Dataset Information

Routine antenatal ultrasound in low- and middle-income countries: first look - a cluster randomised trial.

ABSTRACT:

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.

Tweetable abstract

Antenatal care ultrasound did not improve a composite outcome that included maternal, fetal, and neonatal mortality.

SUBMITTER: Goldenberg RL

PROVIDER: S-EPMC6390492 | biostudies-literature | 2018 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Routine antenatal ultrasound in low- and middle-income countries: first look - a cluster randomised trial.

Goldenberg R L RL Nathan R O RO Swanson D D Saleem S S Mirza W W Esamai F F Muyodi D D Garces A L AL Figueroa L L Chomba E E Chiwala M M Mwenechanya M M Tshefu A A Lokangako A A Bolamba V L VL Moore J L JL Franklin H H Swanson J J Liechty E A EA Bose C L CL Krebs N F NF Michael Hambidge K K Carlo W A WA Kanaiza N N Naqvi F F Pineda I S IS López-Gomez W W Hamsumonde D D Harrison M S MS Koso-Thomas M M Miodovnik M M Wallace D D DD McClure E M EM

BJOG : an international journal of obstetrics and gynaecology 20180615 12

<h4>Objective</h4>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.<h4>Design</h4>Cluster randomised trial.<h4>Setting</h4>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 fo ...[more]

PMID: 29782696

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Project description:ObjectivesThis systematic review examined available literature on the prognostic accuracy of Doppler ultrasound for adverse perinatal outcomes in low/middle-income countries (LMIC).DesignWe searched PubMed, Embase, Cochrane Library and Scopus from inception to April 2020.SettingObservational or interventional studies from LMICs.ParticipantsSingleton pregnancies of any risk profile.InterventionsUmbilical artery (UA), middle cerebral artery (MCA), cerebroplacental ratio (CPR), uterine artery (UtA), fetal descending aorta (FDA), ductus venosus, umbilical vein and inferior vena cava.Primary and secondary outcome measuresPerinatal death, stillbirth, neonatal death, expedited delivery for fetal distress, meconium-stained amniotic fluid, low birth weight, fetal growth restriction, admission to neonatal intensive care unit, neonatal acidosis, Apgar scores, preterm birth, fetal anaemia, respiratory distress syndrome, length of hospital stay, birth asphyxia and composite adverse perinatal outcomes (CAPO).ResultsWe identified 2825 records, and 30 (including 4977 women) from Africa (40.0%, n=12), Asia (56.7%, n=17) and South America (3.3%, n=01) were included. Many individual studies reported associations and promising predictive values of UA Doppler for various adverse perinatal outcomes mostly in high-risk pregnancies, and moderate to high predictive values of MCA, CPR and UtA Dopplers for CAPO. A few studies suggested that the MCA and FDA may be potent predictors of fetal anaemia. No randomised clinical trial (RCT) was found. Most studies were of suboptimal quality, poorly powered and characterised by wide variations in outcome classifications, the timing for the Doppler tests and study populations.ConclusionLocal evidence to guide how antenatal Doppler ultrasound should be used in LMIC is lacking. Well-designed studies, preferably RCTs, are required. Standardisation of practice and classification of perinatal outcomes across countries, following the international standards, is imperative.Prospero registration numberCRD42019128546.

