Pediatrix/Obstetrix Medical Groups, Inc. and McGuff Pharmaceuticals, Inc., have entered into an agreement to support and conduct a clinical trial to test the weekly injection of 17-Alpha-Hydroxyprogesterone Caproate (17OHP) (250mg) as a potential treatment regimen for reduction of neonatal morbidity due to pre-term birth in twin and triplet pregnancies.
Premature delivery is a leading cause of neonatal morbidity and mortality in the United States. The past three decades have seen the introduction of a variety of strategies intended to reduce the rate of pre-term birth. Despite these efforts, the rate of pre-term delivery has been steadily rising and now approximately 12% of all pregnancies in the United States end in pre-term birth. Pre-maturity is the primary reason the United States ranks 28th among industrial nations in infant mortality rates. With the renewed enthusiasm following recent studies using Progesterone in pregnancies at risk for pre-term delivery, there is hope for a more efficacious and safer therapeutic intervention to arrest pre-term birth.
The clinical trials will be conducted through an FDA Registered Investigational New Drug application
(IND # 69536). The study is designed to incorporate two, concurrent, double-blinded, randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for pre-term birth. The two risk factors to be studied include twin pregnancy and triplet pregnancy. The trials will include 321-patients and have two groups: two thirds of the patients enrolled will receive a drug regimen consisting of weekly injections of Hydroxyprogesterone Caproate. The other one-third of patients will receive weekly injections of a placebo.
The study will be carried out at approximately 24 enrolling sites across the United States. Its purpose is to investigate whether patients who receive the study drug have better outcomes than those who do not. The primary outcome measure will be freedom from major neonatal morbidity, defined as one or more of the following:
- Perinatal death (still birth, neonatal death, or miscarriage after randomization)
- Respiratory Distress syndrome (clinically defined by Neonatologist, requirement for intubation, surfactant therapy, radiographic evidence of hyaline membrane disease).
- Use of oxygen therapy at 28 days of newborn life.
- Neonatal sepsis, clinically-defined, with positive blood culture.
- Pneumonia, clinically defined.
- Intraventricular hemorrhage grade 3 or 4
- Periventricular leukomalacia
- Necrotizing enterocolitis requiring surgery
- Retinopathy of pre-maturity
- Newborn asphyxia, defined as arterial pH < 7.0 (cord blood or newborn blood) with ischemic injury of brain, heart, kidneys or liver.
About the 17OHP Study Sponsors and Partners:
Since 1979, Pediatrix has evolved from a small group practice into a national physician group that specializes in both neonatal and maternal-fetal services. Today, Pediatrix employs more than 630 neonatologists and maternal-fetal physician sub specialists, as well as pediatric sub specialists, advanced practitioners and other clinical professionals.
Pediatrix created the Pediatrix-Obstetrix Center for Research and Education so that in sharing new advances and knowledge among physicians and advanced practitioners, they will have the opportunity to discover, better understand and teach health care practices that improve the lives of mothers, children and their families. In the long term, Pediatrix believes the Center will be recognized as the site of choice for clinical research involving newborns and women with complicated pregnancies. Obstetrix Medical Group, a Pediatrix Medical Group subsidiary, is a national group of maternal-fetal physicians who daily work with and understand the special needs involved when caring for at-risk patients.
Maternal-fetal specialists are obstetricians who receive extensive education and training for the treatment of high-risk expectant mothers and their fetuses. McGuff Pharmaceuticals, Inc. is a US Food and Drug Administration (FDA) registered, ISO9000 certified contract and generic manufacturer of sterile, injectable, pharmaceuticals. McGuff Pharmaceuticals, Inc. is focused on providing small volume, sterile pharmaceutical products to support the physician and hospital markets.
McGuff Pharmaceuticals, Inc. is uniquely organized with advanced production facilities, innovative leadership and a corporate-wide commitment to the highest standards of quality that drives the production of pilot, preclinical, clinical and commercial production of sterile products. Their services include product development assistance, pre-clinical production, IND support and clinical materials production, as well as contract manufacturing services.
