Elizabeth McClure - Academia.edu (original) (raw)

Papers by Elizabeth McClure

Seminars in Fetal and Neonatal Medicine, 2015

In response to the global effort to accelerate progress towards the Millennium Development Goals ... more In response to the global effort to accelerate progress towards the Millennium Development Goals 4 and 5, a partnership was created between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Bill and Melinda Gates Foundation to establish the Global Network for Women's and Children's Health Research (Global Network) in 2000. The Global Network was developed with a goal of building local maternal and child health research capacity in resource-poor settings. The objective of the network was to conduct research focused on several high-need areas, such as preventing life-threatening obstetric complications, improving birth weight and infant growth, and improving childbirth practices in order to reduce mortality. Scientists from developing countries, together with peers in the USA, lead research teams that identify and address population needs through randomized clinical trials and other research studies. Global Network projects develop and test cost-effective, sustainable interventions for pregnant women and newborns and provide guidance for national policy and for the practice of evidence-based medicine. This article reviews the results of the Global Network's research, the impact on policy and practice, and highlights the capacity-building efforts and collaborations developed since its inception.

Reproductive health, Jan 8, 2015

The Global Network for Women's and Children's Health Research is one of the largest inter... more The Global Network for Women's and Children's Health Research is one of the largest international networks for testing and generating evidence-based recommendations for improvement of maternal-child health in resource-limited settings. Since 2009, Global Network sites in six low and middle-income countries have collected information on antenatal care practices, which are important as indicators of care and have implications for programs to improve maternal and child health. We sought to: (1) describe the quantity of antenatal care attendance over a four-year period; and (2) explore the quality of coverage for selected preventative, screening, and birth preparedness components. The Maternal Newborn Health Registry (MNHR) is a prospective, population-based birth and pregnancy outcomes registry in Global Network sites, including: Argentina, Guatemala, India (Belgaum and Nagpur), Kenya, Pakistan, and Zambia. MNHR data from these sites were prospectively collected from January 1,...

Obstetrics & Gynecology, 2015

Journal of interpersonal violence, Jan 14, 2015

This community-based observational study of 1,325 women seen for antenatal care examined how wome... more This community-based observational study of 1,325 women seen for antenatal care examined how women in Pakistan define violence against women (VAW), with an emphasis on domestic violence, what an acceptable response to violence is, reasons for remaining silent, and whether participants are willing to disclose incidents of domestic violence to others. Nearly half of the study participants believed that physical violence was VAW. Verbal abuse, controlling behavior by the husband, conflict with in-laws, overburdening domestic work, and threatening to leave or remarry were also considered VAW. However, only five respondents (0.4%) considered sexual abuse to be VAW. Most women who screened positive for domestic violence responded by remaining silent or verbal fighting back. None sought professional help. Women who decided to remain silent feared that the abuse would escalate or that responding would not help them. Women cited social stigma and concerns about the impact of the violence on ...

PloS one, 2015

Neonatal mortality associated with preterm birth can be reduced with antenatal corticosteroids (A... more Neonatal mortality associated with preterm birth can be reduced with antenatal corticosteroids (ACS), yet <10% of eligible pregnant women in low-middle income countries. The inability to accurately determine gestational age (GA) leads to under-identification of high-risk women who could receive ACS or other interventions. To facilitate better identification in low-resource settings, we developed a color-coded tape for uterine height (UH) measurement and estimated its accuracy identifying preterm pregnancies. We designed a series of colored-coded tapes with segments corresponding to UH measurements for 20-23.6 weeks, 24.0-35.6 weeks, and >36.0 weeks GA. In phase 1, UH measurements were collected prospectively in the Democratic Republic of Congo, India and Pakistan, using distinct tapes to address variation across regions and ethnicities. In phase 2, we tested accuracy in 250 pregnant women with known GA from early ultrasound enrolled at prenatal clinics in Argentina, India, Pak...

Early human development, Jan 27, 2015

The purpose of the current study was to adapt the Bayley Scales of Infant Development II for use ... more 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.

