Neurodevelopmental assessment of normocephalic children born to Zika virus exposed and unexposed pregnant people.

BACKGROUND: Studies examining the association between in utero Zika virus (ZIKV) exposure and child neurodevelopmental outcomes have produced varied results. METHODS: We aimed to assess neurodevelopmental outcomes among normocephalic children born from pregnant people enrolled in the Zika in Pregnancy in Honduras (ZIPH) cohort study, July-December 2016. Enrollment occurred during the first prenatal visit. Exposure was defined as prenatal ZIKV IgM and/or ZIKV RNA result at enrollment. Normocephalic children, >6 months old, were selected for longitudinal follow-up using the Bayley Scales of Infant and Toddler Development (BSID-III) and the Ages & Stages Questionnaires: Social-Emotional (ASQ:SE-2). RESULTS: One hundred fifty-two children were assessed; after exclusion, 60 were exposed and 72 were unexposed to ZIKV during pregnancy. Twenty children in the exposed group and 21 children in the unexposed group had a composite score <85 in any of the BSID-III domains. Although exposed children had lower cognitive and language scores, differences were not statistically significant. For ASQ:SE-2 assessment, there were not statistically significant differences between groups. CONCLUSIONS: This study found no statistically significant differences in the neurodevelopment of normocephalic children between in utero ZIKV exposed and unexposed. Nevertheless, long-term monitoring of children with in utero ZIKV exposure is warranted. IMPACT: This study found no statistically significant differences in the neurodevelopment in normocephalic children with in utero Zika virus exposure compared to unexposed children, although the exposed group showed lower cognitive and language scores that persisted after adjustment by maternal age and education and after excluding children born preterm and low birth weight from the analysis. Children with prenatal Zika virus exposure, including those normocephalic and have no evidence of abnormalities at birth, should be monitored for neurodevelopmental delays. Follow-up is important to be able to detect developmental abnormalities that might not be detected earlier in life.

Data collection systems for active safety surveillance of vaccines during pregnancy in low- and middle-income countries: developing and piloting an assessment tool (VPASS).

BACKGROUND: There is an urgent need for active safety surveillance to monitor vaccine exposure during pregnancy in low- and middle-income countries (LMICs). Existing maternal, newborn, and child health (MNCH) data collection systems could serve as platforms for post-marketing active surveillance of maternal immunization safety. To identify sites using existing systems, a thorough assessment should be conducted. Therefore, this study had the objectives to first develop an assessment tool and then to pilot this tool in sites using MNCH data collection systems through virtual informant interviews. METHODS: We conducted a rapid review of the literature to identify frameworks on population health or post-marketing drug surveillance. Four frameworks that met the eligibility criteria were identified and served to develop an assessment tool capable of evaluating sites that could support active monitoring of vaccine safety during pregnancy. We conducted semi-structured interviews in six geographical sites using MNCH data collection systems (DHIS2, INDEPTH, and GNMNHR) to pilot domains included in the assessment tool. RESULTS: We developed and piloted the "VPASS (Vaccines during Pregnancy - sites supporting Active Safety Surveillance) assessment tool" through interviews with nine stakeholders, including central-level systems key informants and site-level managers from DHIS2 and GNMNHR; DHIS2 in Kampala (Uganda) and Kigali (Rwanda); GNMNHR from Belagavi (India) and Lusaka (Zambia); and INDEPTH from Nanoro (Burkina Faso) and Manhica (Mozambique). The tool includes different domains such as the system's purpose, the scale of implementation, data capture and confidentiality, type of data collected, the capability of integration with other platforms, data management policies and data quality monitoring. Similarities among sites were found regarding some domains, such as data confidentiality, data management policies, and data quality monitoring. Four of the six sites met some domains to be eligible as potential sites for active surveillance of vaccinations during pregnancy, such as a routine collection of MNCH individual data and the capability of electronically integrating individual MNCH outcomes with information related to vaccine exposure during pregnancy. Those sites were: Rwanda (DHIS2), Manhica (IN-DEPTH), Lusaka (GNMNHR), and Belagavi (GNMNHR). CONCLUSION: This study's findings should inform the successful implementation of active safety surveillance of vaccines during pregnancy by identifying and using active individual MNCH data collection systems in LMICs.

Gaps in the congenital syphilis prevention cascade: qualitative findings from Kern County, California.

BACKGROUND: Congenital syphilis is preventable through timely access to prenatal care, syphilis screening and treatment of pregnant women diagnosed as infected. In 2018, California had the second highest number of congenital syphilis cases in the United States (U.S.), a nearly twofold increase in cases since 2014. This study assessed gaps in preventing congenital syphilis in the high morbidity region of Kern County, California. METHODS: Between May 2018 and January 2019, we conducted five focus group discussions with pregnant/postpartum women and ten semi-structured interviews with prenatal care providers in Kern County. Focus group and interview data were recorded, transcribed, and analyzed to identify emergent themes pertaining to facilitators and barriers at each step (prenatal care, syphilis screening and treatment) in the congenital syphilis prevention cascade. RESULTS: Gaps in congenital syphilis prevention discussed in focus group discussions with pregnant/postpartum women were related to limited prenatal care access, social-, economic-, and cultural-barriers, and substance use and co-occurring intimate partner/domestic violence. The gaps identified from interviews with prenatal care providers included social economic vulnerabilities of pregnant women and stigma and shame around the vulnerabilities, distrust in medical system, prenatal substance use, limited prenatal substance use disorder treatment facilities, and inadequate provider training on context-specific congenital syphilis management strategies. Gaps in partner notification, screening and treatment for syphilis were brought up by pregnant/postpartum women and prenatal care providers. CONCLUSIONS: Congenital syphilis continues to increase in Kern County and throughout the U.S. In high syphilis morbidity areas, comprehensive and tailored public health approaches addressing setting-specific gaps in prenatal screening and treatment are needed.

Understanding perinatal patient's health preferences and patient-provider relationships to prevent congenital syphilis in California and Louisiana.

BACKGROUND: Congenital syphilis (CS) has reemerged as a global maternal and child health crisis. Kern County, California and East Baton Rouge Parish, Louisiana are among the highest CS morbidity regions in the United States. We previously reported on social-ecological and structural barriers to prenatal care and maternal syphilis testing and treatment in these two regions. The aim of this study was to examine perinatal patient's health preferences and perceptions of patient-provider relationships in the prenatal care clinic setting. METHODS: Between May 2018 and January 2019 we conducted 20 in-depth qualitative interviews with prenatal providers and 8 focus group discussions with pregnant and postpartum individuals in Kern County and East Baton Rouge Parish. We applied an adapted health services framework to analyze participants' understanding of health disparities and vulnerable populations; perinatal patient's health and prenatal care preferences; and participants' perspectives of clinical encounters in the context of prenatal care and maternal syphilis testing and treatment. RESULTS: Site-specific determinants of syphilis infection emerged but participants from both locations felt CS prevention efforts should be prioritized among youth, racial/ethnic minority populations, people experiencing socioeconomic limitations and people with other commonly occurring health conditions. Although perinatal patients expressed clear health preferences, they reported inconsistent receipt of respectful, patient-centered care. Inconsistencies were connected with limited ethnic and cultural competence among providers, and implicit, negative attitudes toward patients using substances, experiencing homelessness, or engaging in sex work. Providers clearly aimed to offer high quality prenatal care. However, some clinic and health systems level factors were thought to reduce positive and communicative patient-provider relationships, contributing to gaps in use of prenatal care and syphilis testing and treatment. CONCLUSIONS: Our findings suggest that interventions tailored to address setting-specific determinants (including clinic and health system factors) of disparities in CS risk could improve pregnant people's access to prenatal care and ensure they and their sex partners receive timely syphilis screening and treatment. We recommend all prenatal care providers receive training on how to identify and mitigate implicit biases and provide competent and compassionate patient-centered care.

Geographic Variations in Test Reactivity for the Serological Diagnosis of Trypanosoma cruzi Infection.

