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We thank the participating women and their families; the PNGIMR clinical, administrative, logistics, and laboratory staff; the staff at all participating health centres and hospitals; Lisa Lansfield, Hector Morris, John Bolnga, Jaume Ordi, Albert Serra Pou, Eline Kattenberg, Celine Barnadas, Andrew Raiko, Jane Walker, Sylvia Soso, Nola Ndrewei, Clare Ryan, and Jacob Kumai; DSMB members Julie Simpson and James McCarthy; independent clinician (drug safety) Moses Laman; independent clinical monitor Honor Rose; and Christalla Hajisava. This study was funded by the Malaria in Pregnancy Consortium, through a grant from the Bill & Melinda Gates Foundation (46099); the Pregvax Consortium, through a grant from the European Union's Seventh Framework Programme FP7-2007-HEALTH (PREGVAX 201588) and the Spanish Government (EUROSALUD 2008 Programme); and Pfizer Inc., through an investigator-initiated research grant (WS394663). LJR received a National Health and Medical Research Council (NHMRC) Early Career Fellowship (# 1016443). IM received an NHMRC Senior Research Fellowship (# 1043345). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Analysis of institutional authors

Menendez, CAuthor

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April 21, 2020
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Sulphadoxine- pyrimethamine plus azithromycin for the prevention of low birthweight in Papua New Guinea: a randomised controlled trial

Publicated to:BMC Medicine. 13 (9): 9- - 2015-01-16 13(9), DOI: 10.1186/s12916-014-0258-3

Authors: Unger, Holger W.; Ome-Kaius, Maria; Wangnapi, Regina A.; Umbers, Alexandra J.; Hanieh, Sarah; Suen, Connie S. L. Li Wai; Robinson, Leanne J.; Rosanas-Urgell, Anna; Wapling, Johanna; Lufele, Elvin; Kongs, Charles; Samol, Paula; Sui, Desmond; Singirok, Dupain; Bardaji, Azucena; Schofield, Louis; Menendez, Clara; Betuela, Inoni; Siba, Peter; Mueller, Ivo; Rogerson, Stephen J.;

Affiliations

Inst Trop Med, B-2000 Antwerp, Belgium - Author
James Cook Univ, Fac Med Hlth & Mol Sci, Australian Inst Trop Hlth & Med, Townsville, Qld 4811, Australia - Author
Papua New Guinea Inst Med Res, Goroka 441, Eastern Highlan, Papua N Guinea - Author
Univ Barcelona, Hosp Clin Barcelona, Barcelona Ctr Int Hlth Res CRESIB, E-08036 Barcelona, Spain - Author
Univ Melbourne, Dept Med Biol, Parkville, Vic 3010, Australia - Author
Univ Melbourne, Royal Melbourne Hosp, Dept Med, Parkville, Vic 3050, Australia - Author
Walter & Eliza Hall Inst Med Res, Parkville, Vic 3052, Australia - Author
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Abstract

Background: Intermittent 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. Methods: From 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. Results: Of 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. Conclusions: SPAZ 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.

Keywords

combinationefficacymacrolidesmalariaoutcomespregnancypregnant-womenpreterm deliveryprotectionresistantsexually transmitted infectionstherapyAbdominal painAdultAlbendazoleAnemiaAntimalarial agentAntimalarialsArtemether plus benflumetolArticleAzithromycinBenzathine penicillinBirth weightBrain hematomaChemoprophylaxisChloroquineComparative studyComplicationCongenital disorderControlled studyDiarrheaDizzinessDrug combinationDrug combinationsDrug efficacyDrug induced headacheDrug safetyDyspepsiaEarly interventionFanasil, pyrimethamine drug combinationFemaleFolic acidFollow upGestational ageGonorrheaHigh risk infantHigh risk pregnancyHumansInfant, low birth weightInfant, newbornIntermittent preventive treatmentIronLow birth weightMalariaNewbornPapua new guineaPlaceboPlacenta malariaPlasmodium-falciparumPregnancyPregnancy complications, parasiticPregnancy outcomePregnant womanPremature laborPrematurityPreterm deliveryPrevalencePyrimethaminePyrimethamine plus sulfadoxineQuinineRandomized controlled trialRisk assessmentRisk factorRisk reductionSecond trimester pregnancySexually transmitted infectionsSingle blind procedureSingle-blind methodSkin pruritusSulfadoxineSwellingVomitingYoung adult

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal BMC Medicine due to its progression and the good impact it has achieved in recent years, according to the agency WoS (JCR), it has become a reference in its field. In the year of publication of the work, 2015, it was in position 8/155, thus managing to position itself as a Q1 (Primer Cuartil), in the category Medicine, General & Internal.

From a relative perspective, and based on the normalized impact indicator calculated from World Citations provided by WoS (ESI, Clarivate), it yields a value for the citation normalization relative to the expected citation rate of: 1.89. This indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: ESI Nov 14, 2024)

This information is reinforced by other indicators of the same type, which, although dynamic over time and dependent on the set of average global citations at the time of their calculation, consistently position the work at some point among the top 50% most cited in its field:

  • Weighted Average of Normalized Impact by the Scopus agency: 4.78 (source consulted: FECYT Feb 2024)
  • Field Citation Ratio (FCR) from Dimensions: 18.85 (source consulted: Dimensions Jul 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-07-16, the following number of citations:

  • WoS: 65
  • Scopus: 66
  • Europe PMC: 63

Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-07-16:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 240.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 255 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 5.
  • The number of mentions on the social network Facebook: 1 (Altmetric).
  • The number of mentions on the social network X (formerly Twitter): 4 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.

Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: Australia; Belgium; Guinea.