RECOVERY: The National Standard for Normal Fetal Growth (Data Coordinating Center)

RECOVERY The National Standard for Normal Fetal Growth (Data Coordinating Center) This Project is an American Recovery and Reinvestment Act (ARRA) action. Receipt of award is contingent upon the offeror's meeting the requirements of Section 1512 (reports of use of funds) of the Recovery Act. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Contracts Management Branch, Office of Acquisitions intends to negotiate a sole source modification to the contract with Clinical Trials and Surveys Corp., Contract HHSN275200800003I/HHSN27500001. The contractor currently supports the study for the National Standard for Normal Fetal Growth and is required to establish standardized data collection for the study. In addition, implement laboratory specimen tracking mechanisms and working with the project officer to implement a randomization plan for the assignment of subjects in the study. The contractor is also responsible for statistical support, the accuracy of the data collected and the analysis of clinical data. The primary purposes of this study are: (1) to establish a U.S. national standard for normal fetal growth (velocity) and size for gestational age; (2) to create an individualized standard for optimal fetal growth; (3) to improve accuracy of fetal weight estimation; and (4) to construct an individualized standard for fundal height. This multicenter, prospective study, which officially commenced on September 26, 2008, is being conducted at four clinical sites in the U.S. The study involves the recruitment and follow-up of (1) 2,400 low-risk, normal weight women with an equal number of White, Hispanic, African American and Asian race/ethnicity; (2) 600 obese women; and (3) 250 monochorionic and 250 dichorionic twin pregnancies. Women will be recruited in the first trimester and followed up through pregnancy. Each woman will receive 5 scheduled ultrasound exams, which include 2-dimensional (2D) and 3-dimentinoal (3D) fetal anthropometric measurements. Uterine artery and fetal Doppler studies will be performed at selected gestational weeks. After delivery, neonatal anthropometric measures will be carefully taken. Obstetric and neonatal information will be extracted from medical charts. Recruitment began on July 15, 2009 and is expected to last at least two calendar years. The planned modification will require the contractor to meet additional requirements as they manage, coordinate and monitor potential additional clinical sites in the study. The contractor will also be required to collect additional images associated with the added twin component of the study, and assist in the continuous quality control procedures for all ultrasound measures. Nutritional surveys will be administered to all study participants (rather than only a portion of the participants as is done now); consequently the contractor will be responsible for the collection of the additional data. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302. Interested persons may identify their interests and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received with 15 days after the date of publication of this synopsis will be considered by the Government. A determination by the Government not to compete this proposed modification based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.