Enrollment Of Pregnant Women Research Articles

Shifts in UNAIDS ethics guidance and implications for ethics review of preventive HIV vaccine trials.

IntroductionA major change in the ethics framework for preventive HIV vaccine trials worldwide is the release of the UNAIDS 2021 ethical considerations in HIV prevention trials. This new guidance comes at an exciting time when there are multiple HIV vaccine efficacy trials in the field. Research Ethics Committees (RECs) or Institutional Review Boards are a most likely audience for these guidelines. Our objective is to highlight shifts in ethics recommendations from the earlier 2012 UNAIDS guidance.DiscussionWe review recommendations related to four key issues, namely standard of prevention, post‐trial access to safe and effective vaccines, enrolment of adolescents and enrolment of pregnant women. We outline implications and make recommendations for the ethics review process, including suggested lines of inquiry by RECs and responses by applicants.ConclusionsThere have been several shifts in the UNAIDS ethics guidance with implications for HIV vaccine researchers submitting applications for initial ethics review or re‐certification, and for RECs conducting such reviews. This review may assist RECs in a more efficient and consistent application of ethics recommendations. However, additional tools and training may further help stakeholders comply with new UNAIDS ethics recommendations during protocol development and ethics review.

Impact of continuing education on maternal and child health indicators.

ObjectiveThis study investigated whether the presence of care workers who completed a specialization course on family health was associated with improved care and maternal and child health indicators in municipalities in the state of Mato Grosso do Sul, Brazil.MethodsNegative binomial regression models with fixed effects were used for the 79 municipalities in the state of Mato Grosso do Sul, with repeated observations for the period 2009–2015. For our reference, the parameter “number of professionals who completed the course” calculated the proportion of professionals who completed the course, and was divided by the total number of primary health care professionals in the municipality to create a ratio. The cutoff points used represented tertile distribution: T3: high (0.35–1.00), T2: intermediate (0.02–0.33) and T1: low (0.00–0.01); to avoid biased results, the analysis was also performed for the years prior to the beginning of the course in question (2009 and 2010).ResultsDuring the study period, enrollment of pregnant women, exclusive breastfeeding for children under 4 months, and up-to-date vaccinations in children younger than 1 year to 23 months increased (high to intermediate categories) in municipalities where professionals who completed the specialization course worked. Growth in the intermediate ratio was also observed in indicators related to cervical cancer screening and new diagnoses of congenital syphilis in infants under one year of age.ConclusionsThe presence of care workers who completed a specialization course on family health was seen to be associated with improved care and indicators for maternal and child health in municipalities in the state of Mato Grosso do Sul, Brazil. These findings reaffirm the importance and effectiveness of policies on training and continuing education for the Brazilian Unified Health System.

Prepregnancy Insurance and Timely Prenatal Care for Medicaid Births: Before and After the Affordable Care Act in Ohio.

Background/Objective: Persistent instability in insurance coverage before and after pregnancy among low-income mothers in the United States contributes to delayed prenatal care and poor infant outcomes. States that expand Medicaid under the Affordable Care Act (ACA) make public insurance free for many low-income women regardless of parental or pregnancy status. Our objective is to analyze the effects of expanding Medicaid in Ohio on enrollment of pregnant women and receipt of recommended prenatal care. A key objective in the state is to address infant mortality as Ohio ranks above the national average and racial disparities persist. Materials and Methods: We used linked enrollment/claims/birth certificate data for women with Medicaid-paid deliveries/births, aged 19-44 years with months of last menstrual period (LMP) in calendar year 2011-2015 (N = 290,091). We used interrupted time-series analysis of enrollment prepregnancy and receipt of guideline-concordant screenings (anemia, asymptomatic bacteriuria, chlamydia, human immunodeficiency virus [HIV], and TORCH) and prenatal vitamins after versus before the expansion. We stratified by parity since first-time mothers would be impacted more. Results: We found almost a 12 percentage point increase in enrollment prepregnancy among first-time mothers compared with almost a 6 percentage point increase for parous women. We found significant increases in all screens and vitamins for both groups. TORCH screening increased 8 percentage points and receipt of prenatal vitamins almost 14 percentage points, by the end of 2015 for first-time mothers, compared with 5 and 4 percentage points, respectively, for parous women. Conclusions: Early enrollment and prenatal care for low-income women in Ohio could erode if the state's Medicaid expansion is altered.

Immunization in pregnancy clinical research in low- and middle-income countries - Study design, regulatory and safety considerations.

Immunization of pregnant women is a promising public health strategy to reduce morbidity and mortality among both the mothers and their infants. Establishing safety and efficacy of vaccines generally uses a hybrid design between a conventional interventional study and an observational study that requires enrolling thousands of study participants to detect an unknown number of uncommon events. Historically, enrollment of pregnant women in clinical research studies encountered many barriers based on risk aversion, lack of knowledge, and regulatory ambiguity. Conducting research enrolling pregnant women in low- and middle-income countries can have additional factors to address such as limited availability of baseline epidemiologic data on disease burden and maternal and neonatal outcomes during and after pregnancy; challenges in recruiting and retaining pregnant women in research studies, variability in applying and interpreting assessment methods, and variability in locally acceptable and available infrastructure. Some measures to address these challenges include adjustment of study design, tailoring recruitment, consent process, retention strategies, operational and logistical processes, and the use of definitions and data collection methods that will align with efforts globally.

Birth plans and health insurance enrolment of pregnant women: a cross-sectional survey at two secondary health facilities in Lagos, Nigeria

Objective: We evaluated birth plans and health insurance enrolment of pregnant women at secondary health care level as a strategy for post-2015 goals.Methods: This was a cross-sectional study at two secondary health facilities in Lagos state, Nigeria. A pre-tested questionnaire was used to collect data that were analysed and results presented with frequencies. An overall estimate with 95% confidence interval was used at significant p values of less than 0.05.Results: Five hundred and twenty-four women, with a mean age of 3 0±4.1 years, participated. Most women chose hospital delivery (84%) and had plan for transportation (86.3%) during labour. Few women were well prepared for birth (9.7%) and had health insurance (10.1%). Compared with women without insurance, more health-insured women had plans for transport in labour (p = 0.1383) and identified a place of birth (p = 0.2294), but did not have as much plan for someone to accompany them in the case of an emergency (p = 0.3855) and donate blood (p = 0.5065). Few health insured women saved money for delivery (p = 0.7439).Conclusion: Health insured women did not have better birth plans and expanding pregnant women’s access to health insurance may be an insufficient strategy to achieve post MDG 2015 goals.

Lessons from Prenatal Care Provider-Based Recruitment into the National Children's Study.

In response to recruitment difficulties experienced by the National Children’s Study, alternatives to the door-to-door recruitment method were pilot tested. This report describes outcomes, successes, and challenges of recruiting women through prenatal care providers in Benton County, Arkansas, USA. Eligible women residing in 14 randomly selected geographic segments were recruited. Data were collected during pregnancy, at birth, and at 3, 6, 9, 12, 18, and 24 months postpartum. Participants were compared to non-enrolled eligible women through birth records. Of 6402 attempts to screen for address eligibility, 468 patients were potentially eligible. Of 221 eligible women approached to participate, 151 (68%) enrolled in the 21-year study. Enrolled women were similar to non-enrolled women in age, marital status, number of prenatal care visits, and gestational age and birth weight of the newborn. Women enrolled from public clinics were more likely to be Hispanic, lower educated, younger and unmarried than those enrolled from private clinics. Sampling geographic areas from historical birth records failed to produce expected equivalent number of births across segments. Enrollment of pregnant women from prenatal care providers was successful.

Maternal Mild Thyroid Hormone Insufficiency in Early Pregnancy and Attention-Deficit/Hyperactivity Disorder Symptoms in Children.

Maternal thyroid hormone insufficiency during pregnancy can affect children's cognitive development. Nevertheless, the behavioral outcomes of children exposed prenatally to mild thyroid hormone insufficiency are understudied. To examine whether exposure to maternal mild thyroid hormone insufficiency in early pregnancy was related to symptoms of attention-deficit/hyperactivity disorder (ADHD) in children at 8 years of age. The study was embedded within the Generation R, a population-based birth cohort in the Netherlands. Children in the Generation R Study are followed up from birth (April 1, 2002, through January 31, 2006) until young adulthood. Of the 4997 eligible mother-child pairs with data on maternal thyroid levels (excluding twins), 3873 pairs of children and caregivers (77.5%) visited the Generation R research center for in-depth assessments and were included in the main analyses. Data collection in Generation R started December 1, 2001 (enrollment of pregnant women), and is ongoing. For this study, we used the data that were collected until January 1, 2014. Data analyses started on January 31 and finished June 30, 2014. Maternal hypothyroxinemia, characterized by low levels of free thyroxine coexisting with reference thyrotropin levels, and children's symptoms of ADHD. Maternal thyroid hormone levels (thyrotropin, free thyroxine, thyroid peroxidase antibodies) were measured at a mean (SD) of 13.6 (1.9) weeks of gestation. Children's ADHD symptoms were assessed at 8 years of age using the Conners' Parent Rating Scale-Revised Short Form; higher scores indicate more ADHD symptoms (possible range, 0-36). Maternal hypothyroxinemia (n = 127) in early pregnancy was associated with higher scores for ADHD symptoms in children at 8 years of age after adjustments for child and maternal factors (ie, sex, ethnicity, maternal age, maternal educational level, and income) (increase in ADHD scores, 7% [95% CI, 0.3%-15%]). The results remained essentially unchanged when women with elevated levels of thyroid peroxidase antibodies were excluded from the analyses (increase in ADHD scores, 8% [95% CI, 1%-16%]). Additional adjustment for children's IQ or comorbid autistic symptoms attenuated the association (increase in ADHD scores adjusted for autistic symptoms, 7% [95% CI, 1%-15%]; increase in ADHD scores adjusted for IQ, 6% [95% CI, 1%-14%]). Children exposed to maternal hypothyroxinemia in early pregnancy had more ADHD symptoms, independent of confounders. This finding suggests that intrauterine exposure to insufficient thyroid hormone levels influences neurodevelopment in offspring.

