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Impact of Malaria Infection in Pregnancy on Fetal and Newborn Growth
Sponsor study identifier
observational
1,887
1 country
1
Study Start
February 10, 2009
Actual (reported)Primary Completion
February 2018
Actual (reported)Study Completion
February 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 9, 2009
Actual (reported)February 10, 2009
Actual (reported)February 10, 2009
Actual (reported)February 2018
Actual (reported)February 2018
Actual (reported)Ultrasound measurements
Up to birth
Examination of all newborns
6 months post natal
Pregnant women who present at the SMRU antenatal clinics on the Thai Burmese border.
Pregant women who present at the SMRU ante natal clinics. The antenatal clinics (ANC) are based on the Thai-Burmese border, in a region where Karen people (a minority group in Burma) are the principal inhabitants.
Shoklo Malaria Research Unit
Mae Sot, Changwat Tak, 63110, Thailand
Hashmi A, Carrara VI, Nyein PB, Darakamon MC, Charunwatthana P, McGready R. The Healthy Baby Flipbook: piloting home-based counseling for refugee mothers to improve infant feeding and water, sanitation, and hygiene (WASH) practices. Glob Health Action. 2019;12(1):1560115. doi: 10.1080/16549716.2018.1560115.
Francois Nosten, MD
Shoklo Malaria Research Unit
1,887 participants (actual enrollment reported by the registry).
First Submitted
February 9, 2009
First Posted
February 10, 2009
Study Start
February 10, 2009
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
February 2018
Actual (reported)Study Completion
February 2018
Actual (reported)Last Updated
September 2, 2020
Record last verified: 2020-09
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Source: ClinicalTrials.gov.
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