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 "It's great news for patients," lead author Dr. Arri Coomarasamy, a
professor of gynecology at the University of Birmingham, told
Reuters Health in a telephone interview. It will prevent unnecessary
progesterone treatment for most women, and give extra hope to women
facing a second, third or fourth miscarriage.
"The live birth rate is 5 percentage points higher in the
progesterone group in a pregnant woman who has had a previous
miscarriage and is now bleeding," he said. "If she's had three or
more previous miscarriages, it's 15 percentage points higher."
The bleeding that might signify trouble in the first few months of
pregnancy occurs in about 25 percent of all pregnancies. In perhaps
10 percent to 20 percent of cases, the bleeding can be a harbinger
of a lost pregnancy.
For years, doctors have used progesterone preparations off-label to
treat a threatened miscarriage based in part on a decline in hormone
levels just before a miscarriage. That led to a long-practiced
treatment of giving progesterone even though it was not backed up by
good evidence.
The new study, published in the New England Journal of Medicine,
provides evidence of when the hormone does or does not work.
"In retrospect, it is likely that the initial rationale for hormonal
therapy - that is, the observed fall in pregnancy hormone levels
before pregnancy loss - was, in fact, a consequence rather than a
cause of pregnancy failure," Dr. Michael Green of Massachusetts
General Hospital in Boston writes in an accompanying editorial.
For the 2,238 women who did not have a history of miscarriage, the
rate of live birth after 34 weeks of gestation was 75 percent among
women with bleeding treated with 400 milligrams of micronized
progesterone twice daily versus 72 percent among women treated with
matching placebo. Statistically, that difference is too small to
rule out the possibility it was due to chance.
"There was no benefit of any kind," Coomarasamy said.
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But among women who had experienced one or more miscarriages, 75
percent in the progesterone group gave birth compared with 70
percent who got vaginal placebo suppositories, suggesting that the
hormone helped.
Women in the ultra-high risk group, who had experienced three or
more miscarriages, had a successful pregnancy 72 percent of the time
if they were given progesterone versus 57 percent with placebo.
The findings are expected to increase progesterone use in the UK,
where a 2012 survey showed that it was only given in 4.5 percent of
cases of bleeding in early pregnancy, and to lower use of the
hormone in some countries where up to 90 percent of women get
progesterone if they have bleeding.
"Right now, if a patient starts bleeding, they will go to their
local hospital and doctors will do an ultrasound to see if the
pregnancy is okay," Coomarasamy said. "The doctors would tell the
patient you have two-thirds chance that everything is okay and a
one-third chance of miscarriage. If the patient asks what can be
done about that, right now the answer is nothing. Now, for the first
time, we might be able to say there is a treatment that might help
you if you have had a miscarriage before."
A woman who has never lost a pregnancy may wish to be treated
anyway, but "this is where the doctor will need to share the
evidence and show there is no benefit to be had" for her from
progesterone therapy.
The researchers found no evidence that the treatment, which used a
natural version of progesterone, was harmful.
SOURCE: https://bit.ly/2Lx5Tpz The New England Journal of Medicine,
online May 8, 2019.
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