LAMP Detection of Malaria in PREGnancy (LAMPREG) Trial

Summary

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.

Conditions

• Malaria
• Pregnancy Malaria
• Malaria in Pregnancy

Interventions

DIAGNOSTIC_TEST

LAMP

LAMP testing involves taking a blood specimen using venous puncture, extracting DNA and performing a commercial CE-marked LAMP malaria assay to obtain a malaria result (presence/absence of parasite DNA) at the species level

DIAGNOSTIC_TEST

Microscopy/RDT

Standard of care management of malaria in pregnancy relies on microscopy and/or RDT for diagnosis

Sponsors & Collaborators

• Jimma University

  collaborator OTHER

• Amhara Public Health Institute, Ethiopia

  collaborator UNKNOWN

• Armauer Hansen Research Institute, Ethiopia

  collaborator OTHER

• University of Calgary

  lead OTHER

Principal Investigators

• Dylan Pillai, MD, PhD · University of Calgary

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-18

Primary Completion

2023-11-20

Completion

2023-11-20

Countries

• Canada
• Ethiopia

Study Locations