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Title:   Author  item
                                            MOFID, LAYLA - McGill University - Canadaitem
                                            CASAPIA, MARTIN - McGill University - Canadaitem
                                            MONTRESOR, ANTONIO - Asociacion Civil Selva Amazonicaitem
                                            RAHME, ELHAM - World Health Organization (WHO) - Switzerlanditem
                                            FRASER, WILLIAM - Universite De Sherbrookeitem
                                            MARQUIS, GRACE - McGill University - Canadaitem
                                            VERCRUYSSE, JOZEF - Ghent Universityitem
                                            Allen, Lindsay

                                                         - *A*item
                                            GYORKOS, THERESA - McGill University - Canada
  Submitted to: BMJ Open
                                    Publication Type: Peer Reviewed Journal
                                    Publication Acceptance Date: 5/12/2015
                                    Publication  Date: 6/17/2015
                                    Citation: Mofid, L.S., Casapia, M., Montresor, A., Rahme, E., Fraser, W.D., Marquis, G.S., Vercruysse, J., Allen, L.H., Gyorkos, T.W. 2015. Maternal Deworming Research Study (MADRES) protocol: a double-blind, placebo-controlled randomised trial to determine the effectiveness of deworming in the immediate postpartum period. BMJ Open. 5:e008560.  DOI: 10.1136/bmjopen-2015-008560.Interpretive Summary: This article describes the protocol that is being used to study the effect of deworming on maternal and infant health. Soil-transmitted helminth infections are common in 114 countries and cause more disease than any other of the neglected tropical diseases. The World Health Organization considers women of reproductive age to be at particularly high risk of these infections, the primary consequence of which is anemia. During lactation this anemia may lead to reduced quantity and quality of breast milk, so that infants are exclusively breastfed for a shorter time and weaned at a younger age. There have been no previous studies of the effect of providing deworming treatment to postpartum women on maternal or infant health. The approach in this study, in Iquitos, Peru, is to randomize 1010 mother-infant pairs to treatment with a single 400 mg dose of albendazole or a placebo while in hospital after delivery, testing its effect as part of routine postpartum care. Participants will be visited in their homes at 1, 6, 12 and 24 months following delivery to determine the effects of treatment on outcomes. 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, anemia, fatigue, and breastfeeding practices. All statistical analyses will be performed on an intention-to-treat basis.
                                Technical 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 in hospital 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. Trial registration number: Clinicaltrials.gov: NCT01748929.


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