Chagas disease is a neglected disease caused by Trypanosoma cruzi parasites. Most diagnosis is based on serological tests, but the lack of a gold standard test complicates the measurement of test performance. To overcome this limitation, we used samples from a cohort of well-characterized T. cruzi-infected women to evaluate the reactivity of two rapid diagnostic tests and one enzyme-linked immunosorbent assay (ELISA). Our cohort was derived from a previous study on congenital transmission of T. cruzi and consisted of 481 blood/plasma samples from Argentina (n = 149), Honduras (n = 228), and Mexico (n = 104), with at least one positive T. cruzi PCR. Reactivity of the three tests ranged from 70.5% for the Wiener ELISA to 81.0% for the T-Detect and 90.4% for the Stat-Pak rapid tests. Test reactivity varied significantly among countries and was highest in Argentina and lowest in Mexico. When considering at least two reactive serological tests to confirm seropositivity, over 12% of T. cruzi infection cases from Argentina were missed by serological tests, over 21% in Honduras, and an alarming 72% in Mexico. Differences in test performance among countries were not due to differences in parasitemia, but differences in antibody levels against ELISA antigens were observed. Geographic differences in T. cruzi parasite strains as well as genetic differences among human populations both may contribute to the discrepancies in serological testing. Improvements in serological diagnostics for T. cruzi infections are critically needed to ensure an optimum identification of cases.

Congenital syphilis in East Baton Rouge parish, Louisiana: providers' and women's perspectives.

BACKGROUND: Congenital syphilis is completely preventable through screening and treatment, but rates have been rising in the United States. Certain areas are at particularly high risk. We aimed to assess attitudes, knowledge, and barriers around effective prevention of congenital syphilis among health care providers and community women potentially at risk. METHODS: Two parallel studies were conducted: in-depth interviews with health care providers and focus groups with community women in the area of Baton Rouge, Louisiana. Each group was questioned about their experience in providing or seeking prenatal care, knowledge and attitudes about congenital syphilis, sources of information on testing and treatment, perceptions of risk, standards of and barriers to treatment. Results were transcribed into QSR NVivo V10, codes developed, and common themes identified and organized. RESULTS: Providers identified delays in testing and care, lack of follow-through with partner testing, and need for community connection for prevention, as major contributors to higher rates of congenital syphilis. Women identified difficulties in accessing Medicaid contributing to delayed start of prenatal care, lack of transportation for prenatal care, and lack of knowledge about testing and prevention for congenital syphilis. CONCLUSIONS: Providers and community members were in broad agreement about factors contributing to higher rates of congenital syphilis, although some aspects were emphasized more by one group or another. Evidence-based interventions, likely at multiple levels, need to be tested and implemented to eliminate congenital syphilis.

Maternal and neonatal data collection systems in low- and middle-income countries for maternal vaccines active safety surveillance systems: A scoping review.

BACKGROUND: Most post-licensure vaccine pharmacovigilance in low- and middle-income countries (LMICs) are passive reporting systems. These have limited utility for maternal immunization pharmacovigilance in LMIC settings and need to be supplemented with active surveillance. Our study's main objective was to identify existing perinatal data collection systems in LMICs that collect individual information on maternal and neonatal health outcomes and could be developed to inform active safety surveillance of novel vaccines for use during pregnancy. METHODS: A scoping review was performed following the Arksey and O'Malley six-stage approach. We included studies describing electronic or mixed paper-electronic data collection systems in LMICs, including research networks, electronic medical records, and custom software platforms for health information systems. Medline PubMed, EMBASE, Global Health, Cochrane Library, LILACS, Bibliography of Asian Studies (BAS), and CINAHL were searched through August 2019. We also searched grey literature including through Google and websites of existing relevant perinatal data collection systems, as well as contacted authors of key studies and experts in the field to validate the information and identify additional sources of relevant unpublished information. RESULTS: A total of 11,817 records were identified. The full texts of 264 records describing 96 data collection systems were assessed for eligibility. Eight perinatal data collection systems met our inclusion criteria: Global Network's Maternal Newborn Health Registry, International Network for the Demographic Evaluation of Populations and their Health; Perinatal Informatic System; Pregnancy Exposure Registry & Birth Defects Surveillance; SmartCare; Open Medical Record System; Open Smart Register Platform and District Health Information Software 2. These selected systems were qualitatively characterized according to seven different domains: governance; system design; system management; data management; data sources, outcomes and data quality. CONCLUSION: This review provides a list of active maternal and neonatal data collection systems in LMICs and their characteristics as well as their outreach, strengths, and limitations. Findings could potentially help further understand where to obtain population-based high-quality information on outcomes to inform the conduct of maternal immunization active vaccine safety surveillance activities and research in LMICs.

