Navigation Links
Vaginal progesterone gel may improve infant outcomes and...
Date:10/2/2007

LIVINGSTON, NJ October 2, 2007 For the first time, data show a positive association between the use of vaginal progesterone and infants overall health at birth. Babies born to women with high-risk pregnancies treated with PROCHIEVE 8% (progesterone gel) appear to be less likely to need intensive care than babies born to mothers treated with placebo, Columbia Laboratories, Inc. (NASDAQ:CBRX) announced today. The data are published in the October issue of Ultrasound in Obstetrics & Gynecology (also known as The White Journal), the official publication of the International Society of Ultrasound in Obstetrics and Gynecology.

Researchers conducted a secondary analysis of phase III data from the largest-ever singleton preterm birth prevention study with progesterone looking specifically at a group of 46 women with high-risk pregnancies because they had a short cervix (less than 2.8 cm measured by trans-vaginal ultrasound). This analysis shows several statistically significant findings, including:

  • Only one out of six (16%) newborns of mothers treated with vaginal progesterone gel needed to be admitted to neonatal intensive care units compared to one out of two (52%) newborns of mothers treated with placebo (p-value of 0.016); and

  • Infants born to mothers treated with vaginal progesterone gel who were admitted to intensive care units spent on average only one day in intensive care compared to more than two weeks for those babies of mothers who received placebo (p-value of 0.013).

This is the first and only preterm birth prevention study that is associated with statistically significant improvements in clinically important measures of infant outcomes. Additional studies are being planned to repeat this unique finding.

In addition, the analysis provided new insight into which women with high-risk pregnancies respond to treatment with vaginal progesterone gel. It showed that treatment with vaginal progesterone gel may reduce early preterm birth among women with a short cervix.

When looking at a sample of 46 women with a short cervix of less than 2.8 cm, zero of those who were started on vaginal progesterone gel between 18-to-22 weeks of gestational age delivered prior to 32 weeks of gestation, while almost one in three women (29.6 percent; p=0.014) with a shortened cervix given a placebo delivered prior to 32 weeks of gestation, said Emily DeFranco, DO, primary author of the study and clinical fellow of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and Center for Preterm Birth Research at Washington University School of Medicine in St. Louis. Additionally, the number of admissions and days spent in the neonatal intensive care unit, important measures of neonatal outcome, for babies whose moms were given vaginal progesterone gel were significantly lower than for those whose moms received placebo. Were excited about these promising clinical implications, especially if confirmed in a larger study.

Publishing these findings is an important step toward informing healthcare providers about the group of women who may benefit from vaginal progesterone by reducing their chances for having an early preterm birth, said study co-author John OBrien, M.D., affiliated with Central Baptist Hospital, Lexington, KY. There are currently no FDA-approved treatments available to help prevent preterm birth, so this research, combined with future studies, may lead to viable treatment options.

The published subset of data is from a randomized, double-blind, placebo-controlled study -- the largest study to date evaluating the effect of progesterone on early preterm birth in singletons. The report on these data, entitled Vaginal Progesterone Is Associated With a Decrease in Risk for Early Preterm Birth and Improved Neonatal Outcome in Women with a Short Cervix, is available at http://www3.interscience.wiley.com/cgi-bin/jhome/99020267.

Based on the statistically significant findings in the secondary analysis, we are moving forward with a follow-up study using PROCHIEVE 8%, stated Robert S. Mills, president and chief executive officer of Columbia Laboratories. It is estimated that of the more than 4.1 million live births in the U.S. each year, up to 30 percent of pregnant mothers have a cervical length less than or equal to 3.0 centimeters in mid-pregnancy. This includes many women with first-time pregnancies, the group that has the largest number of premature babies each year. We look forward to publishing the results of the next study.

A normal pregnancy is about 40 weeks. Preterm birth before 37 weeks gestation is a leading cause of infant and neonatal death, continues to rise, and occurs in more than 12 percent of pregnancies in the United States. The negative health effects of preterm birth go far beyond the first days of life; preterm birth is associated with a high prevalence of severe neurological deficits and developmental disabilities.

These negative health outcomes have economic implications, as well. A 2005 March of Dimes study found that employers pay nearly 15 times more in direct healthcare coverage costs for babies born prematurely in their first year of life than for full term babies, with an average cost of $41,610 for a premature baby vs. $2,830 for a healthy, full-term baby. In a separate analysis, the March of Dimes estimates that in 2002, almost half of hospital charges for premature infants, or about $7.4 billion, were billed to employers and other private insurers. This estimate was derived using the Nationwide Inpatient Sample from the Agency for Healthcare Research and Quality.

