Advice re trial.

[nunnie]

When I went for booking, due to my history I was offered to have some tests to see if I am suitable for the OPPTIMUM trial.
On monday I had some issues that my GP sent my to hospital for. Whilst I was being examined they found a raw patch on my cervix, which wasn't related to the pain or issues I had gone in for, will find out more about the patch hopefully at my Consultant appointment on monday, it could be related to a previous biopsy but he didn't have the paperwork, or it could be an infection swabs taken and sent for testing.

Anyway OPPTIMUM researcher has rang, and the test involves taking a swab to check for fibrogen (possibly wrong spelling or word even) if negative all okay if positive I will be offered to join the trial which involves inserting pessaries daily which will be either progesterone or placebo.

With what happened on monday I am a little concerned now that it will just be another thing to worry about, in an already worrying pregnancy for me. And if I have the test and it's positive and I decide not to bother with the trial, then it will always be at the back of my mind that I will labour early, infact even if I join the trial there is still that worry because of the placebo. Sometimes not knowing is better.

Would you want to know?

Hi nunnie, there is a little info on the OPPTIMUM study at www.opptimum.org.uk/general-information.aspx and www.opptimum.org.uk/. If I were you I would suck it & see how you feel - there is a strong chance that the fibronectin test (which I think is just a swab) will be negative, in which case you will not meet the inclusion criteria, so nothing extra to worry about at all. If you do meet the inclusion criteria, you won't know if you're being given placebo or progesterone, but your pregnancy will be monitored even more closely, so the chances of PTL causing a sig problem will be reduced. Discuss your reservations with the researchers - they are Drs and nurses too, and will be happy to talk over the pros and cons. Ultimately they want you to have a healthy delivery and if being involved will stress you out and make you unhappy, they may well advise not to take part.
hth a little.

Thanks jamama, I wasn't aware I would be monitored, as the researcher just went through the basics and is sending leaflet.

I was told by the midwife that singed me up that my Consultant won't discuss or be involved in the trial at all. Who will be monitoring will it be the researchers then?

I am a little out of my zone of knowledge here, but usually ime it is research midwives or doctors (who may be doing a PhD and are already qualified but aren't yet consultants), reporting to consultant-led teams who help conduct and manage the recruitees for these sorts of big trials. This one is big - they are hoping to recruit 10,000 women across the whole of the UK, and what they are ultimately after is outcome data - to determine whether the vaginal delivery of progesterone makes a significant difference to the incidence of preterm labour (earlier than 34 weeks gestation).

Ok thank you. Will wait for leaflet and will hopefully know what's going on with my cervix by then too.

Good luck, whatever you decide.