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1.  Dose of early intervention treatment during children’s first 36 months of life is associated with developmental outcomes: an observational cohort study in three low/low-middle income countries 
BMC Pediatrics  2014;14(1):281.
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.
Infants (78 males, 67 females) born in rural communities in India, Pakistan, and Zambia received a parent-implemented EDI delivered through biweekly home visits by trainers during the first 36 months of life. Outcome was measured at age 36 months with the Mental (MDI) and Psychomotor (PDI) Development Indices of the Bayley Scales of Infant Development-II. Treatment dose was measured by number of home visits completed and parent-reported implementation of assigned developmental stimulation activities between visits. Sociodemographic, prenatal, perinatal, and child health variables were measures as correlates.
Average home visits dose exceeded 91% and mothers engaged the children in activities on average 62.5% of days. Higher home visits dose was significantly associated with higher MDI (mean for dose quintiles 1–2 combined = 97.8, quintiles 3–5 combined = 103.4, p = 0.0017). Higher treatment dose was also generally associated with greater mean PDI, but the relationships were non-linear. Location, sociodemographic, and child health variables were associated with treatment dose.
Receiving a higher dose of EDI during the first 36 months of life is generally associated with better developmental outcomes. The higher benefit appears when receiving ≥91% of biweekly home visits and program activities on ≥67% of days over 3 years. It is important to ensure that EDI is implemented with a sufficiently high dose to achieve desired effect. To this end groups at risk for receiving lower dose can be identified and may require special attention to ensure adequate effect.
PMCID: PMC4288653  PMID: 25344731
Treatment dose; Early developmental intervention; Neurodevelopmental disability; Birth asphyxia; Developing countries
2.  A multi-country study of the “intrapartum stillbirth and early neonatal death indicator” in hospitals in low-resource settings 
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 women who had a term pregnancy and 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 to help to reduce the in-hospital component of perinatal mortality in low-income countries.
PMCID: PMC3893914  PMID: 23796259
Doptone; Fetal heart tones; Hospital-based perinatal mortality; Neonatal mortality; Perinatal mortality; Stillbirth
3.  Clinical, lifestyle, socioeconomic determinants and rate of asymptomatic intracranial atherosclerosis in stroke free Pakistanis 
BMC Neurology  2014;14:155.
Intracranial Atherosclerotic Disease (ICAD) is the most frequent etiology of stroke with high prevalence among Asians. Despite this, early determinants of ICAD have not been described from this region.
The study is an analytical prospective cross-sectional study of 200 adults from Radiology Departments of two diagnostic centers in Karachi. Eligible participants confirmed the absence of stroke symptoms via the Questionnaire for Verifying Stroke Free Status (QVSFS) and underwent an interview covering medical, socio demographic, lifestyle and anthropometric evaluation using locally validated and standardized definitions. Magnetic Resonance Images (MRI) were centrally reviewed to detect ICAD using the criterion used in the Warfarin–Aspirin Symptomatic Intracranial Disease study. The risk factors associated with asymptomatic ICAD are reported along with prevalence ratios.
Of the 200 participants, ICAD was found in 34.5% (n = 69) of the participants. Mean age was 37.1 (S.D 15.1) years with 62% younger than 45 years. Self-reported hypertension was found in 26.5% subjects, diabetes in 9%, dyslipidemia in 5% and depression in 60%. Smokeless tobacco (Adjusted PR 3.27 (1.07-6.05)), Western diet, high socioeconomic status (Adjusted PR 2.26 (1.99-5.62)) and dyslipidemia (Adjusted PR 1.88 (1.25-2.21)) had significant associations with ICAD after multivariable analysis. Age, gender, diabetes, hypertension, depression and physical activity did not have a significant association.
ICAD was found on MRI in one in three asymptomatic Pakistanis and was associated with modifiable risks. Initiatives targeting primary prevention may be able to decrease the burden of disease caused by stroke due to ICAD.
Study Registration Number
NCT02072876 2/25/2014
PMCID: PMC4236665  PMID: 25124284
Intracranial atherosclerosis; Stroke; Asymptomatic; Developing countries; Prevention; Sociodemographic risk factors; Epidemiology
4.  Randomized Trial of Early Developmental Intervention on Outcomes in Children after Birth Asphyxia in Developing Countries 
The Journal of pediatrics  2012;162(4):705-712.e3.
To determine if early developmental intervention (EDI) improves developmental abilities in resuscitated children.
Study design
This was a parallel group, randomized controlled trial of infants unresponsive to stimulation who received bag and mask ventilation as part of their resuscitation at birth and infants who did not require any resuscitation born in rural communities in India, Pakistan, and Zambia. Intervention infants received a parent-implemented EDI delivered with home visits by parent trainers every other week for 3 years started the first month after birth. Parents in both intervention and control groups received health and safety counseling during home visits on the same schedule. The main outcome measure was the Mental Development Index (MDI) of the Bayley Scales of Infant Development, 2nd edition, assessed at 36 months by evaluators unaware of treatment group and resuscitation history.
MDI was higher in the EDI (102.6±9.8) compared with the control resuscitated children (98.0±14.6, one-sided p=0.0202) but there was no difference between groups in the non-resuscitated children (100.1±10.7 vs. 97.7±10.4, p=0.1392). The Psychomotor Development Index (PDI) was higher in the EDI group for both the resuscitated (p=0.0430) and non-resuscitated children (p=0.0164).
This trial of home-based, parent provided EDI in children resuscitated at birth provides evidence of treatment benefits on cognitive and psychomotor outcomes. MDI and PDI scores of both non-resuscitated and resuscitated infants were within normal range, independent of early intervention.
PMCID: PMC3582821  PMID: 23164311
Early intervention; resuscitation; intellectual disability; low and middle income countries; neonatal mortality; infant mortality; developmental outcome
5.  Preconception maternal nutrition: a multi-site randomized controlled trial 
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 NCT01883193.
PMCID: PMC4000057  PMID: 24650219
Preconception; Maternal; Nutrition; Birth length; Epigenetics; Microbiome
6.  First look: a cluster-randomized trial of ultrasound to improve pregnancy outcomes in low income country settings 
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.
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-naïve 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 (NCT # 01990625)
PMCID: PMC3996090  PMID: 24533878
Maternal mortality; Maternal near miss; Perinatal mortality; Obstetric ultrasound; Low-income countries
7.  Prevalence of Suicidal Thoughts and Attempts Among Pregnant Pakistani Women 
To determine the prevalence of suicidal thoughts and attempts and to identify demographic variables and mental health correlates such as anxiety/depression and domestic violence among pregnant women in an urban community in Pakistan.
Cross sectional data from a prospective cohort study are presented.
Women enrolled in an antenatal care clinic and followed to delivery in an urban area of Pakistan
Cohort of pregnant women in Pakistan.
1,369 pregnant women were enrolled and interviewed regarding various maternal characteristics and pregnancy outcomes, and were asked specific questions about suicidal thoughts and attempts and administered the Aga Khan University Anxiety Depression Scale at 20–26 weeks of gestation.
Main outcome measures
Suicidal thoughts and attempts, verbal, sexual or physical abuse.
Overall, 148 of the 1369 (11%) women studied had considered suicide. Of these, 148 women, 67 (45%) had attempted suicide. Eighteen percent of the women were classified as having depression/anxiety, almost half (48%) reported experiencing verbal abuse and 20% reported physical/sexual abuse. Women who had anxiety/depression or had experienced verbal or physical/sexual abuse were significantly more likely to have had suicidal thoughts and attempts.
Women at greatest risk for having suicidal thoughts or a suicide attempt were those who were depressed/anxious and had experienced some form of domestic abuse. With the high prevalence of these conditions, attention should be given to the establishment of effective mental health treatment programs for pregnant women.
