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.

Public Health Relevance

Since 1986, the MFMU Network has done multicenter clinical trials to investigate and ameliorate the major complications in clinical obstetrics-prevention of preterm birth, fetal growth abnormalities, neurologic sequelae, and obstetric and medical problems of pregnancy-which have translated into improvement of maternal-fetal outcomes globally. Our contribution to the Network in the last five years includes screening over 14,000 women and recruiting 1,767; having the third highest recruitment for the recently completed randomized trials and; our division publishing 130 articles on obstetric topics Network focuses on. As evidenced in the past, we plan to continue our success; and to improve on our achievements, we have expanded our hospitals sites from two to four, with concomitant increase in deliveries from 7,000 to over 15,000 annually, recruited 14 additional MFM and 4 new research staff.

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 #
5UG1HD040545-20
Application #
9665498
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
Signore, Caroline
Project Start
2001-04-01
Project End
2021-03-31
Budget Start
2019-04-01
Budget End
2020-03-31
Support Year
20
Fiscal Year
2019
Total Cost
Indirect Cost
Name
University of Texas Health Science Center Houston
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
800771594
City
Houston
State
TX
Country
United States
Zip Code
77030
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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
Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
Pasko, Daniel N; McGee, Paula; Grobman, William A et al. (2018) Variation in the Nulliparous, Term, Singleton, Vertex Cesarean Delivery Rate. Obstet Gynecol 131:1039-1048
Tita, Alan T N; Jablonski, Kathleen A; Bailit, Jennifer L et al. (2018) Neonatal outcomes of elective early-term births after demonstrated fetal lung maturity. Am J Obstet Gynecol 219:296.e1-296.e8
Grobman, William A; Bailit, Jennifer; Sandoval, Grecio et al. (2018) The Association of Decision-to-Incision Time for Cesarean Delivery with Maternal and Neonatal Outcomes. Am J Perinatol 35:247-253
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762

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