Objective
Ultrasound is widely regarded as an important adjunct to antenatal care (ANC) to guide practice and reduce perinatal mortality. We assessed the impact of ANC ultrasound use at health ...centres in resource‐limited countries.
Design
Cluster randomised trial.
Setting
Clusters within five countries (Democratic Republic of Congo, Guatemala, Kenya, Pakistan, and Zambia)
Methods
Clusters were randomised to standard ANC or standard care plus two ultrasounds and referral for complications. The study trained providers in intervention clusters to perform basic obstetric ultrasounds.
Main outcome measures
The primary outcome was a composite of maternal mortality, maternal near‐miss mortality, stillbirth, and neonatal mortality.
Results
During the 24‐month trial, 28 intervention and 28 control clusters had 24 263 and 23 160 births, respectively; 78% in the intervention clusters received at least one study ultrasound; 60% received two. The prevalence of conditions noted including twins, placenta previa, and abnormal lie was within expected ranges. 9% were referred for an ultrasound‐diagnosed condition, and 71% attended the referral. The ANC (RR 1.0 95% CI 1.00, 1.01) and hospital delivery rates for complicated pregnancies (RR 1.03 95% CI 0.89, 1.20) did not differ between intervention and control clusters nor did the composite outcome (RR 1.09 95% CI 0.97, 1.23) or its individual components.
Conclusions
Despite availability of ultrasound at ANC in the intervention clusters, neither ANC nor hospital delivery for complicated pregnancies increased. The composite outcome and the individual components were not reduced.
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Antenatal care ultrasound did not improve a composite outcome that included maternal, fetal, and neonatal mortality.
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Antenatal care ultrasound did not improve a composite outcome that included maternal, fetal, and neonatal mortality.
Objective
We sought to classify causes of stillbirth for six low‐middle‐income countries using a prospectively defined algorithm.
Design
Prospective, observational study.
Setting
Communities in ...India, Pakistan, Guatemala, Democratic Republic of Congo, Zambia and Kenya.
Population
Pregnant women residing in defined study regions.
Methods
Basic data regarding conditions present during pregnancy and delivery were collected. Using these data, a computer‐based hierarchal algorithm assigned cause of stillbirth. Causes included birth trauma, congenital anomaly, infection, asphyxia, and preterm birth, based on existing cause of death classifications and included contributing maternal conditions.
Main outcome measures
Primary cause of stillbirth.
Results
Of 109 911 women who were enrolled and delivered (99% of those screened in pregnancy), 2847 had a stillbirth (a rate of 27.2 per 1000 births). Asphyxia was the cause of 46.6% of the stillbirths, followed by infection (20.8%), congenital anomalies (8.4%) and prematurity (6.6%). Among those caused by asphyxia, 38% had prolonged or obstructed labour, 19% antepartum haemorrhage and 18% pre‐eclampsia/eclampsia. About two‐thirds (67.4%) of the stillbirths did not have signs of maceration.
Conclusions
Our algorithm determined cause of stillbirth from basic data obtained from lay‐health providers. The major cause of stillbirth was fetal asphyxia associated with prolonged or obstructed labour, pre‐eclampsia and antepartum haemorrhage. In the African sites, infection also was an important contributor to stillbirth. Using this algorithm, we documented cause of stillbirth and its trends to inform public health programs, using consistency, transparency, and comparability across time or regions with minimal burden on the healthcare system.
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Major causes of stillbirth are asphyxia, pre‐eclampsia and haemorrhage. Infections are important in Africa.
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Major causes of stillbirth are asphyxia, pre‐eclampsia and haemorrhage. Infections are important in Africa.
Objective
Limited data are available from low‐ and middle‐income countries (LMICs) on the relationship of haemoglobin levels to adverse outcomes at different times during pregnancy. We evaluated the ...association of haemoglobin levels in nulliparous women at two times in pregnancy with pregnancy outcomes.
