Ignite Creation Date:
2024-05-06 @ 3:27 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04634695
Status:
UNKNOWN
Last Update Posted:
2020-11-18
First Post:
2020-11-02
Brief Title:
Assessing to What Extent Dhps-431V Mutation May Influence the Protective Efficacy of IPTp-SP
Sponsor:
Obafemi Awolowo University
Organization:
Obafemi Awolowo University
Study Overview
Official Title:
Assessing the Prevalence and Impact of Dihydropteroate Synthase-431V Mutation on the Protective Efficacy of Intermittent Preventive Treatment During Pregnancy Using Sulphadoxine-pyrimethamine
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEEM-FIT
Brief Summary:
Malaria in pregnancy MiP continues to be a significant public health issue particularly in sub-Saharan Africa The coverage of pregnant women with three or more doses of intermittent preventive treatment using sulphadoxine-pyrimethamine IPTp-SP is recommended to prevent risks associated with MiP in moderate-to-high transmission settings Evidence has recently become available supporting the emergence of a novel Pfdhps-431V mutation in Nigeria This new mutation may further confound the existing SP-resistance thus the intended follow-on project aims to assess the influence of Pfdhps-431V mutation on the protective efficacy of SP during pregnancy
The aims are to detect P falciparum positivity at delivery and pregnancy outcome in participants who must have received three or more doses of IPTp_SP We will attempt to check the presence of existing and new PfdhpsPfdhfr mutations in the samples positive for P falciparum using a quantitative PCR qPCR The prevalence of novel Pfdhps-431V mutant and other PfdhpsPfdhfr resistance alleles among the study population will be estimated The significance of the resistance genes on the efficacy of SP will be described by looking at its associations with the reported IPTp use P falciparum infection maternal anaemia low birth weight and preterm delivery
The aims are to detect P falciparum positivity at delivery and pregnancy outcome in participants who must have received three or more doses of IPTp_SP We will attempt to check the presence of existing and new PfdhpsPfdhfr mutations in the samples positive for P falciparum using a quantitative PCR qPCR The prevalence of novel Pfdhps-431V mutant and other PfdhpsPfdhfr resistance alleles among the study population will be estimated The significance of the resistance genes on the efficacy of SP will be described by looking at its associations with the reported IPTp use P falciparum infection maternal anaemia low birth weight and preterm delivery
Detailed Description:
Malaria in pregnancy MiP is considered a major public health issue with substantial risks for mothers and their babies Intermittent preventive treatment in pregnancy using sulphadoxine-pyrimethamine IPTp-SP is adopted as a part of antenatal care ANC to prevent malaria and reduce the risk associated with MiP However SP-resistance is increasing with the emergence of Plasmodium falciparum dihydropteroate synthase Pfdhps and P falciparum dihydrofolate reductase Pfdhfr resistant genes challenging the benefits and effectiveness of IPTp-SP Still evidence has become available supporting the emergence of a novel Pfdhps-I431V mutation The I431V mutation is found only in West and Central African countries however its impact on SP resistance has not been evaluated We are hypothesizing that the new mutation may confound the existing SP-resistance resulting in an apparent reduction in the protective effect of SP during pregnancy within the region
The study will recruit adult pregnant women and will assess the presence of malaria infection at delivery The study will seek new mutations in vivo using full sequencing This molecular tool will also be used to look at the prevalence of novel Pfdhps-431V mutation among pregnant women undergoing monthly IPTp-SP Attempts will be made to re-evaluate the prevalence of other Pfdhps and Pfdhfr resistance alleles among the study population The significance of the resistance genes on the protective efficacy of SP will be described
The present study is an observational study to be conducted among all booked pregnant women The pregnant women must have received at least three therapeutic doses of sulphadoxine-pyrimethamine as part of routine antenatal care ANC before delivery sion and Pregnant women who consented to participate will be tested for the presence of malaria parasite during the third trimester and at delivery 80-100 µL blood samples will be saved as dried blood spot on Whatman filter paper from the individual with P falciparum malaria positivity Antenatal care ANC contact schedule with proposed timelines for implementation of malaria in pregnancy interventions designed by WHO will be followed in enrolling subjects from 26 weeks of pregnancy The study will be conducted at the antenatal
The study will recruit adult pregnant women and will assess the presence of malaria infection at delivery The study will seek new mutations in vivo using full sequencing This molecular tool will also be used to look at the prevalence of novel Pfdhps-431V mutation among pregnant women undergoing monthly IPTp-SP Attempts will be made to re-evaluate the prevalence of other Pfdhps and Pfdhfr resistance alleles among the study population The significance of the resistance genes on the protective efficacy of SP will be described
The present study is an observational study to be conducted among all booked pregnant women The pregnant women must have received at least three therapeutic doses of sulphadoxine-pyrimethamine as part of routine antenatal care ANC before delivery sion and Pregnant women who consented to participate will be tested for the presence of malaria parasite during the third trimester and at delivery 80-100 µL blood samples will be saved as dried blood spot on Whatman filter paper from the individual with P falciparum malaria positivity Antenatal care ANC contact schedule with proposed timelines for implementation of malaria in pregnancy interventions designed by WHO will be followed in enrolling subjects from 26 weeks of pregnancy The study will be conducted at the antenatal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None