The Paradoxical Effects of Hurricane Katrina on Births and Adverse Birth Outcomes.

Objectives. To review the trends in pregnancy outcomes after Hurricane Katrina and assess effects of the disaster on research and public health related to pregnant women.Methods. We reexamined the 2004-2006 vital statistics data from Alabama, Louisiana, and Mississippi, assessing what the risk of adverse pregnancy outcomes in the population would have been under varying risk scenarios.Results. We saw a reduction in number of births as well as in low birth weight and preterm birth. If the number of births had stayed constant and the relative higher risk in the "missing" births had been between 17% and 100%, the storm would have been associated with an increased risk instead of a decrease. Because the relative decline in births was larger in Black women, the higher risk in the "missing" births required to create a significant increase associated with the storm was generally not as great as for White women.Conclusions. Higher exposure to Katrina may have produced a reduction in births among high-risk women in the region rather than increasing adverse outcomes among those who did give birth.

The "Cocoon," first alongside midwifery-led unit within a Belgian hospital: Comparison of the maternal and neonatal outcomes with the standard obstetric unit over 2 years.

OBJECTIVES: Our aim was to compare maternal and neonatal outcomes of women with a low-risk pregnancy attending the "Cocoon," an alongside midwifery-led birth center and care pathway, with women with a low-risk pregnancy attending the traditional care pathway in a tertiary care hospital in Belgium. METHODS: We performed a retrospective cohort study of maternal and neonatal outcomes of women with a low-risk pregnancy who chose to adhere to the Cocoon pathway of care (n = 590) and women with a low-risk pregnancy who chose the traditional pathway of care (n = 394) from March 1, 2014, to February 29, 2016. We performed all analyses using an intention-to-treat approach. RESULTS: In this setting, the cesarean birth rate was 10.3% compared with 16.0% in the traditional care pathway (adjusted odds ratios [aOR] 0.42 [95% CI 0.25-0.69]), the induction rate was 16.3% compared with 30.5% (0.46 [0.30-0.69]), the epidural analgesia rate was 24.9% compared with 59.1% (0.15 [0.09-0.22]), and the episiotomy rate was 6.8% compared with 14.5% (0.31 [0.17-0.56]). There was no increase in adverse neonatal outcomes. Intrapartum and postpartum transfer rates to the traditional pathway of care were 21.1% and 7.1%, respectively. CONCLUSIONS: Women planning their births in the midwifery-led unit, the Cocoon, experienced fewer interventions with no increase in adverse neonatal outcomes. Our study gives initial support for the introduction of similar midwifery-led care pathways in other hospitals in Belgium.

Using Prenatal Blood Samples to Evaluate COVID-19 Rapid Serologic Tests Specificity.

INTRODUCTION: Background cross-reactivity with other coronaviruses may reduce the specificity of COVID-19 rapid serologic tests. The vast majority of women attend prenatal care, which is a unique source of population-based blood samples appropriate for validation studies. We used stored 2018 serum samples from an existing pregnancy cohort study to evaluate the specificity of COVID-19 serologic rapid diagnostic tests. METHODS: We randomly selected 120 stored serum samples from pregnant women enrolled in a cohort in 2018 in Tegucigalpa, Honduras, at least 1 year before the COVID-19 pandemic. We used stored serum to evaluate four lateral flow rapid diagnostic tests, following manufacturers' instructions. Pictures were taken for all tests and read by two blinded trained evaluators. RESULTS: We evaluated 120, 80, 90, and 90 samples, respectively. Specificity for both IgM and IgG was 100% for the first two tests (95% confidence intervals [CI] 97.0-100 and 95.5-100, respectively). The third test had a specificity of 98.9% (95% CI 94.0-100) for IgM and 94.4% (95% CI 87.5-98.2) for IgG. The fourth test had a specificity of 88.9% (95% CI 80.5-94.5) for IgM and 100% (95% CI 96.0-100) for IgG. DISCUSSION: COVID-19 serologic rapid tests are of variable specificity. Blood specimens from sentinel prenatal clinics provide an opportunity to validate serologic tests with population-based samples.

