NCT04105855|Completed
Malaria Prevalence Around Maferinyah, Guinea
Cross-Sectional Survey of Plasmodium and Other Parasites in Pregnant Women and Infants Around Maferinyah, Guinea
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Cross-Sectional Survey of Plasmodium and Other Parasites in Pregnant Women and Infants Around Maferinyah, Guinea
Sponsor study identifier
Secondary identifiers
observational
3,392
1 country
1
Study Start
July 13, 2020
Actual (reported)Primary Completion
October 30, 2023
Actual (reported)Study Completion
October 30, 2023
Actual (reported)Background: Many women in Sub-Saharan Africa get malaria while they are pregnant. Plasmodium falciparum is a parasite that can cause malaria. Placental malaria (PM) caused by P. falciparum can cause anemia or death in first-time mothers. In infants, it can cause low birth weight, premature birth, or other problems. Some women don t show any signs of having PM. This makes it harder to know if they might have it. Researchers want to learn how much the seasons affect the number of women and infants who get PM as well as the severity of the disease. To do this, they are going to test women and babies who visit a health center in Guinea. Objective: To learn the seasonal burden of P. falciparum infection in pregnant women and otherwise healthy infants. Eligibility: Pregnant women ages 18 years and older (or emancipated minors) and infants ages 6-12 months. Design: Participants will include women and infants who visit the health center in Maf(SqrRoot)(Registered Trademark)rinyah, Guinea, for routine care. They can take part only once per pregnancy. For screening, mothers will talk about their medical history. They will talk about their past pregnancies and their current pregnancy. They will answer questions about where they live and what they do to keep from getting malaria. Babies will be screened with their medical history and demographic information. Participants will also give a blood sample. Adults will have a finger stick. Children will have a heel stick. Or they will have blood taken from a vein. Participation will last for 1 visit to the health center.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2023
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 25, 2019
Actual (reported)September 26, 2019
Actual (reported)July 13, 2020
Actual (reported)October 30, 2023
Actual (reported)October 30, 2023
Actual (reported)Estimate of the seasonal burden of Plasmodium falciparum infection among pregnant women and otherwise healthy infants
seasonal burden of Plasmodium falciparum infection
3 years
Estimate of the frequency of parasitemia due to non-falciparum malaria
3 years
Infants age 6-12 months presenting for routine healthy visits
Women 18 years and older (and emancipated minors) presenting for routine antenatal visits
Pregnant women 18 years of age and older (including emancipated minors) and 6-12 month old infants presenting for routine visits at Maf(SqrRoot)(Registered Trademark)rinyah Health Centers
Maferinyah Rural Health Training and Research Center
Maferinyah, Guinea
Kwan JL, Seitz AE, Fried M, Lee KL, Metenou S, Morrison R, Kabyemela E, Nutman TB, Prevots DR, Duffy PE. Seroepidemiology of helminths and the association with severe malaria among infants and young children in Tanzania. PLoS Negl Trop Dis. 2018 Mar 26;12(3):e0006345. doi: 10.1371/journal.pntd.0006345. eCollection 2018 Mar.
Rogerson SJ, Desai M, Mayor A, Sicuri E, Taylor SM, van Eijk AM. Burden, pathology, and costs of malaria in pregnancy: new developments for an old problem. Lancet Infect Dis. 2018 Apr;18(4):e107-e118. doi: 10.1016/S1473-3099(18)30066-5. Epub 2018 Jan 31.
Finger prick/heel stick samples and peripheral blood
Patrick E Duffy, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
3,392 participants (actual enrollment reported by the registry).
First Submitted
September 25, 2019
First Posted
September 26, 2019
Study Start
July 13, 2020
Actual (reported)Trial to Evaluate CIS43LS in Healthy Adults
Contact the study team to confirm eligibility.
Primary Completion
October 30, 2023
Actual (reported)Study Completion
October 30, 2023
Actual (reported)Last Updated
November 14, 2023
Record last verified: 2023-11
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Source: ClinicalTrials.gov.
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