48 research outputs found
Evaluating the effect of care around labor and delivery practices on early neonatal mortality in the global network\u27s maternal and newborn health registry
Background: Neonatal deaths in first 28-days of life represent 47% of all deaths under the age of five years globally and are a focus of the United Nation\u27s (UN\u27s) Sustainable Development Goals. Pregnant women are delivering in facilities but that does not indicate quality of care during delivery and the postpartum period. The World Health Organization\u27s Essential Newborn Care (ENC) package reduces neonatal mortality, but lacks a simple and valid composite index that measures its effectiveness.Methods: Data on 5 intra-partum and 3 post-partum practices (indicators) recommended as part of ENC, routinely collected in NICHD\u27s Global Network\u27s (GN) Maternal Newborn Health Registry (MNHR) between 2010 and 2013, were included. We evaluated if all 8 practices (Care around Delivery - CAD), combined as an index was associated with reduced early neonatal mortality rates (days 0-6 of life).Results: A total of 150,848 live births were included in the analysis. The individual indicators varied across sites. All components were present in 19.9% births (range 0.4 to 31% across sites). Present indicators (8 components) were associated with reduced early neonatal mortality [adjusted RR (95% CI):0.81 (0.77, 0.85); p \u3c 0.0001]. Despite an overall association between CAD and early neonatal mortality (RR \u3c 1.0 for all early mortality): delivery by skilled birth attendant; presence of fetal heart and delayed bathing were associated with increased early neonatal mortality.Conclusions: Present indicators (8 practices) of CAD were associated with a 19% reduction in the risk of neonatal death in the diverse health facilities where delivery occurred within the GN MNHR. These indicators could be monitored to identify facilities that need to improve compliance with ENC practices to reduce preventable neonatal deaths. Three of the 8 indicators were associated with increased neonatal mortality, due to baby being sick at birth. Although promising, this composite index needs refinement before use to monitor facility-based quality of care in association with early neonatal mortality. Trial registration The identifier of the Maternal Newborn Health Registry at ClinicalTrials.gov is NCT01073475
Preconception nutrition intervention improved birth length and reduced stunting and wasting in newborns in south Asia: The women first randomized controlled trial
South Asia has \u3e50% of the global burden of low birth weight (LBW). The objective was to determine the extent to which maternal nutrition interventions commenced before conception or in the 1st trimester improved fetal growth in this region. This was a secondary analysis of combined newborn anthropometric data for the South Asian sites (India and Pakistan) in the Women First Preconception Maternal Nutrition Trial. Participants were 972 newborn of mothers who were poor, rural, unselected on basis of nutritional status, and had been randomized to receive a daily lipid-based micronutrient supplement commencing â„3 months prior to conception (Arm 1), in the 1st trimester (Arm 2), or not at all (Arm 3). An additional protein-energy supplement was provided if BMI/m2 or gestational weight gain was less than guidelines. Gestational age was established in the 1st trimester and newborn anthropometry obtaine
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Early pregnancy loss in Belagavi, Karnataka, India 2014â2017: a prospective population-based observational study in a low-resource setting
Background
The prevalence of early pregnancy loss through miscarriage and medically terminated pregnancy (MTP) is largely unknown due to lack of early registration of pregnancies in most regions, and especially in low- and middle-income countries. Understanding the rates of early pregnancy loss as well as the characteristics of pregnant women who experience miscarriage or MTP can assist in better planning of reproductive health needs of women.
Methods
A prospective, population-based study was conducted in Belagavi District, south India. Using an active surveillance system of women of childbearing age, all women were enrolled as soon as possible during pregnancy. We evaluated rates and risk factors of miscarriage and MTP between 6 and 20Â weeks gestation as well as rates of stillbirth and neonatal death. A hypothetical cohort of 1000 women pregnant at 6Â weeks was created to demonstrate the impact of miscarriage and MTP on pregnancy outcome.
