Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

Study Overview
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Brief Summary
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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.

Official Title
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Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

Conditions
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Intestinal Diseases, Parasitic

Intervention / Treatment
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* Drug: Albendazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Deliver at Hospital Iquitos Plan to reside in Iquitos or neighbouring area for the next 24 months Able to communicate in Spanish Exclusion Criteria: Deliver multiples Delivery a stillborn or an infant with a serious congenital medical condition Transfered to another hospital prior to discharge
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albendazole<br>single dose 400 mg tablet of albendazole | Drug: Albendazole<br> <br> |
| Placebo Comparator: Placebo<br>Placebo Manufactured by Hersil Laboratories in Lima, Peru | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean (± standard deviation) weight gain (kg) |  | Change between birth and six months of age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant morbidity |  | 1, 6, 12, 24 months following birth | 
| Maternal hemoglobin levels and anemia |  | 1, 6, 12, 24 months following birth | 
| Breastfeeding practices | 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. | 1, 6, 12, 24 months following birth | 
| Maternal energy levels | 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. | 1, 6, 12, 24 months following birth | 
| Maternal STH infection |  | 1 and 6 months following birth | 
| Breast milk quality | Mean concentrations of key breast milk quality indicators (i.e. macronutrients, immunological factors, vitamins, and minerals) will be used to assess breast milk quality. | 1 and 6 months following birth | 
| Breast milk quantity transferred from mother to infant |  | 1 and 6 months following birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Global Health, Deworming, Postpartum, Soil-Transmitted Helminths, Pregnant Women