Evidence map›Paper›PMID 25591391›Full record

Trial reportBMC medicine2015

Sulphadoxine-pyrimethamine plus azithromycin for the prevention of low birthweight in Papua New Guinea: a randomised controlled trial.

Holger W Unger, Maria Ome-Kaius, Regina A Wangnapi, Alexandra J Umbers, Sarah Hanieh, Connie S N Li Wai Suen, Leanne J Robinson, Anna Rosanas-Urgell, Johanna Wapling, Elvin Lufele and 11 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01136850 (Intermittent Preventive Treatment With Azithromycin-containing Regimens for the Prevention of Malarial Infections and Anaemia and the Control of Sexually Transmitted Infections in Pregnant Women in Papua New Guinea), which is not on this map. Cited by 73 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
73citing papers in PubMed, 7 pooled it
18.4field-weighted citation impact, top 1% 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.

NCT01136850 phase3completednot on this map

Intermittent Preventive Treatment With Azithromycin-containing Regimens for the Prevention of Malarial Infections and Anaemia and the Control of Sexually Transmitted Infections in Pregnant Women in Papua New Guinea

TypeinterventionalSponsorUniversity of MelbourneRan2009 to 2013Enrolled2,793ConditionsMalaria in Pregnancy, Sexually Transmitted Infections, AnaemiaArmschloroquine, sulphadoxine pyrimethamine, LLIN, azithromycin, sulphadoxine pyrimethamine, LLIN
3 · Its place in the literature

Who cites it

73 citing papers in PubMed, 7 syntheses or guidelines pooled it, 99 citations in OpenAlex.

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13 more citing papers are in PubMed but not listed here.

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 7 institutions in 4 countries.

Holger W UngerDepartment of Medicine (Royal Melbourne Hospital), The University of Melbourne, Post Office Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia. hwunger@doctors.org.uk.
Maria Ome-KaiusPapua New Guinea Institute of Medical Research, PO Box 60, Goroka, Eastern Highlands Province, 441, Papua New Guinea. marai.kaius@gmail.com.
Regina A WangnapiPapua New Guinea Institute of Medical Research, PO Box 60, Goroka, Eastern Highlands Province, 441, Papua New Guinea. wangnapi.regina@yahoo.com.
Alexandra J UmbersDepartment of Medicine (Royal Melbourne Hospital), The University of Melbourne, Post Office Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia. alex.umbers@gmail.com.
Sarah HaniehDepartment of Medicine (Royal Melbourne Hospital), The University of Melbourne, Post Office Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia. shanieh@unimelb.edu.au.
Connie S N Li Wai SuenWalter and Eliza Hall Institute (WEHI), Parkville, Victoria, 3052, Australia. liwaisuen@wehi.edu.au.
Leanne J RobinsonPapua New Guinea Institute of Medical Research, PO Box 60, Goroka, Eastern Highlands Province, 441, Papua New Guinea. robinson@wehi.edu.au.
Anna Rosanas-UrgellPapua New Guinea Institute of Medical Research, PO Box 60, Goroka, Eastern Highlands Province, 441, Papua New Guinea. arosanas@itg.be.
Johanna WaplingPapua New Guinea Institute of Medical Research, PO Box 60, Goroka, Eastern Highlands Province, 441, Papua New Guinea. jo.wapling@gmail.com.
Elvin LufelePapua New Guinea Institute of Medical Research, PO Box 60, Goroka, Eastern Highlands Province, 441, Papua New Guinea. elvinlufele@gmail.com.
Charles KongsPapua New Guinea Institute of Medical Research, PO Box 60, Goroka, Eastern Highlands Province, 441, Papua New Guinea. charliekongs@gmail.com.
Paula SamolPapua New Guinea Institute of Medical Research, PO Box 60, Goroka, Eastern Highlands Province, 441, Papua New Guinea. samol.jppaula@gmail.com.
Desmond SuiPapua New Guinea Institute of Medical Research, PO Box 60, Goroka, Eastern Highlands Province, 441, Papua New Guinea. sui.desmond0@gmail.com.
Dupain SingirokPapua New Guinea Institute of Medical Research, PO Box 60, Goroka, Eastern Highlands Province, 441, Papua New Guinea. marai.kaius@gmail.com.
Azucena BardajiBarcelona Centre for International Health Research (CRESIB), Hospital Clínic-Universitat de Barcelona, Rossello, 132, 7th floor, 08036, Barcelona, Spain. abardaji@clinic.ub.es.
Louis SchofieldWalter and Eliza Hall Institute (WEHI), Parkville, Victoria, 3052, Australia. schofield@wehi.edu.au.
Clara MenendezBarcelona Centre for International Health Research (CRESIB), Hospital Clínic-Universitat de Barcelona, Rossello, 132, 7th floor, 08036, Barcelona, Spain. menendez@clinic.ub.es.
Inoni BetuelaPapua New Guinea Institute of Medical Research, PO Box 60, Goroka, Eastern Highlands Province, 441, Papua New Guinea. ibetuela@gmail.com.
Peter SibaPapua New Guinea Institute of Medical Research, PO Box 60, Goroka, Eastern Highlands Province, 441, Papua New Guinea. pmaxsiba@gmail.com.
Ivo MuellerWalter and Eliza Hall Institute (WEHI), Parkville, Victoria, 3052, Australia. mueller@wehi.edu.au.
Stephen J RogersonDepartment of Medicine (Royal Melbourne Hospital), The University of Melbourne, Post Office Royal Melbourne Hospital, Parkville, Victoria, 3050, Australia. sroger@unimelb.edu.au.
Papua New Guinea Institute of Medical Research · PGUniversity of Melbourne · AUUniversitat de Barcelona · ESWalter and Eliza Hall Institute of Medical Research · AUAustralian Institute of Tropical Health and Medicine · AUBarcelona Centre for International Affairs · ESInstituut voor Tropische Geneeskunde · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntermittent preventive treatment in pregnancy has not been evaluated outside of Africa. Low birthweight (LBW, <2,500 g) is common in Papua New Guinea (PNG) and contributing factors include malaria and reproductive tract infections.

