Evaluating the Long-term Neurocognitive Effects of Preconceptional Exposure to Iodinated Contrast During Hysterosalpingography (HSG) on the Offspring of the H2Oil Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Behavioural functioning evaluated through the Strengths and Difficulties Questionnaire (SDQ).
研究概览
简要总结
Iodinated contrast is commonly used in hysterosalpingography (HSG), a diagnostic tool in fertility work-up. This study aims to investigate the safety of contrast media used during HSG by evaluating the long-term effects on the neurodevelopment of offspring 6-8 years after exposure to iodinated contrast media.
详细描述
Background: Iodinated contrast is commonly used in hysterosalpingography (HSG), a diagnostic tool in fertility work-up. Yet excessive iodine may pool for a long time in the body, crosses the placenta easily, and can induce hypothyroidism in both mothers and foetuses. Inadequate supplies of thyroid hormones have previously been associated with neurocognitive impairments in offspring. Considering the widespread use of iodinated contrast during fertility work-up, the potential iatrogenic effect of preconceptional iodine exposure on the brain development of the offspring needs to be addressed urgently.
Objectives: This project aims to investigate the safety of contrast media used during HSG by evaluating the long-term effects on the neurodevelopment of offspring 6-8 years after exposure to iodinated contrast media. To do this, the investigators will follow up on a cohort of offspring conceived during the H2Oil randomised controlled trial (NTR 3270), which was set up to evaluate the effect of using water- or oil-based media during HSG on pregnancy rates.
Methods: The study team have previously obtained parental permission for follow-up research in 140 children conceived during the H2Oil study <6 months after exposure to iodine during the HSG. The investigators will conduct comprehensive an in-depth outcome assessment of intelligence, neurocognitive development, school performance, and behavioural functioning.
Relevance: Using this diverse range of methods, the investigators expect to be the first to shed light on the long-term iatrogenic consequences of using iodinated contrast just before conception on the neurodevelopment of their offspring. The findings of this study will have implications for current clinical practice, where HSG is readily used in subfertile women, and will be used to inform the Dutch guidelines for fertility work-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children conceived after the mother underwent HSG procedure in the context of the H2Oil trial (2012-2014)
- •Children must be conceived <6 months after the HSG procedure
- •Parents must have given consent for recontacting for follow up research
排除标准
- •Children conceived after the mother underwent HSG procedure that was not part of the H2Oil trial
- •Children conceived >6 months after the HSG procedure
- •Children whose parents did not give permission to be recontacted for follow up research
- •Children that are not able to comprehend the instructions at the time of assessment
- •Absence or withdrawal of written informed consent
- •Inability to comprehend testing instructions at time of assessment
- •Severe motor disability that interferes with outcome assessment at time of assessment
- •Documented and/or parent-reported diagnosis of a neurological disorder
- •Somatic disorders known to affect the outcome assessments at time of assessment
结局指标
主要结局
Behavioural functioning evaluated through the Strengths and Difficulties Questionnaire (SDQ).
时间窗: 1 Day
Behavioural functioning will be evaluated through the Strengths and Difficulties Questionnaire (SDQ). Both parents and teachers will fill in the SDQ.
Intelligence
时间窗: 1 Day
General intelligence will be assessed using a shortened Fifth version of the Wechsler Intelligence Scale for Children. Full-scale IQ (FSIQ) will be estimated using the subtests Vocabulary, Similarities, Matrix Reasoning, and Block Design.
School performance
时间窗: Between the ages of 4-12, up to 12 years
Longitudinal data on school performance will be collected using standardised tests from the pupil monitoring system developed by the Dutch National Institute for Educational Measurement (CITO-test). CITO-tests are used to assess children's academic performance (reading comprehension, spelling, and arithmetic performance) in primary schools in the Netherlands.
Behavioural functioning evaluated through the Strengths and Weaknesses of ADHD Symptoms And Normal behaviour (SWAN) scale.
时间窗: 1 Day
Behavioural functioning will be evaluated will be evaluated using the Strengths and Weaknesses of ADHD Symptoms And Normal behaviour (SWAN) scale. Both parents and teachers will fill in the SWAN scale.
次要结局
- Verbal Memory(1 Day)
- Visuomotor integration(1 Day)
- Verbal Working Memory(1 Day)
- Processing & Control(1 Day)
- Visual Memory(1 Day)
- Visual Working Memory(1 Day)
研究者
Prof. Velja Mijatovic
Professor in Obstetrics and Gynaecology, Specialist in Reproductive Medicine, Head of Endometriosis Center VUmc
Amsterdam UMC, location VUmc