Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
Primary Purpose
Intestinal Diseases, Parasitic
Status
Completed
Phase
Phase 4
Locations
Peru
Study Type
Interventional
Intervention
Albendazole
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Intestinal Diseases, Parasitic focused on measuring Global Health, Deworming, Postpartum, Soil-Transmitted Helminths, Pregnant Women
Eligibility 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
Sites / Locations
- Asociación Civil Selva Amazónica
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Albendazole
Placebo
Arm Description
single dose 400 mg tablet of albendazole
Placebo Manufactured by Hersil Laboratories in Lima, Peru
Outcomes
Primary Outcome Measures
Mean (± standard deviation) weight gain (kg)
Secondary Outcome Measures
Infant morbidity
Maternal hemoglobin levels and anemia
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.
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.
Maternal STH infection
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.
Breast milk quantity transferred from mother to infant
Full Information
NCT ID
NCT01748929
First Posted
December 7, 2012
Last Updated
August 28, 2017
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT01748929
Brief Title
Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
Official Title
Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 24, 2014 (Actual)
Primary Completion Date
February 13, 2015 (Actual)
Study Completion Date
September 16, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Diseases, Parasitic
Keywords
Global Health, Deworming, Postpartum, Soil-Transmitted Helminths, Pregnant Women
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1010 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Albendazole
Arm Type
Experimental
Arm Description
single dose 400 mg tablet of albendazole
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Manufactured by Hersil Laboratories in Lima, Peru
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean (± standard deviation) weight gain (kg)
Time Frame
Change between birth and six months of age
Secondary Outcome Measure Information:
Title
Infant morbidity
Time Frame
1, 6, 12, 24 months following birth
Title
Maternal hemoglobin levels and anemia
Time Frame
1, 6, 12, 24 months following birth
Title
Breastfeeding practices
Description
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.
Time Frame
1, 6, 12, 24 months following birth
Title
Maternal energy levels
Description
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.
Time Frame
1, 6, 12, 24 months following birth
Title
Maternal STH infection
Time Frame
1 and 6 months following birth
Title
Breast milk quality
Description
Mean concentrations of key breast milk quality indicators (i.e. macronutrients, immunological factors, vitamins, and minerals) will be used to assess breast milk quality.
Time Frame
1 and 6 months following birth
Title
Breast milk quantity transferred from mother to infant
Time Frame
1 and 6 months following birth
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa W Gyorkos, PhD
Organizational Affiliation
McGill University Health Centre/Research Institute of the McGill University Health Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Casapia, MD, MPH
Organizational Affiliation
Asociación Civil Selva Amazónica
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociación Civil Selva Amazónica
City
Iquitos
Country
Peru
12. IPD Sharing Statement
Citations:
PubMed Identifier
28056024
Citation
Mofid LS, Casapia M, Aguilar E, Silva H, Montresor A, Rahme E, Fraser WD, Marquis GS, Vercruysse J, Allen LH, Blouin B, Razuri H, Pezo L, Gyorkos TW. A Double-Blind Randomized Controlled Trial of Maternal Postpartum Deworming to Improve Infant Weight Gain in the Peruvian Amazon. PLoS Negl Trop Dis. 2017 Jan 5;11(1):e0005098. doi: 10.1371/journal.pntd.0005098. eCollection 2017 Jan.
Results Reference
derived
PubMed Identifier
26084556
Citation
Mofid LS, Casapia M, Montresor A, Rahme E, Fraser WD, Marquis GS, Vercruysse J, Allen LH, Gyorkos TW. Maternal Deworming Research Study (MADRES) protocol: a double-blind, placebo-controlled randomised trial to determine the effectiveness of deworming in the immediate postpartum period. BMJ Open. 2015 Jun 17;5(6):e008560. doi: 10.1136/bmjopen-2015-008560.
Results Reference
derived
Learn more about this trial
Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
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