PRISM Follow-up: Child health review following progesterone in pregnancy
The PRISM Follow-up study is looking into the long-term health of children whose mothers participated in the PRISM trial. That trial checked if a hormone called progesterone could help prevent miscarriage in women with early pregnancy bleeding. While earlier results showed progesterone helped some women, we don’t have much information about the long-term health of their children. This new study aims to fill that gap. We will compare the health of children whose mothers took progesterone with those whose mothers didn't, to make sure this treatment is safe for babies in the long run. The findings will help doctors give the best advice to women in the future.
At a glance
What is this study about?
You might remember the PRISM trial, which was a very important study looking into whether a natural hormone called progesterone could help prevent miscarriages in women who had bleeding early in their pregnancy. The trial found that progesterone did help some women, particularly those who had experienced miscarriages before. Because of these findings, doctors in the UK now sometimes recommend progesterone for these women.
While progesterone has been used for a while, we don't have much information about the health of children born to mothers who took it in early pregnancy. It's really good practice in medicine to check on children and their development after they've been part of such a trial. This helps us make sure treatments are safe in the long run, not just for the mother but also for the baby.
This new study, called PRISM Follow-up, is designed to do just that. We want to check the health and development of children who were born during the PRISM trial. We'll be comparing children whose mothers received progesterone with those whose mothers received a dummy treatment (placebo). This information is very important to give us a complete picture of whether progesterone is fully safe for both mother and baby. Ultimately, this will help doctors and parents make informed decisions in the future.
Key takeaways
- This study is checking the long-term health of children from the earlier PRISM trial.
- It aims to see if progesterone in early pregnancy had any effects on their development.
- Participation involves completing a health questionnaire about your child.
- Access to your child's health records will also be sought to gather important information.
- This research will help doctors give clear advice about progesterone use in future pregnancies.
Who may be eligible?
This study is for women who previously took part in the PRISM trial and had a live birth. If you were one of these mothers, you would have already given permission during the PRISM trial to be contacted for future studies like this one.
To join, you need to be willing to give your consent again for this specific follow-up study. You’ll also need to be able to complete a health questionnaire about your child.
If you don't meet these specific conditions, then unfortunately you won't be able to take part in this follow-up study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Did I take part in the original PRISM trial?
- Did I have a live birth after participating in the PRISM trial?
- Did I previously agree to be contacted for future studies related to PRISM?
- Am I able and willing to complete a health questionnaire about my child?
What does participation involve?
If you are eligible and agree to take part, the first step is to tell you more about this follow-up study. You'll receive information about it, and if you're happy to proceed, you'll be asked to sign a consent form. After that, you'll complete a health questionnaire about your child or children.
To get the most accurate information, we also need permission to look at your child's electronic health records, such as those held by their GP or in hospital systems. This is a common and legally allowed way to gather important health details, particularly when tracing previous study participants, without needing to bother you for every piece of information. The study team will only access necessary information to understand your child's health and development. We'd also check to make sure your contact details are up-to-date and, if needed, check on your and your child's health records to confirm contact information or status.
Potential risks and benefits
Locations (1)
- -Unverified- NO COUNTRY SPECIFIED, assuming England, England
Common questions
What was the PRISM trial about?
The PRISM trial looked at whether progesterone treatment could help prevent miscarriage in women who experienced bleeding in early pregnancy.
Why is this follow-up study needed?
We want to check the long-term health of children whose mothers took part in the PRISM trial to make sure progesterone treatment is safe for babies. This helps improve future care.
Will I have to go to any appointments?
No, you won't need to attend any appointments. Your participation will involve completing a questionnaire about your child's health.
How will my child's information be kept private?
All information will be handled with strict confidentiality. Personal details are protected, and any health records accessed are for study purposes only, under special legal provisions.
Who is paying for this study?
The study is being funded by the NIHR Research for Patient Benefit (RfPB) in the UK.
How to find out more
Lee Priest
Always speak to your GP or specialist before deciding to take part in a study.
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