Provider confidence in counseling preconception, pregnant, and postpartum patients regarding COVID-19 vaccination: A cross-sectional survey study.

Background and Aims: Healthcare provider counseling surrounding COVID-19 vaccine in pregnancy and lactation is essential to vaccination uptake in this population; however, provider knowledge and confidence are not well characterized. We aimed to assess knowledge and confidence in COVID-19 vaccine counseling among practitioners who provide care to pregnant persons and to describe factors associated with confidence in counseling. Methods: A web-based anonymous survey was distributed via email to a cross-sectional convenience sample of Obstetrics and Gynecology, Primary Care, and Internal Medicine faculty at three hospitals in a single healthcare network in Massachusetts, United States. Individual demographics and institution-specific variables were included in the survey along with questions assessing both attitudes toward COVID-19 illness and confidence in counseling regarding the use of the vaccine in pregnancy. Results: Almost all providers (151, 98.1%) reported that they received a COVID-19 vaccine, and most (111, 72.1%) reported that they believe the benefits of the vaccine in pregnancy outweigh the risks. Forty-one (26.6%) reported feeling very confident in counseling patients who primarily speak English about the evidence for messenger ribonucleic acid vaccination in pregnancy, and 36 (23%) reported feeling very confident in counseling patients who are not primarily English-speaking. Forty-three providers (28.1%) expressed strong confidence in their comfort talking to individuals with vaccine hesitancy based on historic and continued racism and systemic injustices. The sources that survey respondents most used to find information regarding COVID-19 vaccination in pregnancy were the Centers for Disease Control (112, 74.2%), hospital-specific resources (94, 62.3%), and the American College of Obstetricians and Gynecologists (82, 54.3%). Conclusion: Ensuring that providers feel comfortable bridging the gap between their belief that the vaccine is beneficial for pregnant patients and their comfort with holding conversations with patients regarding vaccination is paramount to ensure equitable access to vaccines for pregnant patients.

Experiences Navigating the Pregnancy Care Continuum During the COVID-19 Pandemic.

INTRODUCTION: The COVID-19 pandemic led to unprecedented changes in care delivery across the pregnancy care continuum. Our primary objective with this research was to characterize the range of ways that the early months of the COVID-19 pandemic affected pregnancy, childbirth, and postpartum care experiences. METHODS: Pregnant and recently pregnant patients (n = 20) from obstetrics and gynecology clinical sites associated with Massachusetts General Hospital were interviewed about their experiences with prenatal care, childbirth, and postpartum care during the first wave of the COVID-19 pandemic. Interview transcripts were analyzed for emergent themes. RESULTS: This sample included 20 pregnant and postpartum people, including 11 individuals who tested positive for COVID-19 during pregnancy or postpartum and nine with suspected infection. The ways in which COVID-19 or suspected COVID-19 affected experiences of prenatal care, childbirth, and postpartum care were complex and varied. Three themes were identified across narratives of pregnancy, birth, and postpartum care: patient perceptions of diminished access to care, stigma due to COVID-19 infection, and limited capacity of providers to honor patient preferences. CONCLUSIONS: A better understanding of pregnant and recently pregnant people's experiences during the early months of the COVID-19 pandemic can inform infection control policies and clinical care delivery practices that are more congruent with the needs and values of pregnant, birthing, and postpartum people as institutions craft responses to future pandemics. Approaches that maximize meaningful access across the pregnancy care continuum, center patients' priorities within adapted care models, and honor patient preferences as much as possible are important aspects of an appropriate response to future waves of COVID-19 and other pandemics.

Emotional Experiences of Pregnant and Postpartum People with Confirmed or Suspected COVID-19 Infection During the Initial Surge of the Pandemic.

Objectives: The COVID-19 pandemic may have a unique emotional impact on pregnant people. This qualitative study aimed to characterize the emotional effects of the COVID-19 pandemic on pregnant and recently pregnant patients who had either suspected or confirmed COVID-19 infection during the initial 6 months of the pandemic. Methods: Pregnant and recently pregnant participants (n = 20) from Massachusetts General Hospital Obstetrics and Gynecology clinical sites with suspected or confirmed COVID-19 infection were interviewed about their experiences during the COVID-19 pandemic. Interviews were transcribed and coded using NVivo 12 software. Using data display matrices, thematic analysis was performed to identify emergent, crosscutting themes. Results: Twenty pregnant and postpartum patients participated of whom 12 had confirmed COVID-19 infection and 8 had suspected infection. The most frequently described emotions were anxiety (90%), uncertainty (80%), fear (70%), relief (65%), and sadness (60%). The following three crosscutting themes were identified: risk, protection, and change. The ways in which participants articulated their emotional reactions to the themes of risk, protection, and change were complex and varied. Conclusions: There was a broad range of negative and positive emotional experiences of pregnancy, birth, and the postpartum period during the first 4 months of the COVID-19 pandemic. A better understanding of pregnant people's emotional experiences may lead to changes in clinical practice and institutional policies that are more supportive of their needs and congruent with their values.