"Preterm birth has such a profound effect on both babies and their families that any research that can help us understand how to prevent preterm birth is a significant advance," said Susan Wysocki, RNC, NP, FAANP, president and chief executive officer National Association of Nurse Practitioners in Women's Health.

The overall Phase III study, Progesterone Vaginal Gel for the Reduction of Recurrent Preterm Birth: Primary Results from a Randomized, Double-blind, Placebo-controlled Trial, did not show a beneficial effect of progesterone treatment on reducing the frequency of preterm birth in a larger population of high-risk women identified with only a history of spontaneous preterm birth.

Progesterone is a natural hormone found in all women, though levels of progesterone increase during pregnancy. Progesterone is also a well-established hormonal supplement required for successful infertility treatments.

About PROCHIEVE 8%

PROCHIEVE 8% is natural progesterone FDA-approved for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatment for infertile women with progesterone deficiency. Several trials showing these benefits have been published. PROCHIEVE 8% is safe for use during pregnancy, and has been safely used for a decade by tens of thousands of women globally to help sustain pregnancy in the first trimester. Its unique bioadhesive delivery system provides controlled and sustained release of progesterone directly where it is needed.

The most common side effects of PROCHIEVE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. PROCHIEVE 8% is contraindicated in patients with active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs. For more information, please visit www.prochieve8.com.


'/>"/>

Contact: Kathleen Cosgrove
kathleen.cosgrove@mslpr.com
617-937-2534
Columbia Laboratories, Inc.
Source:Eurekalert

Related medicine news :

1. Vaginal Birth After C-section Dangerous For Both Mother And Baby
2. PET Scanner detects more Vaginal cancer than CT scans
3. Vaginal Vaccine may prevent periodic infections
4. A new approach to vaginal hysterectomy
5. Dermaseptins: Potent vaginal contraceptives
6. Vaginal atrophy drug Ospemifene found effective in breast cancer Prevention
7. US surge in vaginal reconstruction
8. Increased Risk Of HIV Transmission Following Vaginal Washing
9. Risk Of AIDS Rises With Vaginal Washes
10. Vaginal massage during pregnancy avoids Episiotomy procedure
11. Vaginal Gel That Protects Against HIV To Hit The Markets By 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... ... February 08, 2016 , ... According to research by ... require dental technicians to be certified or obtain continuing education. To increase patient ... “What’s In Your Mouth?” campaign to inform dentists and patients about the possible ...
(Date:2/7/2016)... Clarkston, Metamora, Michigan (PRWEB) , ... February 07, 2016 , ... ... in recognition of National Wear Red Day. National Wear Red Day is the ... stroke in women. Heart disease and stroke cause 1 in 3 deaths among women ...
(Date:2/7/2016)... Scottsdale, AZ (PRWEB) , ... February 07, 2016 ... ... & Neck and Facial Plastics, has added Kybella® to his medical and surgical ... is a newly approved FDA injectable medication used as a non-surgical alternative for ...
(Date:2/6/2016)... ... February 06, 2016 , ... US Sports Camps is proud to ... This event brings together top non-profit leaders, ultimate organizations, and coaches from around the ... Iani, Bay Area Disc Program Director of Youth and Education, describes this year YUCC ...
(Date:2/6/2016)... ... February 06, 2016 , ... Shark Finds and Kevin ... of a new DRTV campaign with Belly Bands. , Having a dog is great—except ... to puppy pads and find nothing works, get Belly Bands, the easiest way ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... part of a major growth and expansion initiative, Dune Medical ... Chmura as President of Dune Inc., its U.S. division. ... experience in the medical device space will play a large ... --> --> In her new ... and operational functions in the U.S. She is tasked with ...
(Date:2/8/2016)... Mich. , Feb. 8, 2016  The University ... announced today that, as part of the ... one of the first hospitals in the U.S. to ... Karin Muraszko , M.D., U-M,s chair of neurosurgery. ... of neurosurgery. --> The BrightMatter technology ...
(Date:2/8/2016)...  Aoxing Pharmaceutical Company, Inc. (NYSE MKT: AXN) today announced ... December 31, 2015, the Company achieved revenue of $8,195,839, a ... quarter in fiscal 2015. --> ... year 2016 was $2,068,635, or $.03 per share, up 265% ... in the Q2 of fiscal year 2015. Gross margin for ...
Breaking Medicine Technology: