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Trial record 53 of 1426 for:    Peru

Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 7, 2012
First Posted Date  ICMJE December 13, 2012
Last Update Posted Date August 29, 2017
Actual Study Start Date  ICMJE February 24, 2014
Actual Primary Completion Date February 13, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Mean (± standard deviation) weight gain (kg) [ Time Frame: Change between birth and six months of age ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • Infant morbidity [ Time Frame: 1, 6, 12, 24 months following birth ]
  • Maternal hemoglobin levels and anemia [ Time Frame: 1, 6, 12, 24 months following birth ]
  • 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.
  • 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.
  • Maternal STH infection [ Time Frame: 1 and 6 months following birth ]
  • 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.
  • Breast milk quantity transferred from mother to infant [ Time Frame: 1 and 6 months following birth ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
Official Title  ICMJE Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Intestinal Diseases, Parasitic
Intervention  ICMJE
  • Drug: Albendazole
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Albendazole
    single dose 400 mg tablet of albendazole
    Intervention: Drug: Albendazole
  • Placebo Comparator: Placebo
    Placebo Manufactured by Hersil Laboratories in Lima, Peru
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2012)
1010
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 16, 2016
Actual Primary Completion Date February 13, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Peru
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01748929
Other Study ID Numbers  ICMJE 12-198-GEN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Theresa Gyorkos, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor  ICMJE McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP