NICHD Maternal-Fetal Medicine Units (MFMU) Network

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 DESCRIPTION (provided by applicant): The Maternal-Fetal Medicine Division of the University of Alabama at Birmingham (UAB) submits this application to renew our participation as a clinical center of the Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units (MFMU) Network. We present our center's ongoing record of exceptional performance overall and specify new attributes and our plans to increase our contributions to the Network's goals of investigating major problems in clinical obstetrics, particularly those related to low birth weight prematurity, obstetric and medical complications of pregnancy. We have a well-established research infrastructure and extensive experience in performing relevant clinical trials and observational studies both within and outside the MFMU Network. As a Network participating center over the last five 5-year cycles, UAB has consistently played a leadership role in providing research direction for the Network at the Steering Committee and sub-committee levels (one UAB-led trial starting and 2 other protocols approved), conducted Network trials with the highest efficiency of any center, and participated significantly in the presentation and publication of data generated. Among 31 clinical centers in the history of the Network, a UAB investigator has first-authored approximately 54 (19.5%) of 277 current MFMU Network publications. Of 453 total Network presentations at national meetings, a UAB investigator presented 19.6%. Current members of the UAB site MFM team have accumulated well over 200 person-years' experience of active participation in support of MFMU research projects; our current research staff similarly cumulate over 250 MFMU person-years. Alan Tita, MD, PhD and Joseph Biggio, MD will continue as PI and Alternate PI, respectively. The investigative team includes two previous site PI's and 7 members who have served or currently serve as Network protocol chairpersons (Dr. Biggio currently for the 3- arm trial to evaluate pessary and vaginal progesterone for PTB prevention in twins - PROSPECT) or Subcommittee members (Dr. Tita is currently on Publications Committee and ALPS and ARRIVE protocol subcommittees; Dr. Biggio is also on the subcommittee of the APPS trial - pessary vs. vaginal progesterone for singleton short cervix study protocol). Finally, on the basis of patient recruitment, protocol adherence, retention and follow-up, data quality, and study start-up time, the MFMU Network Data Coordinating Center ranked us #1 or #2 among the participating centers 71% (10/14) of the time since 2003 (#1 overall, 53% of the time). If successful, in this competitive renewal application, we will deploy our facilities, equipment, data management systems (including our electronic perinatal record system), recruitment resources, reinforced investigative team and highly experienced personnel even more to develop and implement MFMU Network protocols and projects. We believe that we remain well positioned for competitive renewal as an NICHD MFMU Network center for the next five years. We outline plans to potentially expand our target population to at least one ancillary site during the next cycle after appropriate evaluation by the NICHD and Data Coordinating Center.