Enrolling Pregnant Women: Issues in Clinical Research

BackgroundDespite the fact that many pregnant women are affected by a range of serious health conditions and take medications for these conditions, there is widespread reticence to include them in clinical intervention research. Hence, their clinical care is typically not informed by evidence derived from pregnant populations. MethodIn October 2010, the National Institutes of Health Office of Research on Women's Health convened a workshop to address ethical, regulatory, and scientific issues raised by the enrollment of pregnant women in clinical research. This report summarizes three areas that emerged from that meeting as important next steps to be taken to promote ethically responsible and scientifically sound research during pregnancy. FindingsThe three areas are: 1) Reclassify pregnant women from their current status in regulations as a “vulnerable” population to a scientifically “complex” population and change the presumption of exclusion to one of inclusion; 2) examine the institutional review boards' (IRB) gatekeeper role in interpreting regulations governing pregnancy research and identify steps to facilitate IRB approval of ethically informed pregnancy research; and 3) develop a pregnancy-focused research agenda that addresses pressing clinical needs, identifies opportunities to gather information from existing resources and studies, and encourages important new research areas. ConclusionResearch is needed to address the therapeutic needs of pregnant women and to study pregnancy as it may shed light on a pregnant woman's later health and the health of her child.

Reducing Barriers for Pregnant Women in Rural/Remote First Nations Communities to Participate in Lifestyle Intervention Program through Community-Oriented Approaches

We conducted a community-based, participatory action, needs assessment to increase the involvement of pregnant women in a lifestyle intervention program designed to reduce the risk of excessive gestational weight gain and type 2 diabetes in four First Nation (FN) rural/remote communities in Manitoba. In order to identify barriers to recruitment, in depth interviews and focus group sessions were conducted with pregnant women, elders, and healthcare workers in the FN communities. A collaborative forum was held in Winnipeg, as a way to bring all the communities together to discuss the most common barriers and brainstorm possible solutions. Key players in prenatal care in each community, previous research participants, partner programs, healthcare workers, and FN authorities were invited to the forum. Barriers and solutions related to study advertisement, participant transportation, child care for participants, and community involvement in the program were identified and discussed. Building rapport, identifying barriers, and probing for solutions within the communities were all emphasized to help to increase recruitment and program success rate. Several environmental changes were made to community programs based on the suggestions. Enrolment of pregnant women in the lifestyle intervention program was increased from 17 participants in the 2 year pilot study to 29 participants 9 months after the forum. The results suggest that building and maintaining relationships with residents and key players in rural communities and implementing environmental improvements can help to increase interest and participation of FN pregnant women in rural/remote communities to the prenatal lifestyle intervention program (supported by PHAC and CIHR).

Saving the National Children's Study From Its Saviors

Saving the National Children's Study From Its Saviors

Process indicators in the Program for Humanization of Prenatal Care and Childbirth in Ceará State, Brazil: analysis of a historical series (2001-2006)

This was a descriptive, exploratory, documental study of trends that aimed to analyze process indicators in the Program for Humanization of Prenatal Care and Childbirth in Ceará State, Brazil, from 2001 to 2006. The authors analyzed data from 312,507 pregnant women. In 2001, the year the program was implemented in the State, the system tabulated data for three of the seven process indicators; beginning in 2002, all indicators were tabulated. Total enrollment of pregnant women was the only indicator that increased every year until 2006, while the other indicators increased from 2002 until 2005, but declined from 2005 to 2006. When combining the completion of six prenatal visits with a postpartum visit, routine laboratory tests, or both, the percentages declined. Tetanus immunization reached the highest percentage in 2002 (68.34%), decreasing to 60.86% in 2006. The combination of six prenatal visits, a postpartum visit, laboratory tests, tetanus immunization, and HIV test was the indicator with the lowest percentage for the State (15.67%), although it was higher than the national average. Even considering flaws in the use of the Prenatal Care Information System, it is unacceptable that prenatal care still lacks complete coverage for such basic elements as routine laboratory tests and tetanus immunization.