Evidence map›Paper›PMID 21176950›Full record

Trial reportLancet (London, England)2011

Effect of single-dose anthelmintic treatment during pregnancy on an infant's response to immunisation and on susceptibility to infectious diseases in infancy: a randomised, double-blind, placebo-controlled trial.

Emily L Webb, Patrice A Mawa, Juliet Ndibazza, Dennison Kizito, Alice Namatovu, Jacqueline Kyosiimire-Lugemwa, Bridget Nanteza, Margaret Nampijja, Lawrence Muhangi, Patrick W Woodburn and 15 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Lancet (London, England), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 74 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 4 pooled it
7.0field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 4 syntheses or guidelines pooled it, 118 citations in OpenAlex.

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  9. Effects of treating helminths during pregnancy and early childhood on risk of allergy-related outcomes: Follow-up of a randomized controlled trial.Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2017
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  20. A description of congenital anomalies among infants in Entebbe, Uganda.Birth defects research. Part A, Clinical and molecular teratology · 2011
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14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

25 authors at 4 institutions in 2 countries.

Emily L WebbLondon School of Hygiene and Tropical Medicine, London, UK. emily.webb@lshtm.ac.uk
Patrice A Mawa
Juliet Ndibazza
Dennison Kizito
Alice Namatovu
Jacqueline Kyosiimire-Lugemwa
Bridget Nanteza
Margaret Nampijja
Lawrence Muhangi
Patrick W Woodburn
Hellen Akurut
Harriet Mpairwe
Miriam Akello
Nancy Lyadda
Joseph Bukusuba
Macklyn Kihembo
Moses Kizza
Robert Kizindo
Juliet Nabulime
Christine Ameke
Proscovia B Namujju
Robert Tweyongyere
Moses Muwanga
James A G Whitworth
Alison M Elliott
Uganda Virus Research Institute · UGMinistry of Agriculture, Animal Industry and Fisheries · UGLondon School of Hygiene & Tropical Medicine · GBMakerere University · UG

Funding

TUBERCULOSIS RESEARCH MATERIALSN01AI025147 · NIAID · COLORADO STATE UNIVERSITY-FORT COLLINS · PI BRENNAN, PATRICK JOSEPH · 1992 to 1997
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Medical Research Council E743Medical Research Council G0700837NIAID NIH HHS N0I-AI-25147Wellcome Trust 064693Wellcome Trust 074791Wellcome Trust 079110
6 · The paper itself

Abstract

backgroundHelminth infections affect the human immune response. We investigated whether prenatal exposure to and treatment of maternal helminth infections affects development of an infant's immune response to immunisations and unrelated infections.

methodsIn this randomised, double-blind, placebo-controlled trial, we enrolled 2507 women in the second or third trimester of pregnancy who were planning to deliver in Entebbe General Hospital, Entebbe, Uganda. With a computer-generated random number sequence in blocks of 100, we assigned patients to 440 mg albendazole and 40 mg/kg praziquantel (n=628), 440 mg albendazole and a praziquantel-matching placebo (n=625), 40 mg/kg praziquantel and an albendazole-matching placebo (n=626), or an albendazole-matching placebo and praziquantel-matching placebo (n=628). All participants and hospital staff were masked to allocation. Primary outcomes were immune response at age 1 year to BCG, tetanus, and measles immunisation; incidence of infectious diseases during infancy; and vertical HIV transmission. Analysis was by intention-to-treat. This trial is registered, number ISRCTN32849447.

findingsData were available at delivery for 2356 women, with 2345 livebirths; 2115 (90%) of liveborn infants remained in follow-up at 1 year of age. Neither albendazole nor praziquantel treatments affected infant response to BCG, tetanus, or measles immunisation. However, in infants of mothers with hookworm infection, albendazole treatment reduced interleukin-5 (geometric mean ratio 0·50, 95% CI 0·30-0·81, interaction p=0·02) and interleukin-13 (0·52, 0·34-0·82, 0·0005) response to tetanus toxoid. The rate per 100 person-years of malaria was 40·9 (95% CI 38·3-43·7), of diarrhoea was 134·1 (129·2-139·2), and of pneumonia was 22·3 (20·4-24·4). We noted no effect on infectious disease incidence for albendazole treatment (malaria [hazard ratio 0·95, 95% CI 0·79-1.14], diarrhoea [1·06, 0·96-1·16], pneumonia [1·11, 0·90-1·38]) or praziquantel treatment (malaria [1·00, 0·84-1·20], diarrhoea [1·07, 0·98-1·18], pneumonia [1·00, 0·80-1·24]). In HIV-exposed infants, 39 (18%) were infected at 6 weeks; vertical transmission was not associated with albendazole (odds ratio 0·70, 95% CI 0·35-1·42) or praziquantel (0·60, 0·29-1·23) treatment.

interpretationThese results do not accord with the recently advocated policy of routine antenatal anthelmintic treatment, and the value of such a policy may need to be reviewed.

fundingWellcome Trust.

Indexed as

AdultAlbendazoleAnthelminticsCommunicable DiseasesDose-Response Relationship, DrugDouble-Blind MethodFemaleHIV InfectionsHumansInfantInfectious Disease Transmission, VerticalPraziquantelPregnancyPregnancy Complications, ParasiticPrenatal Exposure Delayed EffectsVaccinationAlbendazoleAnthelminticsPraziquantel

Identifiers

PMID21176950
PMCPMC3018567
OpenAlexW2003533521

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.