Author
MOFID, LAYLA - McGill University - Canada | |
CASAPIA, MARTIN - Asociacion Civil Selva Amazonica | |
MONTRESOR, ANTONIO - World Health Organization (WHO) - Switzerland | |
RAHME, ELHAM - McGill University - Canada | |
FRASER, WILLIAM - Universite De Sherbrooke | |
MARQUIS, GRACE - McGill University - Canada | |
VERCRUYSSE, JOZEF - Ghent University | |
Allen, Lindsay - A | |
GYORKOS, THERESA - McGill University - Canada |
Submitted to: BMJ Open
Publication Type: Peer Reviewed Journal Publication Acceptance Date: 5/12/2015 Publication Date: 8/6/2016 Citation: Mofid, L.S., Casapia, M., Montresor, A., Rahme, E., Fraser, W.D., Marquis, G.S., Vercruysse, J., Allen, L.H., Gyorkos, T.W. 2016. 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. doi:10.1136/bmjopen-2015-008560. Interpretive Summary: Soil-transmitted helminth (STH) infections are caused by different species of parasitic worms and are among the most commonly neglected tropical diseases (NTDs) throughout the developing countries. Adult worms live in the intestine and are transmitted by eggs present in feces that comtaminates the soil where sanitation is poor. Worlwide about 2 billion people are infected and can affect children's physical, nutritional and cognitive development and present anemia in mothers. The MADRES project 9Maternal Deworming Research Study) is a single center study of over 1,000 mother-infant pairs to evaluate the effective of de-worming women post-partum on infant weight gain from birth to 6 months and anemia, fatigue and breastfeeding practices of the mothers. The sudy will be conducted in peru and results will be disseminated at health centers and hospitals. 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 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. |