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Background: Both pregnant women and those with multiple long-term conditions are under-served groups in clinical research. Informing and improving research through patient and public involvement, including pregnant women with two or more long-term health conditions, is critical to increasing their inclusion in maternity research. Giant PANDA is a randomised controlled trial, evaluating the effect of a treatment initiation strategy with nifedipine versus labetalol on severe maternal hypertension and a composite outcome of fetal/neonatal death, or neonatal unit admission. We aimed to undertake a mixed methods study-within-a-project within the Giant PANDA trial to understand barriers and facilitators to participation, understand and optimise current representativeness of clinical trial delivery of those with multiple long-term conditions and co-create a checklist to support their inclusion in pregnancy research. Methods: We undertook online workshops with women with lived experience and hybrid workshops with healthcare professionals who look after women with multiple long-term conditions. A site audit of Giant PANDA sites provided insights into research delivery capacity and health system set-up, and how this influences inclusion. An extension to the Giant PANDA screening log captured data on multiple long-term conditions enabling analysis of the impact of these health conditions on women's inclusion in the trial. We co-created a checklist of recommendations for those designing and recruiting to similar clinical trials. Results: Five key recommendations were identified including a need to (1) involve women with multiple long-term conditions as partners in maternity research and (2) minimise barriers that stop them from taking part through (3) designing and delivering research that is flexible in time and place (4) consider research as part of care for everyone, including those with multiple long-term conditions and (5) measure and report inclusion of those with two or more health conditions in maternity research. Multiple long-term conditions were not a barrier to recruitment or randomisation in the Giant PANDA trial. Conclusion: Women with multiple long-term conditions would like opportunities to find out about and participate in research which accounts for their needs. Our checklist aims to support those designing and delivering maternity research to optimise inclusion of individuals with multiple-long term conditions. Trial registration: Giant PANDA: EudraCT number: 2020-003410-12, ISRCTN: 12,792,616. Plain English summary: Pregnant women with two or more long-term health problems may be less likely to be included in research. Including them in research is important to ensure we give the best care. Giant PANDA is a study comparing two medicines (nifedipine or labetalol) to manage high blood pressure in pregnancy. As part of the study, we looked at the number of women with two or more long-term health conditions included. We talked to women with experience of two or more long-term health conditions in pregnancy, and healthcare staff who look after these women. Finally, we looked at how maternity research is set up in Giant PANDA study sites. We found that women with two or more health conditions were taking part in the Giant PANDA study. Women with two or more long-term conditions would like the choice to be included in research which considers their needs. This includes being involved in the planning and ongoing support for studies. Research needs to be part of routine care, flexible, and not time consuming to help those with two or more health conditions take part. Our findings have been used to make a checklist to help plan and support studies for women and birthing people with two or more long-term health conditions. [ABSTRACT FROM AUTHOR]

Objective: The objectives of this study were to identify common social media misconceptions about COVID-19 vaccination in pregnancy, explain the spread of misinformation, and identify solutions to guide clinical practice and policy. Methodology: A systematic review was conducted and the databases Embase and Medline were searched from December 2019 to February 8, 2023, using terms related to social media, pregnancy, COVID-19 vaccines and misinformation. The inclusion criteria were original research studies that discussed misinformation about COVID-19 vaccination during pregnancy on social media. The exclusion criteria were review articles, no full text, and not published in English. Two independent reviewers conducted screening, extraction, and quality assessment. Results: Our search identified 76 articles, of which 3 fulfilled eligibility criteria. Included studies were of moderate and high quality. The social media platforms investigated included Facebook, Google Searches, Instagram, Reddit, TikTok, and Twitter. Misinformation was related to concerns regarding vaccine safety, and its association with infertility. Misinformation was increased due to lack of content monitoring on social media, exclusion of pregnant women from early vaccine trials, lack of information from reputable health sources on social media, and others. Suggested solutions were directed at pregnancy care providers (PCPs) and public health/government. Suggestions included: (i) integrating COVID-19 vaccination information into antenatal care, (ii) PCPs and public health should increase their social media presence to disseminate information, (iii) address population-specific vaccine concerns in a culturally relevant manner, and others. Conclusion: Increased availability of information from reputable health sources through multiple channels could increase COVID-19 vaccine uptake in the pregnant population and help combat misinformation. Highlights of the Study: Examples of misinformation on social media include safety of the COVID-19 vaccine, infertility, and harmful side-effects. Misinformation disseminated rapidly due to lack of social media monitoring, increased anti-vaccination messages, and lack of accurate information. Suggested solutions directed at care providers include integrating COVID-19 vaccination discussions into antenatal care. Public health and physicians should increase their presence on social media to disseminate vaccine-promoting information. [ABSTRACT FROM AUTHOR]

Pregnant women might have an increased risk of SARS-COV-2 infection. Although evidence towards the efficacy and safety of COVID-19 is growing still there is room for improvement on the knowledge towards pregnancy adverse events, such as miscarriage. We explored the association of COVID-19 vaccine with the risk of miscarriages using the Real-World. We identified a cohort of vaccinated pregnancies using the BIFAP database which contains systematically recorded data on care patients in Spain (N = 4054). We then restricted it to those women who had a miscarriage using a validated algorithm (N = 607). Among them, we performed a case-crossover design to evaluate the effect of intermittent exposures on the risk of miscarriage. Adjusted Odds Ratio with their confidence intervals were calculated using two analytical approaches: conditional logistic regression and Generalized Linear Mixed-Effects Models. A total of 225 (37.1%) were aged 35–39 years. The most common comorbidities were asthma, migraine, gastritis, and hypothyroidism. A total of 14.7% received only one dose of COVID-19 and 85.3% two doses, respectively. A total of 36.8% of women with one dose and 27.6% with two doses received the vaccine 7 days prior to the miscarriage. Corresponding adjusted estimates for the risk of miscarriage using the conditional logistic regression where as follows: 1.65 (95% CI 0.85–3.23) when using as the sum of 3 control moments among women with one dose, 1.02 (95% CI 0.72–1.46) among women with two doses and 1.03 (95% CI 0.72, 1.46) using the whole study population. Very similar results were obtained when conducting the Generalized Linear Mixed-Effects Models. There was no overall increased risk of miscarriage onset associated with COVID-19 vaccine although contradictory results were found according to the number of doses. Further studies are required with larger sample sizes to assess this association. [ABSTRACT FROM AUTHOR]

Background: Informed consent as stipulated in regulatory human research guidelines requires volunteers to be well-informed about what will happen to them in a trial. However, researchers may be faced with the challenge of how to ensure that a volunteer agreeing to take part in a clinical trial is truly informed. This study aimed to find out volunteers' comprehension of informed consent and voluntary participation in Human Immunodeficiency Virus (HIV) clinical trials during the registration cohort. Methods: We conducted a qualitative study among volunteers who were enrolled in the registration cohort of HIV clinical trials in Dar es Salaam, Tanzania. A purposive sampling strategy was used to obtain twenty study participants. The data were collected between June and September 2020 using a semi-structured interview guide. In-depth interviews were used to collect the data to obtain deep insights of the individual study participants on the comprehension of informed consent and participation in the clinical trial. A thematic analysis approach was used to analyze the data. Themes and subthemes were supported by the quotes from the participants. Results: Volunteers described comprehension of informed consent from different perspectives. They reported that various components of the informed consent such as study procedure, confidentiality, risk and benefits were grasped during engagement meetings. Furthermore, the volunteers' decision to participate in the registration cohort was voluntary. However, trial aspects such as health insurance, free condoms, and medical checkups could have indirectly influenced their reluctance to withdraw from the study. Conclusion: Engagement meetings may increase the comprehension of informed consent among potential participants for HIV clinical trials. However, trial incentives may influence participation, and thus future research should focus on the challenges of giving incentives in the study. This will ensure comprehension and voluntary participation in the context of HIV clinical trials. [ABSTRACT FROM AUTHOR]

Background: This chart review aimed to assess the COVID-19 vaccination status of pregnant patients prior to hospitalization for delivery and vaccine administration while hospitalized postpartum., Methods: This was a retrospective chart review of pregnant patients admitted for delivery at WakeMed Hospital during a six-month period who were offered COVID-19 vaccination immediately following delivery. We analyzed demographic characteristics by vaccination status prior to admission, during hospitalization, and at discharge. ANOVA, chi-squared, and multinomial logistic regression analyses were performed., Results: Data analysis was performed on 1,476 obstetric patients admitted for delivery, of which 260 (17.6%) were vaccinated prior to admission. Of the 1,216 unvaccinated postpartum patients, 257 (21.1%) received a vaccine dose. Among our population, for every year increase in age, the odds of being vaccinated before admission and receiving vaccination while hospitalized postpartum were higher than those of remaining unvaccinated. The odds of being vaccinated before admission versus remaining unvaccinated at discharge were lower for Black patients compared to White patients. The odds of receiving vaccination during hospitalization were higher for Asian and Hispanic/ Latino patients compared to White patients. The odds of being vaccinated prior to admission versus remaining unvaccinated at discharge were higher for those with private insurance compared to those with public insurance., Limitations: At the time of our intervention, we did not collect data on COVID-19 infection status of the patient at the time of admission. Additionally, vaccination counseling and administration had not been added to standardized order sets, thus variations in counseling by providers may have impacted patient acceptance., Conclusions: Compared to patients who remained unvaccinated following discharge, patients vaccinated prior to admission were more likely to be older with private insurance, and less likely to be Black, while patients vaccinated during hospitalization once postpartum were more likely to be older and either Asian or Hispanic/Latino., Competing Interests: Acknowledgments: The authors thank Amanda Edwards, MMS, PA, for her help in leading the vaccine administration program and obtaining the administration data. Ms. Edwards is employed at the WakeMed-Raleigh Campus and has no disclosures or funding statement. We also thank The Howard W. Odum Institute for Research in Social Science at UNC-Chapel Hill for help with data analysis. The Odum Institute has no disclosures or funding statements. Funding: None. Declaration of interests: The authors declare there is no conflict of interest., (Copyright ©2024 by the North Carolina Institute of Medicine and The Duke Endowment. All rights reserved.)