title: Maternal Deworming Research Study (MADRES) protocol: a double-blind, placebo-controlled randomised trial to determine the effectiveness of deworming in the immediate postpartum period.
abstract: BACKGROUND
  Soil-transmitted helminth infections are endemic in 114 countries worldwide, and cause the highest burden of disease among all neglected tropical diseases. The WHO includes women of reproductive age as a high-risk group for infection. The primary consequence of infection in this population is anaemia. During lactation, anaemia may contribute to reduced quality and quantity of milk, decreasing the duration of exclusive breastfeeding and lowering the age at weaning. To date, no study has investigated the effects of maternal postpartum deworming on infant or maternal health outcomes.
  
  
  METHODS
  A single-centre, parallel, double-blind, randomised, placebo-controlled trial will be carried out in Iquitos, Peru, to assess the effectiveness of integrating single-dose 400 mg albendazole into routine maternal postpartum care. A total of 1010 mother-infant pairs will be randomised to either the intervention or control arm, following inhospital delivery and prior to discharge. Participants will be visited in their homes at 1, 6, 12 and 24 months following delivery for outcome ascertainment. The primary outcome is infant mean weight gain between birth and 6 months of age. Secondary outcomes include other infant growth indicators and morbidity, maternal soil-transmitted helminth infection and intensity, anaemia, fatigue, and breastfeeding practices. All statistical analyses will be performed on an intention-to-treat basis.
  
  
  BACKGROUND
  Research ethics board approval has been obtained from the McGill University Health Centre (Canada), the Asociación Civil Impacta Salud y Educación (Peru) and the Instituto Nacional de Salud (Peru). A data safety and monitoring committee is in place to oversee study progression and evaluate adverse events. The results of the analyses will be published in peer-reviewed journals, and presented at national and international conferences.
  
  
  BACKGROUND
  Clinicaltrials.gov: NCT01748929.
authors.affiliation: Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada.
authors.forename: Layla S
authors.identifier: http://orcid.org/0000-0003-2970-6085
authors.initials: LS
authors.lastname: Mofid
authors.affiliation: Asociación Civil Selva Amazónica, Iquitos, Peru.
authors.forename: Martín
authors.initials: M
authors.lastname: Casapía
authors.affiliation: Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland.
authors.forename: Antonio
authors.initials: A
authors.lastname: Montresor
authors.affiliation: Research Institute of the McGill University Health Centre, Division of Clinical Epidemiology, Montréal, Québec, Canada.
authors.forename: Elham
authors.initials: E
authors.lastname: Rahme
authors.affiliation: Département d'obstétrique et de gynécologie, Université de Sherbrooke, Sherbrooke, Québec, Canada.
authors.forename: William D
authors.initials: WD
authors.lastname: Fraser
authors.affiliation: School of Dietetics and Human Nutrition, McGill University, Ste. Anne-de-Bellevue, Québec, Canada.
authors.forename: Grace S
authors.initials: GS
authors.lastname: Marquis
authors.affiliation: Department of Virology, Parasitology and Immunology, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium.
authors.forename: Jozef
authors.initials: J
authors.lastname: Vercruysse
authors.affiliation: USDA, ARS Western Human Nutrition Research Center, University of California, Davis, California, USA.
authors.forename: Lindsay H
authors.initials: LH
authors.lastname: Allen
authors.affiliation: Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada Research Institute of the McGill University Health Centre, Division of Clinical Epidemiology, Montréal, Québec, Canada.
authors.forename: Theresa W
authors.initials: TW
authors.lastname: Gyorkos
mesh_terms: D000328:Adult; D015766:Albendazole / Q000008:administration & dosage*; D000871:Anthelmintics / Q000008:administration & dosage*; D001942:Breast Feeding; D003362:Cost-Benefit Analysis; D004311:Double-Blind Method; D005260:Female; D006373:Helminthiasis / Q000150:complications / Q000188:drug therapy / Q000517:prevention & control*; D006801:Humans; D007223:Infant; D007228:Infant Nutrition Disorders / Q000517:prevention & control*; D007227:Infant Nutritional Physiological Phenomena; D007231:Infant, Newborn; D007774:Lactation; D008297:Male; D039382:Maternal Nutritional Physiological Phenomena; D009035:Mothers; D010568:Peru / Q000453:epidemiology; D049590:Postpartum Period; D011247:Pregnancy; D012987:Soil / Q000469:parasitology; D016896:Treatment Outcome
chemical_list: D000871:Anthelmintics; D012987:Soil; D015766:Albendazole
keywords: PARASITOLOGY; albendazole; helminthiasis; intervention study; postpartum; randomised controlled trials