Mail-order pharmacy dispensing of mifepristone for medication abortion after in-person clinical assessment.

OBJECTIVE(S): To estimate the effectiveness, acceptability, and feasibility of medication abortion with mifepristone dispensed by a mail-order pharmacy after in-person clinical assessment. STUDY DESIGN: This is an interim analysis of an ongoing prospective cohort study conducted at five sites. Clinicians assessed patients in clinic and, if they were eligible for medication abortion and ≤ 63 days' gestation, electronically sent prescriptions for mifepristone 200 mg orally and misoprostol 800 mcg buccally to a mail-order pharmacy, which shipped medications for next-day delivery. Participants completed surveys three and 14 days after enrollment, and we abstracted medical chart data. RESULTS: Between January 2020 and April 2021 we enrolled 240 participants and obtained clinical outcome information for 227 (94.6%); 3 reported not taking either medication. Of those with abortion outcome information (N = 224), 216 (96.4%) completed day-3 and 212 (94.6%) day-14 surveys. Of the 224 that took medications, none reported taking past 70 days' gestation, and complete medication abortion occurred for 217 participants (96.9%, 95% CI 93.7%-98.7%). Most received medications within three days (82.1%, 95% CI 76.5%-86.9%). In the day-3 survey, 95.4% (95% CI 91.7%-97.8%) reported being very (88.4%) or somewhat (6.9%) satisfied with receiving medications by mail. In the day-14 survey, 89.6% (95% CI 84.7%-93.4%) said they would use the mail-order service again if needed. Eleven (4.9%, 95% CI 2.5%-8.6%) experienced adverse events; two were serious (one blood transfusion, one hospitalization), and none were related to mail-order pharmacy dispensing. CONCLUSIONS: Medication abortion with mail-order pharmacy dispensing of mifepristone appears effective, feasible, and acceptable to patients. IMPLICATIONS: The in-person dispensing requirement for mifepristone, codified in the drug's Risk Evaluation and Mitigation Strategy, should be removed.

Publicly Funded Family Planning: Lessons From California, Before And After The ACA's Medicaid Expansion.

California has a long tradition of providing publicly funded family planning services to low-income residents. The Affordable Care Act (ACA) increased contraceptive coverage in 2012, and in January 2014 it extended Medicaid eligibility by increasing the income cut-off from 100 percent to 138 percent of the federal poverty level and allowing individuals without dependent children to enroll. We assessed the impact of the ACA's Medicaid expansion on low-income Californian women's receipt of health insurance and needed health care, including contraceptive counseling and prescription contraception, using data for the period 2013-16 from 4,567 women ages 18-44 with low incomes (less than 138 percent of poverty). After the ACA expansion, the proportion of uninsured low-income women in California decreased significantly, while the share enrolled in Medicaid increased. However, the proportion of the women who reported using health care and family planning services remained unchanged. Despite the ACA's explicit attention to contraceptive services, improvements in the delivery of family planning services have yet to be fully realized in California.

Cost-effectiveness of emergency contraception options over 1 year.

BACKGROUND: The copper intrauterine device is the most effective form of emergency contraception and can also provide long-term contraception. The levonorgestrel intrauterine device has also been studied in combination with oral levonorgestrel for women seeking emergency contraception. However, intrauterine devices have higher up-front costs than oral methods, such as ulipristal acetate and levonorgestrel. Health care payers and decision makers (eg, health care insurers, government programs) with financial constraints must determine if the increased effectiveness of intrauterine device emergency contraception methods are worth the additional costs. OBJECTIVE: We sought to compare the cost-effectiveness of 4 emergency contraception strategies-ulipristal acetate, oral levonorgestrel, copper intrauterine device, and oral levonorgestrel plus same-day levonorgestrel intrauterine device-over 1 year from a US payer perspective. STUDY DESIGN: Costs (2017 US dollars) and pregnancies were estimated over 1 year using a Markov model of 1000 women seeking emergency contraception. Every 28-day cycle, the model estimated the predicted number of pregnancy outcomes (ie, live birth, ectopic pregnancy, spontaneous abortion, or induced abortion) resulting from emergency contraception failure and subsequent contraception use. Model inputs were derived from published literature and national sources. An emergency contraception strategy was considered cost-effective if the incremental cost-effectiveness ratio (ie, the cost to prevent 1 additional pregnancy) was less than the weighted average cost of pregnancy outcomes in the United States ($5167). The incremental cost-effectiveness ratios and probability of being the most cost-effective emergency contraception strategy were calculated from 1000 probabilistic model iterations. One-way sensitivity analyses were used to examine uncertainty in the cost of emergency contraception, subsequent contraception, and pregnancy outcomes as well as the model probabilities. RESULTS: In 1000 women seeking emergency contraception, the model estimated direct medical costs of $1,228,000 and 137 unintended pregnancies with ulipristal acetate, compared to $1,279,000 and 150 unintended pregnancies with oral levonorgestrel, $1,376,000 and 61 unintended pregnancies with copper intrauterine devices, and $1,558,000 and 63 unintended pregnancies with oral levonorgestrel plus same-day levonorgestrel intrauterine device. The copper intrauterine device was the most cost-effective emergency contraception strategy in the majority (63.9%) of model iterations and, compared to ulipristal acetate, cost $1957 per additional pregnancy prevented. Model estimates were most sensitive to changes in the cost of the copper intrauterine device (with higher copper intrauterine device costs, oral levonorgestrel plus same-day levonorgestrel intrauterine device became the most cost-effective option) and the cost of a live birth (with lower-cost births, ulipristal acetate became the most cost-effective option). When the proportion of obese women in the population increased, the copper intrauterine device became even more most cost-effective. CONCLUSION: Over 1 year, the copper intrauterine device is currently the most cost-effective emergency contraception option. Policy makers and health care insurance companies should consider the potential for long-term savings when women seeking emergency contraception can promptly obtain whatever contraceptive best meets their personal preferences and needs; this will require removing barriers and promoting access to intrauterine devices at emergency contraception visits.

Visits to Registered Nurses: An Opportunity to Increase Contraceptive Access in California.

BACKGROUND: In 2013, California passed Assembly Bill (A.B.) 2348, approving registered nurses (RNs) to dispense patient self-administered hormonal contraceptives and administer injections of hormonal contraceptives. The Family Planning, Access, Care and Treatment (Family PACT) program, which came into effect in 1997 to expand low-income, uninsured California resident access to contraceptives at no cost, is one program in which qualified RNs can dispense and administer contraceptives. AIMS: The aims of this study were to (a) describe utilization of RN visits within California's Family PACT program and (b) evaluate the impact of RN visits on client birth control acquisition during the first 18 months after implementation of A.B. 2348 (January 1, 2013 to June 30, 2014). METHODS: A descriptive observational design using administrative databases was used. Family PACT claims were retrieved for RN visits and contraception. Paid claims for contraceptive dispensing and/or administration visits by physicians, nurse practitioners, certified nurse midwives, and physician assistants were compared before and after the implementation of A.B. 2348 at practice sites where RN visits were and were not utilized. Contraceptive methods and administration procedures were identified using Healthcare Common Procedure Coding System codes, National Drug Codes, and Common Procedural Terminology codes. Claims data for healthcare facilities were abstracted by site location based on a unique combination of National Provider Identifier (NPI), NPI Owner, and NPI location number. RESULTS: RN visits were found mainly in Northern California and the Central Valley (73%). Sixty-eight percent of RN visits resulted in same-day dispensing and/or administration of hormonal (and/or barrier) methods. Since benefit implementation, RN visits resulted in a 10% increase in access to birth control dispensing and/or administration visits. RN visits were also associated with future birth control acquisition and other healthcare utilization within the subsequent 30 days. DISCUSSION: RN visits, though underutilized across the state, have resulted in increased access to contraception in some communities, an effect that may continue to grow with time and can serve as a model for other states.

Pregnancy context and women's health-related quality of life.

