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 DESCRIPTION (provided by applicant): Recommendations in obstetric guidelines are often based on single center observational studies or randomized clinical trials (RCTs) that may not be compliant with CONSORT statement. Since 1986, the MFMU Network has ameliorated these shortcomings while focusing on leading causes of maternal-neonatal morbidity. The MFM Division at UT- Houston shares this vision, has commitment and a proven track record of successfully participating in, and publication. Research in our division-preterm labor, fetal growth abnormalities, neurological sequelae, obstetric complications-is congruent with NICHD goals. Hence, we are reapplying for the fourth cycle to be an active participant of the MFMU Network. Our PI, Dr. Suneet P. Chauhan, and alternate PI, Dr. Baha M. Sibai, have culturally transformed the division by emphasizing recruitment of eligible women in trials and publications. These improvements are exemplified by the fact that for both in APEX and SCAN, the Network studies in 2010, UT-Houston recruitment was ranked 11th out of 14 centers. Since then we have screened 14,500 women, and recruited 1,767. Now, in May 2015, we were ranked 3rd in the Network for recruitment of the recent RCTs-STAN, ALPS, and ARRIVE. The reasons for the formative changes are: research staff with 30 years of experience in L&D and 21 years as researchers; infrastructure which facilitates screening and enrollment of eligible women and; recent recruitment of 14 MFM enthusiastic about clinical trials. In the coming years, we will build on our success because of the addition of two new official sites, with 8,300 additional deliveries annually; strategically ensuring weekly clinical responsibilities at the new sites of PI and MFM conducive to recruitment; daily presence of MFM faculty and fellows on L&D at the main center, which enhances recruitment and compliance with Network and other funded studies. The objective evidence of our commitment to trials is that since 2011, MFM in our division has published 256 articles, with 88 being multi-center, 52 focused on obstetric complications, 42 on preterm labor or birth, 18 on fetal growth abnormalities, 14 on neurologic sequelae and 6 RCT. In addition to Network studies, MFM faculty is currently involved in eight RCTs, six of which are multi-center. We also have transitional research on nanovectors to prevent placental transfer of tocolytics and complications of prematurity following fetal surgery. While committed to these studies, we are cognizant of Network studies being the top priority. In summary, because of the proven record of recruitment and publications, an infrastructure for continued improvement, UT-Houston should continue to be vital part of MFMU Network.
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Limited Competition: Clinical Centers for Completion of Ongoing MFMU Network Protocols (UG1 Clinical Trial Optional)Activity Code
Limited Competition: Clinical Centers for Completion of Ongoing MFMU Network Protocols (UG1 Clinical Trial Optional)Activity Code
Eunice Kennedy Shriver NICHD Maternal Fetal Medicine Units Network
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