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Molecular Testing

LAMP Testing for Malaria in Pregnancy (LAMPREG Trial)

N/A

Recruiting

Led By Dylan Pillai, MD, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at delivery and post hoc

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether using a molecular test to detect malaria cases can reduce maternal and infant morbidity and mortality.

Who is the study for?

The LAMPREG trial is for pregnant women in Ethiopia who are in their first or early second trimester. They must consent to participate and not have a high-risk pregnancy, severe malaria, multiple previous births (multiparity), undatable pregnancy, or be in the third trimester.

What is being tested?

This study compares standard malaria detection by microscopy with an enhanced method using LAMP testing on maternal and infant health outcomes. Pregnant women will either receive usual care or additional LAMP tests regardless of symptoms and treated if positive.

What are the potential side effects?

There may not be direct side effects from the diagnostic interventions themselves; however, treatments following a positive test result could include quinine or ACTs which can have side effects like nausea, dizziness, or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of the study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Obstetric Delivery

Secondary study objectives

Absolute birth weight

Maternal hemoglobin

Neonatal hemoglobin at birth

+2 more

Other study objectives

Assessment of the development of placental malaria

Performance of diagnosis methods compared to qRT-PCR as a gold standard

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention armExperimental Treatment2 Interventions

The remaining two-thirds of participants will be actively screened (symptomatic and asymptomatic) for Plasmodium infection at each antenatal visit, using both LAMP and conventional techniques (microscopy and RDT). If either is positive, participants will be treated with antimalarial therapy according to Ethiopian Ministry of Health guidelines. If both are negative then they receive no treatment.

Group II: Standard of careActive Control1 Intervention

One third of individuals get allocated to the standard of care arm. At each antenatal visit as per Ethiopian guidelines, pregnant women enrolled in the study will be submitted to the standard of care for malaria in pregnancy. If the pregnant mothers are symptomatic for malaria, they receive microscopy (blood smear for Plasmodium detection) and then are treated with anti-malarial therapy if microscopy is positive for Plasmodium. If it is negative they receive no treatment. If they are asymptomatic, they do not receive any further investigations or treatment in relation to malaria.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LAMP

2020

N/A

~30

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