Global disparities in public health guidance for the use of COVID-19 vaccines in pregnancy.

INTRODUCTION: Gaps in information about the safety and efficacy of COVID-19 vaccines in pregnancy have led to substantial global variation in public health guidance regarding the use of COVID-19 vaccines in pregnancy over the course of the pandemic. METHODS: We conducted systematic screenings of public health authorities' websites across 224 countries and territories every 3 weeks to track the development of policies on COVID-19 vaccine use in pregnancy. Policies were categorised using a 1-5 permissiveness scale, with 1 indicating policies that recommended use, and 5 indicating policies that recommended against use. RESULTS: As of 30 September 2021, 176 countries/territories had issued explicit guidance on COVID-19 vaccine use in pregnancy, with 38% recommending use, 28% permitting use, 15% permitting use with qualifications, 2% not recommending but with exceptions, and 17% not recommending use whatsoever. This represented a significant shift from May 2021, when only 6% of countries/territories with such policies recommended the use of COVID-19 vaccines in pregnancy (p<0.001). However, no policy positions could be found for 21% of all countries and territories, the vast majority being low and middle income. Policy positions also varied widely by vaccine product, with Pfizer/BioNTech and Moderna vaccines being most commonly recommended or permitted. CONCLUSION: Our study highlights the evolution of policies regarding COVID-19 vaccine use in pregnancy over a 5-month period in 2021, the role of pregnancy-specific data in shaping these policies and how inequities in access for pregnant people persist, both within countries and globally.

Conspiracy theories and misinformation about COVID-19 in Nigeria: Implications for vaccine demand generation communications.

INTRODUCTION: COVID-19 vaccine hesitancy is a worldwide phenomenon and a serious threat to pandemic control efforts. Until recently, COVID-19 vaccine hesitancy was not the cause of low vaccine coverage in Nigeria; vaccine scarcity was the problem. As the global supply of COVID-19 vaccines improves in the second half of 2021 and more doses are deployed in Nigeria, the supply/demand dynamic will switch. Vaccine acceptance will become a key driver of coverage; thus, amplifying the impact of vaccine hesitancy. Conspiracy theories and misinformation about COVID-19 are rampant and have been shown to drive vaccine hesitancy and refusal. This study systematically elicits the misinformation and conspiracy theories circulating about COVID-19 among the Nigerian public to understand relevant themes and potential message framing for communication efforts to improve vaccine uptake. METHODS: From February 1 to 8, 2021, we conducted 22 focus group discussions and 24 key informant interviews with 178 participants from six states representing the six geopolitical zones. Participants were purposively selected and included sub-national program managers, healthcare workers, and community members. All interviews were iteratively analyzed using a framework analysis approach. RESULTS: We elicited a total of 33 different conspiracy theories or misinformation that participants had heard about the COVID-19 virus, pandemic response, or vaccine. All participants had heard some misinformation. The leading claim was that COVID-19 was not real, and politicians took advantage of the situation and misused funds. People believed certain claims based on distrust of government, their understanding of Christian scripture, or their lack of personal experience with COVID-19. CONCLUSIONS: Our study is the first to report a thematic analysis of the range of circulating misinformation about COVID-19 in Nigeria. Our findings provide new insights into why people believe these theories, which could help the immunization program improve demand generation communication for COVID-19 vaccines by targeting unsubstantiated claims.

Prolonged Second Stage of Labor and Anal Sphincter Injury in a Contemporary Cohort of Term Nulliparas.

OBJECTIVE: This study aimed to assess whether a prolonged second stage of labor is an independent predictor of obstetric anal sphincter injury (OASI) in a contemporary cohort of nulliparous and term parturients, and to evaluate whether predelivery factors can accurately predict OASI. STUDY DESIGN: This was a nested case-control study within a cohort of consecutive nulliparous term parturients with a singleton gestation who underwent a vaginal delivery at a single institution between January 2014 and January 2015. Cases were defined as women with a third- or fourth-degree laceration at the time of delivery, and controls were women without a third- or fourth-degree laceration. A prolonged second stage was defined as a second stage of ≥3 hours. Univariable and multivariable regression analyses were performed to examine the relationship between prolonged second stage of labor and third- or fourth-degree lacerations. Receiver operator curves were developed to assess the predictive capacity of predelivery information for third- and fourth-degree lacerations. RESULTS: Of 1,197 births, 63 women had third- or fourth-degree lacerations (5.3%). With each additional hour of the second stage, the rate of OASI increased, with 2.9% of women with a second stage of <1 hour with OASI, 3.5% between 1 and 2 hours, 5.7% between 2 and 3 hours, 7.8% between 3 and 4 hours, 16.1% between 4 and 5 hours, and 28.6% among women with a second stage length >5 hours (p < 0.001). In multivariable regression analysis, operative vaginal delivery (adjusted odds ratio [aOR] = 5.92, 95% confidence interval [CI]: 3.17-11.07) and a prolonged second stage (aOR = 1.92, 95% CI: 1.06-3.51) were independent predictors of third- and fourth-degree lacerations. A predictive model was developed from these results (area under the curve [AUC] = 0.75, 95% CI: 0.68-0.81). CONCLUSION: Prolonged second stage of labor is a predictor of OASI, after adjustment for operative vaginal delivery. A model using predelivery risk factors has a reasonable prediction of OASI. KEY POINTS: · Prolonged second stage labor is associated with obstetric anal sphincter injury in term nulliparas.. · Predelivery risk factors reasonably predict obstetric anal sphincter injury in term nulliparas.. · Improved models are needed for clinical risk-stratification..

Menopause-related medication use among women age 45-75 experiencing incarceration in North Carolina 2015-2016.

PURPOSE: This study aims to estimate the prevalence of individuals receiving hormone therapy for menopause management and the prevalence of underlying conditions that may constrain options for pharmacologic menopause management in the prison context. DESIGN/METHODOLOGY/APPROACH: This study reviewed all prescriptions dispensed by the North Carolina Department of Public Safety between July 1, 2015, and June 30, 2016, for relevance to menopause management. Relevant medications were those either recommended for menopause management or those indicated for management of conditions that may complicate menopause management, as per the 2015 clinical decision-support algorithm tool developed by the North American Menopause Society. Analysis was restricted to women between the ages of 45 and 75. FINDINGS: Of 1,120 women, a majority (77.8%) were between the ages of 45 and 54. Less than 5% of individuals in this study were prescribed estrogen-containing therapy. The most commonly prescribed medications that may constrain options for menopause treatment were related to hypertension and other cardiovascular disease or mental health conditions. RESEARCH LIMITATIONS/IMPLICATIONS: The retrospective nature of this data set limits the findings, given that researchers did not have access to diagnoses or data on polypharmacy. Still, this study indicates that many women over 45 experiencing incarceration are living with health conditions that may complicate menopause symptom management with hormone therapy. Future research in carceral settings must examine the prevalence of menopause-related symptoms as well as access to and quality of comprehensive menopause management. ORIGINALITY/VALUE: There is a paucity of literature around the menopause-related needs of individuals experiencing incarceration. To the best of the authors' knowledge, no other research has examined prevalence of pharmacologic menopause management among women who are incarcerated.

Ending the evidence gap for pregnancy, HIV and co-infections: ethics guidance from the PHASES project.

INTRODUCTION: While pregnant people have been an important focus for HIV research, critical evidence gaps remain regarding prevention, co-infection, and safety and efficacy of new antiretroviral therapies in pregnancy. Such gaps can result in harm: without safety data, drugs used may carry unacceptable risks to the foetus or pregnant person; without pregnancy-specific dosing data, pregnant people face risks of both toxicity and undertreatment; and delays in gathering evidence can limit access to beneficial next-generation drugs. Despite recognition of the need, numerous barriers and ethical complexities have limited progress. We describe the process, ethical foundations, recommendations and applications of guidance for advancing responsible inclusion of pregnant people in HIV/co-infections research. DISCUSSION: The 26-member international and interdisciplinary Pregnancy and HIV/AIDS: Seeking Equitable Study (PHASES) Working Group was convened to develop ethics-centred guidance for advancing timely, responsible HIV/co-infections research with pregnant people. Deliberations over 3 years drew on extensive qualitative research, stakeholder engagement, expert consultation and a series of workshops. The guidance, initially issued in July 2020, highlights conceptual shifts needed in framing research with pregnant people, and articulates three ethical foundations to ground recommendations: equitable protection from drug-related risks, timely access to biomedical advances and equitable respect for pregnant people's health interests. The guidance advances 12 specific recommendations, actionable within the current regulatory environment, addressing multiple stakeholders across drug development and post-approval research, and organized around four themes: building capacity, supporting inclusion, achieving priority research and ensuring respect. The recommendations describe strategies towards ethically redressing the evidence gap for pregnant people around HIV and co-infections. The guidance has informed key efforts of leading organizations working to advance needed research, and identifies further opportunities for impact by a range of stakeholder groups. CONCLUSIONS: There are clear pathways towards ethical inclusion of pregnant people in the biomedical research agenda, and strong agreement across the HIV research community about the need for - and the promise of - advancing them. Those who fund, conduct, oversee and advocate for research can use the PHASES guidance to facilitate more, better and earlier evidence to optimize the health and wellbeing of pregnant people and their children.

