Clinical risk factors of adverse outcomes among women with COVID-19 in the pregnancy and postpartum period: a sequential, prospective meta-analysis.

OBJECTIVE: This sequential, prospective meta-analysis sought to identify risk factors among pregnant and postpartum women with COVID-19 for adverse outcomes related to disease severity, maternal morbidities, neonatal mortality and morbidity, and adverse birth outcomes. DATA SOURCES: We prospectively invited study investigators to join the sequential, prospective meta-analysis via professional research networks beginning in March 2020. STUDY ELIGIBILITY CRITERIA: Eligible studies included those recruiting at least 25 consecutive cases of COVID-19 in pregnancy within a defined catchment area. METHODS: We included individual patient data from 21 participating studies. Data quality was assessed, and harmonized variables for risk factors and outcomes were constructed. Duplicate cases were removed. Pooled estimates for the absolute and relative risk of adverse outcomes comparing those with and without each risk factor were generated using a 2-stage meta-analysis. RESULTS: We collected data from 33 countries and territories, including 21,977 cases of SARS-CoV-2 infection in pregnancy or postpartum. We found that women with comorbidities (preexisting diabetes mellitus, hypertension, cardiovascular disease) vs those without were at higher risk for COVID-19 severity and adverse pregnancy outcomes (fetal death, preterm birth, low birthweight). Participants with COVID-19 and HIV were 1.74 times (95% confidence interval, 1.12-2.71) more likely to be admitted to the intensive care unit. Pregnant women who were underweight before pregnancy were at higher risk of intensive care unit admission (relative risk, 5.53; 95% confidence interval, 2.27-13.44), ventilation (relative risk, 9.36; 95% confidence interval, 3.87-22.63), and pregnancy-related death (relative risk, 14.10; 95% confidence interval, 2.83-70.36). Prepregnancy obesity was also a risk factor for severe COVID-19 outcomes including intensive care unit admission (relative risk, 1.81; 95% confidence interval, 1.26-2.60), ventilation (relative risk, 2.05; 95% confidence interval, 1.20-3.51), any critical care (relative risk, 1.89; 95% confidence interval, 1.28-2.77), and pneumonia (relative risk, 1.66; 95% confidence interval, 1.18-2.33). Anemic pregnant women with COVID-19 also had increased risk of intensive care unit admission (relative risk, 1.63; 95% confidence interval, 1.25-2.11) and death (relative risk, 2.36; 95% confidence interval, 1.15-4.81). CONCLUSION: We found that pregnant women with comorbidities including diabetes mellitus, hypertension, and cardiovascular disease were at increased risk for severe COVID-19-related outcomes, maternal morbidities, and adverse birth outcomes. We also identified several less commonly known risk factors, including HIV infection, prepregnancy underweight, and anemia. Although pregnant women are already considered a high-risk population, special priority for prevention and treatment should be given to pregnant women with these additional risk factors.

How does qualitative data collection modality affect disclosure of sensitive information and participant experience? Findings from a quasi-experimental study.

Focus groups (FGs) and individual interviews (IDIs) can be conducted in-person or in several different online contexts. We conducted a quasi-experimental study and assessed sharing of sensitive or dissenting information and participant comfort in FGs and IDIs across four modalities: (1) in-person, (2) online video-based, (3) online chat-based (synchronous), and (4) online email/message board-based (asynchronous). Participants were systematically assigned to one of the four modalities and randomized to one of 24 FGs or 48 IDIs (N = 171). The study topic was medical risk during pregnancy. All participants also completed a survey on their perceptions of the data collection process. We found no significant difference in the frequency of disclosure of sensitive information by modality. Text-based FGs (chat and message board) were more likely to contain dissenting opinions than visually-based FGs (in-person and video). Participants also reported feeling less rapport and personal comfort in sharing information in the FG video modality than other modalities. These findings provide initial data that can guide researchers in choosing among data collection modalities to maximize participant engagement and comfort.

Optimizing the design of a contraceptive microarray patch: a discrete choice experiment on women's preferences in India and Nigeria.

BACKGROUND: Efforts are underway to develop an easy-to-use contraceptive microarray patch (MAP) that could expand the range of self-administrable methods. This paper presents results from a discrete choice experiment (DCE) designed to support optimal product design. METHODS: We conducted a DCE survey of users and non-users of contraception in New Delhi, India (496 women) and Ibadan, Nigeria (two versions with 530 and 416 women, respectively) to assess stated preferences for up to six potential product attributes: effect on menstruation, duration of effectiveness, application pain, location, rash after application, and patch size. We estimated Hierarchical Bayes coefficients (utilities) for each attribute level and ran simulations comparing women's preferences for hypothetical MAPs with varying attribute combinations. RESULTS: The most important attributes of the MAP were potential for menstrual side effects (55% of preferences in India and 42% in Nigeria) and duration (13% of preferences in India and 24% in Nigeria). Women preferred a regular period over an irregular or no period, and a six-month duration to three or one month. Simulations show that the most ideal design would be a small patch, providing 6 months of protection, that would involve no pain on administration, result in a one-day rash, and be applied to the foot. CONCLUSIONS: To the extent possible, MAP developers should consider method designs and formulations that limit menstrual side effects and provide more than one month of protection.

