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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01748929
Other study ID # 12-198-GEN
Secondary ID
Status Completed
Phase Phase 4
First received December 7, 2012
Last updated August 28, 2017
Start date February 24, 2014
Est. completion date September 16, 2016

Study information

Verified date August 2017
Source McGill University Health Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1010
Est. completion date September 16, 2016
Est. primary completion date February 13, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Intervention

Drug:
Albendazole

Placebo


Locations

Country Name City State
Peru Asociación Civil Selva Amazónica Iquitos

Sponsors (1)

Lead Sponsor Collaborator
McGill University Health Center

Country where clinical trial is conducted

Peru, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean (± standard deviation) weight gain (kg) Change between birth and six months of age
Secondary Infant morbidity 1, 6, 12, 24 months following birth
Secondary Maternal hemoglobin levels and anemia 1, 6, 12, 24 months following birth
Secondary 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. 1, 6, 12, 24 months following birth
Secondary 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. 1, 6, 12, 24 months following birth
Secondary Maternal STH infection 1 and 6 months following birth
Secondary 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. 1 and 6 months following birth
Secondary Breast milk quantity transferred from mother to infant 1 and 6 months following birth
See also
  Status Clinical Trial Phase
Completed NCT01314937 - The Effect of a Deworming Intervention to Improve Early Childhood Growth and Development in Resource-poor Areas Phase 4