Pregnant Individuals' Views on Fetal Tissue Research in the United States.

OBJECTIVE: Fetal tissue research has driven significant medical advances but remains publicly contentious in the United States. The views of pregnant individuals in the United States regarding the donation of fetal tissue offer an important and previously unexplored perspective on this issue. METHODS: We conducted a secondary analysis of data from two separate, broader qualitative studies. Pregnant and recently pregnant individuals (N=79) from clinical sites at the University of North Carolina at Chapel Hill, Johns Hopkins University, and Massachusetts General Hospital were interviewed individually using a semi-structured guide addressing a range of issues related to infectious disease research and pregnancy, including the acceptability of fetal tissue research. Interviews were transcribed, coded, and analyzed for emergent themes. RESULTS: Among this sample of predominantly Black (61%), reproductive-aged pregnant and recently pregnant participants, the majority (72%) generally supported fetal tissue research. The following three themes were identified: choice, respect, and meaning. Respondents discussed the deeply personal nature of decisions surrounding fetal tissue research, emphasizing the importance of informed consent and respect for the person's emotional state when approaching for consent. The ways in which participants regarded how to respectfully handle fetal tissue also shaped views about the acceptability of donation, both for and against. For many participants, fetal tissue donation to research represented one way of ascribing meaning to pregnancy termination or loss. CONCLUSION: Among this diverse sample of pregnant and recently pregnant individuals, most were supportive of fetal tissue donation for research. A better understanding of pregnant individuals' views on this topic may lead to policies and practices that are congruent with the needs and values of people facing decisions regarding the disposition of fetal remains.

Advancing research in pregnancy during COVID-19: Missed opportunities and momentum in the US.

Pregnant people's exclusion from COVID-19 vaccine research highlights both the harms of excluding pregnant people from clinical trials and the growing public support for their equitable inclusion. Protectionary tendencies must be challenged for the sake of progress. The COVID-19 pandemic presents an opportunity to translate recognition of an unjust paradigm into action.

Experiences of menopause during incarceration.

OBJECTIVE: Despite increasing representation of older women in US jail and prison facilities, their menopause experiences and access to related care remain uncharacterized. Our objective is to explore the menopause experiences of women incarcerated in jail and prison facilities. METHODS: We conducted a pilot study of four semi-structured in-depth interviews with women in the community who experienced menopause symptoms while incarcerated in either a prison or jail facility. RESULTS: Preliminary findings suggest critical gaps in access to menopause-related resources and medical care. Participants described that lifestyle and medical interventions for menopause in prison were inaccessible, and that untreated symptoms contributed to significant distress. Participants reported feeling as though medical staff did not believe their concerns and were dismissive of their complaints. In some cases, menopause symptoms and symptom management exacerbated the ways in which institutional barriers reproduce criminalization within the carceral system. CONCLUSIONS: Individuals going through the menopause transition while experiencing incarceration have significant unmet needs and poor access to relieving lifestyle changes or medical interventions. Policy and practice changes should address menopause-related needs of individuals experiencing incarceration.

Video Summary:http://links.lww.com/MENO/A730 .

The Costs of Contradictory Messages About Live Vaccines in Pregnancy.

