Clinical trial NCT03955263: Malaria In Pregnancy in Central India
Official title: Prevalence of Asymptomatic Malaria During Pregnancy and Its Effect on Pregnancy Outcomes in Women Attending Antenatal Clinic in Central India
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnant Women
Keywords: asymptomatic
Malaria
pregnancy
prevalence
RT-PCR
Lead sponsor: Lata Medical Research Foundation, Nagpur
Sponsor class: OTHER
First posted: 2019-05-20
Enrollment: 887
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women in their first / second trimester attending Antenatal clinics at district level women and children's hospital at Nagpur

Brief 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

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 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

Eligibility criteria: Inclusion Criteria:

- Pregnant woman in first / second trimester of pregnancy

Exclusion Criteria:

* Pregnant woman in first / second trimester of pregnancy those do not consent

Primary outcomes:
measure: Asymptomatic parasitaemia
timeFrame: January 2019 to December 2019
measure: Effect of malaria on duration of pregnancy
timeFrame: January 2019 to December 2019
measure: Outcome of the pregnancy
timeFrame: January 2019 to December 2019
measure: Birth weight
timeFrame: January 2019 to December 2019
measure: Infant Outcome
timeFrame: January 2019 to December 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Lata Medical Research Foundation
state: Maharashtra
Study officials:
affiliation: Program Director and CFO, Lata Medical Research Foundation
name: Archana Patel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: