Association of Assisted Reproductive Technologies Parameters With the Perinatal Outcome in Singleton and Multiple Pregnancies: A Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12,084
- 试验地点
- 6
- 主要终点
- Small for gestational age neonates
研究概览
简要总结
The goal of this prospective cohort study is to examine how different parameters of assisted reproductive technologies (ART) are associated with the perinatal outcome in individuals with singleton or multiple gestations. The main questions it aims to answer are:
Are ART pregnancies associated with a higher risk of:
- Small for gestational age neonates?
- Fetal growth restriction, either early- or late-onset?
- Development of preeclampsia?
- Stillbirth (intrauterine fetal death after 22 weeks not due to known anomalies)?
- Are certain ART parameters-such as the type of fertilization (e.g., IVF vs. ICSI), embryo stage at transfer, use of fresh vs. frozen embryos, or ovarian stimulation protocols-more strongly associated with adverse outcomes?
Are ART pregnancies associated with placental and umbilical cord abnormalities, including:
- Placenta previa?
- Vasa previa?
- Single umbilical artery?
- Velamentous or marginal cord insertion?
Researchers will compare outcomes between pregnancies conceived through ART and those conceived spontaneously.
Participants will:
- Be individuals aged 18 or older undergoing routine first-trimester ultrasound between 11 and 14 weeks of gestation
- Provide detailed medical, obstetric, and ART-related information
- Undergo routine prenatal assessments, including ultrasound evaluations of fetal growth, Doppler studies, and placental characteristics
- Have perinatal outcomes such as gestational age at birth, mode of delivery, birthweight, and complications systematically recorded
Statistical models will be used to adjust for confounding factors such as maternal age, BMI, parity, and smoking.
The aim is to better understand how ART and specific ART parameters may influence maternal and neonatal health and to improve counseling and clinical care for people using fertility treatments.
详细描述
Rationale:
In this multicenter prospective cohort study, our primary aim is to determine the association of various assisted reproductive technologies (ART) parameters with the perinatal outcome after adjusting for key confounders such as maternal age, BMI, parity and smoking. Our primary outcomes will be small for gestational age neonates, fetal growth restriction, preeclampsia and stillbirth. Additionally, the investigators will examine the association between ART and a range of placental/umbilical abnormalities-such as placenta previa, vasa previa, single umbilical artery, and abnormal cord insertions-and explore how these structural aberrations may act as a mediator. Together, this comprehensive approach is intended to clarify the mechanisms linking ART to adverse obstetric outcomes and ultimately inform improved clinical care and counseling for couples considering ART.
Objectives:
Primary Objective:
To evaluate the association between ART parameters and a series of adverse perinatal outcomes both in singleton and in multiple pregnancies, analyzed as distinct populations. ART pregnancies will be examined both as a collective cohort and within subgroups stratified by specific ART techniques and treatment protocols.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Small for gestational age neonates
时间窗: At delivery/birth
Small for gestational age neonates defined as birthweight lower than the 10th percentile
Development of preeclampsia
时间窗: From the 20th gestational week and up to 8 weeks after the delivery/birth
New onset of hypertension (systolic pressure ≥140 and/or diastolic pressure ≥90 mmHg) and proteinuria or the new onset of hypertension plus significant end-organ dysfunction with or without proteinuria, typically presenting after 20 weeks of gestation or postpartum.
Fetal growth restriction
时间窗: From the 22nd gestational week and up to the delivery/birth
Fetal growth restriction, either early-onset (\<32 weeks) or late-onset (\>32 weeks), characterized by an estimated fetal weight below the 3rd percentile or below the 10th percentile based on the Fetal Medicine Foundation fetal growth charts accompanied by abnormal Doppler findings; or birthweight below the 5th centile based on the FMF neonatal growth charts
Stillbirth
时间窗: From the 24th gestational week and up to the delivery/birth
Stillbirth (intrauterine demise after 22 weeks gestation not attributable to other causes (i.e. congenital infections, structural defects, genetic anomalies)
次要结局
- Velamentous and marginal cord insertions(From the 20th gestational week up to the 24th gestational week.)
- Single umbilical artery(From the 20th gestational week up to the 24th gestational week.)
- Placenta previa(From the 20th gestational week up to the 24th gestational week.)
- Vasa previa(From the 20th gestational week up to the 24th gestational week.)
研究者
Themistoklis Dagklis
Associate Professor of Obstetrics and Gynecology
Aristotle University Of Thessaloniki