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临床试验/NCT05952583
NCT05952583招募中不适用

Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation

Leiden University Medical Center6 个研究点 分布在 6 个国家目标入组 274 人开始时间: 2023年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
274
试验地点
6
主要终点
Composite outcome

研究概览

简要总结

Optimal diagnostic management and underlying pathophysiological mechanisms of selective fetal growth restriction (sFGR) in monochorionic diamniotic (MCDA) twin pregnancies have not been fully clarified.

The current diagnostic classification system based on three different umbilical artery flow patterns has no increasing scale of severity and the predictive value is limited. Since there is no treatment available for sFGR, predicting fetal deterioration is key in preventing single or double fetal demise. Outcome prediction is furthermore important in the selection of cases that will be offered selective reduction (to provide the larger twin with better prospects), as well as determining monitor frequency and possible hospital admission. As outcome prediction is clinically challenging, patient counselling is too, and parents often encounter a great deal of uncertainty during the pregnancy.

Furthermore, little is known about the brain development of sFGR children (both during pregnancy and after birth). Moreover, the psychological impact of an sFGR pregnancy of the future parent)s) has not been studied before. The impact of these factors should be taken into account during patient counseling, which is currently not the case.

By our knowledge, this is the first international, multicenter, prospective cohort study on that will address the abovementioned questions and knowledge gaps in MCDA pregnancies complicated by selective fetal growth restriction.

详细描述

Selective fetal growth restriction (sFGR) in monochorionic twins may negatively impact the pregnancy. There is a substantial risk of fetal deterioration resulting in (iatrogenic) preterm birth or even intrauterine demise of one, or both fetuses. There are important unresolved challenges on a diagnostic level and underlying pathophysiological mechanisms of sFGR have not been fully clarified.

The current diagnostic classification system based on three different umbilical artery flow patterns has no increasing scale of severity and the observed flow patterns may be volatile in nature. This hinders optimal diagnostic management and complicates outcome prediction as the survival outcome differs per umbilical artery flow type. Consequently, parents encounter a great deal of uncertainty during the pregnancy. Since there is no treatment available for sFGR, predicting fetal deterioration is key in preventing single or double demise.

By testing several predictors, the investigators are aiming to improve outcome prediction at the time of sFGR diagnosis. The investigators furthermore hypothesize that additional ultrasound parameters could be of benefit in making the current classification system more accurate and less variable. Extensive histological placental examinations will shine a light on microscopic abnormalities which can increase our knowledge of the pathophysiology. Examining neurodevelopment of sFGR twins at two years of age will additionally be of great value for our understanding of the impact of sFGR and contribute to adequate patient counselling. Our study will evaluate the impact of a sFGR pregnancy on parental mental health and parent-to-infant(s) attachment, which has not been carried out this extensively before.

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 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • MCDA twin pregnancy
  • Diagnosis of sFGR before 28+0 weeks of GA (independent of Doppler flows)
  • Pregnant woman ≥ 18 years and able to consent
  • Partner (who has (future) parental responsibility - if applicable) ≥ 18 years and able to consent
  • Written informed consent of both parents (if applicable) for participation in the longitudinal follow-up until 2 years after birth)

排除标准

  • The presence of lethal anomalies (one or both fetuses)
  • Multiple pregnancy higher order than twins;
  • TTTS/TAPS present at moment of sFGR diagnosis.

结局指标

主要结局

Composite outcome

时间窗: 2 years

The composite outcome consists of fetal single or double demise, including selective fetal reduction and/or an iatrogenic elective birth \< 32 weeks of gestational age because of fetal distress).

次要结局

  • Prenatal and postnatal attachment(2 years)
  • Ultrasound parameters(2 years)
  • Post-traumatic stress(2 years)
  • PARCA-R evaluation(2 years)

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

ejtverweij

Principal Investigator

Leiden University Medical Center

研究点 (6)

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