Results
A total of 30,166 women enrolled from 2014 to 2017 were included in this analysis. The rate of miscarriage per 1000 ongoing pregnancies between 6 and 8Â weeks was 115.3, between 8 and 12Â weeks the miscarriage rate was 101.9 per 1000 ongoing pregnancies and between 12 and 20Â weeks the miscarriage rate was 60.3 per 1000 ongoing pregnancies. For those periods, the MTP rate was 40.2, 45.4, and 48.3 per 1000 ongoing pregnancies respectively. The stillbirth rate was 26/1000 and the neonatal mortality rate was 24/1000. The majority of miscarriages (96.6%) were unattended and occurred at home. The majority of MTPs occurred in a hospital and with a physician in attendance (69.6%), while 20.7% of MTPs occurred outside a health facility. Women who experienced a miscarriage were older and had a higher level of education but were less likely to be anemic than those with an ongoing pregnancy at 20Â weeks. Women with MTP were older, had a higher level of education, higher parity, and higher BMI, compared to those with an ongoing pregnancy, but these results were not consistent across gestational age periods.
Conclusions
Of women with an ongoing pregnancy at 6Â weeks, about 60% will have a living infant at 28Â days of age. Two thirds of the losses will be spontaneous miscarriages and one third will be secondary to a MTP. High maternal age and education were the risk factors associated with miscarriage and MTP.
Trial registration
The trial is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration:
NCT01073475
Duration of third stage labour and postpartum blood loss: a secondary analysis of the WHO CHAMPION trial data
Background: Obstetric haemorrhage continues to be a leading cause of maternal mortality, contributing to more than a quarter of the 2,443,000 maternal deaths reported between 2003 and 2009. During this period, about 70% of the haemorrhagic deaths occurred postpartum. In addition to other identifiable risk factors for greater postpartum blood loss, the duration of the third stage of labour (TSL) seems to be important, as literature shows that a longer TSL can be associated with more blood loss. To better describe the association between the duration of TSL and postpartum blood loss in women receiving active management of third stage of labour (AMTSL), this secondary analysis of the WHO CHAMPION trial data has been conducted. Methods: This was a secondary analysis of the WHO CHAMPION trial conducted in twenty-three sites in ten countries. We studied the association between the TSL duration and blood loss in the sub cohort of women from the CHAMPION trial (all of whom received AMTSL), with TSL upto 60 min and no interventions for postpartum haemorrhage. We used a general linear model to fit blood loss as a function of TSL duration on the log scale, arm and center, using a normal distribution and the log link function. We showed this association separately for oxytocin and for Heat stable (HS) carbetocin. Results: For the 10,040 women analysed, blood loss rose steeply with third stage duration in the first 10 min, but more slowly after 10 min. This trend was observed for both Oxytocin and HS carbetocin and the difference in the trends for both drugs was not statistically significant (p-value = 0.2070). Conclusions: There was a positive association between postpartum blood loss and TSL duration with either uterotonic. Blood loss rose steeply with TSL duration until 10 min, and more slowly after 10 min.Fil: Chikkamath, Sumangala B.. S. Nijalingappa Medical College; IndiaFil: Katageri, Geetanjali M.. S. Nijalingappa Medical College; IndiaFil: Mallapur, Ashalata A.. S. Nijalingappa Medical College; IndiaFil: Vernekar, Sunil S.. Jawaharlal Nehru Medical College Belgaum; IndiaFil: Somannavar, Manjunath S.. Jawaharlal Nehru Medical College Belgaum; IndiaFil: Piaggio, Gilda. No especifĂca;Fil: Carroli, Guillermo. Centro Rosarino de Estudios Perinatales; ArgentinaFil: de Carvalho, JosĂ© Ferreira. No especifĂca;Fil: Althabe, Fernando. Organizacion Mundial de la Salud; Argentina. Consejo Nacional de Investigaciones CientĂficas y TĂ©cnicas. Oficina de CoordinaciĂłn Administrativa Parque Centenario. Centro de Investigaciones en EpidemiologĂa y Salud PĂșblica. Instituto de Efectividad ClĂnica y Sanitaria. Centro de Investigaciones en EpidemiologĂa y Salud PĂșblica; ArgentinaFil: Hofmeyr, G. Justus. University of Botswana; Estados Unidos. University of the Witwatersrand; SudĂĄfricaFil: Widmer, Mariana. Organizacion Mundial de la Salud; ArgentinaFil: Gulmezoglu, Ahmet Metin. No especifĂca;Fil: Goudar, Shivaprasad S.. Jawaharlal Nehru Medical College Belgaum; Indi
Maternal Characteristics Affect Fetal Growth Response in the Women First Preconception Nutrition Trial.
