Ultrasound Study in Pregnant Women With Malaria (UPS)
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Impact of Malaria Infection in Pregnancy on Fetal and Newborn Growth|
- Ultrasound measurements [ Time Frame: Up to birth ] [ Designated as safety issue: No ]
- Examination of all newborns [ Time Frame: 6 months post natal ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Pregnant women who present at the SMRU antenatal clinics on the Thai Burmese border.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840502
|Contact: Marcus Rijken, MDfirstname.lastname@example.org|
|Contact: Phaikyeong Cheah, PhDemail@example.com|
|Shoklo Malaria Research Unit||Recruiting|
|MaeSod, Tak, Thailand, 63110|
|Contact: Francois Nosten, MD firstname.lastname@example.org|
|Principal Investigator:||Francois Nosten, MD||Shoklo Malaria Research Unit|