Progesterone May Help Pregnant Women With a Short Cervix Avoid Preterm Laborby Katlyn Joy | April 7, 2011 12:00 AM
The National Institutes of Health announced April 6, 2011 that a new study published in Ultrasound in Obstetrics and Gynecology showed promising results from the use of inexpensive progesterone gel in women who were found to have a short cervix through ultrasound screening. Dr. Romero served as Principal Investigator of the study while Sonia S. Hassan, MD served as lead author of the study.
A woman with a shortened cervix has a 25% risk of premature labor. The cervix is located at the opening of the uterus and opens and shortens during labor. A shortened cervix is associated with decreased progesterone.
Women in the study received either placebo or they applied the vaginal progesterone gel between the 19th and 23rd weeks of pregnancy until the 37th week or until the rupture of membranes or labor started. The results were startling as the treatment reduced prematurity up to 45%. Those who received the progesterone treatments also had reduced rates of respiratory distress syndrome in their newborns, at 3% versus 7.6%.
Prematurity is associated with an elevated risk of death in their first year, respiratory problems, mental retardation, cerebral palsy, blindness, hearing impairments and learning disabilities and delays. Premature birth is the leading cause of perinatal morbidity and mortality worldwide and has an economic impact of billion annually. More than 500,000 or 1 in 8 babies are born preterm each year in the US.
The study involved participants from Asia, Europe, North and South America and was done in collaboration between NIH and Columbia Laboratories, Inc. and involved 44 medical centers worldwide.
The study involved 465 healthy women between the ages of 15 and 45 in ten countries. All the women who identified as have an increased risk of prematurity due to transvaginal ultrasound measurements of the cervix of 10 to 20 millimeters, considered to be shorter than average.
Approximately half the women were US subjects. The women either received placebo or the progesterone gel. They were instructed to self-administer the gel daily in the morning.
No notable side effects were observed. Both the placebo and progesterone groups reported a low incidence, 2%, of mild symptoms such as vaginal itching or discharge, nausea and yeast infections.
Dr. Roberto Romero, Chief of the Perinatology Research Branch of the NIH stated, "The study published today offers hope to women, families, and children. Worldwide, more than 12 million premature babies, 500,000 of them in the US 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 shortcervix with a natural hormone � progesterone.
"Sonographic short cervix is a powerful predictor of preterm delivery. Our data indicate that universal transvaginal screening of women in the midtrimester to identify patients at risk can be coupled with vaginal progesterone to reduce the frequency of preterm birth and improve neonatal outcome. The availability of such clinical option would represent a significant advance in the prevention of early preterm birth and its associated complications," stated Dr. Sonia S. Hassan
Those associated with the study are hopeful that once the results become known in the medical community, cervical screenings will become a standard component of prenatal care and women identified as being at risk will receive the simple, low cost treatment, saving potentially hundreds of thousands of lives each year.
Women who know they are at risk of premature labor due to previous preterm births should discuss the study with their healthcare provider to contemplate possible treatments available now.
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