- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01071668
Onset of Labor and Metabolomics (GEM-2) (GEM-2)
Feasibility Study to Develop the Analysis of the Metabolome During the Onset of Labor During Pregnancy
Premature birth is a public health problem and its incidence has recently increased in all developed countries. In Canada, it represented 6.4% of births in 1981 and 7.6% in 2000. In the last decade, the survival rate of premature infants has increased considerably, but neurological vulnerability has not changed. Premature births are the cause of approximately 28% of neonatal mortality in the world and is the major cause of perinatal mortality and morbidity in developed countries.
Approximately 75-80% of preterm births are spontaneous preterm birth. This type of premature birth included the preterm labor and premature rupture of membranes before term. The contractile activity represents one of the fundamental properties of the uterus during pregnancy and childbirth. The abnormalities associated with uterine contractions are the cause of pathological conditions with important consequences for the mother and fetus.
Metabolomics involves a new technology to investigate small molecules that characterize biochemical pathways of interest. The change in concentration levels of these molecules in various biological samples such as urine and blood in the presence of a disease or a patient can be particularly useful for identifying new biomarkers.
The hypothesis of this study is that gestational metabolomes detected in maternal fluids differ according to pathological situations and lead to the initiation of spontaneous labor. The whole research program has two complementary objectives in order to expect a decrease of prematurity: a) better understanding of all the physiological mechanisms leading to prematurity and b) better identification of patients at high risk for a better management of these women.
연구 개요
상태
정황
상세 설명
Metabolomics involves a new technology using the methods of separation and detection complex to investigate a set of small molecules that characterize biochemical pathways of interest. The change in concentration levels of these molecules in various biological samples such as urine and blood in the presence of a disease or a patient can detect metabolic fingerprints that can be particularly useful for identifying new biomarkers. These will thereafter be quantified and validated by metabolic profiling. To our knowledge, there are few studies on metabolomics and pregnancy.
Methods:
The studied population will be pregnant women between 20-30 weeks of gestation without any obstetrical complications.
Vaginal secretions, blood and urine samples will be taken:
- After inclusion in the project
- At hospital admission for delivery
- During labor
Blood and urine sample will also be taken:
- 48 hours after delivery
- 6-8 weeks after delivery
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Quebec
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Sherbrooke, Quebec, 캐나다, J1H 5N4
- Centre Hospitalier de l'Université de Sherbrooke
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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 single pregnancy
- Adults (> 18 years old)
Exclusion Criteria:
- Women with a severe congenital fetal malformation
- Fetal death
- Preexisting hypertension (ie before 20 weeks of gestation)
- Anti-phospholipid syndrome
- Lupus,
- Nephropathy, etc.
- Viral infections (HIV or hepatitis)
- Women who want an elective Caesarean section are excluded
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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GEM-2 Cohort
Women who have a low risk pregnancy before onset of labor.
Patients included in the study who will be hospitalized with spontaneous labor at term with intact membranes or preterm labor will be included in the study group.
Patients with premature rupture of membranes or induction of labor will be analyzed separately.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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comparison between the metabolic patterns of women before and during labor
기간: one and half year
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one and half year
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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The study also looks at the comparison of metabolic patterns in late pregnancy and postpartum.
기간: one and half year
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one and half year
|
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The project will characterize the metabolome in different fluids collected
기간: one and half year
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one and half year
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The study will compare the metabolome of women with spontaneous onset of labor with that of women with premature rupture of membranes or induction of labor
기간: one and half year
|
one and half year
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- 09-041
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. .
임신에 대한 임상 시험
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The Nazareth Hospital, Israel완전한Streptococcus B Carrier State Complicating Pregnancy이스라엘