The objective of this secondary analysis was to identify maternal characteristics that modified the effect of maternal supplements on newborn size. Participants included 1465 maternal-newborn dyads in Guatemala, India, and Pakistan. Supplementation commenced before conception (Arm 1) or late 1st trimester (Arm 2); Arm 3 received usual care. Characteristics included body mass index (BMI), stature, anemia, age, education, socio-economic status (SES), parity, and newborn sex. Newborn outcomes were z-scores for length (LAZ), weight (WAZ), and weight to length ratio-for-age (WLRAZ). Mixed-effect regression models included treatment arm, effect modifier, and arm * effect modifier interaction as predictors, controlling for site, characteristics, and sex. Parity (para-0 vs. para â„1), anemia (anemia/no anemia), and sex were significant effect modifiers. Effect size (95% CI) for Arm 1 vs. 3 was larger for para-0 vs. â„1 for all outcomes (LAZ 0.56 (0.28, 0.84, p \u3c 0.001); WAZ 0.45 (0.20, 0.07, p \u3c 0.001); WLRAZ 0.52 (0.17, 0.88, p \u3c 0.01) but only length for Arm 2 vs. 3. Corresponding effects for para â„1 were \u3e0.02. Arm 3 z-scores were all very low for para-0, but not para â„1. Para-0 and anemia effect sizes for Arm 1 were \u3e Arm 2 for WAZ and WLRAZ, but not LAZ. Arm 1 and 2 had higher WAZ for newborn boys vs. girls. Maternal nulliparity and anemia were associated with impaired fetal growth that was substantially improved by nutrition intervention, especially when commenced prior to conception
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Neonatal deaths in rural Karnataka, India 2014-2018: a prospective population-based observational study in a low-resource setting.
BACKGROUND: Neonatal mortality causes a substantial proportion of the under-5 mortality in low and middle-income countries (LMIC).
METHODS: We undertook a prospective, population-based research study of pregnant women residing in defined geographic areas in the Karnataka State of India, a research site of the Global Network for Women\u27s and Children\u27s Health Research. Study staff collected demographic and health care characteristics on eligible women enrolled with neonatal outcomes obtained at delivery and day 28. Cause of neonatal mortality at day 28 was assigned by algorithm using prospectively defined variables.
RESULTS: From 2014 to 2018, the neonatal mortality rate was 24.5 per 1,000 live births. The cause of the 28-day neonatal deaths was attributed to prematurity (27.9%), birth asphyxia (25.1%), infection (23.7%) and congenital anomalies (18.4%). Four or more antenatal care (ANC) visits was associated with a lower risk of neonatal death compared to fewer ANC visits. In the adjusted model, compared to liveborn infantsââ„â2500 g, infants born weighingâ\u3câ1000 g RR for mortality was 25.6 (95%CI 18.3, 36.0), for 1000-1499 g infants the RR was 19.8 (95% CI 14.2, 27.5) and for 1500-2499 g infants the RR was 3.1 (95% CI 2.7, 3.6). However, more than one-third (36.8%) of the deaths occurred among infants with a birthweightââ„â2500 g. Infants born preterm (\u3câ37 weeks) were also at higher risk for 28-day mortality (RR 7.9, 95% CI 6.9, 9.0) compared to infantsââ„â37 weeks. A one-week decrease in gestational age at delivery was associated with a higher risk of mortality with a RR of 1.3 (95% CI 1.3, 1.3). More than 70% of all the deliveries occurred at a hospital. Among infants who died, 50.3% of the infants had received bag/mask ventilation, 47.3% received antibiotics, and 55.6% received oxygen.
CONCLUSIONS: Consistent with prior research, the study found that infants who were preterm and low-birth weight remained at highest risk for 28-day neonatal mortality in India. Although most of births now occur within health facilities, a substantial proportion are not receiving basic life-saving interventions. Further efforts to understand the impact of care on infant outcomes are needed. Study registration The trial is registered at clinicaltrials.gov. ClinicalTrial.gov Trial Registration: NCT01073475
Repeat 24-hour recalls and locally developed food composition databases: a feasible method to estimate dietary adequacy in a multi-site preconception maternal nutrition RCT.
Background:
Our aim was to utilize a feasible quantitative methodology to estimate the dietary adequacy of \u3e900 first-trimester pregnant women in poor rural areas of the Democratic Republic of the Congo, Guatemala, India and Pakistan. This paper outlines the dietary methods used. Methods:
Local nutritionists were trained at the sites by the lead study nutritionist and received ongoing mentoring throughout the study. Training topics focused on the standardized conduct of repeat multiple-pass 24-hr dietary recalls, including interview techniques, estimation of portion sizes, and construction of a unique site-specific food composition database (FCDB). Each FCDB was based on 13 food groups and included values for moisture, energy, 20 nutrients (i.e. macro- and micronutrients), and phytate (an anti-nutrient). Nutrient values for individual foods or beverages were taken from recently developed FAO-supported regional food composition tables or the USDA national nutrient database. Appropriate adjustments for differences in moisture and application of nutrient retention and yield factors after cooking were applied, as needed. Generic recipes for mixed dishes consumed by the study population were compiled at each site, followed by calculation of a median recipe per 100 g. Each recipeâs nutrient values were included in the FCDB. Final site FCDB checks were planned according to FAO/INFOODS guidelines. Discussion:
This dietary strategy provides the opportunity to assess estimated mean group usual energy and nutrient intakes and estimated prevalence of the population âat riskâ of inadequate intakes in first-trimester pregnant women living in four low- and middle-income countries. While challenges and limitations exist, this methodology demonstrates the practical application of a quantitative dietary strategy for a large international multi-site nutrition trial, providing within- and between-site comparisons. Moreover, it provides an excellent opportunity for local capacity building and each site FCDB can be easily modified for additional research activities conducted in other populations living in the same area
Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): a randomised, double-blind, placebo-controlled trial.
BACKGROUND: Preterm birth remains a common cause of neonatal mortality, with a disproportionately high burden in low-income and middle-income countries. Meta-analyses of low-dose aspirin to prevent pre-eclampsia suggest that the incidence of preterm birth might also be decreased, particularly if initiated before 16 weeks of gestation.
METHODS: ASPIRIN was a randomised, multicountry, double-masked, placebo-controlled trial of low-dose aspirin (81 mg daily) initiated between 6 weeks and 0 days of pregnancy, and 13 weeks and 6 days of pregnancy, in nulliparous women with an ultrasound confirming gestational age and a singleton viable pregnancy. Participants were enrolled at seven community sites in six countries (two sites in India and one site each in the Democratic Republic of the Congo, Guatemala, Kenya, Pakistan, and Zambia). Participants were randomly assigned (1:1, stratified by site) to receive aspirin or placebo tablets of identical appearance, via a sequence generated centrally by the data coordinating centre at Research Triangle Institute International (Research Triangle Park, NC, USA). Treatment was masked to research staff, health providers, and patients, and continued until 36 weeks and 7 days of gestation or delivery. The primary outcome of incidence of preterm birth, defined as the number of deliveries before 37 weeks\u27 gestational age, was analysed in randomly assigned women with pregnancy outcomes at or after 20 weeks, according to a modified intention-to-treat (mITT) protocol. Analyses of our binary primary outcome involved a Cochran-Mantel-Haenszel test stratified by site, and generalised linear models to obtain relative risk (RR) estimates and associated confidence intervals. Serious adverse events were assessed in all women who received at least one dose of drug or placebo. This study is registered with ClinicalTrials.gov, NCT02409680, and the Clinical Trial Registry-India, CTRI/2016/05/006970.