methodsFrom November 2009 to February 2013, we conducted a parallel group, randomised controlled trial in pregnant women (≤ 26 gestational weeks) in PNG. Sulphadoxine-pyrimethamine (1,500/75 mg) plus azithromycin (1 g twice daily for 2 days) (SPAZ) monthly from second trimester (intervention) was compared against sulphadoxine-pyrimethamine and chloroquine (450 to 600 mg, daily for three days) (SPCQ) given once, followed by SPCQ placebo (control). Women were assigned to treatment (1:1) using a randomisation sequence with block sizes of 32. Participants were blinded to assignments. The primary outcome was LBW. Analysis was by intention-to-treat.

resultsOf 2,793 women randomised, 2,021 (72.4%) were included in the primary outcome analysis (SPCQ: 1,008; SPAZ: 1,013). The prevalence of LBW was 15.1% (305/2,021). SPAZ reduced LBW (risk ratio [RR]: 0.74, 95% CI: 0.60-0.91, P = 0.005; absolute risk reduction (ARR): 4.5%, 95% CI: 1.4-7.6; number needed to treat: 22), and preterm delivery (0.62, 95% CI: 0.43-0.89, P = 0.010), and increased mean birthweight (41.9 g, 95% CI: 0.2-83.6, P = 0.049). SPAZ reduced maternal parasitaemia (RR: 0.57, 95% CI: 0.35-0.95, P = 0.029) and active placental malaria (0.68, 95% CI: 0.47-0.98, P = 0.037), and reduced carriage of gonorrhoea (0.66, 95% CI: 0.44-0.99, P = 0.041) at second visit. There were no treatment-related serious adverse events (SAEs), and the number of SAEs (intervention 13.1% [181/1,378], control 12.7% [174/1,374], P = 0.712) and AEs (intervention 10.5% [144/1,378], control 10.8% [149/1,374], P = 0.737) was similar. A major limitation of the study was the high loss to follow-up for birthweight.

conclusionsSPAZ was efficacious and safe in reducing LBW, possibly acting through multiple mechanisms including the effect on malaria and on sexually transmitted infections. The efficacy of SPAZ in the presence of resistant parasites and the contribution of AZ to bacterial antibiotic resistance require further study. The ability of SPAZ to improve pregnancy outcomes warrants further evaluation.

trial registrationClinicalTrials.gov NCT01136850 (06 April 2010).

Indexed as

Infant, Low Birth WeightAdultAntimalarialsAzithromycinChloroquineDrug CombinationsFemaleHumansInfant, NewbornMalariaPapua New GuineaPregnancyPregnancy Complications, ParasiticPyrimethamineSingle-Blind MethodSulfadoxineAntimalarialsAzithromycinChloroquineDrug Combinationsfanasil, pyrimethamine drug combinationPyrimethamineSulfadoxine

Identifiers

PMID25591391
PMCPMC4305224
OpenAlexW1999835984

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.