Progesterone and pregnancy

Research ethics committees have recently started objecting to randomised trial acronyms, like PROMISE or PROTECT, because people may be unduly encouraged to participate, thinking the trial is testing a “promising” treatment, or “protecting” them in some way. But what about experimental treatments given outside randomised trials? No-one seems to care how they’re named.

PROMISE is an ongoing trial (details here) testing the effect of progesterone to prevent recurrent miscarriage and PROTECT a planned trial from the same group, to test the same drug to treat threatened miscarriage. PROTECT got caught up in the above ethical nonsense and had to change its acronym to PRISM.  But the drug they are testing is “pro/gest/erone”, the “for/gestation/steroid”!

Progesterone is one of many hormones needed for pregnancy, and early in IVF pregnancies, where the natural source from the ovary is missing, it works.  But that’s it.

Most miscarriages are caused by chromosomal problems for which no treatment could possibly work and, although difficult to prove, many of the rest are probably caused by lethal genetic abnormalities.  No progesterone deficiency syndrome causing miscarriage, has ever been described, and no animal studies have shown benefit. P4-ene-3,20-dione would never have been heard of again.

But it was called progesterone. Doctors prescribed it, women swallowed it, and since most women, even after recurrent miscarriage, will have a successful pregnancy anyway, they easily convinced themselves it worked, and half a dozen badly designed trials appeared to show an implausibly large benefit. It’s a similar story for premature birth (click here).

At last decent trials are being done. It’s bonkers for ethicists to fret about women getting pushed into them, rather than about the millions swallowing the For Gestation Steroid outside.

It must work – the name says so.

Jim Thornton