Clinical Trial: Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

Brief Summary: 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.

Detailed Summary:
Sponsor: McGill University Health Center

Current Primary Outcome: Mean (± standard deviation) weight gain (kg) [ Time Frame: Change between birth and six months of age ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Infant morbidity [ Time Frame: 1, 6, 12, 24 months following birth ]
  • Maternal hemoglobin levels and anemia [ Time Frame: 1, 6, 12, 24 months following birth ]
  • Breastfeeding practices [ Time Frame: 1, 6, 12, 24 months following birth ]
    The prevalence of current, exclusive, predominant and partial breastfeeding will be used to assess breastfeeding practices. In accordance with WHO criteria, infants will be considered as exclusively breastfed if they ingest only breast milk (excluding vitamins and medications); considered as predominantly breastfed if, in addition to breast milk, they also ingest water, juice, teas, vitamins or medications, and considered as partially breastfed if their primary nutrition source is other than breast milk.
  • Maternal energy levels [ Time Frame: 1, 6, 12, 24 months following birth ]
    Maternal energy levels will be measured using an adapted 5-item version of the Fatigue Assessment Scale (FAS) (Michielsen et al. 2004). This scale assesses symptoms of physical and cognitive fatigue.
  • Maternal STH infection [ Time Frame: 1 and 6 months following birth ]
  • Breast milk quality [ Time Frame: 1 and 6 months following birth ]
    Mean concentrations of key breast milk quality indicators (i.e. macronutrients, immunological factors, vitamins, and minerals) will be used to assess breast milk quality.
  • Breast milk quantity transferred from mother to infant [ Time Frame: 1 and 6 months following birth ]


Original Secondary Outcome: Same as current

Information By: McGill University Health Center

Dates:
Date Received: December 7, 2012
Date Started: February 2014
Date Completion: September 2016
Last Updated: March 29, 2016
Last Verified: March 2016