Ignite Creation Date:
2024-05-06 @ 1:11 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03955263
Status:
UNKNOWN
Last Update Posted:
2019-05-30
First Post:
2019-05-16
Brief Title:
Malaria In Pregnancy in Central India
Sponsor:
Lata Medical Research Foundation Nagpur
Organization:
Lata Medical Research Foundation Nagpur
Study Overview
Official Title:
Prevalence of Asymptomatic Malaria During Pregnancy and Its Effect on Pregnancy Outcomes in Women Attending Antenatal Clinic in Central India
Status:
UNKNOWN
Status Verified Date:
2019-05
Last Known Status:
ACTIVE_NOT_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:
MIP
Brief Summary:
The present study is planned to be conducted at a district level women and childrens 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 firstsecond 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
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 firstsecond 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
Detailed Description:
Public Health Rationale
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 Pfalciparum 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 childrens 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 firstsecond 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 firstsecond 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
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 Pfalciparum 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 childrens 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 firstsecond 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 firstsecond 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
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