Consequences and Course of Uterine Fibroids in Pregnancy

妊娠期子宫肌瘤的后果和病程

• 批准号: 6731852
• 负责人: KATHERINE E HARTMANN
• 金额: $ 56.55万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-01-01 至 2008-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6731852
• 关键词: clinical research; disease /disorder proneness /risk; epidemiology; female; human subject; leiomyoma; outcomes research; pathologic process; placenta; pregnancy; pregnancy disorder; premature infant human; spontaneous abortion; uterus preneoplastic state

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.

描述（由申请人提供）：美国有数千万育龄妇女患有子宫肌瘤，通常称为肌瘤；然而，人们对子宫肌瘤的影响以及怀孕期间子宫肌瘤的影响知之甚少。我们建议在调查妊娠期间和妊娠后肌瘤的自然史的同时，研究肌瘤与特定不良妊娠结局的关联。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对所有参与者进行超声检查（美国），以减少肌瘤错误分类；完善妊娠事件和结果的评估；并研究肌瘤的大小和位置如何影响风险。根据“从头开始：早期妊娠健康研究”的程序，我们建议建立一个由来自北卡罗来纳州 13 个县的 3,300 名女性组成的队列。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，在妊娠 6-7 周内进行美国筛查，并在妊娠 10 周前进行计算机辅助电话访谈 (CATI)。将为所有医疗参与者在 20-22 周进行第二次 CATI，并记录结果，包括医疗记录审查。我们还将在妊娠第一个月的超声检查中，从患有肌瘤的女性中随机选择 300 名女性，从没有肌瘤的女性中随机选择 100 名女性，作为回报，在怀孕后 14-16 周、26-28 周和 3 个月进行超声检查。在子队列中，我们将在怀孕后 3 个月进行最后一次 CATI。通过这样做，我们将回答以下主要研究问题： 1. 患有子宫肌瘤的女性自然流产 (SAB) 的风险是否更高？ 2. 患有子宫肌瘤的女性自发性早产 (PTB) 的风险是否较高？以及这些次要问题： 3. 肌瘤大小或粘膜下位置是否与 SAB 或 PTB 风险增加相关？ 4. 胎盘下方的肌瘤是否与 PTB 风险增加相关？ 5. 子宫肌瘤在怀孕期间和怀孕后可能会改变大小吗？生长模式与年龄、种族、体重指数、母亲体重增加、临床葡萄糖耐量测量、高血压、妊娠结局、哺乳期或孕后避孕选择有关吗？如果肌瘤或某些肌瘤对怀孕产生不利影响，鉴于肌瘤的高患病率，其临床和公共健康后果将是巨大的。通过前瞻性调查肌瘤特征和风险，这项研究有可能为许多怀孕或计划怀孕的肌瘤女性的护理提供信息。