Fetal, Obstetrics and Reproduction Genomics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 主要终点
- Number of Participants with preeclampsia (PE) during pregnancy
研究概览
简要总结
The purpose of this study is to determine the impact of a clinical screening strategy and genomic analysis of the factors involved in Placental Dysfunction (Preeclampsia and IUGR) in women of advanced maternal age undergoing assisted reproduction techniques (ART), specifically, in vitro fertilization (IVF) and oocyte donation.
详细描述
Given society's shift towards later childbearing, partly related to increased career development, women are increasingly delaying childbearing and, as a result, face declining biological fertility and increased maternal morbidity and adverse perinatal pregnancy outcomes, as well as increased use of ART. Preeclampsia (PE) complicates 2% of pregnancies and is a leading cause of severe maternal and perinatal complications. There is no curative treatment, and the only recognized beneficial primary prevention is low-dose aspirin. Finding an effective method of predicting and preventing placental dysfunction (PD) in women of advanced maternal age undergoing ART remains a challenge.
The investigators believe that maternal and perinatal complications in this group of pregnant women could be detected preclinically and allow early preventive actions.
On the other hand, establishing a differentiated genomic pattern in this group of patients would allow preventive actions both pregestational and during gestation. Furthermore, FORgenomics can be used to externally validate a prediction model for the development of PE and IUGR in pregnancy after IVF/ovodon. Our results could be applicable in most healthcare settings and have important implications for maternal-fetal health.
The justification and hypothesis of this proposal is: (1) maternal and perinatal complications in this group of pregnant women could be detected preclinically and allow preventive actions by systematic screening based on Doppler ultrasound of uterine arteries and anti-angiogenic factors (sFlt-1/PlGF ratio) at 13, 16, 20 and 26 weeks to identify pregnant women at high risk for developing PE; (2) morphological ultrasound at 13, 16 and 20 weeks would help to establish a standardized procedure for early detection of congenital anomalies and (3) establishing a differentiated genomic pattern in this group of patients would allow preventive actions both pregestational and during gestation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Age ≥40 years
- •Signed informed consent
- •Gestation obtained by IVF or ovodonation
排除标准
- •Non-ongoing pregnancy
- •Gestation obtained by artificial insemination
- •Naturally obtained gestation, without ART
- •Multiple pregnancy
- •Pregnancies complicated by major fetal abnormality identified at the first-trimester ultrasound
- •Age <18 years
- •Poor understanding of the Spanish or English languages
- •Refusal in informed consent to participate in the study
- •Participation in another intervention study that could modify follow-up
结局指标
主要结局
Number of Participants with preeclampsia (PE) during pregnancy
时间窗: ≥20 weeks to <37 weeks of gestation
Defined as systolic blood pressure ≥ 140mmHg or diastolic blood pressure ≥ 90mmHg with an interval of at least 4 h after 20 weeks' gestation plus any of the following: (i) proteinuria (\>300 mg/24 h) or a urine protein/creatinine ratio \> 0.3 mg/mmol); (ii) end-organ dysfunction: systolic blood pressure \> 160 mmHg, diastolic blood pressure \>110 mmHg, platelet count \<100x109/L, blood alanine and aspartate transaminases \>70 IU/L, serum creatinine \>1. 1 mg/dL, lactate dehydrogenase \>700 IU/L, right upper quadrant or epigastric pain, dyspnea and/or cerebral/visual disturbances. Or (iii) utero-placental dysfunction (estimated fetal weight \<3rd centile or \<10th centile with abnormal uterine or umbilical Doppler \[pulsatility index \>95th centile\]) as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP) with minor adaptations for study purposes.
Number of fetuses diagnosed with intrauterine growth restriction (IUGR) during pregnancy
时间窗: ≥20 weeks to <37 weeks of gestation
IUGR will be defined by the following criteria: Estimated fetal weight (EFW) between percentile (p) 3 and p 10 with Doppler alteration (uterine arteries \> p 95 or cerebroplacental index \< p 5, or middle cerebral artery \< p 5, or umbilical artery \> p 95). PFE \< p 3 independently of feto-maternal Doppler.
次要结局
- Cesarean section rate(During birth)
- Number of fetuses and newborns with severe perinatal morbidity(From birth up to 7 days of life)
- Maternal anxiety and psychological impact(From conception up to 4 days after birth)
- Number of Participants with pregnancy-related maternal morbidity(From conception up to 4 days after birth)
- Maternal experience and psychological impact(From conception up to 4 days after birth)