NCT01748929|CompletedPhase 4DMC
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Sponsor study identifier
interventional
1,010
1 country
1
Study Start
February 24, 2014
Actual (reported)Primary Completion
February 13, 2015
Actual (reported)Study Completion
September 16, 2016
Actual (reported)Women of reproductive age are considered a high-risk group for worm infections by the World Health Organization. Maternal infection and anemia contribute to infant malnutrition by affecting milk quality and quantity, and duration of exclusive breastfeeding. To date, no study has investigated the health benefits of postpartum deworming to infants or mothers. A randomized controlled trial will be conducted in Peru to investigate the effectiveness of integrating deworming into routine postpartum care. The primary measure of effect will be infant weight gain between birth and six months of age. Other infant and maternal health indicators will also be ascertained.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 16, 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 7, 2012
Actual (reported)December 13, 2012
Actual (reported)February 24, 2014
Actual (reported)February 13, 2015
Actual (reported)September 16, 2016
Actual (reported)Mean (± standard deviation) weight gain (kg)
Change between birth and six months of age
Infant morbidity
1, 6, 12, 24 months following birth
Maternal hemoglobin levels and anemia
1, 6, 12, 24 months following birth
Breastfeeding practices
1, 6, 12, 24 months following birth
Maternal energy levels
1, 6, 12, 24 months following birth
Maternal STH infection
1 and 6 months following birth
single dose 400 mg tablet of albendazole
Placebo Manufactured by Hersil Laboratories in Lima, Peru
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Asociación Civil Selva Amazónica
Iquitos, Peru
Mofid LS, Casapia M, Aguilar E, Silva H, Montresor A, Rahme E, Fraser WD, Marquis GS, Vercruysse J, Allen LH, Blouin B, Razuri H, Pezo L, Gyorkos TW. A Double-Blind Randomized Controlled Trial of Maternal Postpartum Deworming to Improve Infant Weight Gain in the Peruvian Amazon. PLoS Negl Trop Dis. 2017 Jan 5;11(1):e0005098. doi: 10.1371/journal.pntd.0005098. eCollection 2017 Jan.
Mofid LS, Casapia M, Montresor A, Rahme E, Fraser WD, Marquis GS, Vercruysse J, Allen LH, Gyorkos TW. 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. 2015 Jun 17;5(6):e008560. doi: 10.1136/bmjopen-2015-008560.
Theresa W Gyorkos, PhD
McGill University Health Centre/Research Institute of the McGill University Health Centre
Martin Casapia, MD, MPH
Asociación Civil Selva Amazónica
1,010 participants (actual enrollment reported by the registry).
First Submitted
December 7, 2012
First Posted
December 13, 2012
Study Start
February 24, 2014
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 13, 2015
Actual (reported)Study Completion
September 16, 2016
Actual (reported)Last Updated
August 29, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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