Elizabeth M McClure

University of California, Merced, Merced, California, United States

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Publications (105)451.69 Total impact

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    ABSTRACT: The purpose of the current study was to adapt the Bayley Scales of Infant Development II for use as a screening measure that could be used by health care professionals in Low Middle Income (LMI) countries with 12month old infants to determine if they needed further assessment and early intervention. The adaptations were made as part of a larger study of children participating in a home-based early intervention program in India, Pakistan, and Zambia. Using Item Response Theory, a brief 12month screener, with excellent sensitivity and specificity was identified. The proposed 12month screener contains 7 mental/cognitive items and 5 motor items. Children who cannot perform more than 3 items on the mental scale (sensitivity 79%, specificity 85%) and/or 3 items on the motor scale (sensitivity 96%, specificity 95%) should be referred for further assessment. This screener can reliably be used to determine if a child needs further developmental assessment. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
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    ABSTRACT: To evaluate the impact of neonatal resuscitation and basic obstetric care on intrapartum-related neonatal mortality in low and middle-income countries, using the mathematical model, Maternal and Neonatal Directed Assessment of Technology (MANDATE). Using MANDATE, we evaluated the impact of interventions for intrapartum-related events causing birth asphyxia (basic neonatal resuscitation, advanced neonatal care, increasing facility birth, and emergency obstetric care) when implemented in home, clinic, and hospital settings of sub-Saharan African and India for 2008. Total intrapartum-related neonatal mortality (IRNM) was acute neonatal deaths from intrapartum-related events plus late neonatal deaths from ongoing intrapartum-related injury. Introducing basic neonatal resuscitation in all settings had a large impact on decreasing IRNM. Increasing facility births and scaling up emergency obstetric care in clinics and hospitals also had a large impact on decreasing IRNM. Increasing prevalence and utilization of advanced neonatal care in hospital settings had limited impact on IRNM. The greatest improvement in IRNM was seen with widespread advanced neonatal care and basic neonatal resuscitation, scaled-up emergency obstetric care in clinics and hospitals, and increased facility deliveries, resulting in an estimated decrease in IRNM to 2.0 per 1,000 live births in India and 2.5 per 1,000 live births in sub-Saharan Africa. With more deliveries occurring in clinics and hospitals, the scale-up of obstetric care can have a greater effect than if modeled individually. Use of MANDATE enables health leaders to direct resources towards interventions that could prevent intrapartum-related deaths. A lack of widespread implementation of basic neonatal resuscitation, increased facility births, and emergency obstetric care are missed opportunities to save newborn lives.
    Maternal and Child Health Journal 02/2015; DOI:10.1007/s10995-015-1699-9 · 2.24 Impact Factor
  • Robert L Goldenberg, Elizabeth M McClure
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    ABSTRACT: With decreased equipment cost, provision of ultrasound is now feasible in some low resource settings. Screening obstetric ultrasound may identify potential pregnancy complications and, with this knowledge, allow women to plan to deliver at the appropriate level of care. In this article, we describe a 10-day course with quality assurance activities to train ultrasound-naïve, nonphysician healthcare professionals at midlevel health facilities to perform screening obstetric ultrasound. Those trained will participate in a cluster randomized controlled trial to assess the impact of screening obstetric ultrasound on maternal and newborn outcomes.
    Ultrasound Quarterly 12/2014; 30(4):262-6. DOI:10.1097/RUQ.0000000000000096 · 1.40 Impact Factor
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    ABSTRACT: We performed a multi country cluster randomized controlled trial to evaluate whether a multifaceted intervention to increase the use of antenatal corticosteroids at health facilities and communities would reduce neonatal mortality at 28 days of life in preterm infants. 102 clusters in Argentina, Guatemala, Kenya, India, Pakistan, and Zambia were randomized. In the intervention clusters, kits containing vials of dexamethasone, syringes, gloves, and instructions for administration were distributed. In the intervention clusters we also did (1) diffuse recommendations for antenatal corticosteroids use to health providers, (2) train health providers on identification of women at high risk of preterm birth, (3) provide reminders to health providers on the use of the kits, and (4) use a color-coded tape to measure uterine height to estimate gestational age in women with unknown gestational age.
    142nd APHA Annual Meeting and Exposition 2014; 11/2014
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    ABSTRACT: The positive effects of early developmental intervention (EDI) on early child development have been reported in numerous controlled trials in a variety of countries. An important aspect to determining the efficacy of EDI is the degree to which dosage is linked to outcomes. However, few studies of EDI have conducted such analyses. This observational cohort study examined the association between treatment dose and children's development when EDI was implemented in three low and low-middle income countries as well as demographic and child health factors associated with treatment dose.
