Develop a Multi-disciplinary Approach for a Personalized Prenatal Diagnostics and Care for Twin Pregnancies
试验速览
- 阶段
- 不适用
- 入组人数
- 1,200
- 试验地点
- 7
- 主要终点
- Adverse pregnancy outcome
研究概览
简要总结
Different screening modalities evaluation to develop algorithms to predict pregnancy complications in twin pregnancies, and evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.
详细描述
This is a multi-center study to identify biomarkers or marker combinations for early prediction of pregnancy complications in twin pregnancies in the first, second or third trimester.
In the future, the identified patients' risk will enable patients' referrals for proper prevention when such will become available
Specifically the investigators aim for
- Predicting the risk to develop preeclampsia, IUGR, preterm delivery, gestational Diabetes Melitus
- Assessment of major and minor markers for chromosomal and structural anomalies
- Identification of placenta accrete spectrum disorders and vasa previa
- Diagnosis of specific MC twin complications such as TTTS
The investigators will stratify and assess all the above according to chorionicity and delivery with complications at <32 weeks, <34 weeks, <37 weeks, and at any 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years;
- •Di-chorionic (DC)or Mono-chorionic (MC) twin pregnancies;
- •Both live fetuses at 11+0-13+6 weeks of gestation;
- •Informed and written consent
排除标准
- •Monoamniotic twins
- •Triplet pregnancies that had undergone embryo reduction to twins or with one vanishing twin
- •Women who are unconscious or severely ill, those with learning difficulties, or serious mental illness;
- •Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol.
结局指标
主要结局
Adverse pregnancy outcome
时间窗: through study completion, an average of 1 year
preterm delivery before 37 weeks of gestation , or hypertension of \>90/140, from gestational week 24 and above throughout pregnancy , baby birth weight below the 5 lower centile for the gestation week, or shoulder dyctorcia at delivery, or newborn admission to NICU for any complication or placental position complications such as placenta accreta, or vasa previa, or intra uterine fetal death,
Adverse neonatal outcome
时间窗: through study completion, an average of 2 year
Admission to neonatal intensive care unit, Sepsis, asphyxia, intraventricular hemorrhage, intrauterine growth retardation
Evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.
时间窗: through study completion, an average of 2 year including stored samples collected before vaccination was avaluable.
Testing blood sample drawn for the study for antybody levels in conjunction to BNT162b2 Pfeizer/BioNTech vaccination
次要结局
未报告次要终点
研究者
Assaf Harofeh MC
Prof. Ron Maymon, MD, PhD Chairman ObGyn
Assaf-Harofeh Medical Center