Evidence map›Paper›PMID 27221319›Full record

Trial reportReproductive health2016

The Antenatal Corticosteroids Trial (ACT): a secondary analysis to explore site differences in a multi-country trial.

Karen Klein, Elizabeth M McClure, Daniela Colaci, Vanessa Thorsten, Patricia L Hibberd, Fabian Esamai, Ana Garces, Archana Patel, Sarah Saleem, Omrana Pasha and 11 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Reproductive health, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01084096 (Trial of the Use of Antenatal Corticosteroids in Developing Countries), which is not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
3.9field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01084096 nacompletednot on this map

Trial of the Use of Antenatal Corticosteroids in Developing Countries

TypeinterventionalSponsorNICHD Global Network for Women's and Children's HealthRan2011 to 2014Enrolled103,117ConditionsPreterm BirthArmsIncreasing use of Antenatal Corticosteroids (ACS)
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. Article
  6. Antenatal Corticosteroids:Global health, science and practice · 2018
    Article
  7. Article
  8. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 16 institutions in 7 countries.

Karen KleinInstitute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina. kklein@iecs.org.ar.
Elizabeth M McClureRTI International, Durham, NC, USA.
Daniela ColaciInstitute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina.
Vanessa ThorstenRTI International, Durham, NC, USA.
Patricia L HibberdMassachusetts General Hospital, Boston, MA, USA.
Fabian EsamaiMoi University School of Medicine, Eldoret, Kenya.
Ana GarcesFundación para la Alimentación y Nutrición de Centro América y Panamá, Guatemala City, Guatemala.
Archana PatelLata Medical Research Foundation, Indira Gandhi Government Medical College, Nagpur, India.
Sarah SaleemDepartment of Community Health Sciences, Aga Khan University, Karachi, Pakistan.
Omrana PashaDepartment of Community Health Sciences, Aga Khan University, Karachi, Pakistan.
Elwyn ChombaUniversity Teaching Hospital, Lusaka, Zambia.
Waldemar A CarloUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Nancy F KrebsUniversity of Colorado School of Medicine, Denver, Colorado, USA.
Shivaprasad GoudarKLE University's Jawaharlal Nehru Medical College, Belgaum, Karnataka, India.
Richard J DermanChristiana Health Care, Newark, DE, USA.
Edward A LiechtySchool of Medicine, Indiana University, Indianapolis, IN, USA.
Marion Koso-ThomasEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.
Pierre M BuekensTulane School of Public Health & Tropical Medicine, New Orleans, Louisiana, USA.
José M BelizánInstitute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina.
Robert L GoldenbergDepartment of Obstetrics and Gynecology, Columbia University, New York, NY, USA.
Fernando AlthabeInstitute for Clinical Effectiveness and Health Policy (IECS), Buenos Aires, Argentina.
Instituto de Efectividad Clínica y Sanitaria · ARAga Khan University · PKRTI International · USChristiana Care Health System · USColumbia University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USGovernment Medical College · INIndiana University – Purdue University Indianapolis · USInstitute of Nutrition of Central America and Panama · GTKLE University · INMassachusetts General Hospital · USMoi University · KETulane University · USUniversity of Alabama at Birmingham · USUniversity of Colorado Denver · USUniversity Teaching Hospital · ZM

