"LAMPREG TRIAL" Active Case Detection and Treatment of Malaria in Pregnancy Using LAMP Technology: A Pragmatic Randomized Multi-Center Diagnostic Outcomes Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,424
- 试验地点
- 5
- 主要终点
- Proportion of deliveries with low birth weight
研究概览
简要总结
Objective: The aim of this study is to evaluate the impact of enhanced malaria cases detection using molecular testing (LAMP) on maternal and infant morbidity and mortality in a prospective study design.
A pragmatic randomized control diagnostic trial will be conducted from October 2020 until March 1 2022 in pregnant mothers at sites in Ethiopia. Both symptomatic and asymptomatic first and early second trimester pregnant women will be included in the study and individually randomized to either standard of care or enhanced cased detection arms using LAMP for malaria. Women (n=2583) will be enrolled during a seven-month period encompassing the peak transmission seasons and then followed until delivery. In the standard of care arm, venous blood sample will be collected from each study participant and the presence of Plasmodium infection will be diagnosed by microscopy in symptomatic patients. Pregnant women who test positive for malaria will be referred and treated for malaria with quinine or artemisinin combination therapies (ACTs) as per national guidelines. In the intervention arm, mothers who are symptomatic or asymptomatic will be tested by a commercially available CE-approved LAMP malaria test and microscopy/RDT for malaria at each clinic visit and treated if positive by any test. Pregnant mothers who require treatment will be referred and treated with either quinine or artemisinin combination therapy (ACTs) as per national guidelines. The primary outcome is the proportion of deliveries with low birth weight based on WHO definition, with secondary outcomes of:(i)absolute birth weight; (ii) maternal hemoglobin;(ii) neonatal hemoglobin at birth;(iv) neonatal mortality; (v) stillbirth; and (vi) prematurity in each arm of the study.
详细描述
Malaria in pregnancy often results in high degree of morbidity and mortality of the pregnant mother and the fetus. Early and accurate diagnosis of subclinical infections will be critical to malaria elimination and specifically the goals of the World Health Organization to reduce the burden of disease by 90% before 2030. This goal can only be achieved using highly sensitive methods such as LAMP that are capable of detecting subclinical infections with very low parasitemia. Currently both Giemsa stained blood film microscopy and RDT are the only laboratory methods that are used to diagnose malaria both in pregnant mothers and the general population. This leaves a big gap in the detection of low-level infections and asymptomatic malaria due to the documented lack of sensitivity of the aforementioned methods. This, in turn, predisposes pregnant mothers to malaria-related complications that endangers the life of the mother and the fetus. In this study, we propose that the use of a highly sensitive LAMP technique will enable us to detect more asymptomatic Plasmodium infections in pregnant women. This consequently results in early treatment of the pregnant mothers and may avert maternal and fetal morbidity and mortality. This study is of particular importance in Ethiopia where IPT is not used for pregnant women and therefore accurate screening is paramount.
OBJECTIVES
General objective To assess the impact of LAMP in the diagnosis of malaria in pregnancy and its potential role in reducing mortality and morbidity attributable to malaria. We hypothesize that the additional sensitivity of LAMP coupled with active case detection in detecting malaria in pregnancy will result in additional cases being identified and treated.
Specific objectives
- To evaluate the impact of LAMP versus microscopy/RDT for the detection of malaria in pregnant mothers in terms maternal and infant morbidity and mortality.
- To evaluate the impact of enhanced case detection of malaria in pregnancy by screening asymptomatic mothers at each antenatal visit until delivery.
- To determine the impact of treating LAMP-positive asymptomatic and symptomatic pregnant women as compared to standard of care. Treatment is per national guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Must be a pregnant woman in the first or second trimester at time of enrollment
- •Consent to the study
排除标准
- •Pregnant woman in the third trimester at time of enrollment
- •Multiparity
- •Severe malaria at inclusion as per WHO criteria
- •At risk pregnancy as per Ethiopian guidelines
- •Impossibility to date pregnancy
结局指标
主要结局
Proportion of deliveries with low birth weight
时间窗: At the head to toe assessment of the baby within 24 hours of delivery
Birth weight will be considered as low if \< 2500 g
次要结局
- Absolute birth weight(At the head to toe assessment of the baby within 24 hours of delivery)
- Neonatal hemoglobin at birth(At the head to toe assessment of the baby within 24 hours of delivery)
- Maternal hemoglobin(During the pregnancy and at delivery)
- Proportion of fetal loss(During the study time, for each inclusion until delivery)
- Prematurity(At delivery)
研究者
Dylan R Pillai
Professor
University of Calgary