Malaria In Pregnancy in Central India

Pregnant Women Clinical Trial

— MIP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03955263
• Other study ID #: RPC#30
• Status: Active, not recruiting
• Start date: September 28, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: May 2019
• Source: Lata Medical Research Foundation, Nagpur
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 887
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant woman in first / second trimester of pregnancy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Malaria
• Pregnant Women

Locations

Country	Name	City	State
India	Lata Medical Research Foundation	Nagpur	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Lata Medical Research Foundation, Nagpur

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asymptomatic parasitaemia	Number of women having asymptomatic malaria which 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.	January 2019 to December 2019
Primary	Effect of malaria on duration of pregnancy	Difference in mean gestational age at delivery or end of pregnancy among women with versus those without RT-PCR-confirmed malaria infection during pregnancy.	January 2019 to December 2019
Primary	Outcome of the pregnancy	Number of live births, still birth / miscarriage, elective termination / death after delivery	January 2019 to December 2019
Primary	Birth weight	Difference in mean birth weight among all infants and among term singleton infants born to women with versus those without RT-PCR-confirmed malaria infection during pregnancy	January 2019 to December 2019
Primary	Infant Outcome	Number of episode of Fever till 42 days of infant age among all infants and among term singleton infants born to women with versus those without RT-PCR-confirmed malaria infection during pregnancy	January 2019 to December 2019