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OpenTrials
Completed

NCT Number: NCT01748929

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.

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Key information

Conditions

Intestinal Diseases, Parasitic Digestive System Diseases Gastrointestinal Diseases Infections Intestinal Diseases Parasitic Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Asociación Civil Selva Amazónica

Iquitos, Peru

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albendazole

Drug

Placebo

Drug

Primary outcomes

  1. Mean (± standard deviation) weight gain (kg)

    Time frame: Change between birth and six months of age

Secondary outcomes

  1. Infant morbidity

    Time frame: 1, 6, 12, 24 months following birth

  2. Maternal hemoglobin levels and anemia

    Time frame: 1, 6, 12, 24 months following birth

  3. 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.

  4. 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.

  5. Maternal STH infection

    Time frame: 1 and 6 months following birth

  6. 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.

  7. Breast milk quantity transferred from mother to infant

    Time frame: 1 and 6 months following birth

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 13, 2012
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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