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

Award Number: UG1HD040545
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $343,200 )
2024	2024	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON	7000 FANNIN ST FL 9	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	002	25	3/22/2024	NON-COMPETING CONTINUATION	$308,880
2024	2024	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON	7000 FANNIN ST FL 9	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	003	25	4/30/2024	NON-COMPETING CONTINUATION	$34,320
2024	2023	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON	7000 FANNIN ST FL 9	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	001	24	3/5/2024	COMPETING CONTINUATION	$5,648
2024	2022	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON	7000 FANNIN ST FL 9	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	000	23	3/5/2024	NON-COMPETING CONTINUATION	-$5,648
														Subtotal = $343,200

Issue Date FY: 2023 ( Subtotal = $343,200 )
2023	2023	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	001	24	3/31/2023	COMPETING CONTINUATION	$343,200
2023	2023	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	002	24	4/5/2023	COMPETING CONTINUATION	-$343,200
2023	2023	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	003	24	4/11/2023	COMPETING CONTINUATION	$343,200
2023	2022	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	000	23	3/8/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $343,200

Issue Date FY: 2022 ( Subtotal = $302,997 )
2022	2022	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	002	23	4/27/2022	NON-COMPETING CONTINUATION	$302,997
2022	2021	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	001	22	11/11/2021	COMPETING CONTINUATION	$1,413
2022	2020	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	000	21	11/11/2021	NON-COMPETING CONTINUATION	-$1,413
														Subtotal = $302,997

Issue Date FY: 2021 ( Subtotal = $267,382 )
2021	2021	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	000	22	3/29/2021	COMPETING CONTINUATION	$302,997
2021	2021	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	001	22	5/17/2021	COMPETING CONTINUATION	-$35,615
														Subtotal = $267,382

Issue Date FY: 2020 ( Subtotal = $292,598 )
2020	2020	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	000	21	3/20/2020	NON-COMPETING CONTINUATION	$292,598
														Subtotal = $292,598

Issue Date FY: 2019 ( Subtotal = $292,598 )
2019	2019	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	000	20	4/5/2019	NON-COMPETING CONTINUATION	$292,598
2019	2019	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	001	20	6/11/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $292,598

Issue Date FY: 2018 ( Subtotal = $292,598 )
2018	2018	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	001	19	5/1/2018	NON-COMPETING CONTINUATION	$29,260
2018	2018	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON, THE	7000 FANNIN ST	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	000	19	3/10/2018	NON-COMPETING CONTINUATION	$263,338
														Subtotal = $292,598

Issue Date FY: 2017 ( Subtotal = $292,598 )
2017	2017	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON	7000 FANNIN ST STE 1006	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	001	18	6/13/2017	NON-COMPETING CONTINUATION	$29,260
2017	2017	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT HOUSTON	7000 FANNIN ST STE 1006	HOUSTON	TX	77030	HARRIS	USA	Child Health and Human Development Extramural Research	000	18	3/16/2017	NON-COMPETING CONTINUATION	$263,338
														Subtotal = $292,598

Issue Date FY: 2016 ( Subtotal = $58,797 )
2016	2016	UNIVERSITY OF TEXAS, GRADUATE SCHOOL BIOMEDICAL SCIENCE	POST OFFICE BOX 20367	HOUSTON	TX	77225	HARRIS	USA	Child Health and Human Development Extramural Research	000	17	3/9/2016	COMPETING CONTINUATION	$58,797
														Subtotal = $58,797

Grand Total All Awards = $2,485,968

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

Award Number: UG1HD040545

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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