Long-term health assessment of children following first trimester progesterone treatment in the PRISM trial (PRISM Follow-up)
A prospective observational study to follow up children born to women following first-trimester progesterone treatment who participated in the PRISM trial.
This is a prospective observational study to follow up children born to women who participated in the PRISM trial (https://www.isrctn.com/ISRCTN14163439). Health Utilities Index (HUI3) score of the children – a rating scale used to measure general health status and health-related quality of life (HRQoL). The Health Utilities Index 3 (HUI3) is a generic, preference-based, comprehensive system for measuring health status and health-related quality of life. HUI3 was developed to apply to both clinical and general population studies, and to have structural independence among the attributes. Each HUI attribute (dimension) has 3–6 levels of classification and is very responsive to changes in health caused by treatment therapies or other influences. The questionnaire is validated and commonly used as an outcome measure in clinical studies and population health surveys. The HUI3 classification system is comprised of 8 attributes – (i) Vision, (ii) Hearing, (iii) Speech, (iv) Ambulation, (v) Dexterity, (vi) Emotion, (vii) Cognition and (viii) Pain, each measuring 5 or 6 levels of ability (including low ability and disability). EQ-5D-Y-3L score of the children: The EQ-5D-Y-3L descriptive system comprises the five dimensions: (i) mobility, (ii) self-care, (iii) usual activities, (iv) pain/discomfort and (v) anxiety and depression. Within this validated questionnaire, each dimension has three levels: no problems, some problems, and extreme problems. The participant is asked to indicate their child(ren)’s health state by ticking the box next to the most appropriate statement in each of the five dimensions. Additional secondary outcomes for the children: 1. Autism spectrum disorder (ASD) – a neurodevelopmental disorder characterised by deficits in social communication and the presence of restricted interests and repetitive behaviours. 2. Attention deficit hyperactivity disorder (ADHD) – an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes wi
1. Participation in the PRISM Trial and had a live birth 2. Previously gave informed consent as part of the PRISM trial to be contacted about future follow-up studies 3. Willing and able to give informed consent for this study 4. Ability to confirm they wish to complete the parental follow-up questionnaire
Not meeting the key inclusion criteria