Scope of Work Relationship between Plasma Concentration of 17-hydroxyprogesterone caproate (17-OHPC) and Preterm Birth This study evaluates the relationship between plasma concentrations of 17-OHPC and the rate of spontaneous preterm birth (sPTB). Subjects who would be offered 17-OHPC because of a history of sPTB are the target population. Consenting subjects with a singleton gestation will be randomized to either a dose of 250 or 500 mg weekly from 16 0/7 to 21 6/7 weeks. Weekly contact with the subject will serve to monitor side effects and compliance. Biological specimens will be collected during pregnancy and at delivery. The NICHD Obstetric-Fetal Pharmacology Research Center includes a group of clinical centers (UTMB, Northwestern and Pittsburgh) recognized for their expertise in perinatal medicine, will collaborate in this study. The University of Pittsburgh serves as the lead clinical site for this study under the direction of the principal investigator. Each clinical center will have a clinical primary investigator who is responsible for overseeing the conduct of the study at her/his clinical center. All participating clinical centers will perform the following Scope of Work: a. Obtain IRB approval (initial and continuing review) b. Undergo training in protocol procedures and undertake the necessary training assessments c. Follow the Safety Monitoring Plan for notification and reporting of serious adverse events (SAEs) d. Adhere to local IRB reporting policies e. Maintain essential documentation on site and provide necessary documentation for the Master File as directed by the lead clinical site f. Identify and recruit women who are potential candidates for participation in the study g. Obtain signed informed consent and HIPAA authorization for eligible participants h. Schedule and conduct study visits per protocol and Manual of Operating Procedures (MOP) o Assess subject for potential side effects, adverse effects, and serious adverse events according to the protocol and Safety Monitoring Plan o Collect data according to the protocol and MOP o Obtain specimens according to the protocol and MOP o Store and transport specimens according to protocol and MOP i. Enter data into the REDCap database set up by the lead site j. Respond to data and other queries from the lead clinical site k. De-identify, copy and send participant records for review as required by the lead clinical site l. Maintain records, including completed data forms, consent forms, correspondence, and participant contact information as required by the lead clinical site
|Effective start/end date||7/1/18 → 6/30/20|
- Magee-Womens Health Corporation (1423 NU // 5U54HD047905-14)
- National Institute of Child Health and Human Development (1423 NU // 5U54HD047905-14)
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