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NCT01748929

Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

Completed Phase 4 Last updated 29 August 2017
What this trial tests

Phase 4 trial testing Albendazole in Intestinal Diseases, Parasitic in 1,010 participants. Completed in 16 September 2016.

Timeline
24 February 2014
Primary endpoint
13 February 2015
16 September 2016

Quick facts

Lead sponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment1,010
Start date24 February 2014
Primary completion13 February 2015
Estimated completion16 September 2016
Sites1 location across Peru

Drugs / interventions tested

Conditions studied

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Who can join

Eligibility, female only, with Intestinal Diseases, Parasitic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Double-Blind Randomized Controlled Trial of Maternal Postpartum Deworming to Improve Infant Weight Gain in the Peruvian Amazon.
    Mofid LS, Casapía M, Aguilar E, Silva H, et al · · 2017 · cited 13× · PMID 28056024 · DOI 10.1371/journal.pntd.0005098
  2. Interventions to improve linear growth during exclusive breastfeeding life-stage for children aged 0-6 months living in low- and middle-income countries: a systematic review with network and pairwise meta-analyses.
    Park JJH, Siden E, Harari O, Dron L, et al · · 2019 · cited 11× · PMID 33062941 · DOI 10.12688/gatesopenres.13082.2
  3. Maternal Deworming Research Study (MADRES) protocol: a double-blind, placebo-controlled randomised trial to determine the effectiveness of deworming in the immediate postpartum period.
    Mofid LS, Casapía M, Montresor A, Rahme E, et al · · 2015 · cited 7× · PMID 26084556 · DOI 10.1136/bmjopen-2015-008560
  4. Maternal postpartum deworming and infant milk intake: Secondary outcomes from a trial.
    Mofid LS, Casapía M, Montresor A, Rahme E, et al · · 2021 · cited 5× · PMID 33729674 · DOI 10.1111/mcn.13183

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