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Malaria In Pregnancy in Central India (MIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03955263
Recruitment Status : Unknown
Verified May 2019 by Lata Medical Research Foundation, Nagpur.
Recruitment status was:  Active, not recruiting
First Posted : May 20, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Lata Medical Research Foundation, Nagpur

Study Description
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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


Condition or disease
Pregnant Women

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

Study Design
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Study Type : Observational
Actual Enrollment : 887 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Asymptomatic Malaria During Pregnancy and Its Effect on Pregnancy Outcomes in Women Attending Antenatal Clinic in Central India
Actual Study Start Date : September 28, 2018
Actual Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria Pregnancy

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Asymptomatic parasitaemia [ Time Frame: January 2019 to December 2019 ]
    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.

  2. Effect of malaria on duration of pregnancy [ Time Frame: January 2019 to December 2019 ]
    Difference in mean gestational age at delivery or end of pregnancy among women with versus those without RT-PCR-confirmed malaria infection during pregnancy.

  3. Outcome of the pregnancy [ Time Frame: January 2019 to December 2019 ]
    Number of live births, still birth / miscarriage, elective termination / death after delivery

  4. Birth weight [ Time Frame: January 2019 to December 2019 ]
    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

  5. Infant Outcome [ Time Frame: January 2019 to December 2019 ]
    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


Biospecimen Retention:   Samples Without DNA
Dried Blood Spots

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955263


Locations
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India
Lata Medical Research Foundation
Nagpur, Maharashtra, India, 440022
Sponsors and Collaborators
Lata Medical Research Foundation, Nagpur
Investigators
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Principal Investigator: Archana Patel, MD, PhD Program Director and CFO, Lata Medical Research Foundation
More Information
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Responsible Party: Lata Medical Research Foundation, Nagpur
ClinicalTrials.gov Identifier: NCT03955263    
Other Study ID Numbers: RPC#30
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lata Medical Research Foundation, Nagpur:
asymptomatic
Malaria
pregnancy
prevalence
RT-PCR
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases