Study on the Risks of Symptomatic Dengue on Pregnancy (ERiDenG)
Prospective Study on the Risks of Symptomatic Dengue on Pregnancy
Dengue fever is the most common arbovirus worldwide (390 million people infected per year) and is a global public health problem. This public health problem is also becoming European due to its rapid expansion over the past decade with an increase in cases of 400% and the appearance of the first indigenous cases of dengue in Europe. Studies on the consequences of dengue fever on pregnancy find contradictory results. In fact, most of these studies are observational studies describing the risk of dengue fever for pregnancy, without comparison with a control group or comparing the different pregnancy morbidities to those found during pregnancy in the general population. Other research is retrospective case-control studies with major biases in the definitions of obstetric complications, which makes the results questionable.
The study therefore proposes to carry out a prospective case-control study with rigorous matching criteria, strict definitions of cases, controls and obstetric complications.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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-
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Saint-Pierre、法国、97448
- 招聘中
- CHU de la Réunion
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首席研究员：
- Marine LAFONT, PH
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria for the case :
- Pregnant patients
- Major
- Affiliated with social security
- Symptomatic or pauci-symptomatic dengue
- Biological confirmation of dengue fever
Inclusion Criteria for the control :
- Pregnant patients
- Major
- Affiliated with social security
- Asymptomatic
Exclusion Criteria for the 2 group :
- Multiple pregnancy
- Patient's refusal
- Protected persons: person deprived of liberty by judicial or administrative decision, minor, and person subject to a legal protection measure: guardianship or curators)
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Case
women who contracted symptomatic dengue fever during pregnancy
|
数据采集
|
|
Control
women who did not contract symptomatic dengue fever during pregnancy
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数据采集
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group
大体时间：at childbirth
|
Birth weight <3rd percentile according to Sentinel Network Perinatal Database : AUDIPOG
|
at childbirth
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Evaluate the difference in the proportion of prematurity between the case group and the control group
大体时间：at childbirth
|
Prematurity: birth between 22 and 37 weeks of amenorrhea
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at childbirth
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Evaluate the difference in the proportion of late miscarriage between the case group and the control group
大体时间：at childbirth
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late miscarriage: Birth between 14 and 22 weeks of amenorrhea
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at childbirth
|
|
Evaluate the difference in the proportion of fetal death in utero between the case group and the control group
大体时间：at childbirth
|
fetal death in utero : Negative cardiac activity in utero between 14 weeks and before childbirth
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at childbirth
|
|
Evaluate the difference in the proportion of preeclampsia between the case group and the control group
大体时间：at childbirth
|
preeclampsia: Arterial hypertension> 140 and / or 90 mmHg and proteinuria / 24h> 0.3g / 24h
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at childbirth
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Evaluate the difference in the proportion of bleeding from delivery between the case group and the control group between the case group and the control group
大体时间：at childbirth
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bleeding from delivery: Blood loss> 500 mL in immediate postpartum up to 2 hours postpartum
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at childbirth
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Evaluate the difference in the proportion of small weight for gestational age between the case group and the control group between the case group and the control group
大体时间：at childbirth
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Birth weight <10th percentile according to Sentinel Network Perinatal Database : AUDIPOG
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at childbirth
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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