Funding

Zika in Pregnancy Supplemental Funding requestU01HD040636 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI MCCLURE, ELIZABETH M · 2001 to 2017
$37.5M
UAB/AKU Global Network Research UnitU01HD040607 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI GOLDENBERG, ROBERT L · 2001 to 2012
$8.5M
Complementary feeding: a Global Network cluster randomized controlled trialU01HD040657 · NICHD · UNIVERSITY OF COLORADO DENVER · PI HAMBIDGE, K MICHAEL · 2001 to 2012
$8.1M
UMKC-JNMC Global Network for Women's and Children's Health Research UnitU01HD042372 · NICHD · UNIVERSITY OF MISSOURI KANSAS CITY · PI DERMAN, RICHARD J · 2001 to 2012
$6.9M
Neonatal Resuscitation in Developing CountriesU01HD043464 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI CARLO FONT, WALDEMAR A. · 2003 to 2012
$6.6M
Evidence-Based Global Health Interventions for Mothers and Children, ArgentinaU01HD040477 · NICHD · UNIVERSITY OF NORTH CAROLINA CHAPEL HILL · PI BUEKENS, PIERRE · 2001 to 2013
$5.6M
Boston University/Lata Medical Research Foundation Global Network for Women's Children's Health Research UnitUG1HD078439 · NICHD · BOSTON UNIVERSITY MEDICAL CAMPUS · PI Patricia L Hibberd · 2018 to 2026
$5.5M
Nutrition-specific interventions to improve long-term maternal-child health outcomesUG1HD076474 · NICHD · UNIVERSITY OF COLORADO DENVER · PI Edwin Jose Asturias, NANCY F KREBS · 2018 to 2026
$5.4M
The Global Network and Preconception Maternal NutritionU10HD076474 · NICHD · UNIVERSITY OF COLORADO DENVER · PI HAMBIDGE, K MICHAEL, KREBS, NANCY F · 2013 to 2017
$5.1M
Global Network for Women's and Children's Health ResearchU10HD076461 · NICHD · INDIANA UNIVERSITY INDIANAPOLIS · PI LIECHTY, EDWARD A. · 2013 to 2017
$4.1M
Improving Quality of Care for the Treatment of Childhood PneumoniaU01HD058322 · NICHD · TUFTS UNIVERSITY BOSTON · PI HIBBERD, PATRICIA L · 2008 to 2012
$4.0M
CCHS-JNMC Global Network for Women's & Children's Health Research UnitU10HD076457 · NICHD · THOMAS JEFFERSON UNIVERSITY · PI DERMAN, RICHARD J · 2013 to 2017
$3.7M
FIC NIH HHS D43 TW009083NCCIH NIH HHS K24 AT003683NICHD NIH HHS U01 HD040477NICHD NIH HHS U01 HD040607NICHD NIH HHS U01 HD040636NICHD NIH HHS U01 HD040657NICHD NIH HHS U01 HD042372NICHD NIH HHS U01 HD043464NICHD NIH HHS U01 HD058322NICHD NIH HHS U01 HD058326NICHD NIH HHS U10 HD076457NICHD NIH HHS U10 HD076461NICHD NIH HHS U10 HD076474NICHD NIH HHS U10 HD078437NICHD NIH HHS U10 HD078438NICHD NIH HHS U10 HD078439NICHD NIH HHS UG1 HD076461NICHD NIH HHS UG1 HD076474NICHD NIH HHS UG1 HD078439
6 · The paper itself

Abstract

backgroundThe Antenatal Corticosteroid Trial (ACT) assessed the feasibility, effectiveness, and safety of a multifaceted intervention to increase the use of antenatal corticosteroids (ACS) in mothers at risk of preterm birth at all levels of care in low and middle-income countries. The intervention effectively increased the use of ACS but had no overall impact on neonatal mortality in the targeted <5(th) percentile birth weight infants. Being in the intervention clusters was also associated with an overall increase in neonatal deaths. We sought to explore plausible pathways through which this intervention increased neonatal mortality.

methodsWe conducted secondary analyses to assess site differences in outcome and potential explanations for the differences in outcomes if found. By site, and in the intervention and control clusters, we evaluated characteristics of the mothers and care systems, the proportion of the <5(th) percentile infants and the overall population that received ACS, the rates of possible severe bacterial infection (pSBI), determined from clinical signs, and neonatal mortality rates.

resultsThere were substantial differences between the sites in both participant and health system characteristics, with Guatemala and Argentina generally having the highest levels of care. In some sites there were substantial differences in the health system characteristics between the intervention and control clusters. The increase in ACS in the intervention clusters was similar among the sites. While overall, there was no difference in neonatal mortality among <5(th) percentile births between the intervention and control clusters, Guatemala and Pakistan both had significant reductions in neonatal mortality in the <5(th) percentile infants in the intervention clusters. The improvement in neonatal mortality in the Guatemalan site in the <5(th) percentile infants was associated with a higher level of care at the site and an improvement in care in the intervention clusters. There was a significant increase overall in neonatal mortality in the intervention clusters compared to the control. Across sites, this increase in neonatal mortality was statistically significant and most apparent in the African sites. This increase in neonatal mortality was accompanied by a significant increase in pSBI in the African sites.

conclusionsThe improvement in neonatal mortality in the Guatemalan site in the <5(th) percentile infants was associated with a higher level of care and an improvement in care in the intervention clusters. The increase in neonatal mortality in the intervention clusters across all sites was largely driven by the poorer outcomes in the African sites, which also had an increase in pSBI in the intervention clusters. We emphasize that these results come from secondary analyses. Additional prospective studies are needed to assess the effectiveness and safety of ACS on neonatal health in low resource settings.

trial registration

trial registrationclinicaltrials.gov (NCT01084096).

Indexed as

Developing CountriesAdolescentAdultAfrica South of the SaharaAsiaDelivery, ObstetricDrug UtilizationFeasibility StudiesFemaleGlucocorticoidsHumansInfantInfant MortalityInfant, NewbornLatin AmericaMaternal AgeGlucocorticoids

Identifiers

PMID27221319
PMCPMC4878061
OpenAlexW2404467147

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.