The WOMAN trial

UK clinical research is a bureacratic nightmare.  Dozens of regulators can scupper each project and demand changes.  Participants end up reading lengthy information sheets, and signing innumerable forms.  Only the most dogged researchers and patients persist.

For genuinely risky experiments the paperwork may be justified, but for most trials of treatments already in widespread use it delays progress, and in the long run harms patients.   So it’s lovely when common sense prevails.

WOMAN is a randomised trial to see whether a medicine called tranexamic acid can help mothers who bleed heavily after giving birth.   The drug is already widely used to treat heavy periods, so we know it’s safe.  We also know that it works for non-pregnant patients bleeding for other reasons.  But we are not sure if it does more good than harm in pregnancy.  It probably helps stop bleeding, but pregnant women are susceptible to blood clots, and it might possibly increase these.   No-one knows how the balance of risks pans out, so policies vary widely.  Some doctors always give the drug, some never do.  In Sweden they always use it, but I’ve been practising obstetrics in England for nearly 30 years and never have.  We can’t both be right.

Only a randomised trial in many thousands of women can answer the question.

But how can you get informed consent from a woman who has just given birth and is bleeding heavily?  She’ll be exhausted and frightened, doctors and midwives will be rushing round trying to stem the flow, put up drips, X match blood.  It’s hopeless.  If she’s under anaesthetic it’s impossible.  But these are just the patients the trial needs to recruit.

Some people think the solution is for everyone, hundreds of thousands of women, to be told about the trial before they go into labour so they can give permission if they later bleed.   But that won’t work.  Women already have dozens of forms and paperwork to think about in the antenatal clinic.  They aren’t going to consider seriously a hypothetical research question which will probably never arise.

Fortunately the regulators and lawyers who set the rules for trials, created a common sense exemption for just this situation.  If the risks were minimal and the research question sufficiently important, consent could be deferred till the situation had stabilised.   And praise be!  The UK research ethics committee agreed that the WOMAN trial qualified.

We joined about four weeks ago in Nottingham, and it’s working really well.  We’ve already recruited four participants.  Some doctors were concerned when they first heard about it, but nothing is secret.  We tell parents and staff what we’re doing, and if the parents say no, we don’t recruit.  But we don’t waste time wrestling with information sheets and consent forms, and we are honest about it.  We leave all that for the following morning.

So far everyone has understood, and been delighted.   Around the world over a thousand women have been recruited.   More UK centres will join soon.

It won’t be long before we find out whether tranexamic acid does more good than harm, or not.  We can then give it to everyone, or no-one, and many lives will be saved.

Jim Thornton

Read more about the WOMAN trial here

1 March 2012 update – I’ve just been sent these two articles describing people’s views about all this. Snowden2012-Women&PartnersViewsOfEmergencyConsentPPH-VERA-2-MW      Snowden2012-Women&PartnersExperiencesPPH-VERA-1-MW

They aren’t easy to read but I think they are saying that people find the whole thing frightening and are somewhat sympathetic to the approach of letting the doctor decide about recruitment.