We tell you here about the PROMISE and TABLET trials

The PROMISE trial

What is it?

The PROMISE (progesterone in miscarriage treatment) trial is a major research study that aims to find out whether having progesterone supplements in the first 12 weeks of pregnancy reduce miscarriage risk in women with previous unexplained recurrent loss.

It is a randomised, double-blind, placebo-controlled trial:

Randomised Women taking part need to agree to be placed at random in either the treatment or non-treatment (placebo) group

Double-blind The women in the study won’t be told whether they are in the treatment or non-treatment group – and nor will their doctors. So both are “blinded” to this information.

Placebo-controlled The best way to compare the treatment and non-treatment groups is for them to have exactly the same conditions except the actual drug. This is done by giving the non-treatment group a placebo (dummy) tablet that looks exactly like the real treatment, but has no active ingredients.

The lead researchers are keen to recruit as many women as possible so they can be sure that numbers are big enough to make the eventual results reliable.  So if you might be interested in taking part, here’s what you need to know:

Who can take part?

The researchers are recruiting women who:

  • are aged 18 to 39
  • have had three or more first trimester miscarriages
    • first trimester = before 14 weeks of pregnancy
    • the miscarriages don’t have to have been in a row, so if you have had a healthy pregnancy before or in between your miscarriages, you may still be eligible.
  • have had normal results for all the usual investigations
  • are willing to be selected at random to have either the treatment or a placebo, without knowing which they are given

Where is it taking place?

There are 32 hospitals in the UK and another 8 in the Netherlands already taking part or waiting to start.  They are:

Ayrshire                   Ayrshire Maternity Unit

Birmingham           Birmingham Women’s Hospital

Birmingham Heartlands Hospital

City Hospital

Coventry                University Hospitals, Coventry and Warwickshire

Exeter                    Royal Devon & Exeter Trust, Wonford Hospital

Liverpool               Liverpool Women’s Hospital

London                  Guys’ and St Thomas’ Hospitals

Kings College Hospital

St Mary’s Hospital, Paddington

West Middlesex Hospital

Luton and Dunstable

Chelsea and Westminster – waiting to start (at January 2012)

Manchester            St Mary’s Hospital

N Cumbria             Carlisle and Whitehaven – waiting to start (at January 2012)

Nottingham           Queens Medical Centre – waiting to start (at January 2012)

Portsmouth           Queen Alexandra Hospital, Portsmouth

Sheffield                Royal Hallamshire Hospital

Southampton        Princess Anne Hospital

-       and hospitals in Amsterdam, Groningen, Heerlen, Leiden, Utrecht, Veldhoven and Zwolle.

If you would like to take part but don’t live near one of these centres, you may still be eligible to join the trial.  Please contact the PROMISE trial co-ordinator Dr Ewa Truchanovicz on 0121 623 6835.

You will need to travel to one of the centres to discuss and sign the consent forms, but after that all the follow-ups will be done by phone, and the trial medication will be delivered to your home address.

You can also read more at www.medscinet.net/promise.

A personal view

Our thanks to one of the members of our support forum, who has allowed us to reprint her message to another member regarding the PROMISE trial.

I just thought I would drop you a line as I did the Promise trial in June. It was easy – they just ask past history questions etc. and if you fit the criteria, when you get pregnant, you let them know asap and they request the medication. It is random, so the details are put into the computer which selects what you are having, either placebo or progesterone. As Ruth has already mentioned, you won’t know what you are getting.

You take 2 pessaries in the morning and 2 on the night and although it’s not pleasant, it’s not bad and after a day or two it soon becomes the norm.

Unfortunately for me it didn’t work. However, my first 5 miscarriages were all at 5 1/2 weeks and I went to 6.5 weeks this time. I don’t know what I took – I could have had the placebo. I can’t find out until the whole trial ends, so that will be interesting.

Although it didn’t work for me, I don’t regret doing it at all and would do it again (except you can’t take the trial more than once), As I see it, it can’t hurt and as far as my trial went, yes it didn’t help me, but if it has helped any women in the future going through what all we are, then it was well worth it.

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The TABLET trial

The TABLET trial is another randomised, double-blind, placebo-controlled trial which is looking at the role of thyroid antibodies in women with unexplained miscarriage.

They are particularly interested in seeing whether a drug called Levothyroxine reduces the risk of miscarriage in women who have thyroid antibodies even through their thyroid hormones are in the normal range.

As with the PROMISE trial, the lead researchers are keen to recruit as many women as possible so they can be sure that numbers are big enough to make the eventual results reliable.  So if you might be interested in taking part, here’s what you need to know:

Who can take part?

The researchers are recruiting women who:

  • are aged 16 – 40
  • hope to conceive in the next year
  • have had a previous miscarriage or are due to have fertility treatment
  • do not have known thyroid disease – and
  • are willing to be selected at random to have either the treatment or a placebo, without knowing which they are given.

Where is it taking place?

The following hospitals are currently recruiting patients:

  • Birmingham Women’s Hospital
  • Birmingham Heartlands Hospital
  • City and Sandwell Hospitals
  • Ealing Hospital, London
  • Liverpool Women’s Hospital
  • Crosshouse Hospital, Ayrshire
  • Walsgrave Hospital, Coventry
  • St Thomas’s Hospital, London
  • Guy’s Hospital, London
  • Kings College Hospital, London
  • James Cook Hospital, Midlesborough
  • Arrowe Park Hospital, Wirral
  • The Royal London Hospital
  • St Bartholomews Hospital
  • Watford Hospital
  • Wrightington, Wigan and Leigh Hospitals
  • St Mary’s Hospital, Manchester
  • Royal Bournemouth Hospital

As of January 2013, the following hospitals will be recruiting soon:

  • St Mary’s Hospital, Paddington, London
  • Queen’s Medical Centre, Nottingham
  • Countess of Chester Hospital
  • Sunderland City Hospital
  • Frimley Park Hospital
  • University College Hospital, Lodnon

There is also information on the trial website at www.bham.ac.uk/tablet.

If you would like more information or you wish to join the trial, please contact the TABLET office at tablet-trial@trials.bham.ac.uk.

If you have other questions or concerns about the trial, you can contact Krys Baker, the trial co-ordinator, at k.baker@bham.ac.uk,  or TABLET research fellow Dr Rima Dhillon at rima.dhillon@doctors.org.uk.

If your questions are less medical/scientific and more about feelings or concerns, do contact us at info@miscarriageassociation.org.uk.