Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Theresa Gyorkos, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01748929
First received: December 7, 2012
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Intestinal Diseases, Parasitic
Drug: Albendazole
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Mean (± standard deviation) weight gain (kg) [ Time Frame: Change between birth and six months of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1010
Study Start Date: February 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Albendazole
single dose 400 mg tablet of albendazole
Drug: Albendazole
Placebo Comparator: Placebo

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748929

Locations
Peru
Asociación Civil Selva Amazónica
Iquitos, Peru
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Theresa W Gyorkos, PhD McGill University Health Center
Principal Investigator: Martin Casapia, MD, MPH Asociación Civil Selva Amazónica
  More Information

No publications provided

Responsible Party: Dr. Theresa Gyorkos, Principal Investigator, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01748929     History of Changes
Other Study ID Numbers: 12-198-GEN
Study First Received: December 7, 2012
Last Updated: August 25, 2014
Health Authority: Canada: Ethics Review Committee
Peru: Ethics Committee
Peru: Instituto Nacional de Salud

Additional relevant MeSH terms:
Intestinal Diseases
Intestinal Diseases, Parasitic
Parasitic Diseases
Gastrointestinal Diseases
Digestive System Diseases
Albendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 27, 2014