Evidence map›Paper›PMID 28468653›Full record

Trial reportBMC pregnancy and childbirth2017

A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study.

Matthew K Hoffman, Shivaprasad S Goudar, Bhalachandra S Kodkany, Norman Goco, Marion Koso-Thomas, Menachem Miodovnik, Elizabeth M McClure, Dennis D Wallace, Jennifer J Hemingway-Foday, Antoinette Tshefu and 16 more

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pregnancy and childbirth, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 5% 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.

NCT02409680 nacompletednot on this map

Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas (ASPIRIN)

TypeinterventionalSponsorNICHD Global Network for Women's and Children's HealthRan2016 to 2019Enrolled11,976ConditionsPremature BirthArmsLow dose aspirin, Placebo
NCT03871491 phase3completednot on this mapstarted 2020, after this paper: background citation

Prevention of Maternal and Neonatal Death/Infections With a Single Oral Dose of Azithromycin in Women in Labor (in Low- and Middle-income Countries): a Randomized Controlled Trial

TypeinterventionalSponsorNICHD Global Network for Women's and Children's HealthRan2020 to 2022Enrolled58,747ConditionsMaternal Death, Maternal Infections Affecting Fetus or Newborn, Neonatal SEPSIS, Maternal Sepsis During LaborArmsAzithromycin, Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.

  1. Antiplatelet agents for preventing pre-eclampsia and its complications.The Cochrane database of systematic reviews · 2019
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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

26 authors at 17 institutions in 7 countries.

Matthew K HoffmanChristiana Care, Newark, DE, USA.
Shivaprasad S GoudarKLE's JN Medical College, Belgaum, India.
Bhalachandra S KodkanyKLE's JN Medical College, Belgaum, India.
Norman GocoRTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, USA. ngoco@rti.org.
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.
Elizabeth M McClureRTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, USA.
Dennis D WallaceRTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, USA.
Jennifer J Hemingway-FodayRTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, USA.
Antoinette TshefuKinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.
Adrien LokangakaKinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo.
Carl L BoseUniversity of North Carolina, Chapel Hill, NC, USA.
Elwyn ChombaUniversity Teaching Hospital, Lusaka, Zambia.
Musaku MwenechanyaUniversity Teaching Hospital, Lusaka, Zambia.
Waldemar A CarloUniversity of Alabama at Birmingham, Birmingham, AL, USA.
Ana GarcesInstituto de Nutrición de Centroamérica y Panamá (INCAP), Guatemala City, Guatemala.
Nancy F KrebsUniversity of Colorado School of Medicine, Denver, CO, USA.
K Michael HambidgeUniversity of Colorado School of Medicine, Denver, CO, USA.
Sarah SaleemAga Khan University, Karachi, Pakistan.
Robert L GoldenbergColumbia University, New York, NY, USA.
Archana PatelLata Medical Research Foundation, Nagpur, India.
Patricia L HibberdBoston University School of Public Health, Boston, MA, USA.
Fabian EsamaiDepartment of Child Health and Paediatrics, Moi University School of Medicine, Eldoret, Kenya.
Edward A LiechtySchool of Medicine, Indiana University, Indianapolis, IN, USA.
Robert SilverUniversity of Utah, Salt Lake City, UT, USA.
Richard J DermanThomas Jefferson University, Philadelphia, PA, USA.
RTI International · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USKLE University · INMinistry of Public Health · CDUniversity of Colorado Denver · USUniversity Teaching Hospital · ZMAga Khan University · PKBoston University · USColumbia University · USIndiana University – Purdue University Indianapolis · USInstitute of Nutrition of Central America and Panama · GTLata Medical Research Foundation · INMoi University · KEThomas Jefferson University · USUniversity of Alabama at Birmingham · USUniversity of North Carolina at Chapel Hill · USUniversity of Utah · US

Funding

Zika in Pregnancy Supplemental Funding requestU01HD040636 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI MCCLURE, ELIZABETH M · 2001 to 2017
$37.5M
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
TJU-JNMC Global Network for Women's & Children's Health Research UnitUG1HD076457 · NICHD · THOMAS JEFFERSON UNIVERSITY · PI RICHARD J DERMAN · 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
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
Heart Rate Detection during Resuucitation to Reduce Early Neonatal MortalityU10HD078437 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI CARLO FONT, WALDEMAR A. · 2013 to 2017
$3.3M
Columbia University/Aga Khan University Global Network Research UnitU10HD078438 · NICHD · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI GOLDENBERG, ROBERT L · 2013 to 2017
$3.2M
Maternal and Child Health Benefits from Reducing Household Air PollutionU10HD078439 · NICHD · MASSACHUSETTS GENERAL HOSPITAL · PI HIBBERD, PATRICIA L · 2013 to 2017
$3.1M
A Strategy to Reduce Stunting of Growth in Early Infancy: a Global Network StudyU10HD076465 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BOSE, CARL · 2013 to 2017
$2.9M
NICHD NIH HHS U01 HD040636NICHD NIH HHS U10 HD076457NICHD NIH HHS U10 HD076461NICHD NIH HHS U10 HD076465NICHD NIH HHS U10 HD076474NICHD NIH HHS U10 HD078437NICHD NIH HHS U10 HD078438NICHD NIH HHS U10 HD078439NICHD NIH HHS UG1 HD076457NICHD NIH HHS UG1 HD076474NICHD NIH HHS UG1 HD078439
6 · The paper itself

Abstract

backgroundPreterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) may substantially reduce the rate of PTB.

methodsHypothesis: LDA initiated in the first trimester reduces the risk of preterm birth. Study Design Type: Prospective randomized, placebo-controlled, double-blinded multi-national clinical trial conducted in seven low and middle income countries. Trial will be individually randomized with one-to-one ratio (intervention/control) Population: Nulliparous women between the ages of 14 and 40, with a singleton pregnancy between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, no more than two previous first trimester pregnancy losses, and no contraindications to aspirin.

interventionDaily administration of low dose (81 mg) aspirin, initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA, compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly. OUTCOMES: Primary outcome: Incidence of PTB (birth prior to 37 0/7 weeks GA). Secondary outcomes Incidence of preeclampsia/eclampsia, small for gestational age and perinatal mortality. DISCUSSION: This study is unique as it will examine the impact of LDA early in pregnancy in low-middle income countries with preterm birth as a primary outcome. The importance of developing low-cost, high impact interventions in low-middle income countries is magnified as they are often unable to bear the financial costs of treating illness.

trial registrationClinicalTrials.gov identifier: NCT02409680 Date: March 30, 2015.

Indexed as

Pregnancy Trimester, FirstAdolescentAdultAnti-Inflammatory Agents, Non-SteroidalAspirinDeveloping CountriesDouble-Blind MethodFemaleGestational AgeHumansIncidenceInfantInfant MortalityInfant, Small for Gestational AgeParityPre-EclampsiaAnti-Inflammatory Agents, Non-SteroidalAspirinLow dose AspirinPrematurityPreterm birth

Identifiers

PMID28468653
PMCPMC5415791
OpenAlexW2611282986

What OpenQuestion holds

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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.