PMCID: PMC3918941  PMID: 21050149
Suicidal thoughts; suicide attempts; pregnancy; abuse; anxiety/depression
8.  Anemia prevalence and risk factors in pregnant women in an urban area of Pakistan 
Food and nutrition bulletin  2008;29(2):132-139.
Anemia affects almost two-thirds of pregnant women in developing countries and contributes to maternal morbidity and mortality and to low birthweight.
To determine the prevalence of anemia and the dietary and socioeconomic factors associated with anemia in pregnant women living in an urban community setting in Hyderabad, Pakistan.
This was a prospective, observational study of 1,369 pregnant women enrolled at 20 to 26 weeks of gestation and followed to 6 weeks postpartum. A blood sample was obtained at enrollment to determine hemoglobin levels. Information on nutritional knowledge, attitudes, and practice and dietary history regarding usual food intake before and during pregnancy were obtained by trained interviewers within 1 week of enrollment.
The prevalence of anemia (defined by the World Health Organization as hemoglobin < 11.0 g/dL) in these subjects was 90.5%; of these, 75.0% had mild anemia (hemoglobin from 9.0 to 10.9 g/dL) and 14.8% had moderate anemia (hemoglobin from 7.0 to 8.9 g/dL). Only 0.7% were severely anemic (hemoglobin < 7.0 g/dL). Nonanemic women were significantly taller, weighed more, and had a higher body mass index. Multivariate analysis after adjustment for education, pregnancy history, iron supplementation, and height showed that drinking more than three cups of tea per day before pregnancy (adjusted prevalence odds ratio [aPOR], 3.2; 95% confidence interval [CI], 1.3 to 8.0), consumption of clay or dirt during pregnancy (aPOR, 3.7; 95% CI, 1.1 to 12.3), and never consuming eggs or consuming eggs less than twice a week during pregnancy (aPOR, 1.7; 95% CI, 1.1 to 2.5) were significantly associated with anemia. Consumption of red meat less than twice a week prior to pregnancy was marginally associated with anemia (aPOR, 1.2; 95% CI, 0.8 to 1.8) but was significantly associated with lower mean hemoglobin concentrations (9.9 vs. 10.0 g/dL, p = .05) during the study period. A subanalysis excluding women with mild anemia found similar associations to those of the main model, albeit even stronger.
A high percentage of women at 20 to 26 weeks of pregnancy had mild to moderate anemia. Pica, tea consumption, and low intake of eggs and red meat were associated with anemia. Women of childbearing age should be provided nutritional education regarding food sources of iron, especially prior to becoming pregnant, and taught how food choices can either enhance or interfere with iron absorption.
PMCID: PMC3917507  PMID: 18693477
Anemia; developing countries; pregnancy
9.  Prevalence of Anxiety, Depression and Associated Factors among Pregnant Women of Hyderabad, Pakistan 
The International journal of social psychiatry  2009;55(5):10.1177/0020764008094645.
Few studies have examined the relationship between antenatal depression, anxiety and domestic violence in pregnant women in developing countries, despite the World Health Organization's estimates that depressive disorders will be the second leading cause of the global disease burden by 2020. There is a paucity of research on mood disorders, their predictors and sequelae among pregnant women in Pakistan.
To determine the prevalence of anxiety and depression and evaluate associated factors, including domestic violence, among pregnant women in an urban community in Pakistan.
All pregnant women living in identified areas of Hyderabad, Pakistan were screened by government health workers for an observational study on maternal characteristics and pregnancy outcomes. Of these, 1368 (76%) of eligible women were administered the validated Aga Khan University Anxiety Depression Scale at 20–26 weeks of gestation.
18 percent of the women were anxious and/or depressed. Psychological distress was associated with husband unemployment (p=0.032), lower household wealth (p=0.027), having 10 or more years of formal education (p=0.002), a first (p=0.002) and an unwanted pregnancy (p<0.001). The strongest factors associated with depression/anxiety were physical/sexual and verbal abuse; 42% of women who were physically and/or sexually abused and 23% of those with verbal abuse had depression/anxiety compared to 8% of those who were not abused.