The increased risk of harm from COVID-19 infection in pregnancy highlights the importance of including pregnant people in COVID-19 vaccine development and deployment. Promising vaccines being developed include replication-competent platforms, which are typically contraindicated during pregnancy because of theoretical risk. However, replicating vaccines are administered in and around pregnancy, either inadvertently because of unknown pregnancy status or when recommended.The historical cases of Ebola virus, yellow fever, and rubella demonstrate that contradictory messages around the safety of live vaccines in pregnancy have critical public health costs. First, restricting study or use of replicating vaccines in pregnancy may delay or deny access to the only available protection against deadly diseases. Additionally, not vaccinating pregnant people may slow epidemic control. Finally, uncertainty and worry around the safety of live vaccines may lead to terminations of otherwise desired pregnancies after inadvertent vaccination in pregnancy.If one of the vaccines deployed to combat the current global COVID-19 pandemic is replication competent, historical cases offer important lessons for ethical and effective protection for pregnant populations.

Establishing Better Evidence on Remote Monitoring for Postpartum Hypertension: A Silver Lining of the Coronavirus Pandemic.

The transformation of our health care system in response to coronavirus disease 2019 (COVID-19) provides a unique opportunity to examine the use of telehealth for postpartum care. The postpartum period can pose significant risks and challenges, particularly for women with hypertensive disorders of pregnancy. Remote blood pressure monitoring has proven feasible and acceptable among women and providers but has not been widely implemented or researched. Early studies have identified improved outcomes with use of telehealth, including increased compliance with care and decreased disparity in hypertension follow-up. Preliminary data make a compelling case for remote monitoring as a promising treatment strategy to manage postpartum hypertension. Remote monitoring technology should be incorporated as a standard component for the comprehensive management of postpartum hypertension during COVID-19. As a consequence of the pandemic, we now have an opportunity to research the impact of postpartum remote blood pressure monitoring on maternal outcome and disparities within these outcomes.

Pregnant women's perceptions of risks and benefits when considering participation in vaccine trials.

INTRODUCTION: Despite historical exclusion, there has been recent recognition of the need to address the health of pregnant women in research on vaccines against emerging pathogens. However, pregnant women's views and decision-making processes about vaccine research participation during infectious disease outbreaks remain underexplored. This study aims to examine women's decision-making processes around vaccine research participation during infectious disease outbreaks. METHODS: We conducted qualitative semi-structured in-depth interviews with pregnant and recently pregnant women (n = 13), eliciting their views on four hypothetical Zika Virus vaccine research scenarios and probing their decision-making processes around participation. After recorded interviews were transcribed, thematic analysis was conducted based on a priori and emergent themes. RESULTS: Most women interviewed were accepting of vaccine research scenarios. Three broad themes-evidence, risk, and trust-characterized women's decision-making processes. Women varied in how different types and levels of evidence impacted their considerations, which risks were most salient to their decision-making processes, and from whom they trusted recommendations about vaccine research participation. Exemplary quotes from each theme are presented, and lessons for vaccine development during the current COVID-19 pandemic and future outbreaks are discussed. CONCLUSION: Some pregnant women are accepting of participation in vaccine research during infectious disease outbreaks. Incorporating their priorities into trial design may facilitate their participation and generation of evidence for this important population.

Views among Malawian women about joining HIV prevention clinical trials when pregnant.

BACKGROUND: The pressing need to expand the biomedical HIV prevention evidence base during pregnancy is now increasingly recognized. Women's views regarding participation in such trials and initiating PrEP while pregnant are critical to inform evolving policy and best practices aimed at responsibly expanding evidence-based access for this population. METHODS: We conducted 35 semi-structured interviews with reproductive-aged women in Malawi in the local language, Chichewa. Participants were HIV-negative and purposively sampled to capture a range of experience with research during pregnancy. Women's perspectives on enrolling in three hypothetical HIV prevention trial vignettes while pregnant were explored, testing: (1) oral PrEP (Truvada) (2) a vaginal ring (dapivirine), and (3) a randomized trial comparing the two. The vignettes were read aloud to participants and a simple visual was provided. Interviews were audio-recorded, transcribed, translated, and coded using NVivo 11. Thematic analysis informed the analytic approach. RESULTS: A majority of women accepted participation in all trials. Women's views on research participation varied largely based on their assessment of whether participation or nonparticipation would best protect their own health and that of their offspring. Women interested in participating described power dynamics with their partner as fueling their HIV exposure concerns and highlighted health benefits of participation-principally, HIV protection and access to testing/treatment and ancillary care, and perceived potential risks of the vignettes as low. Women who were uninterested in participating highlighted potential maternal and fetal health risks of the trial, challenges of justifying prevention use to their partner, and raised some modality-specific concerns. Women also described ways their social networks, sense of altruism and adherence requirements would influence participation decisions. CONCLUSIONS: The majority of participants conveyed strong interest in participating in biomedical HIV prevention research during pregnancy, largely motivated by a desire to protect themselves and their offspring. Our results are consistent with other studies that found high acceptance of HIV prevention products during pregnancy, and support the current direction of HIV research policies and practices that are increasingly aimed at protecting the health of pregnant women and their offspring through responsible research, rather than defaulting to their exclusion.

