"While the prior NICHD MFMU network trial demonstrated that this drug should be used for women with this obstetrical history, it is important that further research is done to understand the potential neonatal benefits" said Sean C. Blackwell, MD, Chair, Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Texas Health Science Center in Houston, Texas. "The vast amount of data collected through the new trial will also provide a robust platform for extensive secondary analyses."
St. Louis, MO January 21, 2014 K V Pharmaceutical Company (KV) announced today it has enrolled 677 women in its ongoing international Phase 3B safety and efficacy trial of Makena (hydroxyprogesterone caproate injection), the only FDA approved medication indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The latest trial enrollment figures make this study the largest randomized controlled trial to date assessing the impact of progestogen therapy on reducing the risk of recurrent singleton preterm birth.
KV Pharmaceutical Clinical Study On Reducing The Risk Of Recurrent Preterm Birth Becomes Largest Of Its Kind
23 and 25 months of age born to women enrolled in this trial. The effectiveness of Makena is based on improvement in the proportion of women who delivered .
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Preterm birth defined as birth prior to 37 weeks is a significant cause of morbidity and mortality and ranks among the top 10 global causes of burdens of disease. Women who have delivered prematurely at any gestational age, including 34 37 weeks, are at increased risk for a subsequent preterm birth.
As with the original trial conducted by the NICHD MFMU Network on 463 women (Meis et al, NEJM 2003), this randomized controlled trial sponsored by KV will evaluate the impact of Makena, hydroxyprogesterone caproate injection made under Good Manufacturing Practices (GMP), on reducing the rate of preterm birth in women pregnant at high risk for recurrent preterm delivery. The new trial will enroll more than 1,700 women, a sufficient sample size to detect improvements in overall newborn health in high risk pregnancies in addition to assessing the surrogate marker Nike Air Force Blue High Top of preterm birth less than 35 weeks of gestational age. Previously, the largest trial comparing a progestogen to placebo for recurrent Black Air Force Ones Low Top
"We look forward to partnering with leading external researchers to maximize the scientific value of this data" said Michael Jozwiakowski, Vice President of Research and Development for KV Pharmaceutical. "Not only will this trial satisfy important commitments made when FDA approved Makena, but we sincerely believe that the data from this study will help further advance women's healthcare."
In addition to investing in this trial, KV is also sponsoring a companion follow up study to evaluate children between Air Force 1 Flyknit Low Cut
before 37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity. One of the primary endpoints of this ongoing trial is to determine the impact of Makena on neonatal health. While there are many risk factors for preterm birth, the safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. Makena is not intended for use in women with multiple gestations or other risk factors for preterm birth. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
The FDA approval of Makena is based on the surrogate marker of effectiveness, namely the improvement in the proportion of women who delivered Air Force Nike Low
preterm birth was O'Brien et al. (Ultrasound Obstetrics and Gynecology 2007), which enrolled 659 women.
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