Anxiety and depression commonly occur during pregnancy in Pakistani women; rates are highest in women experiencing sexual/physical as well as verbal abuse, but they also are increased among women with unemployed spouses and those with lower household wealth. These results suggest that developing a screening and treatment program for domestic violence and depression/anxiety during pregnancy may improve the mental health status of pregnant Pakistani women.
PMCID: PMC3875176  PMID: 19592433
Pregnancy; depression; anxiety; Pakistan; measurement
Nutrition reviews  2011;69(0 1):10.1111/j.1753-4887.2011.00434.x.
The rationale is considered for promoting the availability of local, affordable, non-fortified food sources of bioavailable iron in developing countries. Intakes of iron from the regular consumption of meat from the age of six months are evaluated with respect to physiological requirements. The paper includes a description of two major randomized controlled trials of meat as a first and regular complementary food that are currently in progress. These trials involve poor communities in Guatemala, Pakistan, Zambia, Democratic Republic of the Congo and China.
PMCID: PMC3875190  PMID: 22043884
iron; meat; complementary feeding
11.  High HIV Incidence among Persons Who Inject Drugs in Pakistan: Greater Risk with Needle Sharing and Injecting Frequently among the Homeless 
PLoS ONE  2013;8(12):e81715.
The incidence of HIV among persons who inject drugs (PWIDU) has fallen in many nations, likely due to successes of clean needle/syringe exchange and substance abuse treatment and service programs. However in Pakistan, prevalence rates for PWID have risen dramatically. In several cities, prevalence exceeded 20% by 2009 compared to a 2003 baseline of just 0.5%. However, no cohort study of PWID has ever been conducted.
We enrolled a cohort of 636 HIV seronegative PWID registered with three drop-in centers that focus on risk reduction and basic social services in Karachi. Recruitment began in 2009 (March to June) and PWID were followed for two years. We measured incidence rates and risk factors associated with HIV seroconversion.
Incidence of HIV was 12.4 per 100 person-years (95% exact Poisson confidence interval [CI]: 10.3–14.9). We followed 474 of 636 HIV seronegative persons (74.5%) for two years, an annual loss to follow-up of <13 per 100 person years. In multivariable Cox regression analysis, HIV seroconversion was associated with non-Muslim religion (Adjusted risk ratio [ARR] = 1.7, 95%CI:1.4, 2.7, p = 0.03), sharing of syringes (ARR = 2.3, 95%CI:1.5, 3.3, p<0.0001), being homeless (ARR = 1.7, 95%CI:1.1, 2.5, p = 0.009), and daily injection of drugs (ARR = 1.1, 95%CI:1.0, 1.3, p = 0.04).
Even though all members of the cohort of PWID were attending risk reduction programs, the HIV incidence rate was very high in Karachi from 2009–2011. The project budget was low, yet we were able to retain three-quarters of the population over two years. Absence of opiate substitution therapy and incomplete needle/syringe exchange coverage undermines success in HIV risk reduction.
PMCID: PMC3864804  PMID: 24358123
12.  A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial 
BMC Medicine  2013;11:215.
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 NCT01073488
PMCID: PMC3853358  PMID: 24090370
Stillbirth; Neonatal mortality; Maternal mortality; Emergency obstetric care
13.  Assessment of Obstetric and Neonatal Health Services in Developing Country Health Facilities 
American journal of perinatology  2013;30(9):787-794.
To describe the staffing and availability of medical equipment and medications and the performance of procedures at health facilities providing maternal and neonatal care at African, Asian, and Latin American sites participating in a multicenter trial to improve emergency obstetric/neonatal care in communities with high maternal and perinatal mortality.
