Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

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.

Study Overview

• Status: Completed
• Conditions: Intestinal Diseases, Parasitic
• Intervention / Treatment: Drug: Placebo; Drug: Albendazole

• Study Type: Interventional
• Enrollment (Actual): 1010
• Phase: Phase 4

Contacts and Locations

Study Locations

• Peru
  • Iquitos, Peru
    • Asociacion Civil Selva Amazonica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Albendazole; single dose 400 mg tablet of albendazole	Drug: Albendazole
Placebo Comparator: Placebo; Placebo Manufactured by Hersil Laboratories in Lima, Peru	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean (± standard deviation) weight gain (kg)	Change between birth and six months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant morbidity		1, 6, 12, 24 months following birth
Maternal hemoglobin levels and anemia		1, 6, 12, 24 months following birth
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
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
Maternal STH infection		1 and 6 months following birth
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
Breast milk quantity transferred from mother to infant		1 and 6 months following birth

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Martin Casapia, MD, MPH, Asociacion Civil Selva Amazonica; Principal Investigator: Theresa W Gyorkos, PhD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2014
• Primary Completion (Actual): February 13, 2015
• Study Completion (Actual): September 16, 2016

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Actual): August 29, 2017
• Last Update Submitted That Met QC Criteria: August 28, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Postpartum; Global Health; Pregnant Women; Deworming; Soil-Transmitted Helminths
• Additional Relevant MeSH Terms: Digestive System Diseases; Infections; Gastrointestinal Diseases; Intestinal Diseases; Parasitic Diseases; Intestinal Diseases, Parasitic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antiprotozoal Agents; Antiparasitic Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Albendazole
• Other Study ID Numbers: 12-198-GEN