Tens of millions of reproductive age women in the U.S. have uterine leiomyomata, commonly called fibroids; yet, the influence of fibroids in pregnancy and vice versa is poorly understood. We propose to examine the association of fibroids with specific adverse pregnancy outcomes while investigating the natural history of fibroids during and after pregnancy. We will advance current knowledge by: recruiting an ethnically diverse population early in pregnancy; using a standardized research protocol to conduct ultrasound (US) for all participants to reduce fibroid misclassification; refining assessment of pregnancy events and outcomes; and investigating how size and location of fibroids affect risk. Based on procedures in place for """"""""Right from the Start: A Study of Early Pregnancy Health"""""""", we propose to build a cohort of 3,300 women from 13 counties in North Carolina. We will include approximately 15% Hispanic, 35% African American, and 45% white women, obtaining an US in the 6-7th wk of gestation and a computer assisted telephone interview (CATI) before 10wks gestation. A second CATI, at 20-22 wks, and documentation of outcome, including medical record review, will be done for all medical participants. We will also randomly select a subcohort of 300 women from among those with fibroids and 100 from those without fibroids on 1st trimester US in return for US at 14-16 weeks, 26-28 wks, and 3 months post-pregnancy. In the subcohort, we will conduct a final CATI 3 months after pregnancy. By doing so, we will answer these primary research questions: 1. Are women with fibroids at higher risk of spontaneous abortion (SAB)? 2. Are women with fibroids at higher risk for a spontaneous preterm birth (PTB)? and these secondary questions: 3. Is fibroid size or submucosal location associated with increased risk of SAB or PTB? 4. Are fibroids beneath the placenta associated with increased risk of PTB? 5. Are fibroids likely to change size during and after pregnancy? Is growth pattern related to age, race, BMI, maternal weight gain, clinical glucose tolerance measures, hypertension, pregnancy outcome, lactation, or post-pregnancy contraceptive choice? If fibroids, or certain fibroids, have an adverse effect on pregnancy, the clinical and public health consequences would be substantial given the high prevalence of fibroids. By prospectively investigating fibroid characteristics and risk, this research has potential to inform care for many women with fibroids who are pregnant or planning pregnancy.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Research Project (R01)
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Study Section
Epidemiology and Disease Control Subcommittee 2 (EDC)
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Ilekis, John V
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University of North Carolina Chapel Hill
Obstetrics & Gynecology
Schools of Medicine
Chapel Hill
United States
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Hartmann, Katherine E; Velez Edwards, Digna R; Savitz, David A et al. (2018) THE AUTHORS REPLY. Am J Epidemiol 187:1133-1134
Hartmann, Katherine E; Velez Edwards, Digna R; Savitz, David A et al. (2017) Prospective Cohort Study of Uterine Fibroids and Miscarriage Risk. Am J Epidemiol 186:1140-1148
Sundermann, Alexandra C; Hartmann, Katherine E; Jones, Sarah H et al. (2017) Validation of maternal recall of early pregnancy medication exposure using prospective diary data. Ann Epidemiol 27:135-139.e2
Pryor, Jason; Patrick, Stephen W; Sundermann, Alexandra C et al. (2017) Pregnancy Intention and Maternal Alcohol Consumption. Obstet Gynecol 129:727-733
Sundermann, Alexandra C; Hartmann, Katherine E; Jones, Sarah H et al. (2017) Interpregnancy Interval After Pregnancy Loss and Risk of Repeat Miscarriage. Obstet Gynecol 130:1312-1318
Burrows, Courtney K; Kosova, Gülüm; Herman, Catherine et al. (2016) Expression Quantitative Trait Locus Mapping Studies in Mid-secretory Phase Endometrial Cells Identifies HLA-F and TAP2 as Fecundability-Associated Genes. PLoS Genet 12:e1005858
Michels, Kara A; Hartmann, Katherine E; Archer, Kristin R et al. (2016) The Relationship between Total Fibroid Burden and First Trimester Bleeding and Pain. Paediatr Perinat Epidemiol 30:115-23
Velez Edwards, Digna R; Hartmann, Katherine E (2014) Racial differences in risk of spontaneous abortions associated with periconceptional over-the-counter nonsteroidal anti-inflammatory drug exposure. Ann Epidemiol 24:111-115.e1
Michels, Kara A; Velez Edwards, Digna R; Baird, Donna D et al. (2014) Uterine leiomyomata and cesarean birth risk: a prospective cohort with standardized imaging. Ann Epidemiol 24:122-6
Aldridge, Tiara D; Hartmann, Katherine E; Michels, Kara A et al. (2014) First-trimester antihistamine exposure and risk of spontaneous abortion or preterm birth. Pharmacoepidemiol Drug Saf 23:1043-50

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