Short-course Benznidazole treatment to reduce Trypanosoma cruzi parasitic load in women of reproductive age (BETTY): a non-inferiority randomized controlled trial study protocol.

BACKGROUND: Retrospective observational studies suggest that transmission of Trypanosoma cruzi does not occur in treated women when pregnant later in life. The level of parasitemia is a known risk factor for congenital transmission. Benznidazole (BZN) is the drug of choice for preconceptional treatment to reduce parasitic load. The fear of treatment-related side effects limits the implementation of the Argentine guideline recommending BZN 60d/300 mg (or equivalent) treatment of T. cruzi seropositive women during the postpartum period to prevent transmission in a future pregnancy. A short and low dose BZN treatment might reduce major side effects and increase compliance, but its efficacy to reduce T. cruzi parasitic load compared to the standard 60d/300 mg course is not yet established. Clinical trials testing alternative BZN courses among women of reproductive age are urgently needed. METHODS AND DESIGN: We are proposing to perform a double-blinded, non-inferiority randomized controlled trial comparing a short low dose 30-day treatment with BZN 150 mg/day (30d/150 mg) vs. BZN 60d/300 mg. We will recruit not previously treated T. cruzi seropositive women with a live birth during the postpartum period in Argentina, randomize them at 6 months postpartum, and follow them up with the following specific aims: Specific aim 1: to measure the effect of BZN 30d/150 mg compared to 60d/300 mg preconceptional treatment on parasitic load measured by the frequency of positive Polymerase Chain Reaction (PCR) (primary outcome) and by real-time quantitative PCR (qPCR), immediately and 10 months after treatment. Specific aim 2: to measure the frequency of serious adverse events and/or any adverse event leading to treatment interruption. TRIAL REGISTRATION: ClinicalTrials.gov . Identifier: NCT03672487 . Registered 14 September 2018.

Improving the quality of maternal and newborn health outcomes through a clinical mentorship program in the Democratic Republic of the Congo: study protocol.

BACKGROUND: The Democratic Republic of the Congo (DRC) boasts one of the highest rates of institutional deliveries in sub-Saharan Africa (80%), with eight out of every ten births also assisted by a skilled provider. However, the maternal and neonatal mortality are still among the highest in the world, which demonstrates the poor in-facility quality of maternal and newborn care. The objective of this ongoing project is to design, implement, and evaluate a clinical mentorship program in 72 health facilities in two rural provinces of Kwango and Kwilu, DRC. METHODS: This is an ongoing quasi-experimental study. In the 72 facilities, 48 facilities were assigned to the group where the clinical mentorship program is being implemented (intervention group), and 24 facilities were assigned to the group where the clinical mentorship program is not being implemented (control group). The groups were selected and assigned based on administrative criteria, taking into account the number of deliveries in each facility, the coverage of health zones, accessibility, and ease of implementation of a clinical mentorship program. The main activities are organizing and training a national team of mentors (including senior midwives, obstetricians, and pediatricians) in clinical mentoring, deploying them to mentor all health providers (mentees) performing maternal and newborn health (MNH) services, and providing in-service training in routine and Emergency Obstetrical and Newborn Care (EmONC) to the mentees in health facilities over an 18-month period. Baseline and endline assessments are carried out to evaluate the effectiveness of the clinical mentorship program on the quality of MNH care and the effective coverage of key interventions to reduce maternal and neonatal mortality. Findings will be disseminated nationwide and internationally, as scientific evidence is scarce. A national strategy, guidelines, and tools for clinical mentorship in MNH will be developed for replication in other provinces, thus benefitting the entire country. DISCUSSION: This is the largest project on clinical mentorship aimed to improving the quality of MNH care in Africa. This program is expected to generate one of the first pieces of scientific evidence on the effectiveness of a clinical mentorship program in MNH on a scientifically designed and sustainable model.

