Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

Intestinal Diseases, Parasitic Clinical Trial

Official title:

Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748929
• Other study ID #: 12-198-GEN
• 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
• 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

Related Conditions & MeSH terms

• Intestinal Diseases
• Intestinal Diseases, Parasitic
• Parasitic Diseases

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