Study Design
In 2009, prior to intervention, we surveyed 136 hospitals and 228 clinics in 7 sites in Africa, Asia, and Latin America regarding staffing, availability of equipment/ medications, and procedures including cesarean section.
The coverage of physicians and nurses/midwives was poor in Africa and Latin America. In Africa, only 20% of hospitals had full-time physicians. Only 70% of hospitals in Africa and Asia had performed cesarean sections in the last 6 months. Oxygen was unavailable in 40% of African hospitals and 17% of Asian hospitals. Blood was unavailable in 80% of African and Asian hospitals.
Assuming that adequate facility services are necessary to improve pregnancy outcomes, it is not surprising that maternal and perinatal mortality rates in the areas surveyed are high. The data presented emphasize that to reduce mortality in these areas, resources that result in improved staffing and sufficient equipment, supplies, and medication, along with training, are required.
PMCID: PMC3664648  PMID: 23329566
emergency obstetric and neonatal care; developing countries; perinatal mortality
14.  The Maternal and Newborn Health Registry Study of the Global Network for Women’s and Children’s Health Research 
To implement a vital statistics registry system to register pregnant women and document birth outcomes in the Global Network for Women’s and Children’s Health Research sites in Asia, Africa, and Latin America.
The Global Network sites began a prospective population-based pregnancy registry to identify all pregnant women and record pregnancy outcomes up to 42 days post-delivery in more than 100 defined low-resource geographic areas (clusters). Pregnant women were registered during pregnancy, with 42-day maternal and neonatal follow-up recorded—including care received during the pregnancy and postpartum periods. Recorded outcomes included stillbirth, neonatal mortality, and maternal mortality rates.
In 2010, 72 848 pregnant women were enrolled and 6-week follow-up was obtained for 97.8%. Across sites, 40.7%, 24.8%, and 34.5% of births occurred in a hospital, health center, and home setting, respectively. The mean neonatal mortality rate was 23 per 1000 live births, ranging from 8.2 to 48.5 per 1000 live births. The mean stillbirth rate ranged from 13.7 to 54.4 per 1000 births.
The registry is an ongoing study to assess the impact of interventions and trends regarding pregnancy outcomes and measures of care to inform public health.
PMCID: PMC3417109  PMID: 22738806
Maternal mortality; Neonatal mortality; Perinatal mortality; Pregnancy; Registry; Stillbirth
15.  Neurodevelopmental Outcomes in Infants Requiring Resuscitation in Developing Countries 
The Journal of Pediatrics  2011;160(5):781-785.e1.
To determine whether resuscitation of infants who failed to develop effective breathing at birth increases survivors with neurodevelopmental impairment.
Study design
Infants unresponsive to stimulation who received bag and mask ventilation at birth in a resuscitation trial and infants who did not require any resuscitation were randomized to early neurodevelopmental intervention or control. Infants were evaluated by trained neurodevelopmental evaluators masked to both their resuscitation history and intervention group. The 12-month neurodevelopmental outcome data for both resuscitated and non-resuscitated infants randomized to the control groups are reported.
The study provided no evidence of a difference between the resuscitated (N = 86) and the non-resuscitated infants (N = 115) in the percentage of infants at 12 months with a mental developmental index < 85 on the Bayley Scales of Infant Development-II (primary outcome) (18% versus 12%; p = 0.22) and in other neurodevelopmental outcomes.
The overwhelming majority of infants who received resuscitation with bag and mask ventilation at birth have 12-month neurodevelopmental outcomes in the normal range. Longer follow-up is needed because of increased risk for neurodevelopmental impairments.
PMCID: PMC3309169  PMID: 22099522
Resuscitation; intellectual disability; low and middle income countries; neonatal mortality; infant mortality; developmental outcome
16.  Antenatal corticosteroids trial in preterm births to increase neonatal survival in developing countries: study protocol 
Reproductive Health  2012;9:22.