A Prospective, Population-Based Study of Trends in Operative Vaginal Delivery Compared to Cesarean Delivery Rates in Low- and Middle-Income Countries, 2010-2016.

OBJECTIVE: Few data are available on cesarean delivery and operative vaginal delivery trends in low- and middle-income countries. Our objective was to analyze a prospective population-based registry including eight sites in seven low- and middle-income countries to observe trends in operative vaginal delivery versus cesarean delivery rates over time, across sites. STUDY DESIGN: A prospective population-based study, including home and facility births among women enrolled from 2010 to 2016, was performed in communities in Argentina, Democratic Republic of Congo, Guatemala, India, Kenya, Pakistan, and Zambia. Women were enrolled during pregnancy and delivery outcome data were collected. RESULTS: We analyzed 354,287 women; 4,119 (1.2%) underwent an operative vaginal delivery and 45,032 (11.2%) delivered by cesarean. Across all sites with data for 7 years, rates of operative vaginal delivery decreased from 1.6 to 0.3%, while cesarean delivery increased from 6.4 to 14.4%. Similar trends were seen when individual country data were analyzed. Operative vaginal delivery rates decreased in both hospitals and clinics, except in the hospital setting at one of the Indian sites. CONCLUSION: In low- and middle-income countries, operative vaginal delivery is becoming less utilized while cesarean delivery is becoming an increasingly common mode of delivery.

Sources of influence on pregnant women's preferred mode of delivery in Buenos Aires, Argentina.

BACKGROUND: Understanding influences on women's preferred delivery mode is vital for planning interventions to reduce cesarean rates and for ensuring that women receive correct information. Our objectives were to: determine if sources of information influencing a pregnant woman's preferred delivery mode and knowledge of cesarean indications differ by sociodemographic characteristics; to conduct a factor analysis of items related to information sources influencing this preference; and to determine if knowledge differs by information sources influencing this preference or their underlying latent constructs. METHODS: Data from a prospective cohort study conducted in Buenos Aires was analyzed. Healthy nulliparous women aged 18-35, at >32 weeks of gestation and with live, singleton pregnancies participated. The primary research questions were evaluated using Chi-square tests, factor analysis, logistic regression, and generalized estimating equations. RESULTS: A total of 382 women participated in the study. Women of lower socioeconomic status were more influenced by people, magazines and TV/movies in their mode of delivery preferences, and had poorer knowledge of cesarean indications. Sources of influence for preferred delivery mode and factors derived in factor analysis were not associated with knowledge level when considered individually or together, or when adjusted for sociodemographic characteristics, or when accounting for clustering by the hospital sector (public or private). CONCLUSIONS: Higher socioeconomic status is associated with being less influenced by people and with better knowledge of indications for cesarean delivery. Knowledge of cesarean indications was not associated with the source of information about mode of delivery preferences.

The Gulf oil spill, miscarriage, and infertility: the GROWH study.

PURPOSE: To examine whether reported exposure to the Gulf oil spill (2010) was related to reproductive reported miscarriage or infertility. METHODS: 1524 women aged 18-45 recruited through prenatal and Women, Infant, and Children (WIC) clinics, and community events were interviewed about their experience of the oil spill and reproductive history. 1434 women had information on outcomes of at least one pregnancy, and 633 on a pregnancy both before and after the spill. Generalized estimating equations were used to examine the relationship between contact with oil and economic and social consequences of the spill with postponement of pregnancy, miscarriage, and infertility (time to pregnancy >12 months or reported fertility issues), with adjustment for age, race, BMI, smoking, and socioeconomic status. Results were compared for pregnancies occurring prior to and after the oil spill. RESULTS: 77 (5.1%) women reported postponing pregnancy due to the oil spill, which was more common in those with high contact with oil or overall high exposure (aOR 2.92, 95% CI 1.31-6.51). An increased risk of miscarriage was found with any exposure to the oil spill (aOR, 1.54, 95% CI 1.17-2.02). Fertility issues were more common in the overall most highly exposed women (aOR 1.88, 1.19-2.95), when the data were limited to those with pregnancies before and after. However, no particular aspect of oil spill exposure was strongly associated with the outcomes, and effects were almost as strong for pregnancies prior to the oil spill. CONCLUSIONS: The oil spill appears to have affected reproductive decision-making. The evidence is not strong that exposure to the oil spill was associated with miscarriage or infertility.

