Limited Competition: Clinical Centers for Completion of Ongoing MFMU Network Protocols (UG1 Clinical Trial Optional)Activity Code

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Project Summary Irrespective of whether the pregnancy is high- or low-risk, the national guidelines influencing the management of upwards of 3.7 million births in the US annually are often based on retrospective data. Hence, the need for prospectively collected data from multiple-centers or, whenever feasible, randomized clinical trials (RCT), with unbiased treatment effect. For the last 19 years University of Texas-Houston (UTH) has been a vital part of Maternal-Fetal Medicine Units (MFMU) Network to garner unbiased data. The UTH research team consists of 11 people, with combined experience of 84 years conducting research and over 100 years of working on labor and delivery. Prioritizing participation in the Network is ingrained in our Division. Our Chair and the MFM Fellowship Director have both served as Network PI and alternate PI. Within our Division we have a combined experience of being PI or alternate PI for 37 years. For the current 4 RCT, out of the 12 Network centers, our recruitment of eligible people ranks between 1st and 4th and, our ranking for the number of people randomized to these trials is between 2nd and 5th. The people we recruit for the Network trials deliver at 3 hospitals, with upwards of 11,000 combined births annually. The majority of the individuals we manage are racially and ethnically diverse, so over 85% of those recruited for the ongoing MFMU studies are underrepresented minorities. Our follow-up rates have been consistently greater 90%, except for the follow-up of ALPS children. We have taken several measures to increase follow-up rates. We are attempting to contact the families after hours or on weekends, offering Saturday appointments for study visits, and increasing our use of social media. We continue to refine our strategies to optimize follow-up rates. To be a valuable member of the Network, the center must have evidence of academic productivity. Since, 2016, we have published over 260 peer-reviewed articles, which were congruent with the aims of the MFMU Network. In the last 5 years, UTH faculty and Fellows have published 14 RCT, with 11 trials (78%) being multi-centered. If the Network is to upend the national guidelines' reliance on retrospective studies, centers must encourage and engage Fellows and junior faculty to undertake hypothesis generating secondary analyses and RCT. Independent of the Network, we recently published 12 secondary analyses, and our MFM Fellows are conducting 6 RCT, which do not compete with MFMU trials. It's notable that a nidus for the upcoming Network trial—Prescription After Cesarean Trial—was an RCT published by a recent graduate of our fellowship (Dinis J et al. Am J Obstet Gynecol. 2020). We remain committed to ensuring proper conduct of the studies, maintaining our performance ranks in the top-half of all aspects, including rate of eligible people randomized, follow-up and data quality merits.