Women's views about contraception requirements for biomedical research participation.

The scientific and ethical importance of including women of reproductive age in biomedical research is widely acknowledged. Concerns about preventing fetal exposure to research interventions have motivated requirements for contraception among reproductive aged women in biomedical studies-often irrespective of risks and benefits or a woman's actual potential for pregnancy, raising important questions about when such requirements are appropriate. The perspectives of women themselves on these issues are largely unexplored. We conducted 140 interviews, 70 in the U.S. and 70 in Malawi, with women either living with or at-risk for HIV, exploring their views about the practice of requiring contraception in clinical trials. A majority of women interviewed from both countries indicated overall support for the practice, with seven themes characterizing advantages and disadvantages raised: reproductive control, health effects, prevention of fetal harm, burden on women, deferral to authority, autonomy regarding enrollment and birth control method, and relationship concerns. While women in the US frequently raised prevention of fetal harm as a key advantage, many other positives noted by women in both countries were related to contraception use in general, not specific to a trial context. With regard to disadvantages, U.S. women tended to focus on biomedical risks such as side effects and impact on fertility, whereas Malawian women focused on the social risks of contraception requirements, including violations of trust in marital relations and suspicions of potential infidelity. Given the potential benefits and burdens highlighted, contraception in research should be sensitive to actual fetal risk assessments; directed where justified at optimizing effective pregnancy prevention; responsive to women's reproductive preferences; and made available as an ancillary benefit even where risk thresholds do not justify requirement-in order to facilitate trials that are both ethical and robustly oriented around the interests and lives of women who will participate in them.

Pregnant women's attitudes toward Zika virus vaccine trial participation.

INTRODUCTION: As Zika virus infection during pregnancy can cause a range of congenital anomalies, pregnant women may be a target population for vaccination in future outbreaks. Their inclusion in vaccine trials is critical to ensure safe and effective vaccines in pregnancy. Though many vaccine candidates are in development, pregnant women's willingness to participate in Zika virus vaccine research is unknown. This study aims to describe pregnant women's attitudes toward Zika virus vaccine research participation, as well as perceived barriers to and facilitators of enrollment. METHODS: Pregnant and recently postpartum women (n = 128) attending prenatal care at Massachusetts General Hospital completed surveys querying their willingness to participate in four hypothetical Zika virus vaccine trials and their motivations for participation. Demographics, information on prior Zika virus exposure, and vaccine acceptance were collected. RESULTS: Most women (77%) accepted participation in at least one hypothetical Zika virus vaccine trial, and women were significantly more likely to accept prospective enrollment in an inactivated vaccine trial compared to a live-attenuated vaccine trial (p-value <0.0001) or a nucleic acid-based vaccine trial (p-value <0.0444). Important motivators for participation included evidence from research with pregnant and non-pregnant people, a desire to protect the baby from Zika, perceptions of vaccine safety, and provider recommendation. CONCLUSIONS: A majority of women in this cohort were willing to participate in a Zika virus vaccine trial while pregnant, however, differences in acceptance exist between vaccine platforms. The high value placed on evidence by participants highlights the importance of gathering and communicating pregnancy-specific data to potential research participants and their providers. Women's motivations for accepting research participation during pregnancy are important to inform the Zika virus vaccine research agenda, candidate prioritization, and trial design.

Women's Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy.

Clinical research to inform the evidence base to guide nonobstetrical care during pregnancy is critically important for the well-being of women and their future offspring. Conversations about regulations for such research, including whether paternal consent should ever be required, should be informed by the perspectives of those most affected, namely, pregnant women. We conducted in-depth interviews with 140 pregnant women living with or at risk of HIV-70 in Malawi, 70 in the United States-exploring their views on requiring paternal consent for pregnant women's participation in trials offering the prospect of direct benefit solely to the fetus. The majority of women supported such a requirement; others raised concerns. A trio of themes-the father's or pregnant woman's rights, fetal protection, and gender/relationship dynamics-characterized views both supporting and against a paternal consent requirement, expanding the range of considerations that should inform approaches to paternal involvement in research with pregnant women.