Lancet, 2010

Infection is an important cause of stillbirths worldwide: in low-income and middle-income countri... more Infection is an important cause of stillbirths worldwide: in low-income and middle-income countries, 50% of stillbirths or more are probably caused by infection. By contrast, in high-income countries only 10-25% of stillbirths are caused by infection. Syphilis, where prevalent, causes most infectious stillbirths, and is the infection most amenable to screening and treatment. Ascending bacterial infection is a common cause of stillbirths, but prevention has proven elusive. Many viral infections cause stillbirths but aside from vaccination for common childhood diseases, we do not have a clear prevention strategy. Malaria, because of its high prevalence and extensive placental damage, accounts for large numbers of stillbirths. Intermittent malarial prophylaxis and insecticide-treated bednets should decrease stillbirths. Many infections borne by animals and vectors cause stillbirths, and these types of infections occur frequently in low-income countries. Research that better defi nes the relation between these infections and stillbirths, and develops strategies to reduce associated adverse outcomes, should play an important part in reduction of stillbirths in low-income countries.

The Lancet, 2011

Stillbirth is a common adverse pregnancy outcome, with nearly 3 million third-trimester stillbirt... more Stillbirth is a common adverse pregnancy outcome, with nearly 3 million third-trimester stillbirths occurring worldwide each year. 98% occur in low-income and middle-income countries, and more than 1 million stillbirths occur in the intrapartum period, despite many being preventable. Nevertheless, stillbirth is practically unrecognised as a public health issue and few data are reported. In this fi nal paper in the Stillbirths Series, we call for inclusion of stillbirth as a recognised outcome in all relevant international health reports and initiatives. We ask every country to develop and implement a plan to improve maternal and neonatal health that includes a reduction in stillbirths, and to count stillbirths in their vital statistics and other health outcome surveillance systems. We also ask for increased investment in stillbirth-related research, and especially research aimed at identifying and addressing barriers to the aversion of stillbirths within the maternal and neonatal health systems of low-income and middle-income countries. Finally, we ask all those interested in reducing stillbirths to join with advocates for the improvement of other pregnancy-related outcomes, for mothers and their off spring, so that a united front for improved pregnancy and neonatal care for all will become a reality.

Background Antenatal corticosteroids for pregnant women at risk of preterm birth are among the mo... more Background Antenatal corticosteroids for pregnant women at risk of preterm birth are among the most eff ective hospital-based interventions to reduce neonatal mortality. We aimed to assess the feasibility, eff ectiveness, 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.

Previous research has indicated positive effects of early developmental intervention (EDI) on the... more 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. 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 &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp; Stages Questionnaire administered by evaluators blind to intervention assignment and risk condition. Longitudinal 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. 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.

Background: Resuscitation following birth asphyxia reduces mortality, but may be argued to increa... more Background: Resuscitation following birth asphyxia reduces mortality, but may be argued to increase risk for neurodevelopmental disability in survivors. Aims: To test the hypothesis that development of infants who received resuscitation following birth asphyxia is not significantly different through 36 months of age from infants who had healthy births. Study design: Prospective observational cohort design comparing infants exposed to birth asphyxia with resuscitation or healthy birth. Subjects: 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 b 1500 g, severely abnormal neurological examination at 7 days, mother b 15 years, 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 36 months = 376. Outcome measure(s): Bayley Scales of Infant Development-II Mental (MDI) and Psychomotor (PDI) Development Index. Results: 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. Conclusions: 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.

American Journal of Perinatology, 2014

Objective Postpartum hemorrhage (PPH) is a major cause of maternal mortality, with almost 300,000... more 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.

The Lancet, 2011

In this fi rst paper of The Lancet's Stillbirths Series we explore the present status of stillbir... more In this fi rst paper of The Lancet's Stillbirths Series we explore the present status of stillbirths in the world-from global health policy to a survey of community perceptions in 135 countries. Our fi ndings highlight the need for a strong call for action. In times of global focus on motherhood, the mother's own aspiration of a liveborn baby is not recognised on the world's health agenda. Millions of deaths are not counted; stillbirths are not in the Global Burden of Disease, nor in disability-adjusted life-years lost, and they are not part of the UN Millennium Development Goals. The grief of mothers might be aggravated by social stigma, blame, and marginalisation in regions where most deaths occur. Most stillborn babies are disposed of without any recognition or ritual, such as naming, funeral rites, or the mother holding or dressing the baby. Beliefs in the mother's sins and evil spirits as causes of stillbirth are rife, and stillbirth is widely believed to be a natural selection of babies never meant to live. Stillbirth prevention is closely linked with prevention of maternal and neonatal deaths. Knowledge of causes and feasible solutions for prevention is key to health professionals' priorities, to which this Stillbirths Series paper aims to contribute.