    BMC Pediatrics 10/2014; 14(1):281. DOI:10.1186/1471-2431-14-281 · 1.92 Impact Factor
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    ABSTRACT: 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. 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. 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). 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. Eunice Kennedy Shriver National Institute of Child Health and Human Development. Copyright © 2014 Elsevier Ltd. All rights reserved.
  • 2014 American Academy of Pediatrics National Conference and Exhibition; 10/2014
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    ABSTRACT: Objective Postpartum hemorrhage (PPH) is a major cause of maternal mortality, with almost 300,000 cases and ∼72,000 PPH deaths annually in sub-Saharan Africa. Novel prevention methods practical in community settings are required. Tranexamic acid, a drug to reduce bleeding during surgical cases including postpartum bleeding, is potentially suitable for community settings. Thus, we sought to determine the impact of tranexamic acid on PPH-related maternal mortality in sub-Saharan Africa. Study Design We created a mathematical model to determine the impact of interventions on PPH-related maternal mortality. The model was populated with baseline birth rates and mortality estimates based on a review of current interventions for PPH in sub-Saharan Africa. Based on a systematic review of literature on tranexamic acid, we assumed 30% efficacy of tranexamic acid to reduce PPH; the model assessed prophylactic and treatment tranexamic acid use, for deliveries at homes, clinics, and hospitals. Results With tranexamic acid only in the hospitals, less than 2% of the PPH mortality would be reduced. However, if tranexamic acid were available in the home and clinic settings for PPH prophylaxis and treatment, a nearly 30% reduction (nearly 22,000 deaths per year) in PPH mortality is possible. Conclusion These analyses point to the importance of preventive and treatment interventions compatible with home and clinic use, especially for sub-Saharan Africa, where the majority of births occur at home or community health clinics. Given its feasibility to be given in the home, tranexamic acid has potential to save many lives.
    American Journal of Perinatology 10/2014; DOI:10.1055/s-0034-1390347 · 1.57 Impact Factor
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    ABSTRACT: Objective Preeclampsia/eclampsia (PE/E) remains a major cause of maternal death in low-income countries. We evaluated interventions to reduce PE/E-related maternal mortality in sub-Saharan Africa.DesignMathematical model to assess impact of interventions on PE/E-related maternal morbidity and mortalitySettingsub-Saharan Africa countries.PopulationPregnant women in sub-Saharan Africa, 2012.MethodsA systematic literature review populated a decision-tree mathematical model with interventions to diagnose, prevent, and treat women with PE/E. The impact of increased use of interventions (diagnostics, transfer to a hospital, magnesium sulfate (MgSO4) use, cesarean section/labor induction) on PE/E-related maternal mortality was analyzed.Main outcome measuresPrevalence of PE/E and PE/E-associated maternal mortality rates in sub-Saharan Africa.ResultsWithout interventions, an estimated 20 570 PE/E-associated deaths would have occurred in sub-Saharan Africa in 2012. With current low rates of diagnosis, MgSO4 use, transfers and cesarean section/induction rates, about 17 520 maternal deaths were associated with PE/E in 2012. Higher use of MgSO4 would have prevented about 610 deaths. With high diagnostic levels, MgSO4 use, transfer and cesarean section/induction, mortality was reduced to 3750 annual deaths, saving about 13 770 maternal lives. If all MgSO4 use was removed from the model, 4060 maternal deaths would occur, increasing maternal deaths by only 310.Conclusions In sub-Saharan Africa, our model suggests that increasing use of PE/E diagnostics, transfer to higher levels of care and increased hospitalization with cesarean section/induction of labor would substantially reduce maternal mortality from PE/E. Increasing use of MgSO4 would have a smaller impact on maternal mortality.This article is protected by copyright. All rights reserved.
    Acta Obstetricia Et Gynecologica Scandinavica 10/2014; 94(2). DOI:10.1111/aogs.12533 · 1.85 Impact Factor
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    08/2014; 2(8):e444. DOI:10.1016/S2214-109X(14)70261-X
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    ABSTRACT: To quantify maternal, fetal and neonatal mortality in low- and middle-income countries, to identify when deaths occur and to identify relationships between maternal deaths and stillbirths and neonatal deaths.