FINDINGS: From March 23, 2016 to June 30, 2018, 14â361 women were screened for inclusion and 11â976 women aged 14-40 years were randomly assigned to receive low-dose aspirin (5990 women) or placebo (5986 women). 5780 women in the aspirin group and 5764 in the placebo group were evaluable for the primary outcome. Preterm birth before 37 weeks occurred in 668 (11·6%) of the women who took aspirin and 754 (13·1%) of those who took placebo (RR 0·89 [95% CI 0·81 to 0·98], p=0·012). In women taking aspirin, we also observed significant reductions in perinatal mortality (0·86 [0·73-1·00], p=0·048), fetal loss (infant death after 16 weeks\u27 gestation and before 7 days post partum; 0·86 [0·74-1·00], p=0·039), early preterm delivery (\u3c34 \u3eweeks; 0·75 [0·61-0·93], p=0·039), and the incidence of women who delivered before 34 weeks with hypertensive disorders of pregnancy (0·38 [0·17-0·85], p=0·015). Other adverse maternal and neonatal events were similar between the two groups.
INTERPRETATION: In populations of nulliparous women with singleton pregnancies from low-income and middle-income countries, low-dose aspirin initiated between 6 weeks and 0 days of gestation and 13 weeks and 6 days of gestation resulted in a reduced incidence of preterm delivery before 37 weeks, and reduced perinatal mortality.
FUNDING: Eunice Kennedy Shriver National Institute of Child Health and Human Development
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Evaluating the effect of care around labor and delivery practices on early neonatal mortality in the Global Networkâs Maternal and Newborn Health Registry
Background
Neonatal deaths in first 28-days of life represent 47% of all deaths under the age of five years globally and are a focus of the United Nationâs (UNâs) Sustainable Development Goals. Pregnant women are delivering in facilities but that does not indicate quality of care during delivery and the postpartum period. The World Health Organizationâs Essential Newborn Care (ENC) package reduces neonatal mortality, but lacks a simple and valid composite index that measures its effectiveness.
Methods
Data on 5 intra-partum and 3 post-partum practices (indicators) recommended as part of ENC, routinely collected in NICHDâs Global Networkâs (GN) Maternal Newborn Health Registry (MNHR) between 2010 and 2013, were included. We evaluated if all 8 practices (Care around Delivery â CAD), combined as an index was associated with reduced early neonatal mortality rates (days 0â6 of life).
Results
A total of 150,848 live births were included in the analysis. The individual indicators varied across sites. All components were present in 19.9% births (range 0.4 to 31% across sites). Present indicators (8 components) were associated with reduced early neonatal mortality [adjusted RR (95% CI):0.81 (0.77, 0.85); pâ<â0.0001]. Despite an overall association between CAD and early neonatal mortality (RRâ<â1.0 for all early mortality): delivery by skilled birth attendant; presence of fetal heart and delayed bathing were associated with increased early neonatal mortality.
Conclusions
Present indicators (8 practices) of CAD were associated with a 19% reduction in the risk of neonatal death in the diverse health facilities where delivery occurred within the GN MNHR. These indicators could be monitored to identify facilities that need to improve compliance with ENC practices to reduce preventable neonatal deaths. Three of the 8 indicators were associated with increased neonatal mortality, due to baby being sick at birth. Although promising, this composite index needs refinement before use to monitor facility-based quality of care in association with early neonatal mortality.