OBJECTIVE: The objective was to quantify the association of pregnancy context and health-related quality of life (HRQoL). STUDY DESIGN: English- or Spanish-speaking women, aged 16-44, with pregnancies <24 weeks' gestation were enrolled in this cross-sectional study between June 2014 and June 2015. Participants completed self-assessments of pregnancy "context," including timing, intention, wantedness, desirability, happiness, and planning (measured with the London Measure of Unplanned Pregnancy). HRQoL was measured using the Patient Reported Outcomes Measurement Information System Global Short Form. Associations between measures of pregnancy context and HRQoL scores in the lowest tertile were examined using multivariable logistic regression to adjust for potential confounding variables. RESULTS: We enrolled 161 participants (mean age=27.2±6.6 years). Only 14% self-identified as White, non-Hispanic; 42% Hispanic; 37% Black, non-Hispanic; and 7% multiracial. Most (79%) participants were unmarried, and 75% were parenting. Mean gestational age was 9±4.6 weeks. In unadjusted models, women reporting mixed feelings about wanting to have a baby, an undesired pregnancy or feeling unhappy about learning of their pregnancy more frequently had low mental and physical HRQoL compared to women reporting wanted, desired, happy pregnancies. Women with an unplanned pregnancy or pregnancy occurring at the wrong time also had lower physical HRQoL than women reporting pregnancies that were planned or happened at the right time. However, after multivariate adjustment, including history of depression, pregnancy contexts were not associated with low mental or physical HRQoL. CONCLUSIONS: After adjusting for multiple confounders, pregnancy context is not significantly associated with HRQoL. IMPLICATIONS: The focus on pregnancy intention in public health programs may not sufficiently assess multidimensional aspects of pregnancy context and may not align with patient-centered outcomes such as HRQoL.

The impact of out-of-pocket expense on IUD utilization among women with private insurance.

BACKGROUND: The study was conducted to evaluate the impact of out-of-pocket expense on intrauterine device (IUD) utilization among women with private insurance. STUDY DESIGN: We reviewed the records of all women with private insurance who requested an IUD for contraception from an urban academic gynecology practice from May 2007 through April 2008. For each patient, we determined the out-of-pocket expense that would be incurred and whether she ultimately had an IUD placed. The total charge for placement of a copper or levonorgestrel IUD (including the device) was $815. RESULTS: Ninety-five women requested an IUD during the study period. The distribution of out-of-pocket expense was bimodal: less than $50 for 35 (37%) women and greater than $500 for 52 (55%) women. Intrauterine device insertion occurred in 24 (25%) women, 19 of whom had an out-of-pocket expense less than $50. In univariate and multivariable analysis, women with insurance coverage that resulted in less than $50 out-of-pocket expense for the IUD were more likely to have an IUD placed than women required to pay $50 or more (adjusted odds ratio=11.4, 95% confidence interval=3.6-36.6). CONCLUSIONS: Women requesting an IUD for contraception are significantly more likely to have an IUD placed when out-of-pocket expense is less than $50.

Breastfeeding and subsequent maternal visceral adiposity.

Women gain visceral fat during pregnancy. Studies examining the impact of breastfeeding on maternal body composition are inconclusive. We examined the extent to which breastfeeding was associated with visceral adiposity in a sample of US women. This was a cross-sectional analysis of 351 women aged 45-58 years, who were free of clinical cardiovascular disease and had not used oral contraceptives or hormone replacement therapy in the 3 months prior to enrollment in the Study of Women's Health Across the Nation (SWAN)-Heart Study (2001-2003). History of breastfeeding was self-reported. Computed tomography was used to assess abdominal adiposity. Among premenopausal/early-peri-menopausal mothers, those who never breastfed had 28% greater visceral adiposity (95% confidence interval (CI): 11-49, P = 0.001), 4.7% greater waist-hip ratio (95% CI: 1.9-7.4, P < 0.001), and 6.49 cm greater waist circumference (95% CI: 3.71-9.26, P < 0.001) than mothers who breastfed all of their children for ≥3 months in models adjusting for study site; age; parity; years since last birth; socioeconomic, lifestyle, and family history variables; early adult BMI; and current BMI. In comparison to women who were nulliparous, mothers who breastfed all of their children for ≥3 months had similar amounts of visceral fat (P > 0.05). In contrast, premenopausal/early-peri-menopausal mothers who had never breastfed had significantly greater visceral adiposity (42% (95% CI: 17-70), P < 0.001), waist circumference (6.15 cm (95% CI: 2.75-9.56), P < 0.001), and waist-hip ratio (3.7% (95% CI: 0.69-6.8), P = 0.02) than nulliparous women. No significant relationships were observed among late peri-menopausal/postmenopausal women. In conclusion, until menopause, mothers who did not breastfeed all of their children for ≥3 months exhibit significantly greater amounts of metabolically active visceral fat than mothers who had breastfed all of their children for ≥3 months.

Reliability of laparoscopic compared with hysteroscopic sterilization at 1 year: a decision analysis.

OBJECTIVE: To estimate the probability of successful sterilization after an hysteroscopic or laparoscopic sterilization procedure. METHODS: An evidence-based clinical decision analysis using a Markov model was performed to estimate the probability of a successful sterilization procedure using laparoscopic sterilization, hysteroscopic sterilization in the operating room, and hysteroscopic sterilization in the office. Procedure and follow-up testing probabilities for the model were estimated from published sources. RESULTS: In the base case analysis, the proportion of women having a successful sterilization procedure on the first attempt is 99% for laparoscopic sterilization, 88% for hysteroscopic sterilization in the operating room, and 87% for hysteroscopic sterilization in the office. The probability of having a successful sterilization procedure within 1 year is 99% with laparoscopic sterilization, 95% for hysteroscopic sterilization in the operating room, and 94% for hysteroscopic sterilization in the office. These estimates for hysteroscopic success include approximately 6% of women who attempt hysteroscopically but are ultimately sterilized laparoscopically. Approximately 5% of women who have a failed hysteroscopic attempt decline further sterilization attempts. CONCLUSION: Women choosing laparoscopic sterilization are more likely than those choosing hysteroscopic sterilization to have a successful sterilization procedure within 1 year. However, the risk of failed sterilization and subsequent pregnancy must be considered when choosing a method of sterilization.

Use of emergency contraception by US teens: effect of access on promptness of use and satisfaction.

STUDY OBJECTIVE: To examine the effect of policies regarding access to emergency contraception (EC) on teens' promptness of EC use and satisfaction with EC access experience. SETTING: Online survey. PARTICIPANTS: Females, ages 14 to 19, who had engaged in unprotected intercourse at a time when they were aware of EC. MAIN OUTCOME MEASURES: Outcomes included promptness of EC use and satisfaction with EC access experience. Outcomes were compared according to method of obtaining EC and state policies regarding EC access. RESULTS: Surveys were completed by 531 teens from 49 states; 58% were Caucasian and 14% were African American. Only 48% of participants reported ever using EC. Teens who obtained EC without a prescription were more likely to use EC within 24 hours of unprotected intercourse (odds ratio = 2.17; 95% confidence interval: 1.06-4.44). Minors who obtained EC in pharmacist-access states were more likely to be satisfied with their EC access experience (odds ratio = 3.05; 95% confidence interval: 1.11-8.35). CONCLUSION: Fewer than half of participants had used EC, despite being aware of EC at the time of unprotected intercourse. Policies allowing minors to access EC without a prescription may increase timely use of EC.

Hormonal contraception use and pregnancy in adolescents with sickle cell disease: analysis of Michigan Medicaid claims.

BACKGROUND: Access to effective family planning is of great importance for women with sickle cell disease (SCD) due to the increased frequency of pregnancy complications. However, little is known regarding use of hormonal contraception, complications of contraception, and pregnancy in young women with SCD. STUDY DESIGN: We abstracted diagnostic codes, procedure codes and pharmacy claims from women with SCD, aged 13-21 years, enrolled in Michigan Medicaid between 1/1/2000 and 12/31/2003 with ≥ 9 months of continuous eligibility. RESULTS: We identified 250 women with SCD with an average period of continuous Medicaid enrollment of 20 months. Claims for hormonal contraception could be identified in only 20 patients (8%, 95% CI 5-12%). The most commonly prescribed method (n=12) was depot medroxyprogesterone (DMPA) acetate. Venous thromboembolism and osteopenia were rarely identified (n ≤ 10) and occurred only in women with no recorded use of hormonal contraception. In the total population, 64 patients had one pregnancy and 16 had ≥ 2 pregnancies during the 4-year study period. Among adolescents (13-18 years), 49 (30%) of 195 patients (95% CI 24-37%) had 59 pregnancies. By 12 weeks postpartum, few patients (n ≤ 10) with a record of delivery had hormonal contraception claims. CONCLUSIONS: In a publicly insured population of young women with SCD, pregnancy was more commonly identified than hormonal contraception use. Our work suggests that significant gaps may exist in family planning care for young women with SCD.

Unintended pregnancy influences racial disparity in tubal sterilization rates.

BACKGROUND: Minority women are more likely than white women to choose tubal sterilization as a contraceptive method. Disparities in rates of unintended pregnancy may help explain observed racial/ethnic differences in sterilization, but this association has not been investigated. OBJECTIVE: To examine the associations among race/ethnicity, unintended pregnancy, and tubal sterilization. DESIGN AND PARTICIPANTS: Cross-sectional analysis of data from a nationally representative sample of women aged 15-44 years [65.7% white, 14.8% Hispanic, and 13.9% African American (AA)] who participated in the 2002 National Survey of Family Growth. MAIN MEASURES: Race/ethnicity, history of unintended pregnancy, and tubal sterilization. A logistic regression model was used to estimate the effect of race/ethnicity on unintended pregnancy while adjusting for socio-demographic variables. A series of logistic regression models was then used to examine the role of unintended pregnancy as a confounder for the relationship between race/ethnicity and sterilization. KEY RESULTS: Overall, 40% of white, 48% of Hispanic, and 59% of AA women reported a history of unintended pregnancy. After adjusting for socio-demographic variables, AA women were more likely (OR: 2.0; 95% CI: 1.6-2.4) and Hispanic women as likely (OR: 1.0; 95% CI: 0.80-1.2) as white women to report unintended pregnancy. Sterilization was reported by 29% of women who had ever had an unintended pregnancy compared to 7% of women who reported never having an unintended pregnancy. In unadjusted analysis, AA and Hispanic women had significantly higher odds of undergoing sterilization (OR: 1.5; 95% CI: 1.3-1.9 and OR: 1.4; 95% CI: 1.2-1.7, respectively). After adjusting for unintended pregnancy, this relationship was attenuated and no longer significant (OR: 1.2; 95% CI: 0.95-1.4 for AA women and OR: 1.3; 95% CI: 1.0-1.6 for Hispanic women). CONCLUSION: Minority women, who more frequently experience unintended pregnancy, may choose tubal sterilization in response to prior experiences with an unintended pregnancy.

Unintended pregnancy and associated maternal preconception, prenatal and postpartum behaviors.

BACKGROUND: This study was conducted to determine the relationship between unintended pregnancy and maternal behaviors before, during and after pregnancy. STUDY DESIGN: Data were analyzed from a stratified random sample of 9048 mothers who delivered live born infants between 2001 and 2006 and completed the Pregnancy Risk Assessment Monitoring System (PRAMS) survey 2 to 9 months after delivery. Binary and ordinal logistic regression methods with appropriate survey weights were used to control for socio-demographic factors. RESULTS: Compared to women with intended pregnancies, mothers with unwanted pregnancies were more likely to consume less than the recommended amount of preconception folic acid [adjusted odds ratio (OR) 2.39, 95% confidence interval (CI) 1.7-3.2], smoke prenatally (OR 2.03, 95% CI 1.5-2.9), smoke postpartum (OR 1.86, 95% CI 1.35-2.55) and report postpartum depression (OR 1.98, 95% CI 1.48-2.64); they were less likely to initiate prenatal care during the first trimester (OR 0.34, 95% CI 0.3-0.5) and breastfeed for 8 or more weeks (OR 0.74, 95% CI 0.57-0.97). Compared to women with intended pregnancies, women with mistimed pregnancies were also more likely to consume inadequate folic acid, delay prenatal care and report postpartum depression. CONCLUSION: Even after controlling for multiple socio-demographic factors, unwanted and mistimed pregnancies were associated with unhealthy perinatal behaviors.

The impact of race and ethnicity on receipt of family planning services in the United States.

OBJECTIVE: This study sought to examine the independent effect of patient race or ethnicity on the use of family planning services and on the likelihood of receiving counseling for sterilization and other birth control methods. METHODS: This study used national, cross-sectional data collected by the 2002 National Survey of Family Growth (NSFG). Our analysis included women aged 18-44 years who had heterosexual intercourse within the past 12 months, who were not actively seeking to get pregnant, and who had not undergone surgical sterilization. The primary outcome was receipt of family planning services within the past 12 months. Specific services we examined were (1) provision of or prescription for a method of birth control, (2) checkup related to using birth control, (3) counseling about sterilization, and (4) counseling about birth control. RESULTS: Although we found no racial/ethnic differences in the overall use of family planning services, there were racial/ethnic differences in the specific type of service received. Hispanic and black women were more likely than white women to receive counseling for birth control (adjusted OR 1.5, 95% confidence interval [CI] 1.2, 1.8, and adjusted OR 1.3, 95% CI 1.1, 1.7, respectively). Hispanic women were more likely than white women to report having been counseled about sterilization (adjusted OR 1.5, 95% CI 1.0, 2.3). CONCLUSIONS: Minority women were more likely to receive counseling about sterilization and other birth control methods. However, there were no differences in access to family planning services by race or ethnicity. Future studies are needed to examine the quality and content of contraceptive counseling received by minority compared with nonminority women.

Race, insurance status, and desire for tubal sterilization reversal.

OBJECTIVE: To examine the independent effects of race/ethnicity and insurance status on desire for tubal sterilization reversal. DESIGN: Secondary analysis of cross-sectional data collected by the 2002 National Survey of Family Growth (NSFG). SETTING: Interviews were conducted in person by a trained female interviewer in the participant's home. PATIENT(S): The NSFG is designed to represent women and men 15-44 years of age in the U.S. household population. The sample consisted of 934 women who had undergone tubal sterilization at any time before being interviewed. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Desire for sterilization reversal. RESULT(S): Among women older than 30 years at time of surgery, black women were significantly more likely to desire sterilization reversal compared with white women (adjusted odds ratio, 2.6; 95% confidence interval, 1.2, 5.8). In the total cohort and in the subset of women 30 years or younger, there were no significant racial/ethnic variations in desire for sterilization reversal. CONCLUSION(S): Among women over age 30 at the time of tubal sterilization, black women were much more likely to express desire for reversal than white women.

Race, insurance status, and tubal sterilization.

OBJECTIVE: To examine the independent effects of race or ethnicity and insurance status on use of tubal sterilization rates. METHODS: This study used cross-sectional data collected by the 2002 National Survey of Family Growth. The survey is designed to represent women and men aged 15-44 years in the household population of the United States. Our main outcome measure was tubal sterilization at any time before interview. A multivariable logistic regression model was used to estimate the effects of race or ethnicity and insurance status on rates of tubal sterilization after adjusting for important confounders. RESULTS: The sample consisted of 7,643 women: 66% were white, 15% were Hispanic, and 14% were African American; 68% had private insurance and 32% had public or no insurance. After adjusting for age, insurance status, parity, income, education, marital status, and religion, African-American women were more likely than white women to undergo tubal sterilization (adjusted odds ratio 1.43, 95% confidence interval 1.08-1.88). After adjusting for age, race or ethnicity, parity, income, education, marital status, and religion, women with public or no insurance were more likely to undergo sterilization compared with women with private insurance (adjusted odds ratio 1.38, 95% confidence interval 1.09-1.74). CONCLUSION: African-American women and women with no or public insurance were more likely to have undergone tubal sterilization compared with white women and women with private insurance, respectively. Additional research to identify factors that influence women's decision to undergo sterilization is warranted. LEVEL OF EVIDENCE: II.