Bulletin of the World Health Organization, 2014

To quantify maternal, fetal and neonatal mortality in low- and middle-income countries, to identi... more 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. A prospective study of pregnancy outcomes was performed in 106 communities at seven sites in Argentina, Guatemala, India, Kenya, Pakistan and Zambia. Pregnant women were enrolled and followed until six weeks postpartum. Between 2010 and 2012, 214,070 of 220,235 enrolled women (97.2%) completed follow-up. The maternal mortality ratio was 168 per 100,000 live births, ranging from 69 per 100,000 in Argentina to 316 per 100,000 in Pakistan. Overall, 29% (98/336) of maternal deaths occurred around the time of delivery: most were attributed to haemorrhage (86/336), pre-eclampsia or eclampsia (55/336) or sepsis (39/336). Around 70% (4349/6213) of stillbirths were probably intrapartum; 34% (1804/5230) of neonates died on the day of delivery and 14% (755/5230) died the day after. Stillbirths were more common in women who died than in those alive six weeks postpartum (risk ratio, RR: 9.48; 95% confidence interval, CI: 7.97-11.27), as were perinatal deaths (RR: 4.30; 95% CI: 3.26-5.67) and 7-day (RR: 3.94; 95% CI: 2.74-5.65) and 28-day neonatal deaths (RR: 7.36; 95% CI: 5.54-9.77). Most maternal, fetal and neonatal deaths occurred at or around delivery and were attributed to preventable causes. Maternal death increased the risk of perinatal and neonatal death. Improving obstetric and neonatal care around the time of birth offers the greatest chance of reducing mortality.

Journal of Maternal-Fetal and Neonatal Medicine, 2008

Objective. The main objective of this study was to identify factors associated with variation in ... more Objective. The main objective of this study was to identify factors associated with variation in the rate of acute postpartum hemorrhage (PPH), defined as blood loss 500 mL within 2 hours of delivery, observed in a randomized clinical trial of misoprostol for the prevention of PPH, conducted in rural India. Although the women in the misoprostol group had a significantly lower probability of having a PPH, we also noted a reduction in the rate of PPH in the placebo group over the course of the study. We hypothesized that this was due to the changing skills of the auxiliary nurse midwives (ANMs) over the course of the study. Methods. We conducted a post-hoc analysis examining variation in PPH rates over the duration of the trial among the women randomized to the placebo arm (n ¼ 808). Descriptive, correlation analysis and generalized estimating equations (GEE) were used to predict PPH rates. With no direct measure of ANM skills, we used proxy measures, including: (1) the ANM's point of entry into the study (original ANMs at the initiation of the trial were less skilled than replacement ANMs);

Journal of Maternal-Fetal and Neonatal Medicine, 2009

To understand the rates, causes and risk factors for stillbirth in developing countries as well a... more To understand the rates, causes and risk factors for stillbirth in developing countries as well as the strategies that have been evaluated to reduce stillbirth. We searched the English literature for 2003-2008 for all articles related to stillbirth and perinatal mortality in developing countries and reviewed all related publications. Despite the large number of stillbirths worldwide, the topic of stillbirths in developing countries has received very little research, programmatic or policy attention. In many developing countries, almost half of the deliveries occur at home, and under-reporting of stillbirths is a significant problem. Reliable data about rates and causes are unavailable in many areas of the world. Nevertheless, of the estimated 3.2 million stillbirths that occur yearly world-wide, the vast majority occur in developing countries. Rates in many developing countries are 10-fold greater or more than in developed countries. There is not a standard international classification system that defines cause of death, nor is there agreement about the lower limits of birthweight or gestational age that define stillbirth, making comparisons of causes of stillbirth or rates over time or between sites problematic. From available data, prolonged and obstructed labour, pre-eclampsia and various infections, all without adequate treatment, appear to account for the majority of stillbirths in developing countries. Identification and treatment of maternal syphilis has been effective in reducing stillbirth risk, as has improvements in access to emergency obstetrical services and particularly caesarean section. Further research is needed to understand the causes and the best preventive strategies for stillbirth specific to geographic areas. However, based on current data, better access to appropriate obstetric care, particularly during labour and delivery and better screening and treatment of syphilis should reduce developing country stillbirth rates dramatically.

Seminars in Fetal and Neonatal Medicine, 2009

s u m m a r y Infection may cause stillbirth by several mechanisms, including direct infection, p... more s u m m a r y Infection may cause stillbirth by several mechanisms, including direct infection, placental damage, and severe maternal illness. Various organisms have been associated with stillbirth, including many bacteria, viruses, and protozoa. In developed countries, between 10% and 25% of stillbirths may be caused by an infection, whereas in developing countries, which have much higher stillbirth rates, the contribution of infection is much greater. In developed countries, ascending bacterial infection, both before and after membrane rupture, with organisms such as Escherichia coli, group B streptococci, and Ureaplasma urealyticum is usually the most common infectious cause of stillbirth. However, in areas where syphilis is prevalent, up to half of all stillbirths may be caused by this infection alone. Malaria may be an important cause of stillbirth in women infected for the first time in pregnancy. The two most important viral causes of stillbirth are parvovirus and Coxsackie virus, although a number of other viral infections appear to be causal. Toxoplasma gondii, Listeria monocytogenes, and the organisms that cause leptospirosis, Q fever, and Lyme disease have all been implicated as etiologic for stillbirth. In certain developing countries, the stillbirth rate is high and the infection-related component so great that achieving a substantial reduction in stillbirth should be possible by reducing maternal infections. However, because infection-related stillbirth is uncommon in developed countries, and because those that do occur are caused by a wide variety of organisms, reducing this etiologic component of stillbirth much further will be difficult.

PLoS Neglected Tropical Diseases, 2014

Background: Relative contribution of these infections on anemia in pregnancy is not certain. Whil... more Background: 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.

Obstetrics & Gynecology, 2010

To estimate the effects of chlorhexidine vaginal and baby wipes on fetal and neonatal mortality, ... more To estimate the effects of chlorhexidine vaginal and baby wipes on fetal and neonatal mortality, respectively, and infection-related morbidity.

Seminars in Fetal and Neonatal Medicine, 2015

In response to the global effort to accelerate progress towards the Millennium Development Goals ... more In response to the global effort to accelerate progress towards the Millennium Development Goals 4 and 5, a partnership was created between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the Bill and Melinda Gates Foundation to establish the Global Network for Women&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s and Children&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s Health Research (Global Network) in 2000. The Global Network was developed with a goal of building local maternal and child health research capacity in resource-poor settings. The objective of the network was to conduct research focused on several high-need areas, such as preventing life-threatening obstetric complications, improving birth weight and infant growth, and improving childbirth practices in order to reduce mortality. Scientists from developing countries, together with peers in the USA, lead research teams that identify and address population needs through randomized clinical trials and other research studies. Global Network projects develop and test cost-effective, sustainable interventions for pregnant women and newborns and provide guidance for national policy and for the practice of evidence-based medicine. This article reviews the results of the Global Network&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s research, the impact on policy and practice, and highlights the capacity-building efforts and collaborations developed since its inception.

Reproductive health, Jan 8, 2015

The Global Network for Women's and Children's Health Research is one of the largest inter... more The Global Network for Women's and Children's Health Research is one of the largest international networks for testing and generating evidence-based recommendations for improvement of maternal-child health in resource-limited settings. Since 2009, Global Network sites in six low and middle-income countries have collected information on antenatal care practices, which are important as indicators of care and have implications for programs to improve maternal and child health. We sought to: (1) describe the quantity of antenatal care attendance over a four-year period; and (2) explore the quality of coverage for selected preventative, screening, and birth preparedness components. The Maternal Newborn Health Registry (MNHR) is a prospective, population-based birth and pregnancy outcomes registry in Global Network sites, including: Argentina, Guatemala, India (Belgaum and Nagpur), Kenya, Pakistan, and Zambia. MNHR data from these sites were prospectively collected from January 1,...

Obstetrics & Gynecology, 2015

Journal of interpersonal violence, Jan 14, 2015

This community-based observational study of 1,325 women seen for antenatal care examined how wome... more This community-based observational study of 1,325 women seen for antenatal care examined how women in Pakistan define violence against women (VAW), with an emphasis on domestic violence, what an acceptable response to violence is, reasons for remaining silent, and whether participants are willing to disclose incidents of domestic violence to others. Nearly half of the study participants believed that physical violence was VAW. Verbal abuse, controlling behavior by the husband, conflict with in-laws, overburdening domestic work, and threatening to leave or remarry were also considered VAW. However, only five respondents (0.4%) considered sexual abuse to be VAW. Most women who screened positive for domestic violence responded by remaining silent or verbal fighting back. None sought professional help. Women who decided to remain silent feared that the abuse would escalate or that responding would not help them. Women cited social stigma and concerns about the impact of the violence on ...

PloS one, 2015

Neonatal mortality associated with preterm birth can be reduced with antenatal corticosteroids (A... more Neonatal mortality associated with preterm birth can be reduced with antenatal corticosteroids (ACS), yet <10% of eligible pregnant women in low-middle income countries. The inability to accurately determine gestational age (GA) leads to under-identification of high-risk women who could receive ACS or other interventions. To facilitate better identification in low-resource settings, we developed a color-coded tape for uterine height (UH) measurement and estimated its accuracy identifying preterm pregnancies. We designed a series of colored-coded tapes with segments corresponding to UH measurements for 20-23.6 weeks, 24.0-35.6 weeks, and >36.0 weeks GA. In phase 1, UH measurements were collected prospectively in the Democratic Republic of Congo, India and Pakistan, using distinct tapes to address variation across regions and ethnicities. In phase 2, we tested accuracy in 250 pregnant women with known GA from early ultrasound enrolled at prenatal clinics in Argentina, India, Pak...

Early human development, Jan 27, 2015

The purpose of the current study was to adapt the Bayley Scales of Infant Development II for use ... more 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.

Lancet, 2010

Infection is an important cause of stillbirths worldwide: in low-income and middle-income countri... more Infection is an important cause of stillbirths worldwide: in low-income and middle-income countries, 50% of stillbirths or more are probably caused by infection. By contrast, in high-income countries only 10-25% of stillbirths are caused by infection. Syphilis, where prevalent, causes most infectious stillbirths, and is the infection most amenable to screening and treatment. Ascending bacterial infection is a common cause of stillbirths, but prevention has proven elusive. Many viral infections cause stillbirths but aside from vaccination for common childhood diseases, we do not have a clear prevention strategy. Malaria, because of its high prevalence and extensive placental damage, accounts for large numbers of stillbirths. Intermittent malarial prophylaxis and insecticide-treated bednets should decrease stillbirths. Many infections borne by animals and vectors cause stillbirths, and these types of infections occur frequently in low-income countries. Research that better defi nes the relation between these infections and stillbirths, and develops strategies to reduce associated adverse outcomes, should play an important part in reduction of stillbirths in low-income countries.

The Lancet, 2011

Stillbirth is a common adverse pregnancy outcome, with nearly 3 million third-trimester stillbirt... more Stillbirth is a common adverse pregnancy outcome, with nearly 3 million third-trimester stillbirths occurring worldwide each year. 98% occur in low-income and middle-income countries, and more than 1 million stillbirths occur in the intrapartum period, despite many being preventable. Nevertheless, stillbirth is practically unrecognised as a public health issue and few data are reported. In this fi nal paper in the Stillbirths Series, we call for inclusion of stillbirth as a recognised outcome in all relevant international health reports and initiatives. We ask every country to develop and implement a plan to improve maternal and neonatal health that includes a reduction in stillbirths, and to count stillbirths in their vital statistics and other health outcome surveillance systems. We also ask for increased investment in stillbirth-related research, and especially research aimed at identifying and addressing barriers to the aversion of stillbirths within the maternal and neonatal health systems of low-income and middle-income countries. Finally, we ask all those interested in reducing stillbirths to join with advocates for the improvement of other pregnancy-related outcomes, for mothers and their off spring, so that a united front for improved pregnancy and neonatal care for all will become a reality.

Background Antenatal corticosteroids for pregnant women at risk of preterm birth are among the mo... more Background Antenatal corticosteroids for pregnant women at risk of preterm birth are among the most eff ective hospital-based interventions to reduce neonatal mortality. We aimed to assess the feasibility, eff ectiveness, 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.

