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.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
-
Saint-Pierre、フランス、97448
- 募集
- CHU de la Réunion
-
主任研究者：
- Marine LAFONT, PH
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Case
women who contracted symptomatic dengue fever during pregnancy
|
データ収集
|
|
Control
women who did not contract symptomatic dengue fever during pregnancy
|
データ収集
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluate the difference in the proportion of intrauterine growth retardation (IUGR) between the Case group and the Control group
時間枠：at childbirth
|
Birth weight <3rd percentile according to Sentinel Network Perinatal Database : AUDIPOG
|
at childbirth
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Evaluate the difference in the proportion of prematurity between the case group and the control group
時間枠：at childbirth
|
Prematurity: birth between 22 and 37 weeks of amenorrhea
|
at childbirth
|
|
Evaluate the difference in the proportion of late miscarriage between the case group and the control group
時間枠：at childbirth
|
late miscarriage: Birth between 14 and 22 weeks of amenorrhea
|
at childbirth
|
|
Evaluate the difference in the proportion of fetal death in utero between the case group and the control group
時間枠：at childbirth
|
fetal death in utero : Negative cardiac activity in utero between 14 weeks and before childbirth
|
at childbirth
|
|
Evaluate the difference in the proportion of preeclampsia between the case group and the control group
時間枠：at childbirth
|
preeclampsia: Arterial hypertension> 140 and / or 90 mmHg and proteinuria / 24h> 0.3g / 24h
|
at childbirth
|
|
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
時間枠：at childbirth
|
bleeding from delivery: Blood loss> 500 mL in immediate postpartum up to 2 hours postpartum
|
at childbirth
|
|
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
時間枠：at childbirth
|
Birth weight <10th percentile according to Sentinel Network Perinatal Database : AUDIPOG
|
at childbirth
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 2020/CHU/41
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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