    Bulletin of the World Health Organisation 08/2014; 92(8):605-12. DOI:10.2471/BLT.13.127464 · 5.11 Impact Factor
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    ABSTRACT: Objective To use ultrasound to explore the impact of malaria in pregnancy on fetal growth and newborn outcomes among a cohort of women enrolled in an intermittent presumptive treatment in pregnancy (IPTp) with sulfadoxine/pyrimethamine (SP) program in coastal Kenya. Methods Enrolled women were tested for malaria at first prenatal care visit, and physical and ultrasound examinations were performed. In total, 477 women who had term, live births had malaria tested at delivery and their birth outcomes assessed, and were included in the study. Results Peripheral malaria was detected via polymerase chain reaction among 10.9% (n = 87) at first prenatal care visit and 8.8% (n = 36) at delivery. Insecticide-treated bed nets (ITNs) were used by 73.6% (n = 583) and were associated with decreased malaria risk. There was a trend for impaired fetal growth and placental blood flow in malaria-infected women in the second trimester, but not later in pregnancy. Among women with low body mass index (BMI), malaria was associated with reduced birth weight (P = 0.04); anthropometric measures were similar otherwise. Conclusion With IPTp-SP and ITNs, malaria in pregnancy was associated with transient differences in utero, and reduced birth weight was restricted to those with low BMI.
    International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 07/2014; 126(1). DOI:10.1016/j.ijgo.2014.01.016 · 1.41 Impact Factor
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    ABSTRACT: Sarah Saleem et al. Pregnancy-related mortality low-and middle-income countries This online first version has been peer-reviewed, accepted and edited, but not formatted and finalized with corrections from authors and proofreaders. Abstract Objective To quantify maternal, fetal and neonatal mortality in low-and middle-income countries, to identify when deaths occur and to identify relationships between maternal deaths and stillbirths and neonatal deaths.
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    ABSTRACT: Resuscitation following birth asphyxia reduces mortality, but may be argued to increase risk for neurodevelopmental disability in survivors. To test the hypothesis that development of infants who received resuscitation following birth asphyxia is not significantly different through 36months of age from infants who had healthy births. Prospective observational cohort design comparing infants exposed to birth asphyxia with resuscitation or healthy birth. A random sample of infants with birth asphyxia who received bag-and-mask resuscitation was selected from birth records in selected communities in 3 countries. Exclusion criteria: birth weight<1500g, severely abnormal neurological examination at 7days, mother<15years, unable to participate, or not expected to remain in the target area. A random sample of healthy-birth infants (no resuscitation, normal neurological exam) was also selected. Eligible=438, consented=407, and ≥1 valid developmental assessment during the first 36months=376. Bayley Scales of Infant Development-II Mental (MDI) and Psychomotor (PDI) Development Index. Trajectories of MDI (p=.069) and PDI (p=.143) over 3 yearly assessments did not differ between children with birth asphyxia and healthy-birth children. Rather there was a trend for birth asphyxia children to improve more than healthy-birth children. The large majority of infants who are treated with resuscitation and survived birth asphyxia can be expected to evidence normal development at least until age 3. The risk for neurodevelopmental disability should not justify the restriction of effective therapies for birth asphyxia.
    Early human development 05/2014; 90(7). DOI:10.1016/j.earlhumdev.2014.04.013 · 2.12 Impact Factor
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    ABSTRACT: Background Previous research has indicated positive effects of early developmental intervention (EDI) on the development of children in developing countries. Few studies, however, have examined longitudinally when differential treatment effects may be observed and whether differential outcomes are associated with exposure to different risk factors and country of implementation. Also, birth asphyxia as a risk condition has not been well studied. To address these limitations, we conducted a randomized controlled trial to test the hypothesis that there will be differential developmental trajectories favoring those who receive EDI versus a health education intervention in children in rural areas of India, Pakistan, and Zambia.Methods Children with and without birth asphyxia were randomized to EDI or control intervention, which was implemented by parents who received training in biweekly home visits initiated before child age 1 month and continuing until 36 months. Development was assessed in 376 children at ages 12, 24, and 36 months using the Bayley Scales of Infant Development and Ages & Stages Questionnaire administered by evaluators blind to intervention assignment and risk condition.ResultsLongitudinal mixed model analysis indicated that EDI resulted in better development over 36 months in cognitive abilities, regardless of risk condition, maternal resources, child gender, or country. Psychomotor development and parent-reported general development showed similar trends as for cognitive abilities, but were not statistically different between intervention conditions. Developmental differences were observed first at 36 months of age.Conclusion Early developmental intervention has promise for improving development in children across developing countries when exposed to various risk conditions. EDI should be one prominent approach used to begin to address long-term outcomes and intergenerational transmission of poverty.
