Overview

This trial is active, not recruiting.

Condition intestinal diseases, parasitic
Treatments albendazole, placebo
Phase phase 4
Sponsor McGill University Health Center
Start date February 2014
End date February 2015
Trial size 1010 participants
Trial identifier NCT01748929, 12-198-GEN

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
single dose 400 mg tablet of albendazole
albendazole
(Placebo Comparator)
Placebo Manufactured by Hersil Laboratories in Lima, Peru
placebo

Primary Outcomes

Measure
Mean (± standard deviation) weight gain (kg)
time frame: Change between birth and six months of age

Secondary Outcomes

Measure
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
Maternal energy levels
time frame: 1, 6, 12, 24 months following birth
Maternal STH infection
time frame: 1 and 6 months following birth
Breast milk quality
time frame: 1 and 6 months following birth
Breast milk quantity transferred from mother to infant
time frame: 1 and 6 months following birth

Eligibility Criteria

Female participants of any age.

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

Additional Information

Official title Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
Principal investigator Theresa W Gyorkos, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by McGill University Health Center.