[Show abstract][Hide abstract] 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
[Show abstract][Hide abstract] 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; · 1.57 Impact Factor
[Show abstract][Hide abstract] 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; · 1.85 Impact Factor
[Show abstract][Hide abstract] 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 Organization. 08/2014; 92(8):605-12.
[Show abstract][Hide abstract] 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.
[Show abstract][Hide abstract] 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; · 2.12 Impact Factor
[Show abstract][Hide abstract] 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; · 5.42 Impact Factor
[Show abstract][Hide abstract] 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. · 2.52 Impact Factor
[Show abstract][Hide abstract] 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. · 2.52 Impact Factor
[Show abstract][Hide abstract] 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. · 2.52 Impact Factor
[Show abstract][Hide abstract] 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.
[Show abstract][Hide abstract] 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.
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.
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.
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 01/2014; · 1.41 Impact Factor
[Show abstract][Hide abstract] 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.
[Show abstract][Hide abstract] ABSTRACT: Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care.
This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at >=28 weeks gestation or birth weight >=1000 g.
Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention.
This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training and community mobilization will not be sufficient. Our results highlight the critical importance of evaluating outcomes in randomized trials, as interventions that should be effective may not be.Trial registration: ClinicalTrials.gov NCT01073488.
BMC Medicine 10/2013; 11(1):215. · 7.28 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Several recent studies in low-resource countries have claimed that training in-and increased use of-newborn resuscitation resulted in reduced stillbirth rates. In the present article, we explore the ability of various types of birth attendant in some low-resource country locations to gather data that accurately differentiate a stillbirth from a live birth/early neonatal death. We conclude that, in many situations, it cannot be determined whether the infant was a stillbirth or a live birth/early neonatal death, and therefore the least-biased description of study outcomes includes a combined stillbirth and live birth/neonatal death outcome. However, because defining the burden of stillbirth and neonatal death is important from a public health perspective, every effort should be made, in low-income countries and elsewhere, to distinguish between stillbirths and live births/neonatal deaths and to report the results independently.
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 09/2013; · 1.41 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To determine the feasibility of introducing a simple indicator of quality of obstetric and neonatal care and to determine the proportion of potentially avoidable perinatal deaths in hospitals in low-income countries.
Between September 1, 2011, and February 29, 2012, data were collected from consecutive women who were admitted to the labor ward of 1 of 6 hospitals in 4 low-income countries. Fetal heart tones on admission were monitored, and demographic and birth data were recorded.
Data were obtained for 3555 women and 3593 neonates (including twins). The doptone was used on 97% of women admitted. The overall perinatal mortality rate was 34 deaths per 1000 deliveries. Of the perinatal deaths, 40%-45% occurred in the hospital and were potentially preventable by better hospital care.
The results demonstrated that it is possible to accurately determine fetal viability on admission via a doptone. Implementation of doptone use, coupled with a concise data record, might form the basis of a low-cost and sustainable program to monitor and evaluate efforts to improve quality of care and ultimately might help to reduce the in-hospital component of perinatal mortality in low-income countries.
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 06/2013; · 1.41 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Aim To determine the rates of multiple gestation, stillbirth, and perinatal and neonatal mortality and to determine health care system characteristics related to perinatal mortality of these pregnancies in low- and middle-income countries.Methods Pregnant women residing within defined geographic boundaries located in six countries were enrolled and followed to 42 days postpartum.Results Multiple gestations were 0.9% of births. Multiple gestations were more likely to deliver in a health care facility compared with singletons (70 and 66%, respectively, p < 0.001), to be attended by skilled health personnel (71 and 67%, p < 0.001), and to be delivered by cesarean (18 versus 9%, p < 0.001). Multiple-gestation fetuses had a relative risk (RR) for stillbirth of 2.65 (95% confidence interval [CI] 2.06, 3.41) and for perinatal mortality rate (PMR) a RR of 3.98 (95% CI 3.40, 4.65) relative to singletons (both p < 0.0001). Neither delivery in a health facility nor the cesarean delivery rate was associated with decreased PMR. Among multiple-gestation deliveries, physician-attended delivery relative to delivery by other health providers was associated with a decreased risk of perinatal mortality.Conclusions Multiple gestations contribute disproportionately to PMR in low-resource countries. Neither delivery in a health facility nor the cesarean delivery rate is associated with improved PMR.
American Journal of Perinatology 03/2013; · 1.57 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Malaria in pregnancy is a significant contributor to adverse pregnancy outcome, especially in Sub-Saharan Africa. Prevention with sulfadoxine/pyrimethamine (SP) during pregnancy has been recommended in malaria-endemic areas but concerns remain about its benefit. OBJECTIVES: To evaluate the association between recommended preventative SP programs in pregnancy and low birth weight (LBW) and maternal anemia through available clinical trial, observational, and programmatic evaluation studies. SEARCH STRATEGY: Systematic review of published studies on malaria in pregnancy and pregnancy outcomes. SELECTION CRITERIA: Clinical studies from Sub-Saharan Africa from the past 10years were included. DATA COLLECTION AND ANALYSIS: English articles published since 2002 and listed in PubMed were identified using defined keywords, and their source documents were reviewed. Thirty-three studies involving malaria in pregnancy that recorded treatment rates and birth outcomes were included. MAIN RESULTS: SP use among primigravidae was consistently associated with decreased LBW and anemia rates in clinical trials. Effects were less consistent in observational studies. CONCLUSIONS: Although randomized trials have demonstrated the efficacy of SP, studies evaluating scale-up programs found less consistent reductions in LBW and maternal anemia. Additional strategies to improve SP coverage may reduce the LBW and maternal anemia associated with malaria in pregnancy.
International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 03/2013; · 1.41 Impact Factor