Design
ASPIRIN Trial data were used to study the association between haemoglobin levels measured at 6+0–13+6 weeks and 26+0–30+0 weeks of gestation with fetal and neonatal outcomes.
Setting
Obstetric care facilities in Pakistan, India, Kenya, Zambia, The Democratic Republic of the Congo and Guatemala.
Population
A total of 11 976 pregnant women.
Methods
Generalised linear models were used to obtain adjusted relative risks and 95% CI for adverse outcomes.
Main outcome measures
Preterm birth, stillbirth, neonatal death, small for gestational age (SGA) and birthweight <2500 g.
Results
The mean haemoglobin levels at 6+0–13+6 weeks and at 26–30 weeks of gestation were 116 g/l (SD 17) and 107 g/l (SD 15), respectively. In general, pregnancy outcomes were better with increasing haemoglobin. At 6+0–13+6 weeks of gestation, stillbirth, SGA and birthweight <2500 g, were significantly associated with haemoglobin of 70–89 g/l compared with haemoglobin of 110–129 g/l The relationships of adverse pregnancy outcomes with various haemoglobin levels were more marked at 26–30 weeks of gestation.
Conclusions
Both lower and some higher haemoglobin concentrations are associated with adverse fetal and neonatal outcomes at 6+0–13+6 weeks and at 26–30 weeks of gestation, although the relationship with low haemoglobin levels appears more consistent and generally stronger.
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Both lower and some higher haemoglobin concentrations were associated with adverse fetal and neonatal outcomes at 6–13 weeks and 26–30 weeks of gestation.
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Both lower and some higher haemoglobin concentrations were associated with adverse fetal and neonatal outcomes at 6–13 weeks and 26–30 weeks of gestation.
Objective
To describe the causes of maternal death in a population‐based cohort in six low‐ and middle‐income countries using a standardised, hierarchical, algorithmic cause of death (COD) ...methodology.
Design
A population‐based, prospective observational study.
Setting
Seven sites in six low‐ to middle‐income countries including the Democratic Republic of the Congo (DRC), Guatemala, India (two sites), Kenya, Pakistan and Zambia.
Population
All deaths among pregnant women resident in the study sites from 2014 to December 2016.
Methods
For women who died, we used a standardised questionnaire to collect clinical data regarding maternal conditions present during pregnancy and delivery. These data were analysed using a computer‐based algorithm to assign cause of maternal death based on the International Classification of Disease—Maternal Mortality system (trauma, termination of pregnancy‐related, eclampsia, haemorrhage, pregnancy‐related infection and medical conditions). We also compared the COD results to healthcare‐provider‐assigned maternal COD.
Main outcome measures
Assigned causes of maternal mortality.
Results
Among 158 205 women, there were 221 maternal deaths. The most common algorithm‐assigned maternal COD were obstetric haemorrhage (38.6%), pregnancy‐related infection (26.4%) and pre‐eclampsia/eclampsia (18.2%). Agreement between algorithm‐assigned COD and COD assigned by healthcare providers ranged from 75% for haemorrhage to 25% for medical causes coincident to pregnancy.
Conclusions
The major maternal COD in the Global Network sites were haemorrhage, pregnancy‐related infection and pre‐eclampsia/eclampsia. This system could allow public health programmes in low‐ and middle‐income countries to generate transparent and comparable data for maternal COD across time or regions.
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An algorithmic system for determining maternal cause of death in low‐resource settings is described.
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An algorithmic system for determining maternal cause of death in low‐resource settings is described.
Abstract Purpose Patent ductus arteriosus (PDA) ligation in premature infants has been shown to have low surgical morbidity and mortality. Ligation goals include prompt improvement in ...cardiorespiratory failure, with rapid wean from mechanical ventilation; less risk of prolonged mechanical ventilation and subsequent chronic lung disease (CLD); and survival to discharge. This study was designed to examine true morbidity after ligation and elucidate which preoperative factors might predict favorable outcomes. Methods Institutional review board–approved retrospective review of 197 infants less than 38 weeks of gestational age (GA), undergoing PDA ligation via thoracotomy between January 1, 1992, and January 1, 2004. Chronic lung disease defined as need for supplemental oxygen at 36 weeks corrected GA. Student t and χ2 tests were used. Results Mean GA was 27 weeks (range, 23-35 weeks), birth weight was 957 g (range, 440-3170 g); infants underwent ligation at 16 days of life (range, 1-132 days). Duration of surgery was 50.5 minutes (range,13-150 minutes). Mean postoperative times were 27 days to extubation, 60 days to wean from supplemental oxygen, and 84 days to discharge. Early extubation (within 10 days of ligation) occurred in only 54 patients (30%). Only 44 (22%) survived to discharge without CLD. Forty patients (20%) died, with respiratory failure the most common cause (70%). In general, early extubation, survival without CLD and survival to discharge were associated with greater GA and birth weight, higher Apgar scores, greater age and weight at surgery, no preoperative intraventricular hemorrhage, lack of ventilator dependence, and lower ventilator settings ( P < .05). Preoperative amount and duration of indomethacin use, chest x-ray findings, and echocardiographic assessment of ductus size did not predict favorable outcomes (all P > .05). Conclusions Most premature infants currently undergoing PDA ligation at our institution do not experience the anticipated rapid improvements in cardiorespiratory status and go on to develop CLD. Few preoperative variables (including radiographic and echocardiographic assessments) definitively predict outcomes.
Objective.
To identify risk factors for chronic lung disease (CLD) in a population-based cohort of very low birth weight infants, born in an era of surfactant usage. We specifically investigated the ...effects of antenatal steroids, nosocomial infection, patent ductus arteriosus (PDA), fluid management, and ventilator support strategies.
Methods.
Data were prospectively collected on 1244 infants born in North Carolina in 1994 with birth weights 500 to 1500 g, and treated at 1 of the 13 intensive care nurseries across the state. The outcome of interest was CLD, defined as dependency on supplemental oxygen at 36 weeks' postmenstrual age. Multivariate odds ratios (OR) and 95% confidence intervals (CI) were estimated with logistic regression models.
Results.
Among 865 survivors to 36 weeks' postmenstrual age, 224 (26%) had CLD. Nosocomial infection (OR: 2.0; 95% CI: 1.4–3.3), fluid intake on day 2 (OR: 1.06 per 10 mL increase; 95% CI: 1.01–1.11), and the need for ventilation at 48 hours of life (OR: 2.2; 95% CI: 1.3–3.7) were associated with an increased risk of CLD. Among infants ventilated at 48 hours, nosocomial infection (OR: 1.64; 95% CI: 1.02–2.62) and PDA (OR: 1.9; 95% CI: 1.2–3.1) were associated with an increased risk. No association was found with antenatal steroid receipt or increased levels of ventilator support.
Conclusion.
This analysis suggests that with widespread use of surfactant, nosocomial infection, PDA, and water balance persist as risk factors for CLD.
The ductus arteriosus is a vessel that connects the pulmonary artery to the aorta and provides a pulmonary-to-systemic diversion during fetal life. In the vast majority of infants, the ductus ...arteriosus closes by 3 days of life. In some infants, especially preterm infants with lung disease, there is delayed closure of the ductus arteriosus. There has been controversy as to whether or when the ductus arteriosus should be closed by either pharmacologic or surgical methods.
There have been several epidemiologic studies describing an association between a patent ductus arteriosus and the development of morbidities, such as chronic lung disease. These associations have suggested to some that a causal relationship exists between patency of the ductus arteriosus and chronic lung disease and other morbidities. However, recent metaanalyses of randomized, controlled trials of the use of indomethacin for the prevention and treatment of the patent ductus arteriosus have not documented a decrease in the incidence of these morbidities after treatment, despite success in closure of the patent ductus arteriosus.
In preterm infants, patency of the ductus arteriosus may represent a normal physiologic adaptation to allow shunting from either systemic-to-pulmonary circulation (eg, in the first day of life) or from pulmonary-to-systemic circulation (eg, in the presence of severe lung disease). Therapies designed to close the ductus arteriosus are contraindicated in some settings and should not be considered a standard of care at any time until these therapies are proven to decrease long-term clinical morbidities in randomized, placebo-controlled trials.
Objective: To determine whether premature infants who have necrotizing enterocolitis (NEC) have deficiencies in glutamine (GLN) and arginine (ARG), which are essential to intestinal integrity. Study ...design: A 4-month prospective cohort study of serum amino acid and urea levels in premature infants was done. Serum amino acid and urea levels were measured by high-pressure liquid chromatography and enzymatic methods, respectively, on samples obtained on days of life 3, 7, 14, and 21. Results: Infants in the control (n = 32) and NEC groups (n = 13) were comparable for birth weight, gestational age, and Apgar scores. NEC began on mean day of life 14.5 (95% CI, day of life 11 to 18). Median values of GLN were 37% to 57% lower in the NEC group on days 7, 14, and 21 compared with those in the control group (P <.05). On days 7 and 14, median values of ARG, GLN, alanine, lysine, ornithine, and threonine were decreased 36% to 67% (P <.05) in the NEC group. Total nonessential amino and total essential amino acids were 35% to 50% lower in the NEC group on days 7 and 14 (P <.05). Infants in the NEC group had significant reductions in GLN and ARG 7 days before the onset of NEC. Conclusions: Infants who have NEC have selective amino acid deficiencies including reduced levels of GLN and ARG that may predispose to the illness. (J Pediatr 2000;137:785-93)
Inhaled nitric oxide improves oxygenation and lessens the need for extracorporeal-membrane oxygenation in full-term neonates with hypoxaemic respiratory failure and persistent pulmonary hypertension, ...but potential adverse effects are intracranial haemorrhage and chronic lung disease. We investigated whether low-dose inhaled nitric oxide would improve survival in premature neonates with unresponsive severe hypoxaemic respiratory failure, and would not increase the frequency or severity of intracranial haemorrhage or chronic lung disease.
We did a double-blind, randomised controlled trial in 12 perinatal centres that provide tertiary care. 80 premature neonates (gestational age ⩽34 weeks) with severe hypoxaemic respiratory failure were randomly assigned inhaled nitric oxide (n=48) or no nitric oxide (n=32, controls). Our primary outcome was survival to discharge. Analysis was by intention to treat. We studied also the rate and severity of intracranial haemorrhage, pulmonary haemorrhage, duration of ventilation, and chronic lung disease at 36 weeks' postconceptional age.
The two groups did not differ for baseline characteristics or severity of disease. Inhaled nitric oxide improved oxygenation after 60 min (p=0·03). Survival at discharge was 52% in the inhaled-nitric-oxide group and 47% in controls (p=0·65). Causes of death were mainly related to extreme prematurity and were similar in the two groups. The two groups did not differ for adverse events or outcomes (intracranial haemorrhage grade 2–4, 28% inhaled nitric oxide and 33% control; pulmonary haemorrhage 13% and 9%; chronic lung disease 60% and 80%).
Low-dose inhaled nitric oxide improved oxygenation but did not improve survival in severely hypoxaemic premature neonates. Low-dose nitric oxide in the most critically ill premature neonates does not increase the risk of intracranial haemorrhage, and may decrease risk of chronic lung injury.
Chronic lung disease remains one of the most challenging diseases in neonatal medicine because there have been very few effective therapies for its prevention or treatment. Here, Bose and Laughon ...suggest an alternative or complementary explanation to Doyle et al hypothesis that although corticosteroids have a direct toxic effect on the brain, this adverse effect may be balanced by an indirect benefit to the brain by improving lung function.
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