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Maternal Deworming Research Study (MADRES) protocol: a double-blind, placebo-controlled randomised trial to determine the effectiveness of deworming in the immediate postpartum period
  1. Layla S Mofid1,
  2. Martín Casapía3,
  3. Antonio Montresor4,
  4. Elham Rahme2,
  5. William D Fraser5,
  6. Grace S Marquis6,
  7. Jozef Vercruysse7,
  8. Lindsay H Allen8,
  9. Theresa W Gyorkos1,2
  1. 1Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montréal, Québec, Canada
  2. 2Research Institute of the McGill University Health Centre, Division of Clinical Epidemiology, Montréal, Québec, Canada
  3. 3Asociación Civil Selva Amazónica, Iquitos, Peru
  4. 4Department of Control of Neglected Tropical Diseases, World Health Organization, Geneva, Switzerland
  5. 5Département d'obstétrique et de gynécologie, Université de Sherbrooke, Sherbrooke, Québec, Canada
  6. 6School of Dietetics and Human Nutrition, McGill University, Ste. Anne-de-Bellevue, Québec, Canada
  7. 7Department of Virology, Parasitology and Immunology, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium
  8. 8USDA, ARS Western Human Nutrition Research Center, University of California, Davis, California, USA
  1. Correspondence to Dr Theresa W Gyorkos; theresa.gyorkos{at}mcgill.ca

Abstract

Introduction 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 and analysis 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.

Ethics and dissemination 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.

Trial registration number Clinicaltrials.gov: NCT01748929.

  • albendazole
  • helminthiasis
  • PARASITOLOGY
  • postpartum
  • randomised controlled trials
  • intervention study

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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