PRISM Follow-up: Child health review following progesterone in pregnancy

Long-term health assessment of children following first trimester progesterone treatment in the PRISM trial (PRISM Follow-up)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10651813

Enrollment

2502

Registered

2025-10-08

Start date

2025-11-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

A prospective observational study to follow up children born to women following first-trimester progesterone treatment who participated in the PRISM trial. Pregnancy and Childbirth

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: Not meeting the key inclusion criteria

Design outcomes

Primary

Measure	Time frame
General health status and health-related quality of life (HRQoL) measured using the Health Utilities Index (HUI3) at one time point	—

Secondary

Measure	Time frame
1. Health-related quality of life measured using the EuroQol EQ-5D-Y-3L quality-of-life tool at one time point 2. Incidence of childhood health conditions (formally diagnosed by a doctor or relevant specialist) measured using University of Birmingham questions at one time point. The conditions investigated are autism spectrum disorder (ASD), attention deficit hyperactivity disorder (ADHD), dyslexia, dysgraphia, dyspraxia, dyscalculia, obsessive-compulsive disorder (OCD), anxiety and depression.	—

Measure

Time frame

1. Health-related quality of life measured using the EuroQol EQ-5D-Y-3L quality-of-life tool at one time point 2. Incidence of childhood health conditions (formally diagnosed by a doctor or relevant specialist) measured using University of Birmingham questions at one time point. The conditions investigated are autism spectrum disorder (ASD), attention deficit hyperactivity disorder (ADHD), dyslexia, dysgraphia, dyspraxia, dyscalculia, obsessive-compulsive disorder (OCD), anxiety and depression.

—

Countries

England, United Kingdom

Contacts

Public ContactLee;Adam Priest;Devall

;

l.priest.1@bham.ac.uk;a.j.devall@bham.ac.uk-;-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 10, 2026