Clinical trial NCT01748929: Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
Official title: Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intestinal Diseases, Parasitic
Keywords: Global Health
Deworming
Postpartum
Soil-Transmitted Helminths
Pregnant Women
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2012-12-13
Enrollment: 1010
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Mean (± standard deviation) weight gain (kg)
timeFrame: Change between birth and six months of age
Secondary outcomes:
measure: Infant morbidity
timeFrame: 1, 6, 12, 24 months following birth
measure: Maternal hemoglobin levels and anemia
timeFrame: 1, 6, 12, 24 months following birth
measure: Breastfeeding practices
timeFrame: 1, 6, 12, 24 months following birth
measure: Maternal energy levels
timeFrame: 1, 6, 12, 24 months following birth
measure: Maternal STH infection
timeFrame: 1 and 6 months following birth
measure: Breast milk quality
timeFrame: 1 and 6 months following birth
measure: Breast milk quantity transferred from mother to infant
timeFrame: 1 and 6 months following birth
Other outcomes:
Locations:
city: Iquitos
country: Peru
facility: Asociación Civil Selva Amazónica
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Theresa W Gyorkos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociación Civil Selva Amazónica
name: Martin Casapia, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.