Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
887 participants
OBSERVATIONAL
2018-09-28
2020-01-31
Brief Summary
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Objectives:
i) To assess the prevalence of asymptomatic malaria infection with all four species of malarial parasites namely P. falciparum, P. malariae, P. ovale and P. vivax during the first/second trimester of pregnancy among women attending the antenatal clinic at a secondary level urban health facility using PCR (polymerase chain reaction) for malaria parasites.
ii) To determine the effect of malaria on duration of pregnancy, adverse outcomes and birth outcomes at delivery
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Detailed Description
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Despite comprehensive malaria control programmes, control measures specifically aimed at malaria in pregnancy are not adequately available. The epidemiological data are scanty in order to develop effective policies to address this problem. The major barrier to successful eradication or elimination of malaria transmission is the inability to detect and treat asymptomatic carriers of the malarial parasites. Asymptomatic carriers do not seek treatment for infection and thus the life cycle of the infection continues. The systematic identification and treatment of individuals with asymptomatic P.falciparum and P. vivax, as part of a surveillance intervention strategy, are important for reducing the parasite reservoir and would help to decrease transmission of the disease. Data on asymptomatic carriage is not available from India.
Routine screening for malaria and anaemia followed by prompt management should be encouraged to curb the effect of malaria and anaemia on the pregnant women as well as her fetus. The present study is planned to be conducted at a district level women and children's hospital at Nagpur with the following objectives:
Objectives:
i) To assess the prevalence of asymptomatic malaria infection with all four species of malarial parasites namely P. falciparum, P. malariae, P. ovale and P. vivax during the first/second trimester of pregnancy among women attending the antenatal clinic at a secondary level urban health facility using PCR (polymerase chain reaction) for malaria parasites.
ii) To determine the effect of malaria on duration of pregnancy, adverse outcomes and birth outcomes at delivery
Study Design And Study Population:
This is a prospective cohort study of pregnant women in their first/second trimester of pregnancy attending the antenatal clinic at a secondary level healthcare facility at Nagpur, India.
Investigators propose collecting a two-three dried blood spot (DBS) sample for all enrolled women and symptomatic (fever with or without chills) neonates and infants at enrollment when the haemoglobin measurement is performed. Asymptomatic parasitaemia will be detected using a dual-antigen rapid diagnostic kit (RDK), microscopy, and species-specific PCR. PCR for the detection of malaria parasite would be performed at the National Institute for Research in Tribal Health (NIRTH) at Jabalpur, India
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
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Lata Medical Research Foundation, Nagpur
OTHER
Responsible Party
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Principal Investigators
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Archana Patel, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Program Director and CFO, Lata Medical Research Foundation
Locations
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Lata Medical Research Foundation
Nagpur, Maharashtra, India
Countries
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Other Identifiers
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RPC#30
Identifier Type: -
Identifier Source: org_study_id
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