Evidence map›Paper›PMID 27255082›Full record

Trial reportReproductive health2016

The global network antenatal corticosteroids trial: impact on stillbirth.

Robert L Goldenberg, Vanessa R Thorsten, Fernando Althabe, Sarah Saleem, Ana Garces, Waldemar A Carlo, Omrana Pasha, Elwyn Chomba, Shivaprasad Goudar, Fabian Esamai and 12 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled TrialPragmatic Clinical 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
2.6field-weighted citation impact, top 9% 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, 11 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

22 authors at 15 institutions in 6 countries.

Robert L GoldenbergColumbia University, New York, NY, USA. rlg@columbia.edu.
Vanessa R ThorstenRTI International, Durham, NC, USA.
Fernando AlthabeIECS, Buenos Aires, Argentina.
Sarah SaleemColumbia University, New York, NY, USA.
Ana Garces, Guatemala, Guatemala.
Waldemar A CarloUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Omrana PashaAga Khan University, Karachi, Pakistan.
Elwyn ChombaUniversity Teaching Hospital, Lusaka, Zambia.
Shivaprasad GoudarKLE University's JN Medical College,, Belgaum, India.
Fabian EsamaiMoi University, Eldoret, Kenya.
Nancy F KrebsUniversity of Colorado School of Medicine, Denver, CO, USA.
Richard J DermanChristiana Care, Newark, DE, USA.
Edward A LiechtyIndiana University, Indianapolis, IN, USA.
Archana PatelLata Medical Research Foundation, Nagpur, India.
Patricia L HibberdMassachusetts General Hospital, Boston, MA, USA.
Pierre M BuekensTulane School of Public Health and Tropical Medicine, New Orleans, LA, USA.
Marion Koso-ThomasEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.
Menachem MiodovnikEunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.
Alan H JobeCincinnati Children's Hospital, Cincinnati, OH, USA.
Dennis D WallaceRTI International, Durham, NC, USA.
José M BelizánIECS, Buenos Aires, Argentina.
Elizabeth M McClureRTI International, Durham, NC, USA.
RTI International · USAga Khan University · PKEunice Kennedy Shriver National Institute of Child Health and Human Development · USInstituto de Efectividad Clínica y Sanitaria · ARCincinnati Children's Hospital Medical Center · USColumbia University · USIndiana University – Purdue University Indianapolis · USKLE University · INLata Medical Research Foundation · 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
NCCIH 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 HD078438NICHD NIH HHS U10 HD078439NICHD NIH HHS UG1 HD076461NICHD NIH HHS UG1 HD076474NICHD NIH HHS UG1 HD078439
6 · The paper itself

Abstract

backgroundAntenatal corticosteroids are commonly used to reduce neonatal mortality, but most research to date has been in high-resource settings and few studies have evaluated its impact on stillbirth. In the Antenatal Corticosteroids Trial (ACT), a multi-country trial to assess impact of a multi-faceted intervention including antenatal corticosteroids to reduce neonatal mortality associated with preterm birth, we found an overall increase in 28-day neonatal mortality and stillbirth associated with the intervention.

methodsThe ACT was a cluster-randomized trial conducted in 102 clusters across 7 research sites in 6 countries (India [2 sites], Pakistan, Zambia, Kenya, Guatemala and Argentina), comparing an intervention to train birth attendants at all levels of the health system to identify women at risk of preterm birth, administer corticosteroids and refer women at risk. Because of inadequate gestational age dating, the <5(th) percentile birth weight was used as a proxy for preterm birth. A pre-specified secondary outcome of the trial was stillbirth.

resultsAfter adjusting for the pre-trial imbalance in stillbirth rates, the ACT intervention was associated with a non-significant increased risk of stillbirth (aRR 1.08, 95 % CI, 0.99-1.17, p-0.073). Additionally, the stillbirth rate was higher in the term births (1.20 95 % CI 1.06-1.37, 0.004) and among those with signs of maceration (RR 1.18 (1.04-1.35), p = 0.013) in the intervention vs. control clusters. Differences in obstetric care favored the control clusters and maternal infection was likely more common in the intervention clusters.

conclusionsIn this pragmatic trial, limited data were available to identify the causes of the increase in stillbirths in the intervention clusters. A higher rate of stillbirth in the intervention clusters prior to the trial, differences in obstetric care and an increase in maternal infection are potential explanations for the observed increase in stillbirths in the intervention clusters during the trial.

trial registrationclinicaltrials.gov (NCT01084096).

Indexed as

Adrenal Cortex HormonesFemaleGestational AgeHumansPractice Guidelines as TopicPregnancyPremature BirthStillbirthAdrenal Cortex Hormones

Identifiers

PMID27255082
PMCPMC4891888
OpenAlexW2414045790

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.