Use of Intracytoplasmic Sperm Injection and Birth Outcomes in Women Conceiving through In Vitro Fertilization.

BACKGROUND: Despite questionable evidence of benefits over conventional in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI) use has markedly increased in recent decades among couples without male factor infertility. We assessed the frequency of ICSI use and its effect on birth outcomes. METHODS: A retrospective cohort study was conducted in 141 030 women conceiving through IVF using 2006-2010 data from the Society for Assisted Reproductive Technology (SART). RESULTS: Between 2006 and 2010, overall ICSI use in women conceiving through IVF increased from 68.9% to 73.1%. This increase was greater among women without male factor infertility (53.0-59.2%) than in women with male factor infertility (92.0-93.4%). Women conceiving through IVF with and without ICSI had similar rates of multiple pregnancy, preterm delivery, stillbirth, and neonatal death. However, ICSI pregnancies were associated with an increased risk of birth defects over conventional IVF (3.0% for ICSI vs. 2.5% for conventional IVF; adjusted odds ratio (OR) 1.2, 95% confidence interval (CI) 1.2, 1.3). These increases were observed in both women conceiving through ICSI with male factor infertility (3.2% vs. 2.5%; OR 1.4, 95% CI 1.3, 1.5) and without male factor infertility (2.7% vs. 2.5%; OR 1.1, 95% CI 1.1, 1.2). CONCLUSIONS: Higher rates of birth defects were observed among women conceiving through ICSI. Since approximately half of all ICSI procedures are performed in couples without male factor infertility, ICSI may be overused in practice.

Barriers and facilitators to the implementation of antenatal syphilis screening and treatment for the prevention of congenital syphilis in the Democratic Republic of Congo and Zambia: results of qualitative formative research.

BACKGROUND: The impact of untreated syphilis during pregnancy on neonatal health remains a major public health threat worldwide. Given the high prevalence of syphilis during pregnancy in Zambia and Democratic Republic of Congo (DRC), the Preventive Congenital Syphilis Trial (PCS Trial), a cluster randomized trial, was proposed to increase same-day screening and treatment of syphilis during antenatal care visits. To design an accepted and feasible intervention, we conducted a qualitative  formative research. Our objective was to identify context-specific  barriers and facilitators to the implementation of antenatal screening and treatment during pregnancy. METHODS: Qualitative research included in-depth semi-structured interviews with clinic administrators, group interviews with health care providers, and focus groups with pregnant women in primary care clinics (PCCs) in Kinshasa (DRC) and Lusaka (Zambia). RESULTS: A total of 112 individuals participated in the interviews and focus groups. Barriers for the implementation of syphilis testing and treatment were identified at the a) system level: fragmentation of the health system, existence of ANC guidelines in conflict with proposed intervention, poor accessibility of clinics (geographical and functional), staff and product shortages at the PCCs; b) healthcare providers' level: lack of knowledge and training about evolving best practices, reservations regarding same-day screening and treatment; c) Pregnant women level: late enrollment in ANC, lack of knowledge about consequences and treatment of syphilis, and stigma. Based on these results, we developed recommendations for the design of the PCS Trial intervention. CONCLUSION: This research allowed us to identify barriers and facilitators to improve the feasibility and acceptability of a behavioral intervention. Formative research is a critical step in designing appropriate and effective interventions by closing the "know-do gap".

Racial/Ethnic Differences in Sleep Disorders and Reporting of Trouble Sleeping Among Women of Childbearing Age in the United States.

