NCT01748929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,010

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
1.2 years until next milestone

Study Start

First participant enrolled

February 24, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2016

Completed
Last Updated

August 29, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

December 7, 2012

Last Update Submit

August 28, 2017

Conditions

Intestinal Diseases, Parasitic

Keywords

Global HealthDewormingPostpartumSoil-Transmitted HelminthsPregnant Women

Outcome Measures

Primary Outcomes (1)

  • Mean (± standard deviation) weight gain (kg)

    Change between birth and six months of age

Secondary Outcomes (7)

  • Infant morbidity

    1, 6, 12, 24 months following birth

  • Maternal hemoglobin levels and anemia

    1, 6, 12, 24 months following birth

  • Breastfeeding practices

    1, 6, 12, 24 months following birth

  • Maternal energy levels

    1, 6, 12, 24 months following birth

  • Maternal STH infection

    1 and 6 months following birth

  • +2 more secondary outcomes

Study Arms (2)

Albendazole

EXPERIMENTAL

single dose 400 mg tablet of albendazole

Drug: Albendazole

Placebo

PLACEBO COMPARATOR

Placebo Manufactured by Hersil Laboratories in Lima, Peru

Drug: Placebo

Interventions

AlbendazoleDRUG
Albendazole
PlaceboDRUG
Placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Deliver at Hospital Iquitos
  • Plan to reside in Iquitos or neighbouring area for the next 24 months
  • Able to communicate in Spanish

You may not qualify if:

  • Deliver multiples
  • Delivery a stillborn or an infant with a serious congenital medical condition
  • Transfered to another hospital prior to discharge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociación Civil Selva Amazónica

Iquitos, Peru

Location

Related Publications (2)

  • 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.

    PMID: 28056024DERIVED

  • 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.

    PMID: 26084556DERIVED

MeSH Terms

Conditions

Intestinal Diseases, Parasitic

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Parasitic DiseasesInfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 7, 2012

First Posted

December 13, 2012

Study Start

February 24, 2014

Primary Completion

February 13, 2015

Study Completion

September 16, 2016

Last Updated

August 29, 2017

Record last verified: 2017-08

Locations

PE(1)