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）：在美国，数千万育龄妇女患有子宫平滑肌瘤，通常称为肌瘤;然而，对肌瘤在妊娠中的影响以及反之亦然的影响知之甚少。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相关性。我们将通过以下方式推进现有知识：在妊娠早期招募种族多样的人群;使用标准化研究方案对所有参与者进行超声检查（US），以减少肌瘤错误分类;完善妊娠事件和结局的评估;并调查肌瘤的大小和位置如何影响风险。基于“从一开始就正确：早孕健康研究”的程序，我们建议建立一个来自北卡罗来纳州13个县的3,300名妇女的队列。我们将纳入约15%的西班牙裔、35%的非洲裔美国人和45%的白色女性，在妊娠第6- 7周获得US，并在妊娠10周前进行计算机辅助电话访谈（CATI）。将在20-22周时对所有医学受试者进行第二次CATI，并记录结局，包括病历审查。我们还将随机选择300名患有子宫肌瘤的妇女和100名没有子宫肌瘤的妇女作为子队列，在妊娠第一个三个月的US中返回14-16周，26-28周和3个月后的US。在子队列中，我们将在妊娠后3个月进行最终CATI。通过这样做，我们将回答这些主要的研究问题：1。患有子宫肌瘤的女性是否有更高的自然流产风险（SAB）？2.患有子宫肌瘤的女性是否有更高的自发性早产（PTB）风险？和这些次要问题：3.肌瘤大小或黏膜下位置是否与SAB或PTB风险增加相关？4.胎盘下肌瘤与PTB风险增加相关吗？5.子宫肌瘤在怀孕期间和怀孕后会改变大小吗？生长模式是否与年龄、种族、BMI、母体体重增加、临床葡萄糖耐量指标、高血压、妊娠结局、哺乳或妊娠后避孕选择有关？如果子宫肌瘤或某些子宫肌瘤对妊娠有不良影响，鉴于子宫肌瘤的高患病率，临床和公共卫生后果将是巨大的。通过前瞻性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提供护理。