Obstetric practices, evaluative tools, and treatments have been sometimes passed down by tradition or introduced without rigorous study to evaluate their impact on maternal, fetal, and/or neonatal outcomes. Long-term maternal and infant outcomes are particularly understudied, and surrogate markers of morbidity are commonly substituted in studies of smaller size. The impact of pregnancy complications can be devastating, affecting decades of life. The health and financial impacts of adverse maternal and infant outcomes on the family are potentially staggering. With millions of births in the United States each year, even uncommon complications can have a profound societal impact. Since its inception, the Eunice Kennedy Shriver NICHD Maternal-Fetal Medicine Units (MFMU) research network has conducted clinical trials and observational studies that have brought important understanding regarding prediction and prevention of preterm birth (Preterm Prediction Study, 17-OH progesterone in singletons, twins, and triplets, omega-3 supplements, antibiotics for asymptomatic bacterial vaginosis and T. Vaginalis), treatments for those at imminent risk (antibiotics for preterm labor and premature rupture of the membranes, repeated antenatal corticosteroids, magnesium sulfate neuroprotection), cesarean delivery and VBAC, prevention of preeclampsia, and treatment of gestational diabetes, among others. This network played a key role in evaluating technologies used in obstetric practice (ultrasound cervical length, fetal fibronectin, home uterine monitoring, fetal pulse oximetry). In this application, we demonstrate that the Department of Reproductive Biology at Case Western Reserve University (CASE) investigators have the ability to conduct collaborative research, and have successfully participated in and are qualified to continue in the MFMU network. Our investigators have strong backgrounds in clinical and multicenter studies, those involving neonatal and long term infant follow-up, and in the above listed network studies. CASE investigators provide leadership in network study development and administrative committees necessary to study completion and dissemination of their results. There is a strong administrative and research infrastructure to support the MFMU network, including the CASE-Clinical &Translational Science Collaborative. CASE offers the strengths needed to successfully lead and participate in NICHD-MFMU network research which will directly influence obstetric practice and improve pregnancy outcomes nationally and internationally.

Public Health Relevance

Research performed by the CASE Department of Reproductive Biology, within the Eunice Kennedy Shriver NICHD-MFMU network, will inform and change obstetric practice. This research will identify interventions and tools to predict, prevent or mitigate pregnancy complications such as preterm birth, preeclampsia, fetal growth restriction and perinatal infections, among others. Focusing on significant perinatal and long-term outcomes, we will bring to an end procedures and practices that are ineffective or incur undue risks.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD040544-13
Application #
8251929
Study Section
Special Emphasis Panel (ZHD1-DRG-D (50))
Program Officer
Raju, Tonse N
Project Start
2001-04-01
Project End
2016-03-31
Budget Start
2012-04-01
Budget End
2013-03-31
Support Year
13
Fiscal Year
2012
Total Cost
$309,290
Indirect Cost
$112,290
Name
Case Western Reserve University
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
Caritis, Steve N; Feghali, Maisa N; Grobman, William A et al. (2016) What we have learned about the role of 17-alpha-hydroxyprogesterone caproate in the prevention of preterm birth. Semin Perinatol 40:273-80
Yee, Lynn M; Sandoval, Grecio; Bailit, Jennifer et al. (2016) Maternal and Neonatal Outcomes With Early Compared With Delayed Pushing Among Nulliparous Women. Obstet Gynecol 128:1039-1047
Landon, Mark B; Grobman, William A; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units Network (2016) What We Have Learned About Trial of Labor After Cesarean Delivery from the Maternal-Fetal Medicine Units Cesarean Registry. Semin Perinatol 40:281-6
Froehlich, Rosemary J; Sandoval, Grecio; Bailit, Jennifer L et al. (2016) Association of Recorded Estimated Fetal Weight and Cesarean Delivery in Attempted Vaginal Delivery at Term. Obstet Gynecol 128:487-94
Manuck, Tracy A; Rice, Madeline Murguia; Bailit, Jennifer L et al. (2016) Preterm neonatal morbidity and mortality by gestational age: a contemporary cohort. Am J Obstet Gynecol 215:103.e1-103.e14
Bloom, Steven L; Belfort, Michael; Saade, George et al. (2016) What we have learned about intrapartum fetal monitoring trials in the MFMU Network. Semin Perinatol 40:307-17
Salazar, Ashley; Tolivaisa, Susan; Allard, Donna et al. (2016) What we have learned about best practices for recruitment and retention in multicenter pregnancy studies. Semin Perinatol 40:321-7
Rice, Madeline Murguia; Landon, Mark B; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal–Fetal Medicine Units (MFMU) Network (2016) What we have learned about treating mild gestational diabetes mellitus. Semin Perinatol 40:298-302
Blackwell, Sean C; Landon, Mark B; Mele, Lisa et al. (2016) Relationship Between Excessive Gestational Weight Gain and Neonatal Adiposity in Women With Mild Gestational Diabetes Mellitus. Obstet Gynecol 128:1325-1332
Basraon, Sanmaan K; Mele, Lisa; Myatt, Leslie et al. (2016) Relationship of Early Pregnancy Waist-to-Hip Ratio versus Body Mass Index with Gestational Diabetes Mellitus and Insulin Resistance. Am J Perinatol 33:114-21

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