Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

• ClinicalTrials.gov Identifier: NCT01748929
• Recruitment Status: Completed
• First Posted: December 13, 2012
• Last Update Posted: August 29, 2017
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Information provided by (Responsible Party): Dr. Theresa Gyorkos, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information

• First Submitted Date: December 7, 2012
• First Posted Date: December 13, 2012
• Last Update Posted Date: August 29, 2017
• Actual Study Start Date: February 24, 2014
• Actual Primary Completion Date: February 13, 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 11, 2012): Mean (± standard deviation) weight gain (kg) [ Time Frame: Change between birth and six months of age ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 11, 2012)

• 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 ]
  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 [ Time Frame: 1, 6, 12, 24 months following birth ]
  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 [ Time Frame: 1 and 6 months following birth ]
• Breast milk quality [ Time Frame: 1 and 6 months following birth ]
  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 [ Time Frame: 1 and 6 months following birth ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
• Official Title: Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Intestinal Diseases, Parasitic

Intervention

• Drug: Albendazole
• Drug: Placebo

Study Arms

• Experimental: Albendazole
  single dose 400 mg tablet of albendazole
  Intervention: Drug: Albendazole
• Placebo Comparator: Placebo
  Placebo Manufactured by Hersil Laboratories in Lima, Peru
  Intervention: Drug: Placebo

Publications *

• Mofid LS, Casapía 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, Casapía 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 11, 2012): 1010
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 16, 2016
• Actual Primary Completion Date: February 13, 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Peru

Administrative Information

• NCT Number: NCT01748929
• Other Study ID Numbers: 12-198-GEN
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Theresa Gyorkos, McGill University Health Centre/Research Institute of the McGill University Health Centre
• Study Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Not Provided

Investigators

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

• PRS Account: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Verification Date: August 2017