UPDATE 1-Simple treatment cuts preterm births by 45 percent

* Women with a short cervix carried babies longer

* Treatment cut rate of breathing problems in babies
(Adds companies, details, stock moves)

By Julie Steenhuysen

CHICAGO, April 6 (Reuters) – Treating high-risk pregnant
women with the hormone progesterone cut their rate of premature
delivery by 45 percent and helped lower the risk of breathing
complications in their babies, U.S. researchers said on

The late-stage study of the vaginal gel made by Columbia
Laboratories Inc (CBRX.O: Quote, Profile, Research) and Watson Pharmaceuticals Inc
(WPI.N: Quote, Profile, Research) raises hopes for a simple way to prevent premature
birth in women with a short cervix.

“The study published today offers hope to women, families
and children,” Dr. Roberto Romero, chief of the perinatology
research branch of the National Institutes of Health, said in a

“Worldwide, more than 12 million premature babies – 500,000
of them in this country – are born each year, and the results
are often tragic. Our clinical study clearly shows that it is
possible to identify women at risk and reduce the rate of
preterm delivery by nearly half, simply by treating women who
have a short cervix with a natural hormone – progesterone,”
Romero said.

Babies born too early — before the 33rd week of pregnancy
— have a higher risk of early death and long-term health and
developmental problems.

In the United States, 12.8 percent of babies were born
preterm in 2008, raising their risk of dying in their first
year and having breathing difficulties, cerebral palsy,
learning disabilities, blindness and deafness.


The findings, published online in the journal Ultrasound in
Obstetrics and Gynecology, will be used to support the
companies’ application for marketing approval of the hormone
gel, known by the brand Prochieve.

The companies said they plan to file for U.S. approval in
the second quarter of this year.

In the study, researchers at the NIH and 44 medical centers
around the world looked at effects of giving progesterone to
women with a short cervix, which is the part of the uterus that
opens and shortens during labor.

Researchers suspect that women with a short cervix may not
have enough of this hormone, and giving it during pregnancy in
a gel form might help prolong their pregnancies.

The team studied 458 women with a short cervix who got
either a vaginal gel containing progesterone or a placebo
between the 19th and 23rd week of pregnancy.

Only 8.9 percent of women who got the gel delivered before
the 33rd week of pregnancy, compared with 16.1 percent who were
in the placebo group.

The treatment also helped babies. Only 3 percent of babies
born to women treated with progesterone had respiratory
distress syndrome compared with 7.6 percent of babies in the
placebo group.

“We have for a long time known that short cervix is
associated with an increased risk of preterm birth,” said Dr.
Ashley Roman of New York University’s Langone Medical Center,
who was not involved with the research.

Roman said other studies have shown that progesterone can
cut the risk of premature birth in women with this problem. She
said the NIH study is important because it shows that the
treatment also reduces respiratory problems in newborn babies.

“Not only are fewer babies being delivered preterm, fewer
babies have medical problems associated with prematurity,” she
said in a statement.

Watson’s shares were up about 1 percent in afternoon
trading on the New York Stock Exchange, while shares of
Columbia fell about 2 percent after touching an earlier 52-week
high on Nasdaq.
(Editing by Vicki Allen)

UPDATE 1-Simple treatment cuts preterm births by 45 percent