Previous research has indicated positive effects of early developmental intervention (EDI) on the... more 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. 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 &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp; Stages Questionnaire administered by evaluators blind to intervention assignment and risk condition. Longitudinal 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. 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.

Background: Resuscitation following birth asphyxia reduces mortality, but may be argued to increa... more Background: Resuscitation following birth asphyxia reduces mortality, but may be argued to increase risk for neurodevelopmental disability in survivors. Aims: To test the hypothesis that development of infants who received resuscitation following birth asphyxia is not significantly different through 36 months of age from infants who had healthy births. Study design: Prospective observational cohort design comparing infants exposed to birth asphyxia with resuscitation or healthy birth. Subjects: 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 b 1500 g, severely abnormal neurological examination at 7 days, mother b 15 years, 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 36 months = 376. Outcome measure(s): Bayley Scales of Infant Development-II Mental (MDI) and Psychomotor (PDI) Development Index. Results: 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. Conclusions: 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.

American Journal of Perinatology, 2014

Objective Postpartum hemorrhage (PPH) is a major cause of maternal mortality, with almost 300,000... more 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.

The Lancet, 2011

In this fi rst paper of The Lancet's Stillbirths Series we explore the present status of stillbir... more In this fi rst paper of The Lancet's Stillbirths Series we explore the present status of stillbirths in the world-from global health policy to a survey of community perceptions in 135 countries. Our fi ndings highlight the need for a strong call for action. In times of global focus on motherhood, the mother's own aspiration of a liveborn baby is not recognised on the world's health agenda. Millions of deaths are not counted; stillbirths are not in the Global Burden of Disease, nor in disability-adjusted life-years lost, and they are not part of the UN Millennium Development Goals. The grief of mothers might be aggravated by social stigma, blame, and marginalisation in regions where most deaths occur. Most stillborn babies are disposed of without any recognition or ritual, such as naming, funeral rites, or the mother holding or dressing the baby. Beliefs in the mother's sins and evil spirits as causes of stillbirth are rife, and stillbirth is widely believed to be a natural selection of babies never meant to live. Stillbirth prevention is closely linked with prevention of maternal and neonatal deaths. Knowledge of causes and feasible solutions for prevention is key to health professionals' priorities, to which this Stillbirths Series paper aims to contribute.

Bulletin of the World Health Organization, 2014

To quantify maternal, fetal and neonatal mortality in low- and middle-income countries, to identi... more 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. A prospective study of pregnancy outcomes was performed in 106 communities at seven sites in Argentina, Guatemala, India, Kenya, Pakistan and Zambia. Pregnant women were enrolled and followed until six weeks postpartum. Between 2010 and 2012, 214,070 of 220,235 enrolled women (97.2%) completed follow-up. The maternal mortality ratio was 168 per 100,000 live births, ranging from 69 per 100,000 in Argentina to 316 per 100,000 in Pakistan. Overall, 29% (98/336) of maternal deaths occurred around the time of delivery: most were attributed to haemorrhage (86/336), pre-eclampsia or eclampsia (55/336) or sepsis (39/336). Around 70% (4349/6213) of stillbirths were probably intrapartum; 34% (1804/5230) of neonates died on the day of delivery and 14% (755/5230) died the day after. Stillbirths were more common in women who died than in those alive six weeks postpartum (risk ratio, RR: 9.48; 95% confidence interval, CI: 7.97-11.27), as were perinatal deaths (RR: 4.30; 95% CI: 3.26-5.67) and 7-day (RR: 3.94; 95% CI: 2.74-5.65) and 28-day neonatal deaths (RR: 7.36; 95% CI: 5.54-9.77). Most maternal, fetal and neonatal deaths occurred at or around delivery and were attributed to preventable causes. Maternal death increased the risk of perinatal and neonatal death. Improving obstetric and neonatal care around the time of birth offers the greatest chance of reducing mortality.