Objectives Whether racial/ethnic differences in prevalence/reporting of sleep disorders exist in pregnant women/women of child-bearing age is unknown. Study objectives were to estimate prevalence of sleep disorders and to examine racial/ethnic differences in sleep disorders, reporting of sleep issues, and amount of sleep among women of child-bearing age (15-44 years) in the US. Methods Through a secondary analysis of the National Health and Nutrition Examination Survey 2005-2010 (3175 non-pregnant, 432 pregnant women in main analysis), prevalence of sleep disorders, reporting of sleep disorders to a physician/health professional, and amount of sleep were estimated overall, by pregnancy status, and by race/ethnicity stratified by pregnancy status. Racial/ethnic differences in reporting of trouble sleeping by pregnancy status were examined using univariate and multivariate logistic regression. Results Prevalence of diagnosed sleep disorders among women of childbearing age was 4.9 % [3.9 % pregnant; 5.1 % non-pregnant (p < 0.01)]. Significantly fewer pregnant and non-pregnant minority women reported adequate sleep (7-8 h) than non-Hispanic white (white) women (p < 0.05). Among non-pregnant women, odds of report of trouble sleeping were significantly higher for white compared to black (aOR 0.47 [95 % CI 0.36, 0.61]) or Mexican-American women (aOR 0.29 [95 % CI 0.21, 0.41]); non-pregnant minority women were also significantly less likely to report trouble sleeping than white women when controlling for amount of sleep. Among pregnant women, these same trends were found. Discussion Compared to white women, minority women, despite reporting less adequate sleep, are less likely to report trouble sleeping, providing evidence of an important health disparity.

A population-based, multifaceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: the ACT cluster-randomised trial.

BACKGROUND: Antenatal corticosteroids for pregnant women at risk of preterm birth are among the most effective hospital-based interventions to reduce neonatal mortality. We aimed to assess the feasibility, effectiveness, and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids at all levels of health care in low-income and middle-income countries. METHODS: In this 18-month, cluster-randomised trial, we randomly assigned (1:1) rural and semi-urban clusters within six countries (Argentina, Guatemala, India, Kenya, Pakistan, and Zambia) to standard care or a multifaceted intervention including components to improve identification of women at risk of preterm birth and to facilitate appropriate use of antenatal corticosteroids. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birthweight (a proxy for preterm birth) across the clusters. Use of antenatal corticosteroids and suspected maternal infection were additional main outcomes. This trial is registered with ClinicalTrials.gov, number NCT01084096. FINDINGS: The ACT trial took place between October, 2011, and March, 2014 (start dates varied by site). 51 intervention clusters with 47,394 livebirths (2520 [5%] less than 5th percentile for birthweight) and 50 control clusters with 50,743 livebirths (2258 [4%] less than 5th percentile) completed follow-up. 1052 (45%) of 2327 women in intervention clusters who delivered less-than-5th-percentile infants received antenatal corticosteroids, compared with 215 (10%) of 2062 in control clusters (p<0·0001). Among the less-than-5th-percentile infants, 28-day neonatal mortality was 225 per 1000 livebirths for the intervention group and 232 per 1000 livebirths for the control group (relative risk [RR] 0·96, 95% CI 0·87-1·06, p=0·65) and suspected maternal infection was reported in 236 (10%) of 2361 women in the intervention group and 133 (6%) of 2094 in the control group (odds ratio [OR] 1·67, 1·33-2·09, p<0·0001). Among the whole population, 28-day neonatal mortality was 27·4 per 1000 livebirths for the intervention group and 23·9 per 1000 livebirths for the control group (RR 1·12, 1·02-1·22, p=0·0127) and suspected maternal infection was reported in 1207 (3%) of 48,219 women in the intervention group and 867 (2%) of 51,523 in the control group (OR 1·45, 1·33-1·58, p<0·0001). INTERPRETATION: Despite increased use of antenatal corticosteroids in low-birthweight infants in the intervention groups, neonatal mortality did not decrease in this group, and increased in the population overall. For every 1000 women exposed to this strategy, an excess of 3·5 neonatal deaths occurred, and the risk of maternal infection seems to have been increased. FUNDING: Eunice Kennedy Shriver National Institute of Child Health and Human Development.