Determining the Risk Elevation After Maternity (DREAM)
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Ontario
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Ottawa, Ontario, 캐나다, K1H 8L6
- The Ottawa Hospital, General Campus
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Preeclampsia- observational
45 women with preeclampsia
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No preeclampsia- observational
10 women without preeclampsia
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Persistence of high blood pressure (hypertension) and cardiovascular biomarkers in the blood at 6 months after a pregnancy with preeclampsia
기간: Six months after delivery
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Six months after delivery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Dr Laura Gaudet, Ottawa Hospital Research Institute
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20140799-01H
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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