Journal of Maternal-Fetal and Neonatal Medicine, 2008

Objective. The main objective of this study was to identify factors associated with variation in ... more Objective. The main objective of this study was to identify factors associated with variation in the rate of acute postpartum hemorrhage (PPH), defined as blood loss 500 mL within 2 hours of delivery, observed in a randomized clinical trial of misoprostol for the prevention of PPH, conducted in rural India. Although the women in the misoprostol group had a significantly lower probability of having a PPH, we also noted a reduction in the rate of PPH in the placebo group over the course of the study. We hypothesized that this was due to the changing skills of the auxiliary nurse midwives (ANMs) over the course of the study. Methods. We conducted a post-hoc analysis examining variation in PPH rates over the duration of the trial among the women randomized to the placebo arm (n ¼ 808). Descriptive, correlation analysis and generalized estimating equations (GEE) were used to predict PPH rates. With no direct measure of ANM skills, we used proxy measures, including: (1) the ANM's point of entry into the study (original ANMs at the initiation of the trial were less skilled than replacement ANMs);

Journal of Maternal-Fetal and Neonatal Medicine, 2009

To understand the rates, causes and risk factors for stillbirth in developing countries as well a... more To understand the rates, causes and risk factors for stillbirth in developing countries as well as the strategies that have been evaluated to reduce stillbirth. We searched the English literature for 2003-2008 for all articles related to stillbirth and perinatal mortality in developing countries and reviewed all related publications. Despite the large number of stillbirths worldwide, the topic of stillbirths in developing countries has received very little research, programmatic or policy attention. In many developing countries, almost half of the deliveries occur at home, and under-reporting of stillbirths is a significant problem. Reliable data about rates and causes are unavailable in many areas of the world. Nevertheless, of the estimated 3.2 million stillbirths that occur yearly world-wide, the vast majority occur in developing countries. Rates in many developing countries are 10-fold greater or more than in developed countries. There is not a standard international classification system that defines cause of death, nor is there agreement about the lower limits of birthweight or gestational age that define stillbirth, making comparisons of causes of stillbirth or rates over time or between sites problematic. From available data, prolonged and obstructed labour, pre-eclampsia and various infections, all without adequate treatment, appear to account for the majority of stillbirths in developing countries. Identification and treatment of maternal syphilis has been effective in reducing stillbirth risk, as has improvements in access to emergency obstetrical services and particularly caesarean section. Further research is needed to understand the causes and the best preventive strategies for stillbirth specific to geographic areas. However, based on current data, better access to appropriate obstetric care, particularly during labour and delivery and better screening and treatment of syphilis should reduce developing country stillbirth rates dramatically.

Seminars in Fetal and Neonatal Medicine, 2009

s u m m a r y Infection may cause stillbirth by several mechanisms, including direct infection, p... more s u m m a r y Infection may cause stillbirth by several mechanisms, including direct infection, placental damage, and severe maternal illness. Various organisms have been associated with stillbirth, including many bacteria, viruses, and protozoa. In developed countries, between 10% and 25% of stillbirths may be caused by an infection, whereas in developing countries, which have much higher stillbirth rates, the contribution of infection is much greater. In developed countries, ascending bacterial infection, both before and after membrane rupture, with organisms such as Escherichia coli, group B streptococci, and Ureaplasma urealyticum is usually the most common infectious cause of stillbirth. However, in areas where syphilis is prevalent, up to half of all stillbirths may be caused by this infection alone. Malaria may be an important cause of stillbirth in women infected for the first time in pregnancy. The two most important viral causes of stillbirth are parvovirus and Coxsackie virus, although a number of other viral infections appear to be causal. Toxoplasma gondii, Listeria monocytogenes, and the organisms that cause leptospirosis, Q fever, and Lyme disease have all been implicated as etiologic for stillbirth. In certain developing countries, the stillbirth rate is high and the infection-related component so great that achieving a substantial reduction in stillbirth should be possible by reducing maternal infections. However, because infection-related stillbirth is uncommon in developed countries, and because those that do occur are caused by a wide variety of organisms, reducing this etiologic component of stillbirth much further will be difficult.

PLoS Neglected Tropical Diseases, 2014

Background: Relative contribution of these infections on anemia in pregnancy is not certain. Whil... more Background: 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.

Obstetrics & Gynecology, 2010

To estimate the effects of chlorhexidine vaginal and baby wipes on fetal and neonatal mortality, ... more To estimate the effects of chlorhexidine vaginal and baby wipes on fetal and neonatal mortality, respectively, and infection-related morbidity.