Trial registration The identifier of the Maternal Newborn Health Registry at ClinicalTrials.gov is NCT01073475
Antenatal dexamethasone for early preterm birth in low-resource countries
BACKGROUND: The safety and efficacy of antenatal glucocorticoids in women in low-resource countries who are at risk for preterm birth are uncertain. METHODS: We conducted a multicountry, randomized trial involving pregnant women between 26 weeks 0 days and 33 weeks 6 days of gestation who were at risk for preterm birth. The participants were assigned to intramuscular dexamethasone or identical placebo. The primary outcomes were neonatal death alone, stillbirth or neonatal death, and possible maternal bacterial infection; neonatal death alone and stillbirth or neonatal death were evaluated with superiority analyses, and possible maternal bacterial infection was evaluated with a noninferiority analysis with the use of a prespecified margin of 1.25 on the relative scale. RESULTS: A total of 2852 women (and their 3070 fetuses) from 29 secondary- and tertiary-level hospitals across Bangladesh, India, Kenya, Nigeria, and Pakistan underwent randomization. The trial was stopped for benefit at the second interim analysis. Neonatal death occurred in 278 of 1417 infants (19.6%) in the dexamethasone group and in 331 of 1406 infants (23.5%) in the placebo group (relative risk, 0.84; 95% confidence interval [CI], 0.72 to 0.97; P=0.03). Stillbirth or neonatal death occurred in 393 of 1532 fetuses and infants (25.7%) and in 444 of 1519 fetuses and infants (29.2%), respectively (relative risk, 0.88; 95% CI, 0.78 to 0.99; P=0.04); the incidence of possible maternal bacterial infection was 4.8% and 6.3%, respectively (relative risk, 0.76; 95% CI, 0.56 to 1.03). There was no significant between-group difference in the incidence of adverse events. CONCLUSIONS: Among women in low-resource countries who were at risk for early preterm birth, the use of dexamethasone resulted in significantly lower risks of neonatal death alone and stillbirth or neonatal death than the use of placebo, without an increase in the incidence of possible maternal bacterial infection.Fil: Oladapo, Olufemi T.. Organizacion Mundial de la Salud; ArgentinaFil: Vogel, Joshua P.. Organizacion Mundial de la Salud; ArgentinaFil: Piaggio, Gilda. Organizacion Mundial de la Salud; ArgentinaFil: Nguyen, My-Huong. Organizacion Mundial de la Salud; ArgentinaFil: Althabe, Fernando. Consejo Nacional de Investigaciones CientĂficas y TĂ©cnicas. Oficina de CoordinaciĂłn Administrativa Parque Centenario. Centro de Investigaciones en EpidemiologĂa y Salud PĂșblica. Instituto de Efectividad ClĂnica y Sanitaria. Centro de Investigaciones en EpidemiologĂa y Salud PĂșblica; ArgentinaFil: Metin GĂŒlmezoglu, A.. Organizacion Mundial de la Salud; ArgentinaFil: Bahl, Rajiv. Organizacion Mundial de la Salud; ArgentinaFil: Rao, Suman P.N.. Organizacion Mundial de la Salud; ArgentinaFil: de Costa, Ayesha. Organizacion Mundial de la Salud; ArgentinaFil: Gupta, Shuchita. Organizacion Mundial de la Salud; ArgentinaFil: Shahidullah, Mohammod. No especifĂca;Fil: Chowdhury, Saleha B.. No especifĂca;Fil: Ara, Gulshan. No especifĂca;Fil: Akter, Shaheen. No especifĂca;Fil: Akhter, Nasreen. No especifĂca;Fil: Dey, Probhat R.. No especifĂca;Fil: Abdus Sabur, M.. No especifĂca;Fil: Azad, Mohammad T.. No especifĂca;Fil: Choudhury, Shahana F.. No especifĂca;Fil: Matin, M.A.. No especifĂca;Fil: Goudar, Shivaprasad S.. No especifĂca;Fil: Dhaded, Sangappa M.. No especifĂca;Fil: Metgud, Mrityunjay C.. No especifĂca;Fil: Pujar, Yeshita V.. No especifĂca;Fil: Somannavar, Manjunath S.. No especifĂca;Fil: Vernekar, Sunil S.. No especifĂca;Fil: Herekar, Veena R.. No especifĂca;Fil: Bidri, Shailaja R.. No especifĂca;Fil: Mathapati, Sangamesh S.. No especifĂca;Fil: Patil, Preeti G.. No especifĂca;Fil: Patil, Mallanagouda M.. No especifĂca;Fil: Gudadinni, Muttappa R.. No especifĂca;Fil: Bijapure, Hidaytullah R.. No especifĂca;Fil: Mallapur, Ashalata A.. No especifĂca;Fil: Katageri, Geetanjali M.. No especifĂca;Fil: Chikkamath, Sumangala B.. No especifĂca;Fil: Yelamali, Bhuvaneshwari C.. No especifĂca;Fil: Pol, Ramesh R.. No especifĂca;Fil: Misra, Sujata S.. No especifĂca;Fil: Das, Leena. No especifĂca