    Journal of Child Psychology and Psychiatry 05/2014; 55(11). DOI:10.1111/jcpp.12247 · 5.42 Impact Factor
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    ABSTRACT: Neonatal deaths account for over 40% of all under-5 year deaths; their reduction is increasingly critical for achieving Millennium Development Goal 4. An estimated 3 million newborns die annually during their first month of life; half of these deaths occur during delivery or within 24 hours. Every year, 6 million babies require help to breathe immediately after birth. Resuscitation training to help babies breathe and prevent/manage birth asphyxia is not routine in low-middle income facility settings. Helping Babies Breathe (HBB), a simulation-training program for babies wherever they are born, was developed for use in low-middle income countries. We evaluated whether HBB training of facility birth attendants reduces perinatal mortality in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Global Network research sites.Methods/design: We hypothesize that a two-year prospective pre-post study to evaluate the impact of a facility-based training package, including HBB and essential newborn care, will reduce all perinatal mortality (fresh stillbirth or neonatal death prior to 7 days) among the Global Network's Maternal Neonatal Health Registry births >=1500 grams in the study clusters served by the facilities. We will also evaluate the effectiveness of the HBB training program changing on facility-based perinatal mortality and resuscitation practices. Seventy-one health facilities serving 52 geographically-defined study clusters in Belgaum and Nagpur, India, and Eldoret, Kenya, and 30,000 women will be included. Primary outcome data will be collected by staff not involved in the HBB intervention. Additional data on resuscitations, resuscitation debriefings, death audits, quality monitoring and improvement will be collected. HBB training will include training of MTs, facility level birth attendants, and quality monitoring and improvement activities. Our study will evaluate the effect of a HBB/ENC training and quality monitoring and improvement package on perinatal mortality using a large multicenter design and approach in 71 resource-limited health facilities, leveraging an existing birth registry to provide neonatal outcomes through day 7. The study will provide the evidence base, lessons learned, and best practices that will be essential to guiding future policy and investment in neonatal resuscitation.Trial registration: Trial registration ClinicalTrials.gov Identifier: NCT01681017 (URL: http://clinicaltrials.gov/ct2/results?term=NCT01681017).
    BMC Pregnancy and Childbirth 03/2014; 14(1):116. DOI:10.1186/1471-2393-14-116 · 2.15 Impact Factor
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    ABSTRACT: Research directed to optimizing maternal nutrition commencing prior to conception remains very limited, despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy.Methods/Study design: This is an individually randomized controlled trial of the impact on birth length (primary outcome) of the time at which a maternal nutrition intervention is commenced: Arm 1: >= 3 mo preconception vs. Arm 2: 12-14 wk gestation vs. Arm 3: none.192 (derived from 480) randomized mothers and living offspring in each arm in each of four research sites (Guatemala, India, Pakistan, Democratic Republic of the Congo). The intervention is a daily 20 g lipid-based (118 kcal) multi-micronutient (MMN) supplement. Women randomized to receive this intervention with body mass index (BMI) <20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement. Researchers will visit homes biweekly to deliver intervention and monitor compliance, pregnancy status and morbidity; ensure prenatal and delivery care; and promote breast feeding. The primary outcome is birth length. Secondary outcomes include: fetal length at 12 and 34 wk; incidence of low birth weight (LBW); neonatal/infant anthropometry 0-6 mo of age; infectious disease morbidity; maternal, fetal, newborn, and infant epigenetics; maternal and infant nutritional status; maternal and infant microbiome; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk. The primary analysis will compare birth Length-for-Age Z-score (LAZ) among trial arms (independently for each site, estimated effect size: 0.35). Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites. Positive results of this trial will support a paradigm shift in attention to nutrition of all females of child-bearing age.Trial registration: ClinicalTrials.gov NCT 01883193.
