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临床试验/NCT00840502
NCT00840502已完成不适用

Impact of Malaria Infection in Pregnancy on Fetal and Newborn Growth

University of Oxford1 个研究点 分布在 1 个国家目标入组 1,887 人开始时间: 2009年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,887
试验地点
1
主要终点
Ultrasound measurements

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton viable pregnancy. If not detected at enrolment, multiple pregnancies will be excluded from the analysis.
  • Age ≥18 years old.
  • Willing and able to participate and comply with the study protocol and attend the SMRU ANCs regularly.
  • EGA between 9+0 and 13+6 weeks by Ultrasound (CRL)
  • Able to communicate in Burmese, Karen or English language
  • written informed consent to participate in trial and follow consultation

排除标准

  • Evidence of major congenital abnormality in the present pregnancy (e.g. anencephaly, omphalocele, hydrocephalus).
  • Known chronic maternal illness.
  • Thai national whose primary language is Thai

结局指标

主要结局

Ultrasound measurements

时间窗: Up to birth

次要结局

  • Examination of all newborns(6 months post natal)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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