User preferences for a contraceptive microarray patch in India and Nigeria: Qualitative research on what women want.

BACKGROUND: A new contraceptive microarray patch (MAP) for women is in development. Input on this method from potential end-users early in the product development process is important to guide design decisions. This paper presents the qualitative component of a broader study exploring initial acceptability of the MAP and selected product features. The qualitative research was intended to identify product features that are most salient to end-users and to contextualize preferences around them with subsequent research planned to assess quantitatively the relative importance of those features. METHODS: We conducted 16 focus group discussions and 20 in-depth interviews with women and 20 IDIs with family planning providers in New Delhi, India, and Ibadan, Nigeria. Input from the MAP developer served to identify plausible features of the MAP to include in the focus group discussions and in-depth interviews. Interviews were audio-recorded, transcribed into English, coded, and analyzed to examine key dimensions of MAP features. RESULTS: Many participants viewed the MAP as potentially easy to use. Interest in self-application after learning correct use was high, especially in India. Participants favored formulations affording protection from pregnancy for three or six months, if not longer. Interest in a shorter-acting MAP was particularly low in Nigeria. Non-desirable MAP features included a potential localized skin rash and pain at application. Views on patch size and location of application were related to the potential for rash and pain, with a desire to permit discreet use and minimize pain. Results indicate that the side effect profile, effectiveness, and pricing are also important factors for acceptability and uptake of a future product. CONCLUSION: Study findings indicate that a contraceptive MAP is of potential interest to women and that specific MAP attributes will be important to acceptability.

Reproductive health sequelae among women who survived Ebola virus disease in Liberia.

OBJECTIVE: To estimate the incidence of failed pregnancy and menstrual irregularities among Liberian women who had survived Ebola virus disease (EVD) and to identify host-specific and disease-specific factors associated with these outcomes. METHODS: A cross-sectional questionnaire-based study was conducted between August 10, 2016, and February 7, 2017. The study population comprised 111 women aged 18-45 years who had survived EVD and were enrolled in the Longitudinal Liberian Ebola Survivor study based at the Eternal Love Winning Africa Hospital, Monrovia, Liberia. Self-reported data on outcomes related to pregnancy and menstrual changes since recovery from EVD were collected. RESULTS: In all, 29 (26.1%) of the participants had become pregnant since surviving EVD. Of the 23 women whose pregnancies continued to term, 10 (43.4%) reported live birth, 11 (47.8%) reported spontaneous abortion, and two (8.7%) reported stillbirth. Of the 105 women who reported having regular menstruation before EVD, 27 (29.0%) reported experiencing irregular menstruation for unknown reasons after EVD. In bivariate logistic models, no associations were found between failed pregnancy or irregular menstruation and any of the factors of interest. CONCLUSIONS: Adverse pregnancy outcomes and irregular menstruation were frequently reported among EVD survivors in Liberia.

Gluteal fibrosis, post-injection paralysis, and related injection practices in Uganda: a qualitative analysis.

BACKGROUND: Iatrogenic injection injury is a major cause of disability in Ugandan children. Two injuries thought to result from injection of medications into the gluteal region include post-injection paralysis (PIP) and gluteal fibrosis (GF). This study aimed to describe perceptions of local health care workers regarding risk factors, particularly injections, for development of GF and PIP. Specifically, we examine the role of injection practices in the development of these injuries by interviewing a diverse cohort of individuals working in the health sector. METHODS: We conducted a qualitative study in the Kumi and Wakiso Districts of Uganda in November 2017, utilizing 68 key informant interviews with individuals working in healthcare related fields. Interviews were structured utilizing a moderator guide focusing on injection practices, gluteal fibrosis and post-injection paralysis. RESULTS: We identified six themes regarding perceptions of the cause of GF and PIP and organized these themes into a theoretical framework. There was a consensus among the individuals working in healthcare that inadequacies of the health care delivery system may lead to inappropriate intramuscular injection practices, which are presumed to contribute to the development of GF and PIP. Poor access to medications and qualified personnel has led to the proliferation of private clinics, which are often staffed by under-trained practitioners. Misaligned economic incentives and a lack of training may also motivate practitioners to administer frequent intramuscular injections, which cost more than oral medications. A lack of regulatory enforcement enables these practices to persist. However, due to limited community awareness, patients often perceive these practitioners as appropriately trained, and the patients frequently prefer injections over alternative treatment modalities. CONCLUSION: This qualitative study suggests that inappropriate intramuscular injections, may arise from problems in the health care delivery system. To prevent the disability of GF and PIP, it is important to not only address the intramuscular injections practices in Uganda, but also to examine upstream deficits in access, education, and policy enforcement.