Malaria in Pregnancy: Nutrition and Immunologic Effects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,500
- Locations
- 2
- Primary Endpoint
- Incidence of placental malaria
Study Overview
Brief Summary
The purpose of this study is to determine the efficacy of zinc and/or vitamin A supplementation in reducing the risk of placental malaria and its associated adverse pregnancy outcomes.
Detailed Description
Malaria accounts for a major proportion of the disease burden in Tanzania with 14 to 18 million new malaria cases being reported each year resulting in 100,000-125,000 deaths. Malaria results in impaired productivity for those between 15-55 years and lost learning opportunities in the 5-25 year age group. Dar es Salaam is characterized as an area with endemic and perennial malaria, with transmission occurring during the entire year. P. falciparum accounts for more than 95% of malaria infections. A number of interventions have contributed to reducing the burden of the disease in some settings in Tanzania and beyond, including vector control measures, bed nets, and prophylaxis and treatment of malaria. However, malaria remains a serious problem among pregnant women and children. We will examine the efficacy of micronutrient supplements as a means of enhancing immune response to malaria in pregnancy and reducing the risks of associated adverse clinical outcomes. If successful, such a low-cost intervention would be added to the armamentarium against this disease.
NOTE: The time frames listed for the maternal malaria and hemoglobin outcomes were updated on 4/22/15. This record initially indicated that maternal malaria anemia and hemoglobin would be measured at several specific time points throughout the study. Instead, maternal malaria was measured throughout pregnancy and hemoglobin was measured only at delivery. Due to an oversight, we did not update this record when this protocol change took effect at the start of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Primigravida or secundigravidae
- •At or before 13 weeks of gestation
- •HIV-negative
- •Intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter
Exclusion Criteria
- •Not primigravida or secundigravidae
- •After 13 weeks of gestation
- •HIV-positive
- •Do not intend to stay in Dar es Salaam until delivery and for at least 6 weeks thereafter
Outcomes
Primary Outcomes
Incidence of placental malaria
Time Frame: Delivery
Placental infection status will be categorized as infected if there are asexual parasites in the placenta blood; not infected if the placental blood smear is negative; or status unknown if no placental smear is available.
Low birth weight
Time Frame: Delivery
Low birth weight will be defined as birth weight less than 2500 grams.
Secondary Outcomes
- Maternal anemia(Delivery)
- Perinatal death(at or after 28 weeks of gestation and in the first 7 days of life)
- Maternal malaria(During pregnancy)
Investigators
Wafaie Fawzi
Chair, Department of Global Health and Population
Harvard School of Public Health (HSPH)
