Malaria In Pregnancy in Central India — MIP  

Pregnant Women Clinical Trial

Official title: Prevalence of Asymptomatic Malaria During Pregnancy and Its Effect on Pregnancy Outcomes in Women Attending Antenatal Clinic in Central India

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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 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 ;

Related Conditions & MeSH terms

• Malaria
• Pregnant Women

• NCT number: NCT03955263
• Study type: Observational
• Source: Lata Medical Research Foundation, Nagpur
• Status: Active, not recruiting
• Start date: September 28, 2018
• Completion date: January 31, 2020