Project description:BackgroundImproving maternal health has been a primary goal of international health agencies for many years, with the aim of reducing maternal and child deaths and improving access to antenatal care (ANC) services, particularly in low-and-middle-income countries (LMICs). Health interventions with these aims have received more attention from a clinical effectiveness perspective than for cost impact and economic efficiency.MethodsWe collected data on resource use and costs as part of a large, multi-country study assessing the use of routine antenatal screening ultrasound (US) with the aim of considering the implications for economic efficiency. We assessed typical antenatal outpatient and hospital-based (facility) care for pregnant women, in general, with selective complication-related data collection in women participating in a large maternal health registry and clinical trial in five LMICs. We estimated average costs from a facility/health system perspective for outpatient and inpatient services. We converted all country-level currency cost estimates to 2015 United States dollars (USD). We compared average costs across countries for ANC visits, deliveries, higher-risk pregnancies, and complications, and conducted sensitivity analyses.ResultsOur study included sites in five countries representing different regions. Overall, the relative cost of individual ANC and delivery-related healthcare use was consistent among countries, generally corresponding to country-specific income levels. ANC outpatient visit cost estimates per patient among countries ranged from 15 to 30 USD, based on average counts for visits with and without US. Estimates for antenatal screening US visits were more costly than non-US visits. Costs associated with higher-risk pregnancies were influenced by rates of hospital delivery by cesarean section (mean per person delivery cost estimate range: 25-65 USD).ConclusionsDespite substantial differences among countries in infrastructures and health system capacity, there were similarities in resource allocation, delivery location, and country-level challenges. Overall, there was no clear suggestion that adding antenatal screening US would result in either major cost savings or major cost increases. However, antenatal screening US would have higher training and maintenance costs. Given the lack of clinical effectiveness evidence and greater resource constraints of LMICs, it is unlikely that introducing antenatal screening US would be economically efficient in these settings--on the demand side (i.e., patients) or supply side (i.e., healthcare providers).Trial registrationTrial number: NCT01990625 (First posted: November 21, 2013 on https://clinicaltrials.gov ).

Project description:In high-income countries, group antenatal care (ANC) offers an alternative to individual care and is associated with improved attendance, client satisfaction, and health outcomes for pregnant women and newborns. In low- and middle-income country (LMIC) settings, this model could be adapted to address low antenatal care uptake and improve quality. However, evidence on key attributes of a group care model for low-resource settings remains scant. We conducted a systematic review of the published literature on models of group antenatal care in LMICs to identify attributes that may increase the relevance, acceptability and effectiveness of group ANC in such settings. We systematically searched five databases and conducted hand and reference searches. We also conducted key informant interviews with researchers and program implementers who have introduced group antenatal care models in LMICs. Using a pre-defined evidence summary template, we extracted evidence on key attributes-like session content and frequency, and group composition and organization-of group care models introduced across LMIC settings. Our systematic literature review identified nine unique descriptions of group antenatal care models. We supplemented this information with evidence from 10 key informant interviews. We synthesized evidence from these 19 data sources to identify attributes of group care models for pregnant women that appeared consistently across all of them. We considered these components that are fundamental to the delivery of group antenatal care. We also identified attributes that need to be tailored to the context in which they are implemented to meet local standards for comprehensive ANC, for example, the number of sessions and the session content. We compiled these attributes to codify a composite "generic" model of group antenatal care for adaptation and implementation in LMIC settings. With this combination of standard and flexible components, group antenatal care, a service delivery alternative that has been successfully introduced and implemented in high-income country settings, can be adapted for improving provision and experiences of care for pregnant women in LMIC. Any conclusions about the benefits of this model for women, babies, and health systems in LMICs, however, must be based on robust evaluations of group antenatal care programs in those settings.

Project description:BackgroundAntenatal corticosteroids for pregnant women at risk of preterm birth are among the most effective hospital-based interventions to reduce neonatal mortality. We aimed to assess the feasibility, effectiveness, and safety of a multifaceted intervention designed to increase the use of antenatal corticosteroids at all levels of health care in low-income and middle-income countries.MethodsIn this 18-month, cluster-randomised trial, we randomly assigned (1:1) rural and semi-urban clusters within six countries (Argentina, Guatemala, India, Kenya, Pakistan, and Zambia) to standard care or a multifaceted intervention including components to improve identification of women at risk of preterm birth and to facilitate appropriate use of antenatal corticosteroids. The primary outcome was 28-day neonatal mortality among infants less than the 5th percentile for birthweight (a proxy for preterm birth) across the clusters. Use of antenatal corticosteroids and suspected maternal infection were additional main outcomes. This trial is registered with ClinicalTrials.gov, number NCT01084096.FindingsThe ACT trial took place between October, 2011, and March, 2014 (start dates varied by site). 51 intervention clusters with 47,394 livebirths (2520 [5%] less than 5th percentile for birthweight) and 50 control clusters with 50,743 livebirths (2258 [4%] less than 5th percentile) completed follow-up. 1052 (45%) of 2327 women in intervention clusters who delivered less-than-5th-percentile infants received antenatal corticosteroids, compared with 215 (10%) of 2062 in control clusters (p<0·0001). Among the less-than-5th-percentile infants, 28-day neonatal mortality was 225 per 1000 livebirths for the intervention group and 232 per 1000 livebirths for the control group (relative risk [RR] 0·96, 95% CI 0·87-1·06, p=0·65) and suspected maternal infection was reported in 236 (10%) of 2361 women in the intervention group and 133 (6%) of 2094 in the control group (odds ratio [OR] 1·67, 1·33-2·09, p<0·0001). Among the whole population, 28-day neonatal mortality was 27·4 per 1000 livebirths for the intervention group and 23·9 per 1000 livebirths for the control group (RR 1·12, 1·02-1·22, p=0·0127) and suspected maternal infection was reported in 1207 (3%) of 48,219 women in the intervention group and 867 (2%) of 51,523 in the control group (OR 1·45, 1·33-1·58, p<0·0001).InterpretationDespite increased use of antenatal corticosteroids in low-birthweight infants in the intervention groups, neonatal mortality did not decrease in this group, and increased in the population overall. For every 1000 women exposed to this strategy, an excess of 3·5 neonatal deaths occurred, and the risk of maternal infection seems to have been increased.FundingEunice Kennedy Shriver National Institute of Child Health and Human Development.

Project description:BACKGROUND:Antenatal corticosteroids (ACS) for women at high risk of preterm birth is an effective intervention to reduce neonatal mortality among preterm babies delivered in hospital settings, but has not been widely used in low-middle resource settings. We sought to assess the rates of ACS use at all levels of health care in low and middle income countries (LMIC). METHODS:We assessed rates of ACS in 7 sites in 6 LMIC participating in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Global Network for Women and Children's Health Research Antenatal Corticosteroids Trial (ACT), a cluster-randomized trial to assess the feasibility, effectiveness, and safety of a multifaceted intervention designed to increase the use of ACS. We conducted this analysis using data from the control clusters, which did not receive any components of the intervention and intended to follow usual care. We included women who delivered an infant with a birth weight <5th percentile, a proxy for preterm birth, and were enrolled in the Maternal Newborn Health (MNH) Registry between October 2011 and March 2014 in all clusters. A survey of the site investigators regarding existing policies on ACS in health facilities and for health workers in the community was part of pre-trial activities. RESULTS:Overall, of 51,523 women delivered in control clusters across all sites, the percentage of <5th percentile babies ranged from 3.5 % in Kenya to 10.7 % in Pakistan. There was variation among the sites in the use of ACS at all hospitals and among those hospitals having cesarean section and neonatal care capabilities (bag and mask and oxygen or mechanical ventilation). Rates of ACS use for <5th percentile babies in all hospitals ranged from 3.8 % in the Kenya sites to 44.5 % in the Argentina site, and in hospitals with cesarean section and neonatal care capabilities from 0 % in Zambia to 43.5 % in Argentina. ACS were rarely used in clinic or home deliveries at any site. Guidelines for ACS use at all levels of the health system were available for most of the sites. CONCLUSION:Our study reports an overall low utilization of ACS among mothers of <5th percentile infants in hospital and clinic deliveries in LMIC. TRIAL REGISTRATION:clinicaltrials.gov ( NCT01084096 ).

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Dataset Information

Routine antenatal ultrasound in low- and middle-income countries: first look - a cluster randomised trial.

Objective

Design

Setting

Main outcome measures

Results

Conclusions

Tweetable abstract

Publications

Routine antenatal ultrasound in low- and middle-income countries: first look - a cluster randomised trial.

Similar Datasets

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