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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albendazole | Experimental | single dose 400 mg tablet of albendazole |
|
| Placebo | Placebo Comparator | Placebo Manufactured by Hersil Laboratories in Lima, Peru |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albendazole | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean (± standard deviation) weight gain (kg) | Change between birth and six months of age |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asociación Civil Selva Amazónica | Iquitos | Peru |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28056024 | Derived | 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. | |
| 26084556 |
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| ID | Term |
|---|---|
| D007411 | Intestinal Diseases, Parasitic |
| ID | Term |
|---|---|
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D015766 | Albendazole |
| ID | Term |
|---|---|
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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 |
| Derived |
| 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. |
| D004066 |
| Digestive System Diseases |
| D001562 |
| Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |