Identification of Genes of Interest for Severe Forms of Preeclampsia (PRE-OMIQUES)
Identification of Genes of Interest for Severe Forms of Preeclampsia in a Cohort of Pregnant Women With a Precise Phenotype
Preeclampsia is a pregnancy complication characterized by high blood pressure associated with damage to various organs, especially the kidneys. It happens in about 1 to 5% of pregnant women and can cause serious problems for both the mother and the baby.
Several multi-omics studies have already been conducted on preeclampsia, with promising results. However, this is preliminary data that requires further studies. The molecular markers identified in this type of study could potentially be used, first of all, for the early screening of this condition, which is not yet reliably achievable. In addition, the knowledge gained from this research would help us better understand the pathophysiology of preeclampsia. Therefore, the investigators' goal is to carry out a multi-omics analysis of preeclampsia to uncover the genetic and molecular mechanisms involved in this condition.
연구 개요
상세 설명
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Mme STOERKEL Johanne
- 전화번호: 03 88 12 74 55
- 이메일: johanne.stoerkel@chru-strasbourg.fr
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Inclusion criteria for patients in the experimental group P:
- Pregnant women between 18 and 45 years old, between 24 and 41 weeks of amenorrhea (WA), with severe preeclampsia defined according to the criteria of the joint expert recommendations of the French National College of Gynecologists and Obstetricians (CNGOF) and the French Society of Anesthesia and Intensive Care (SFAR) from 2020 "Management of the patient with severe preeclampsia." These criteria are: gestational hypertension with systolic ≥ 140 mmHg and/or diastolic ≥ 90 mmHg, and proteinuria ≥ 0.3g/24h, plus at least one of the following severity criteria:
- Severe hypertension (SBP ≥ 160 mmHg and/or DBP ≥ 110 mmHg) or uncontrolled.
- Proteinuria > 3g/24h.
- Creatinine ≥ 90 μmol/L.
- Oliguria ≤ 500 mL/24h or ≤ 25 mL/h.
- Thrombocytopenia < 100,000/mm3
- Liver enzyme elevation with AST/ALT >2x normal.
- Epigastric abdominal pain and/or persistent or severe right upper quadrant pain "like a band."
- Chest pain, shortness of breath, acute pulmonary edema.
- Neurological signs: severe headaches not responding to treatment, persistent visual or auditory disturbances, hyperactive, widespread, and polykinetic tendon reflexes.
- Patient's free and informed consent regarding the collection of maternal blood and urine.
- Consent from both legal guardians regarding the collection of cord blood, placenta samples, and newborn data.
Inclusion criteria for patients in the control group:
- Pregnant women between 18 and 45 years old and between 24 and 41 weeks of gestation, with a pregnancy without any complications
- Free and informed consent from the patient regarding the collection of maternal blood and urine
- Consent from both holders of parental authority regarding the collection of cord blood, placental fragments, and newborn data
Exclusion Criteria:
EXCLUSION CRITERIA: for all patients
- Diabetes prior to pregnancy
- Multiple pregnancy
- Long-term medication treatment (except usual pregnancy supplements)
- Smoking, alcohol, or drug use during pregnancy
- Pre-existing liver, kidney, or heart failure
- History of bariatric surgery
- Neonatal acidosis with arterial cord pH below 7.0 (rare event)
- Genetic or chromosomal abnormality of the mother and/or newborn diagnosed prenatally
- Fetal malformation diagnosed prenatally
- Refusal to participate in the study
- Person unable to consent or under protection (guardianship, curatorship)
- Minor
- Inability to participate in the entire study
Exclusion criteria for patients in the control group T: For women in the control group, any obstetric condition (apart from delivery complications).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
Experimental group P
a group of 50 pregnant women with severe preeclampsia
|
|
Control group T
a control group of 50 pregnant women without any medical conditions.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Identifying genetic and molecular markers associated with severe forms of preeclampsia
기간: At enrollment
|
Identify, from blood, urine, and placental samples, the changes in genetic and molecular signatures as well as in cell composition associated with severe forms of preeclampsia, by comparing the expression levels of the signatures and the relative abundance of different cell populations between patients with severe preeclampsia and control patients.
|
At enrollment
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- 9262
- 2024-A01653-44 (기타 식별자: ANSM)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .