Malaria In Pregnancy in Central India
MIP
Prevalence of Asymptomatic Malaria During Pregnancy and Its Effect on Pregnancy Outcomes in Women Attending Antenatal Clinic in Central India
1 other identifier
observational
887
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedFirst Submitted
Initial submission to the registry
May 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedMay 30, 2019
May 1, 2019
4 months
May 16, 2019
May 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
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
Outcome of the pregnancy
Number of live births, still birth / miscarriage, elective termination / death after delivery
January 2019 to December 2019
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
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
Eligibility Criteria
Pregnant women in their first / second trimester attending Antenatal clinics at district level women and children's hospital at Nagpur
You may qualify if:
- \- Pregnant woman in first / second trimester of pregnancy
You may not qualify if:
- Pregnant woman in first / second trimester of pregnancy those do not consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lata Medical Research Foundation
Nagpur, Maharashtra, 440022, India
Biospecimen
Dried Blood Spots
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Archana Patel, MD, PhD
Program Director and CFO, Lata Medical Research Foundation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2019
First Posted
May 20, 2019
Study Start
September 28, 2018
Primary Completion
January 31, 2019
Study Completion
January 31, 2020
Last Updated
May 30, 2019
Record last verified: 2019-05