Determining the Risk Elevation After Maternity (DREAM)
調査の概要
詳細な説明
Preeclampsia is a complication of pregnancy that happens in about 5-7% of all births. It is diagnosed when a mother has high blood pressure in pregnancy combined with protein in the urine which is sign that the kidneys are not functioning properly. When a mother has preeclampsia, the placenta makes abnormal amounts of several important proteins that damage the lining of the mother's blood vessels. The blood vessel damage that occurs places women at up to 10 times higher risk of having a heart attack or stroke at a younger age than women who did not have preeclampsia. It usually takes between 8 and 15 years after preeclampsia is diagnosed for the first heart attack or stroke to occur.
Unfortunately, this blood vessel damage is usually silent, meaning that women and their doctors are not aware of it. This makes it hard to predict which women are at highest risk of a heart attack or stroke and therefore need extra medical care to prevent it. Abnormal levels of the placenta proteins in the blood (right after delivery and at three and six months after delivery) as well as abnormalities of the placenta itself may be the earliest way to predict which women with preeclampsia are at risk of premature heart disease or stroke.
The purpose of this study is to collect blood and placentas from women with preeclampsia and without preeclampsia to measure and compare the levels of proteins in the blood and find abnormalities of the placentas that are associated with preeclampsia. We will then see if these tests can predict which women will go on to develop high blood pressure and ultimately be at higher risk of premature heart attack or stroke after pregnancy.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Ontario
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Ottawa、Ontario、カナダ、K1H 8L6
- The Ottawa Hospital, General Campus
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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:
Women with a pregnancy complicated by pre-eclampsia and women who are healthy and have had a normal singleton pregnancy(controls)
Exclusion Criteria:
Women with any of the following conditions will be excluded in both the control & preeclampsia groups:
- known kidney disease prior to pregnancy or laboratory evidence of proteinuria prior to pregnancy
- diabetes (Type I, Type II or Gestational Diabetes)
- known Cardiovascular Disease (myocardial infarction, angina, stroke, or transient ischemic attack
- multiple pregnancies (twins or more)
- who do not understand English or French will be excluded In addition to those listed above, for the control group, women must have no other major maternal pregnancy complications.
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 |
---|---|
Preeclampsia- observational
45 women with preeclampsia
|
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No preeclampsia- observational
10 women without preeclampsia
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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 |
時間枠 |
---|---|
Persistence of high blood pressure (hypertension) and cardiovascular biomarkers in the blood at 6 months after a pregnancy with preeclampsia
時間枠:Six months after delivery
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Six months after delivery
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協力者と研究者
捜査官
- 主任研究者:Dr Laura Gaudet、Ottawa Hospital Research Institute
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
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 (見積もり)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。