachomatis infection is a valid marker of past infection. OBJECTIVE: Our objective was to evaluate the validity of women's self-reported history of Chlamydia trachomatis infection compared with Chlamydia trachomatis serology, a marker for previous infection. STUDY DESIGN: We analyzed data from the Fertility After Contraception Termination study. We compared participants' survey responses with the question, "Have you ever been told by a health care provider that you had Chlamydia?" to serological test results indicating the presence or absence of antibodies to Chlamydia trachomatis as assessed by a microimmunofluorescence assay. Prevalence of past infection, sensitivity, specificity, predictive values, and likelihood ratios were calculated. The Cohen's kappa statistic was computed to assess agreement between self-report and serology. RESULTS: Among 409 participants, 108 (26%) reported having a history of Chlamydia trachomatis infection, whereas 146 (36%) had positive serological test results. Relative to positive microimmunofluorescence assay, the sensitivity and specificity of self-reported history of Chlamydia trachomatis infection were 52.1% (95% confidence interval, 43.6-60.4%) and 87.8% (95% confidence interval, 83.3-91.5%), respectively. The positive predictive value of the self-report was 70.4% (95% confidence interval, 60.8-78.8%), and the negative predictive value was 76.7% (95% confidence interval, 71.6-81.4%). The likelihood ratio was found to be 4.28. Agreement between self-report and serology was found to be moderate (kappa = 0.42, P < .001). CONCLUSION: Self-reported history of Chlamydia trachomatis infection commonly yields false-negative and false-positive results. When definitive status of past Chlamydia trachomatis infection is needed, serology should be obtained.

Peer counselling for the promotion of long-acting, reversible contraception among teens: a randomised, controlled trial.

AIM: To evaluate the impact peer counselling has on same-day desire for long-acting, reversible contraception (LARC) among adolescents attending a family planning clinic. METHODS: A randomised, controlled trial of 110 adolescent females attending an outpatient clinic for contraception in 2013. Adolescents received either brief peer counselling about LARC with routine contraceptive counselling, or routine counselling alone. Bivariate analyses and multivariable logistic regression assessed the primary outcome of same-day desire for LARC and secondary outcomes of change in knowledge and attitudes regarding LARC. RESULTS: Peer counselling was well received and 70% reported that it was helpful in contraceptive decision-making. Peer counselling did not affect same-day desire for LARC, however, adolescents who received the intervention were more likely to report increased knowledge and positive change in attitudes towards LARC (adjusted odds ratios: 6.6 (95% confidence interval: 2.0-22.0 and 6.4 (1.6-26.8), respectively). Factors positively associated with same-day LARC desire included greater reported peer contraceptive influence, peer use of LARC and social support. Twenty of the 36 adolescents who desired LARC at the end of their clinic visit did not receive one most commonly due to a need to schedule a specific appointment for the procedure and the need to return during a menstrual period for intrauterine device placement. CONCLUSION: While brief, point-of-care peer counselling is well received, and can increase adolescent knowledge and positive attitude about our most effective contraceptive methods, barriers to same-day LARC placement limit immediate use.

A self-assessment efficacy tool for spermicide contraceptive users.

BACKGROUND: Easily accessible contraceptive methods, such as chemical and barrier methods, are used currently by approximately 1 in 6 women who use contraception in the United States. Even in the face of suboptimal effectiveness, coitally dependent methods likely will always have a role in fertility management. Because most contraceptive efficacy stratifications use population-based data, for women to make informed decisions about the individual fit of a contraceptive method, better evidence-based, user-friendly tools are needed. OBJECTIVES: Spermicides are a readily available, over-the counter, woman-controlled contraceptive method, but their effectiveness is user-dependent. Patient-decision aids for spermicides and other barrier methods are not well-developed, and overall failure rates could be improved by aids that account for individual characteristics. We sought to derive a prediction rule for successful use of spermicides for pregnancy prevention and to convert those data to a point-of-care instrument that women can use when they are considering spermicide use during contraceptive decision-making. STUDY DESIGN: We pooled local data from 3 randomized clinical trials that were published in 2004, 2007, and 2010 that tested spermicide efficacy. We constructed a prediction rule for unintended pregnancy using bootstrap validation and developed a scoring system. RESULTS: Data from 621 women showed a mean age of 29 years; 49% of the women were African American, and 43% were white. The overall pregnancy rate was 10.3% (95% confidence interval, 7.9-12.7) over 6 months. In adjusted logistic regression, age >35 years was protective against pregnancy (odds ratio, 0.19; 95% confidence interval, 0.06-0.58; P = .003), and multigravidity was associated with high failure rates (odds ratio, 7.24; 95% confidence interval, 3.04-17.3; P < .001). These risk factors (together with frequency of unprotected sex) were used in a model that maximized sensitivity for pregnancy prediction to compute the predicted probability of unintended pregnancy for each woman. This model was 97% accurate in predicting women who had a <5% pregnancy risk while using spermicides. CONCLUSION: Using prospectively collected data, we built a simple risk calculator for contraceptive failure that women can consult when considering spermicide use. This instrument could support patient-centered contraceptive decision-making.

State of family planning.

Family planning and reproductive health services are uniquely impacted by policy and politics in the United States. Recent years have witnessed an unprecedented number of abortion restrictions, and research funding has decreased in related areas. Despite this, both the science and the implementation of improved family planning and abortion methods have progressed in the past decade. This article reviews the current state of family planning, as well as technologies and patient care opportunities for the future.

Psychological coping in the immediate post-abortion period.

BACKGROUND: Women undergoing abortion do psychologically well long-term. Little data, however, describe how women fare in the immediate 1-3 day post-abortion period, when interventions may be most impactful for those who need them. METHODS: We conducted a cohort study of patients undergoing first and second trimester surgical abortion and scored self-reported responses regarding psychological well-being before and after abortion, plus anticipated post-procedural psychological coping. RESULTS: Sixty-two of 148 patients had complete questionnaires. Average predicted psychological scores were 9.7% better than pre-procedural psychological states. Actual psychological coping scores improved by 38% over women's predictions. Women who scored poorly on pre-procedural psychological assessments were more likely to have post-procedural psychosocial concerns (p=0.0376, r=0.2761). CONCLUSION: While most women approach their abortion with optimism, they actually fare even better psychologically than they predict they will during the 1-3 days following procedures. Poor scores on pre-procedural psychological assessments can identify women in need of additional support in the immediate post-abortion period.