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Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

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ClinicalTrials.gov Identifier: NCT01748929
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Theresa Gyorkos, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intestinal Diseases, Parasitic Drug: Albendazole Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1010 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
Actual Study Start Date : February 24, 2014
Actual Primary Completion Date : February 13, 2015
Actual Study Completion Date : September 16, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
Drug Information available for: Albendazole

Arms and Interventions
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Arm Intervention/treatment
Experimental: Albendazole
single dose 400 mg tablet of albendazole
 Drug: Albendazole
Placebo Comparator: Placebo
Placebo Manufactured by Hersil Laboratories in Lima, Peru
 Drug: Placebo


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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748929


Locations
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Peru
Asociación Civil Selva Amazónica
Iquitos, Peru
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Theresa W Gyorkos, PhD McGill University Health Centre/Research Institute of the McGill University Health Centre
Principal Investigator: Martin Casapia, MD, MPH Asociación Civil Selva Amazónica
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Theresa Gyorkos, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT01748929    
Other Study ID Numbers: 12-198-GEN
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Keywords provided by Dr. Theresa Gyorkos, McGill University Health Centre/Research Institute of the McGill University Health Centre:
Global Health
Deworming
Postpartum
Soil-Transmitted Helminths
Pregnant Women
Additional relevant MeSH terms:
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Parasitic Diseases
Intestinal Diseases, Parasitic
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Infections
Albendazole
Anthelmintics
Antiparasitic Agents
 Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents