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.

Public Health Relevance

By continuing to participate in this ongoing multicenter collaborative research program, UAB researchers will help discover new and useful methods to treat and/or prevent major public health problems affecting pregnant women and their infants. These problems include those directly related to pregnancy such as preterm birth, low birth weight and preeclampsia, as well as medical complications coinciding with pregnancy such as diabetes and chronic hypertension. The team will continue involve young investigators in the activities of the MFMU network and thereby inspire the next generation of lead investigators.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Clinical Research Cooperative Agreements - Single Project (UG1)
Project #
5UG1HD027869-29
Application #
9445459
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
Miodovnik, Menachem
Project Start
1991-04-01
Project End
2021-03-31
Budget Start
2018-04-01
Budget End
2019-03-31
Support Year
29
Fiscal Year
2018
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
063690705
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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Kominiarek, Michelle A; Saade, George; Mele, Lisa et al. (2018) Association Between Gestational Weight Gain and Perinatal Outcomes. Obstet Gynecol 132:875-881
Kominiarek, Michelle A; Smid, Marcela C; Mele, Lisa et al. (2018) Child Neurodevelopmental Outcomes by Prepregnancy Body Mass Index and Gestational Weight Gain. Obstet Gynecol 132:1386-1393
Varner, Michael W; Mele, Lisa; Casey, Brian M et al. (2018) Thyroid function in neonates of women with subclinical hypothyroidism or hypothyroxinemia. J Perinatol 38:1490-1495

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