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临床试验/NCT03955263
NCT03955263Unknown不适用

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

Lata Medical Research Foundation, Nagpur1 个研究点 分布在 1 个国家目标入组 887 人开始时间: 2018年9月28日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
887
试验地点
1
主要终点
Asymptomatic parasitaemia

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant woman in first / second trimester of pregnancy

排除标准

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

结局指标

主要结局

Asymptomatic parasitaemia

时间窗: 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.

Effect of malaria on duration of pregnancy

时间窗: 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.

Birth weight

时间窗: 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

Infant Outcome

时间窗: 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

Outcome of the pregnancy

时间窗: January 2019 to December 2019

Number of live births, still birth / miscarriage, elective termination / death after delivery

次要结局

未报告次要终点

研究者

发起方
Lata Medical Research Foundation, Nagpur
申办方类型
Other
责任方
Sponsor

研究点 (1)

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