    BMC Pregnancy and Childbirth 03/2014; 14(1):111. DOI:10.1186/1471-2393-14-111 · 2.15 Impact Factor
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    ABSTRACT: In high-resource settings, obstetric ultrasound is a standard component of prenatal care used to identify pregnancy complications and to establish an accurate gestational age in order to improve obstetric care. Whether or not ultrasound use will improve care and ultimately pregnancy outcomes in low-resource settings is unknown.Methods/design: This multi-country cluster randomized trial will assess the impact of antenatal ultrasound screening performed by health care staff on a composite outcome consisting of maternal mortality and maternal near-miss, stillbirth and neonatal mortality in low-resource community settings. The trial will utilize an existing research infrastructure, the Global Network for Women's and Children's Health Research with sites in Pakistan, Kenya, Zambia, Democratic Republic of Congo and Guatemala. A maternal and newborn health registry in defined geographic areas which documents all pregnancies and their outcomes to 6 weeks post-delivery will provide population-based rates of maternal mortality and morbidity, stillbirth, neonatal mortality and morbidity, and health care utilization for study clusters. A total of 58 study clusters each with a health center and about 500 births per year will be randomized (29 intervention and 29 control). The intervention includes training of health workers (e.g., nurses, midwives, clinical officers) to perform ultrasound examinations during antenatal care, generally at 18-22 and at 32-36 weeks for each subject. Women who are identified as having a complication of pregnancy will be referred to a hospital for appropriate care. Finally, the intervention includes community sensitization activities to inform women and their families of the availability of ultrasound at the antenatal care clinic and training in emergency obstetric and neonatal care at referral facilities. In summary, our trial will evaluate whether introduction of ultrasound during antenatal care improves pregnancy outcomes in rural, low-resource settings. The intervention includes training for ultrasound-naive providers in basic obstetric ultrasonography and then enabling these trainees to use ultrasound to screen for pregnancy complications in primary antenatal care clinics and to refer appropriately.Trial registration: Clinicaltrials.gov (NCT # 01990625).
    BMC Pregnancy and Childbirth 02/2014; 14(1):73. DOI:10.1186/1471-2393-14-73 · 2.15 Impact Factor
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    ABSTRACT: Relative contribution of these infections on anemia in pregnancy is not certain. While measures to protect pregnant women against malaria have been scaling up, interventions against helminthes have received much less attention. In this study, we determine the relative impact of helminthes and malaria on maternal anemia. A prospective observational study was conducted in coastal Kenya among a cohort of pregnant women who were recruited at their first antenatal care (ANC) visit and tested for malaria, hookworm, and other parasitic infections and anemia at enrollment. All women enrolled in the study received presumptive treatment with sulfadoxine-pyrimethamine, iron and multi-vitamins and women diagnosed with helminthic infections were treated with albendazole. Women delivering a live, term birth, were also tested for maternal anemia, fetal anemia and presence of infection at delivery. Of the 706 women studied, at the first ANC visit, 27% had moderate/severe anemia and 71% of women were anemic overall. The infections with highest prevalence were hookworm (24%), urogenital schistosomiasis (17%), trichuria (10%), and malaria (9%). In adjusted and unadjusted analyses, moderate/severe anemia at first ANC visit was associated with the higher intensities of hookworm and P. falciparum microscopy-malaria infections. At delivery, 34% of women had moderate/severe anemia and 18% of infants' cord hemoglobin was consistent with fetal anemia. While none of the maternal infections were significantly associated with fetal anemia, moderate/severe maternal anemia was associated with fetal anemia. More than one quarter of women receiving standard ANC with IPTp for malaria had moderate/severe anemia in pregnancy and high rates of parasitic infection. Thus, addressing the role of co-infections, such as hookworm, as well as under-nutrition, and their contribution to anemia is needed.
    PLoS Neglected Tropical Diseases 02/2014; 8(2):e2724. DOI:10.1371/journal.pntd.0002724 · 4.49 Impact Factor

Publication Stats

1k Citations
451.69 Total Impact Points


  • 2014
    • University of California, Merced
      Merced, California, United States
  • 2011–2014
    • Triangle BioSystems International
      Durham, North Carolina, United States
  • 2007–2014
    • RTI International
      • Division of Statistics and Epidemiology
      Durham, North Carolina, United States
    • Drexel University
      • Department of Obstetrics and Gynecology
      Filadelfia, Pennsylvania, United States
    • Aga Khan University, Pakistan
      Kurrachee, Sindh, Pakistan
  • 2006–2014
    • University of North Carolina at Chapel Hill
      • Department of Epidemiology
      North Carolina, United States
  • 2013
    • Social and Environmental Research Institute
      Гринфилд, Massachusetts, United States
  • 2007–2012
    • Research Triangle Park Laboratories, Inc.
      Raleigh, North Carolina, United States
  • 2010
    • Thomas Jefferson University
      Philadelphia, Pennsylvania, United States
    • Aga Khan University Hospital, Karachi
      Kurrachee, Sindh, Pakistan
  • 2009
    • University of Alabama at Birmingham
      • Department of Pediatrics
      Birmingham, Alabama, United States
  • 2008
    • University of California, Davis
      • Program in International and Community Nutrition
      Davis, CA, United States
    • University of Lusaka
      Lusaka, Lusaka, Zambia