Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

McGill University

Status and phase: Completed; Phase 4

Conditions: Intestinal Diseases, Parasitic

Treatments: Drug: Placebo; Drug: Albendazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01748929

12-198-GEN

Details and patient eligibility

About

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.

Enrollment: 1,010 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,010 participants in 2 patient groups, including a placebo group

Albendazole

Experimental group

Description:

single dose 400 mg tablet of albendazole

Treatment:

Drug: Albendazole

Placebo

Placebo Comparator group

Description:

Placebo Manufactured by Hersil Laboratories in Lima, Peru

Treatment:

Drug: Placebo