Identification of Genes of Interest for Severe Forms of Preeclampsia in a Cohort of Pregnant Women With a Precise Phenotype
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Identifying genetic and molecular markers associated with severe forms of preeclampsia
研究概览
简要总结
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.
详细描述
This study is a cross-sectional, prospective, comparative, and single-center study. It compares a group of 50 pregnant women with severe preeclampsia to a control group of 50 pregnant women without any pathology.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •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).
研究组 & 干预措施
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.
结局指标
主要结局
Identifying genetic and molecular markers associated with severe forms of preeclampsia
时间窗: 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.
次要结局
未报告次要终点