Comprehension of an Over-the-Counter Drug Facts Label Prototype for a Mifepristone and Misoprostol Medication Abortion Product.

OBJECTIVE: To develop a drug facts label prototype for a combination mifepristone and misoprostol product and to conduct a label-comprehension study to assess understanding of key label concepts. METHODS: We followed U.S. Food and Drug Administration guidance, engaged a multidisciplinary group of experts, and conducted cognitive interviews to develop a drug facts label prototype for medication abortion. To assess label comprehension, we developed 11 primary and 13 secondary communication objectives related to indications for use, eligibility, dosing regimen, contraindications, warning signs, side effects, and recognizing the risk of treatment failure, with corresponding target performance thresholds (80-90% accuracy). We conducted individual structured video interviews with people with a uterus aged 12-49 years, recruited through social media. Participants reviewed the drug facts label and responded to questions to assess their understanding of each communication objective. After transcribing and coding interviews, we estimated the proportion of correct responses and exact binomial 95% CIs by age and literacy group. RESULTS: We interviewed 851 people (of 1,507 people scheduled); responses from 844 were eligible for analysis, and 35.7% (n=301) of participants were aged 12-17 years. The overall sample met performance criteria for 10 of the 11 primary communication objectives (93-99% correct) related to indications for use, eligibility for use, the dosing regimen, and contraindications; young people met nine and people with limited literacy met eight of the 11 performance criteria. Only 79% (95% CI 0.76-0.82) of the overall sample understood to contact a health care professional if little or no bleeding occurred soon after taking misoprostol, not meeting the prespecified threshold of 85.0%. CONCLUSION: Overall, high levels of comprehension suggest that people can understand most key drug facts label concepts for a medication abortion product without clinical supervision and recommend minor modifications.

Balancing enhanced contraceptive access with risk of reproductive injustice: A United States comparative case study.

OBJECTIVE: We aimed to examine how peripartum contraceptive care quality improvement efforts address or perpetuate reproductive health injustices. STUDY DESIGN: We conducted a comparative case study of inpatient postpartum contraceptive care implementation in 2017 to 2018, using key informant interviews at 11 United States hospitals. After our primary analysis revealed tensions between enhancing access to contraceptive care and patient-centeredness, we conducted the current inductive content analysis guided by 4 questions developed post-hoc: (1) What are healthcare workers' aspirations for contraceptive quality improvement programs? (2) What are healthcare workers' biases regarding peripartum contraceptive care delivery? (3) Do care delivery processes center patients' needs? (4) Do healthcare workers recognize and engage with structural inequities? RESULTS: Seventy-eight key informants (i.e., clinicians, operations staff, administrators) participated. In nine study sites, we observed evidence of interviewees both mitigating and perpetuating reproductive injustice. Many aspired to provide compassionate, patient-centered care, avoid paternalism, and foster patient autonomy. Simultaneously, interviewees demonstrated biases, including implicit subscription to an ideology of stratified reproduction, stereotyping, and "othering." Even when interviewees endorsed goals of patient-centeredness, care delivery processes sometimes prioritized healthcare systems' needs, and patients were not included on quality improvement teams. Many interviewees recognized structural inequities as driving health outcome disparities, yet relied on individual-level solutions like long-acting reversible contraception, and not structural-level interventions, to address them. CONCLUSION: Alongside enthusiasm for delivering compassionate care exist biases, missed opportunities to center patients, and lack of curiosity about the appropriateness of solving structural-level problems with individual-level solutions. IMPLICATIONS: Our findings call for individual and institutional self-reflection, partnership with patients and communities, and other intentional efforts to mitigate potential for harm in initiatives enhancing access to contraceptive care.

Reimagining Perinatal Mental Health: An Expansive Vision For Structural Change.

Diagnoses of depression, anxiety, or other mental illness capture just one aspect of the psychosocial elements of the perinatal period. Perinatal loss; trauma; unstable, unsafe, or inhumane work environments; structural racism and gendered oppression in health care and society; and the lack of a social safety net threaten the overall well-being of birthing people, their families, and communities. Developing relevant policies for perinatal mental health thus requires attending to the intersecting effects of racism, poverty, lack of child care, inadequate postpartum support, and other structural violence on health. To fully understand and address this issue, we use a human rights framework to articulate how and why policy makers must take progressive action toward this goal. This commentary, written by an interdisciplinary and intergenerational team, employs personal and professional expertise to disrupt underlying assumptions about psychosocial aspects of the perinatal experience and reimagines a new way forward to facilitate well-being in the perinatal period.

Community-informed models of perinatal and reproductive health services provision: A justice-centered paradigm toward equity among Black birthing communities.

Perinatal health outcomes in the United States continue to worsen, with the greatest burden of inequity falling on Black birthing communities. Despite transdisciplinary literature citing structural racism as a root cause of inequity, interventions continue to be mostly physician-centered models of perinatal and reproductive healthcare (PRH). These models prioritize individual, biomedical risk identification and stratification as solutions to achieving equity, without adequately addressing the social and structural determinants of health. The objective of this review is to: (1) examine the association between the impact of structural and obstetric racism and patient-centered access to PRH, (2) define and apply reproductive justice (RJ) as a framework to combat structural and obstetric racism in PRH, and (3) describe and demonstrate how to use an RJ lens to critically analyze physician-led and community-informed PRH models. We conclude with recommendations for building a PRH workforce whose capacity is aligned with racial equity. Institutional alignment with a RJ praxis creates opportunities for advancing PRH workforce diversification and development and improving PRH experiences and outcomes for our patients, communities, and workforce.

Reproductive Justice Disrupted: Mass Incarceration as a Driver of Reproductive Oppression.

We describe how mass incarceration directly undermines the core values of reproductive justice and how this affects incarcerated and nonincarcerated women.Mass incarceration, by its very nature, compromises and undermines bodily autonomy and the capacity for incarcerated people to make decisions about their reproductive well-being and bodies; this is done through institutionalized racism and is disproportionately done to the bodies of women of color. This violates the most basic tenets of reproductive justice-the right to have a child, not to have a child, and to parent the children you have with dignity and in safety.By undermining motherhood and safe pregnancy care, denying access to abortion and contraception, and preventing people from parenting their children at all and by doing so in overpoliced, unsafe environments, mass incarceration has become a driver of forms of reproductive oppression for people in prison and jails and in the community.

A factorial-design randomized controlled trial comparing misoprostol alone to Dilapan with misoprostol and comparing buccal to vaginal misoprostol for same-day cervical preparation prior to dilation & evacuation at 14 weeks 0 days-19 weeks 6 days gestation.

OBJECTIVES: To compare procedure times following same-day cervical preparation using misoprostol 400 mcg alone or misoprostol 400 mcg plus hygroscopic dilators for dilation and evacuation (D&E) before 20 weeks gestation and to compare side effects of buccal and vaginal misoprostol administration. STUDY DESIGN: We randomized women undergoing D&E at 14 weeks 0 days-19 weeks 6 days gestation to receive (1) hygroscopic dilators or not and (2) buccal or vaginal misoprostol using a 2 × 2 factorial design. We assessed two primary outcomes: (1) total procedure time, defined as time to insert hygroscopic dilators plus D&E time, and (2) side effects of misoprostol 4-6 h after initiation of cervical preparation using a 5-point Likert scale assessing nausea, emesis, diarrhea, chills and cramps. RESULTS: We randomized 163 women and 161 completed the study. We completed all procedures in one day. Mean total procedure time was 14.0 and 10.8 min. with and without hygroscopic dilators (difference 3.2 minutes, 95% CI 1.7, 4.6). Mean D&E procedure time was 0.7 (95% CI -0.8, 2.1) min longer without hygroscopic dilators. Initial cervical dilation was 15.6 and 11.7 mm with and without hygroscopic dilators (difference 3.9 mm, 95% CI 3.1, 4.8). Participants receiving buccal misoprostol reported less chills (1.9) than women receiving vaginal misoprostol (2.3), p = 0.04. CONCLUSIONS: Hygroscopic dilators with misoprostol requires more time and increases cervical dilation without shortening D&E time when used for cervical preparation 4-6 h prior to D&E before 20 weeks. Women receiving vaginal misoprostol may have more chills compared to buccal misoprostol. IMPLICATIONS: Adding hygroscopic dilators to misoprostol for same day D&E procedures at less than 20 weeks gestation increases total intervention time without reducing D&E time and is less favored by patients. Clinical judgment requires balancing relative effectiveness with patient preference. Further studies should evaluate the side effect profile of vaginal misoprostol.

Interruption of nonviable pregnancies of 24-28 weeks' gestation using medical methods: release date June 2013 SFP guideline #20133.

The need to interrupt a pregnancy between 24 and 28 weeks of gestation is uncommon and is typically due to fetal demise or lethal anomalies. Nonetheless, treatment options become more limited at these gestations, when access to surgical methods may not be available in many circumstances. The efficacy of misoprostol with or without mifepristone has been well studied in the first and earlier second trimesters of pregnancy, but its use beyond 24 weeks' gestation is less well described. This document attempts to synthesize the existing evidence for the use of misoprostol with or without mifepristone to induce labor for nonviable pregnancies at gestations of 24-28 weeks. The composite evidence suggests that a regimen combining mifepristone and misoprostol may shorten the time to expulsion, though the overall success rates are similar to those seen with misoprostol-only regimens.

Contraception counseling, pregnancy intention and contraception use in women with medical problems: an analysis of data from the Maryland Pregnancy Risk Assessment Monitoring System (PRAMS).

BACKGROUND: Data from the Maryland Pregnancy Risk Assessment Monitoring System (PRAMS) were used to evaluate whether women with selected medical comorbidities are less likely than healthier women to report receiving contraceptive counseling during pregnancy and to report using contraception postpartum. METHODS: We analyzed de-identified data from the 2004-2007 Maryland PRAMS using logistic regression to evaluate these outcomes: undesired pregnancy, self-reported antepartum contraceptive counseling and postpartum contraceptive use for women with and without hypertension, diabetes or heart disease. Survey data were used to estimate response frequency within the Maryland birth population. RESULTS: Patient self-report of contraceptive use increased overall during the postpartum period as compared to the antepartum period, from 44.3%-90.1% (p<.001). Almost one fourth (23%) of 6361 respondents reported receiving no contraceptive counseling. There was no difference in reported contraceptive counseling in women with selected medical comorbidities as compared to those without, and only women with preconception diabetes mellitus were significantly less likely than healthier women to report postpartum contraceptive use. CONCLUSIONS: Overall, there was no difference in the report of receiving contraceptive counseling in women with selected medical comorbidities as compared to than those without. In addition, they were not more likely to report receiving contraceptive counseling either despite higher risk of pregnancy complications. These results indicate lost opportunities for effective counseling that could improve health outcomes.