Consequences and Course of Uterine Fibroids in Pregnancy

描述(申请人提供)：在美国，数以千万计的育龄妇女患有子宫肌瘤，通常称为子宫肌瘤；然而，子宫肌瘤在怀孕期间的影响以及反之亦然，人们对此知之甚少。我们建议在调查妊娠期间和妊娠后肌瘤的自然病史的同时，检查子宫肌瘤与特定不良妊娠结局的关系。我们将通过以下方式推进现有知识：在怀孕早期招募不同种族的人群；使用标准化研究方案为所有参与者进行超声(US)，以减少子宫肌瘤的错误分类；改进对怀孕事件和结局的评估；以及调查肌瘤的大小和位置如何影响风险。根据“从一开始就开始：早孕健康研究”的程序，我们建议建立一个由来自北卡罗来纳州13个县的3300名妇女组成的队列。我们将包括大约15%的西班牙裔，35%的非裔美国人和45%的白人女性，在怀孕6-7周获得美国，并在怀孕10周前进行计算机辅助电话采访(CATI)。将为所有医疗参与者进行第二次CATI，时间为20-22周，并记录结果，包括病历审查。我们还将从妊娠早期子宫肌瘤患者中随机选择300名妇女和100名非子宫肌瘤妇女，以换取怀孕14-16周、26-28周和怀孕后3个月的美国妇女。在亚队列中，我们将在怀孕3个月后进行最后一次CATI。通过这样做，我们将回答这些主要的研究问题：1.患有肌瘤的妇女自然流产(SAB)的风险更高？2.患有肌瘤的妇女自然早产(PTB)的风险更高？还有这些次要问题：3.肌瘤的大小或粘膜下位置是否与SAB或PTB的风险增加有关？4.胎盘下的肌瘤是否与PTB的风险增加有关？5.肌瘤是否可能在怀孕期间和之后改变大小？生长模式是否与年龄、种族、BMI、母亲体重增加、临床糖耐量测量、高血压、妊娠结局、哺乳或孕后避孕选择有关？如果肌瘤或某些肌瘤对妊娠有不良影响，考虑到肌瘤的高患病率，其临床和公共卫生后果将是巨大的。通过前瞻性地调查子宫肌瘤的特征和风险，这项研究有可能为许多怀孕或计划怀孕的子宫肌瘤妇女的护理提供信息。

DESCRIPTION (provided by applicant): 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.