Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth|
- Mean (± standard deviation) weight gain (kg) [ Time Frame: Change between birth and six months of age ] [ Designated as safety issue: No ]
- Infant morbidity [ Time Frame: 1, 6, 12, 24 months following birth ] [ Designated as safety issue: No ]
- Maternal hemoglobin levels and anemia [ Time Frame: 1, 6, 12, 24 months following birth ] [ Designated as safety issue: No ]
- Breastfeeding practices [ Time Frame: 1, 6, 12, 24 months following birth ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Breast milk quality [ Time Frame: 1 and 6 months following birth ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||September 2016|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
single dose 400 mg tablet of albendazole
|Placebo Comparator: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748929
|Asociación Civil Selva Amazónica|
|Principal Investigator:||Theresa W Gyorkos, PhD||McGill University Health Center|
|Principal Investigator:||Martin Casapia, MD, MPH||Asociación Civil Selva Amazónica|