| Prevention of Preterm Delivery |
|Partners In Care, Inc., Gainesville, GA compounds 17 Alpha Hydroxyprogesterone Caproate (17OHPC) (17OHP) (17P) 250 mg/ml to prevent preterm delivery. Once commercially available in the United States from major manufacturers, 17P (Hydroxyprogesterone) is currently available by prescription from compounding pharmacies that compound sterile products. During pregnancy, the placenta produces high levels of progesterone to maintain the pregnancy. One of the factors that stimulate the onset of labor is a drop in progesterone. |
Even with the advances in neonatal care during recent decades, preterm birth is the major cause of handicaps in children without congenital handicaps. Previous treatments to prevent preterm birth have been unsuccessful; it has been shown that the administration of Hydroxyprogesterone Caproate 250 mg/ml weekly to women with a history of previous preterm birth significantly reduces the risk of preterm birth.
Dr. Allison T. North and colleagues of the Department of Obstetrics and Gynecology, Center for Women’s Reproductive Health, University of Alabama at Birmingham investigated the development and health outcomes of 194 children who were exposed to 17 Alpha Hydroxyprogesterone Caproate in the second and third trimesters. The results were compared to 84 unexposed children in a placebo group.
To assess whether there are evident any adverse effects of 17 Alpha-Hydroxyprogesterone Caproate after in utero exposure. This study evaluated surviving children of mothers who participated in a multicenter placebo-controlled trial of weekly intramuscular 17 -hydroxyprogesterone caproate, with a 2:1 allocation to 17 -hydroxyprogesterone caproate and placebo, respectively. The guardian was interviewed about the child’s general health. Children underwent a physical examination and developmental screen with the Ages and Stages Questionnaire. Gender-specific role17 Hydroxyprogesterone Caproate is a natural metabolite of progesterone, which is produced by the placenta during pregnancy. Other than pain at the injection site no other side effects have been reported in recent studies to either mother or child. s were assessed with the Preschool Activities Inventory. Of 348 eligible surviving children, 278 (80%) were available for evaluation (194 in the 17 -hydroxyprogesterone caproate group and 84 in the placebo group). The mean age at follow-up was 48 months. No significant differences were seen in health status or physical examination, including genital anomalies, between 17 -hydroxyprogesterone caproate and placebo children. Scores for gender-specific roles (Preschool Activities Inventory) were within the normal range and similar between 17 -hydroxyprogesterone caproate and placebo groups. 17 -hydroxyprogesterone caproate (17P) seems to be safe for the fetus when administered in the second and third trimesters.
Obstetrics & Gynecology 2007;110:865-872
17 Hydroxyprogesterone Caproate is a natural metabolite of progesterone, which is produced by the placenta during pregnancy. Other than pain at the injection site no other side effects have been reported in recent studies to either mother or child. According to the Society for Medical Decision Making: “Admistering 17P to expectant mothers with prior preterm birth (PPTB) is predicted to reduce medical cost associated with initial hospitalization by $2800 to $2900. Lifetime (discounted) medical cost are predicted to decline by $15,000. The predicted savings greatly the cost of a full 17P regimen, approximated at $500. Even under conservative assumptions about the 17P treatment effect, treatment is predicted to reduce aggregate medical cost. If administered universally to expectant mothers with PPBT, 17p would reduce U.S. Medical cost by over $3 billion annually (calculated over the lifetime of the affected offspring).”
Contact Partners In Care for Hydroxyprogesterone Caproate 250 mg/ml in a five dose 5 ml vial. We ship by UPS. Each prescription is accompanied with an outside lab report for the current lot of 17HP showing the Potency, Sterility and Pyrogenicity.
FDA ANNOUNCMENT 3/30/2011
Prevention of Recurrent Preterm Delivery by 17 Alpha-Hydroxyprogesterone Caproate NEJM
Report: More than 1M preemies die in first month annually 10/4/09
Study: Average preemie costs $49,000 in first year 3/172009
Cervical length changes:effects 17P American Journal of Obestrics & Gynecology Study
Maternal hormone 17P treatment safe for fetus
Progesterone Recommended In Certain High Risk Pregnancies to Help Prevent Preterm Birth ACOG News Release
Assessment of dietary vitamin D requirements during pregnancy and lactation
Help Save Babies From Premature Birth March of Dimes
Medical cost savings with 17 Alpha Hydroxyprogesterone Caproate for prevention of preterm birth
Lasting health consequences follow premature birth
High tech compounding equipment, proper maintenance, written protocols and a written log of each compounded preparation assures that only products meeting the highest standards are prepared and dispensed at Partners In Care. Quality control is a way of life at Partners In Care, Inc. There is a certificate of analysis (C of A) on hand for each lot of each chemical that is use in any product. To ensure that each active ingredient is accurately measure and recorded. The pharmacy’s electronic balance is connected to the computer and the scale weight and percent off is recorded in the log of each product. A lot number is assigned to each log sheet of each product prepared in the pharmacy. See an example of such a log also note that the lot number of each chemical used is also recorded.
Every lot of sterile products that are prepared in bulk e.g. Hyaluronidase, Betamethasone 6mg Solu-Repository, Dexamethasone etc are end stage tested by an outside laboratory for sterility, pyrogenicity and potency. All sterile injectables that are suspensions are also tested for fungal contamination. Partners in Care, Inc has done end stage testing since 2001.
You can be sure of the quality of your compounded prescription, at Partners In Care.
Below is a copy of a Lab Report for one batch of 17 Alpha Hydroxyprogertone Caproate