Preterm birth is a major cause of neonatal mortality, responsible for 28% of neonatal deaths overall. The administration of antenatal corticosteroids to women at high risk of preterm birth is a powerful perinatal intervention to reduce neonatal mortality in resource rich environments. The effect of antenatal steroids to reduce mortality and morbidity among preterm infants in hospital settings in developed countries with high utilization is well established, yet they are not routinely used in developing countries. The impact of increasing antenatal steroid use in hospital or community settings with low utilization rates and high infant mortality among premature infants due to lack of specialized services has not been well researched. There is currently no clear evidence about the safety of antenatal corticosteroid use for community-level births.
We hypothesize that a multi country, two-arm, parallel cluster randomized controlled trial to evaluate whether a multifaceted intervention to increase the use of antenatal corticosteroids, including components to improve the identification of pregnancies at high risk of preterm birth and providing and facilitating the appropriate use of steroids, will reduce neonatal mortality at 28 days of life in preterm newborns, compared with the standard delivery of care in selected populations of six countries. 102 clusters in Argentina, Guatemala, Kenya, India, Pakistan, and Zambia will be randomized, and around 60,000 women and newborns will be enrolled. Kits containing vials of dexamethasone, syringes, gloves, and instructions for administration will be distributed. Improving the identification of women at high risk of preterm birth will be done by (1) diffusing recommendations for antenatal corticosteroids use to health providers, (2) training health providers on identification of women at high risk of preterm birth, (3) providing reminders to health providers on the use of the kits, and (4) using a color-coded tape to measure uterine height to estimate gestational age in women with unknown gestational age. In both intervention and control clusters, health providers will be trained in essential newborn care for low birth weight babies. The primary outcome is neonatal mortality at 28 days of life in preterm infants.
Trial registration Identifier: NCT01084096
PMCID: PMC3477119  PMID: 22992312
Neonatal mortality; Antenatal corticosteroids; Implementation research; Preterm birth
17.  Epidemiology of stillbirth in low-middle income countries: A Global Network Study 
To determine population-based stillbirth rates and to determine whether the timing and maturity of the stillbirths suggest a high proportion of potentially preventable deaths.
Prospective observational study.
Communities in six low-income countries (Democratic Republic of Congo, Kenya, Zambia, Guatemala, India, and Pakistan) and one site in a mid-income country (Argentina).
Pregnant women residing in the study communities.
Over a five-year period, in selected catchment areas, using multiple methodologies, trained study staff obtained pregnancy outcomes on each delivery in their area.
Main outcome measures
Pregnancy outcome, stillbirth characteristics.
Outcomes of 195 400 deliveries were included. Stillbirth rates ranged from 32 per 1 000 in Pakistan to 8 per 1 000 births in Argentina. Three-fourths (76%) of stillbirth off-spring were not macerated, 63% were ≥37 weeks and 48% weighed 2 500g or more. Across all sites, women with no education, of high and low parity, of older age, and without access to antenatal care were at significantly greater risk for stillbirth (p<0.001). Compared to those delivered by a physician, women delivered by nurses and traditional birth attendants had a lower risk of stillbirth.
In these low-middle income countries, most stillbirth offspring were not macerated, were reported as ≥37 weeks’ gestation, and almost half weighed at least 2 500g. With access to better medical care, especially in the intrapartum period, many of these stillbirths could likely be prevented.
PMCID: PMC3412613  PMID: 21916854
Developing countries; intrapartum stillbirth; stillbirth
18.  Home birth attendants in low income countries: who are they and what do they do? 
Nearly half the world’s babies are born at home. We sought to evaluate the training, knowledge, skills, and access to medical equipment and testing for home birth attendants across 7 international sites.
Face-to-face interviews were done by trained interviewers to assess level of training, knowledge and practices regarding care during the antenatal, intrapartum and postpartum periods. The survey was administered to a sample of birth attendants conducting home or out-of-facility deliveries in 7 sites in 6 countries (India, Pakistan, Guatemala, Democratic Republic of the Congo, Kenya and Zambia).
A total of 1226 home birth attendants were surveyed. Less than half the birth attendants were literate. Eighty percent had one month or less of formal training. Most home birth attendants did not have basic equipment (e.g., blood pressure apparatus, stethoscope, infant bag and mask manual resuscitator). Reporting of births and maternal and neonatal deaths to government agencies was low. Indian auxilliary nurse midwives, who perform some home but mainly clinic births, were far better trained and differed in many characteristics from the birth attendants who only performed deliveries at home.
Home birth attendants in low-income countries were often illiterate, could not read numbers and had little formal training. Most had few of the skills or access to tests, medications and equipment that are necessary to reduce maternal, fetal or neonatal mortality.
PMCID: PMC3493311  PMID: 22583622
Home births; Traditional birth attendants; Perinatal mortality
19.  Dating gestational age by last menstrual period, symphysis-fundal height, and ultrasound in urban Pakistan 
To compare the accuracy of the reported date of the last menstrual period (LMP) with that of symphysis-fundal height (SFH) in the estimation of gestational age (GA), using an ultrasound (US) scan as reference.
Gestational age was concurrently assessed by the 3 methods in this prospective, population-based, pregnancy-outcome study conducted in Hyderabad, Pakistan, from June 18, 2003, through August 31, 2005, with 1128 women between 20 and 26 weeks of a singleton pregnancy.
The mean GA was less by ultrasound than by SFH measurement or the reported LMP, and the mean differences with the US result were statistically significant (P <0.001 for both). At delivery, about 75% of the GA values estimated by SFH measurement were within 7 days and almost 91% were within 14 days of the estimation by ultrasound, compared with 65% and 82% for the GA estimated by the reported LMP. Moreover, using the US as reference, the SFH correctly classified 84% of the term, 68% of the preterm, and 86% of the post-term deliveries (weighted κ = 0.58) compared with the corresponding 79%, 61%, and 55% predicted by the reported LMP (weighted κ = 0.44).
The SFH measurement was found to be more accurate than the reported LMP as a tool to estimate GA and therefore date of delivery, but neither were as accurate as a US scan.
PMCID: PMC2914118  PMID: 20537328
Gestational age; Last menstrual period; Pakistan; Symphysis-fundal height; Ultrasound
20.  Classifying perinatal mortality using verbal autopsy: is there a role for nonphysicians? 
Because of a physician shortage in many low-income countries, the use of nonphysicians to classify perinatal mortality (stillbirth and early neonatal death) using verbal autopsy could be useful.
To determine the extent to which underlying perinatal causes of deaths assigned by nonphysicians in Guatemala, Pakistan, Zambia, and the Democratic Republic of the Congo using a verbal autopsy method are concordant with underlying perinatal cause of death assigned by physician panels.
Using a train-the-trainer model, 13 physicians and 40 nonphysicians were trained to determine cause of death using a standardized verbal autopsy training program. Subsequently, panels of two physicians and individual nonphysicians from this trained cohort independently reviewed verbal autopsy data from a sample of 118 early neonatal deaths and 134 stillbirths. With the cause of death assigned by the physician panel as the reference standard, sensitivity, specificity, positive and negative predictive values, and cause-specific mortality fractions were calculated to assess nonphysicians' coding responses. Robustness criteria to assess how well nonphysicians performed were used.
Causes of early neonatal death and stillbirth assigned by nonphysicians were concordant with physician-assigned causes 47% and 57% of the time, respectively. Tetanus filled robustness criteria for early neonatal death, and cord prolapse filled robustness criteria for stillbirth.
There are significant differences in underlying cause of death as determined by physicians and nonphysicians even when they receive similar training in cause of death determination. Currently, it does not appear that nonphysicians can be used reliably to assign underlying cause of perinatal death using verbal autopsy.
PMCID: PMC3160935  PMID: 21819582
21.  Complementary feeding: a Global Network cluster randomized controlled trial 
BMC Pediatrics  2011;11:4.
Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated.
A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial.
Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale for global efforts to enhance local supplies of meat as a complementary food for young children.
Trial registration
PMCID: PMC3032692  PMID: 21232139
22.  Communities, birth attendants and health facilities: a continuum of emergency maternal and newborn care (the global network's EmONC trial) 
Maternal and newborn mortality rates remain unacceptably high, especially where the majority of births occur in home settings or in facilities with inadequate resources. The introduction of emergency obstetric and newborn care services has been proposed by several organizations in order to improve pregnancy outcomes. However, the effectiveness of emergency obstetric and neonatal care services has never been proven. Also unproven is the effectiveness of community mobilization and community birth attendant training to improve pregnancy outcomes.
We have developed a cluster-randomized controlled trial to evaluate the impact of a comprehensive intervention of community mobilization, birth attendant training and improvement of quality of care in health facilities on perinatal mortality in low and middle-income countries where the majority of births take place in homes or first level care facilities. This trial will take place in 106 clusters (300-500 deliveries per year each) across 7 sites of the Global Network for Women's and Children's Health Research in Argentina, Guatemala, India, Kenya, Pakistan and Zambia. The trial intervention has three key elements, community mobilization, home-based life saving skills for communities and birth attendants, and training of providers at obstetric facilities to improve quality of care. The primary outcome of the trial is perinatal mortality. Secondary outcomes include rates of stillbirth, 7-day neonatal mortality, maternal death or severe morbidity (including obstetric fistula, eclampsia and obstetrical sepsis) and 28-day neonatal mortality.
In this trial, we are evaluating a combination of interventions including community mobilization and facility training in an attempt to improve pregnancy outcomes. If successful, the results of this trial will provide important information for policy makers and clinicians as they attempt to improve delivery services for pregnant women and newborns in low-income countries.
Trial Registration NCT01073488
PMCID: PMC3017016  PMID: 21156060
23.  Brain Research to Ameliorate Impaired Neurodevelopment - Home-based Intervention Trial (BRAIN-HIT) 
BMC Pediatrics  2010;10:27.
This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia.
This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors.
The trial is supervised by a trial steering committee, and an independent data monitoring committee monitors the trial. Findings from this trial have the potential to inform about strategies for reducing neurodevelopmental disabilities in at-risk young children in low and middle income countries.
Trial Registration NCT00639184
PMCID: PMC2873519  PMID: 20433740
24.  Stillbirths in an Urban Community in Pakistan 
To determine stillbirth risk factors and gestational age at delivery in a prospective developing country birth cohort.
Study Design
1369 Pakistani women were prospectively enrolled at 20 - 26 weeks, the gestational age determined by ultrasound, and risk factors and pregnancy outcomes assessed.
The stillbirth rate was 33.6/1000 births despite 96% of women receiving prenatal care, 83% attended by skilled providers in hospital and a 20% cesarean section rate. 51% of stillbirths occurred ≥ 37 weeks and 19% from 34-36 weeks. Only 4% had congenital anomalies. Hemoglobin < 8 g/dL, vaginal bleeding and preeclampsia were associated with increased stillbirth risk.
In this developing country with reasonable technical resources defined by hospital delivery and a high cesarean section rate, stillbirth rates were much higher than US rates. That most of the stillbirths were term, did not have congenital anomalies and the demise appeared to be recent, suggests that many Pakistani stillbirths may be preventable with higher quality obstetric care.
PMCID: PMC2150567  PMID: 17826410
stillbirth; obstetrical care; developing countries
25.  Role of gender in health disparity: the South Asian context 
BMJ : British Medical Journal  2004;328(7443):823-826.
South Asia's girls and women do not have the same life advantage as their Western counterparts. A human rights based approach may help to overcome gender related barriers and improve the wellbeing of men, women, and children.
PMCID: PMC383384  PMID: 15070642

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