Malaria Clinical Trial
Official title:
Impact of Malaria Infection in Pregnancy on Fetal and Newborn Growth
Most of the neonatal deaths that occur worldwide every year are associated with low birth
weight (LBW), caused by intrauterine growth restriction (IUGR) and/or preterm delivery.
Accurate assessment of fetal growth and gestational age for timely identification and
management of growth restriction are therefore public health priorities, especially in
developing countries where 98% of all neonatal deaths occur. Every year, more than 50 million
women become pregnant in malaria endemic regions. Malaria infection at any time during
pregnancy reduces birthweight. However, little is known about the relationship between the
timing of infection during pregnancy and the extent of the impact on birth weight. The
mechanisms by which malaria causes LBW also remain unclear. Reduced placental blood flow,
placental changes, red blood cell changes, severe anaemia and pro-inflammatory cytokines have
all been implicated.
In this proposed, longitudinal, observational, minimal risk study, which will take place in
SMRU antenatal clinics on the Thai-Burmese border, the effect of malaria infection during
pregnancy on fetal growth will be determined. Women will be screened before 13+6 weeks of
gestation and followed with regular ultrasound examinations during pregnancy. When a woman
has a malaria infection an extra ultrasound scan will be done to measure growth retardation
or placental blood flow changes. Bloodsamples will be taken to detect changes in red blood
cell properties and putative markers of malaria infection. For this study the maximum amount
of blood taken during pregnancy is 13 cc in an uninfected woman. For each malaria episode an
additional 7 cc blood will be taken. After delivery a placenta and a cord sample will be
taken to detect placental changes. The investigators aim to recruit four hundred pregnant
women over the course of two years. This study involves minimal risk to participants as
ultrasound examination is part of routine antenatal care in many countries in the world.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04601714 -
Baseline Cohort Malaria Morbidity Study
|
||
| Withdrawn |
NCT04020653 -
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
|
Phase 2 | |
| Terminated |
NCT04368910 -
Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
|
Phase 3 | |
| Completed |
NCT03641339 -
Defining Skin Immunity of a Bite of Key Insect Vectors in Humans
|
N/A | |
| Completed |
NCT02544048 -
Markers of T Cell Suppression: Antimalarial Treatment and Vaccine Responses in Healthy Malian Adults
|
||
| Completed |
NCT00527163 -
Role of Nitric Oxide in Malaria
|
||
| Not yet recruiting |
NCT05934318 -
L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)
|
N/A | |
| Active, not recruiting |
NCT04704674 -
Community Dynamics of Malaria Transmission in Humans and Mosquitoes in Fleh-la and Marshansue, Salala District, Bong County, Liberia
|
||
| Completed |
NCT03276962 -
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
|
Phase 2 | |
| Completed |
NCT04966871 -
Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults
|
Phase 1 | |
| Completed |
NCT00289185 -
Study of Safety, Immunogenicity and Efficacy of a Candidate Malaria Vaccine in Tanzanian Infants
|
Phase 2 | |
| Recruiting |
NCT03937817 -
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|
||
| Active, not recruiting |
NCT06153862 -
Africa Ready Malaria Screening
|
N/A | |
| Completed |
NCT04545905 -
Antenatal Care as a Platform for Malaria Surveillance: Utilizing Community Prevalence Measures From the New Nets Project to Validate ANC Surveillance of Malaria in Burkina Faso
|
||
| Recruiting |
NCT06278181 -
Diabetes, Metabolic Syndrome and Risk of Malaria in Cameroon
|
||
| Withdrawn |
NCT02793388 -
A Trial on Supervised Primaquine Use in Ethiopia
|
Phase 4 | |
| Withdrawn |
NCT02793414 -
Diagnostic Utility of Volatile Organic Compounds in Human Breath for Acute Clinical Malaria in Ethiopia
|
||
| Completed |
NCT02793622 -
Prevention of Malaria in HIV-uninfected Pregnant Women and Infants
|
Phase 3 | |
| Completed |
NCT02909712 -
Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania
|
Phase 2 | |
| Completed |
NCT02527005 -
A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients
|
Phase 1 |