An internet based prospective study of time to pregnancy

基于互联网的怀孕时间前瞻性研究

• 批准号: 8225330
• 负责人: ELIZABETH E HATCH
• 金额: $ 51.16万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-15 至 2014-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8225330
• 关键词: Affect; Age; Alcohol consumption; Alcohols; Anti-Inflammatory Agents; Anti-inflammatory; Applications Grants; Asthma; Automobile Driving; Behavior; Behavioral; Bicycling; Birth; Body mass index; Caffeine; Childhood Asthma; Clinical; Cohort Studies; Commuting; Conceptions; Consumption; Contraceptive methods; Couples; Dairy Products; Data; Data Collection; Denmark; Diet; Dietary Factors; Disease; Economic Burden; Education; Enrollment; Epidemiologic Methods; Epidemiologic Studies; Evaluation; Fatty Acids; Fatty acid glycerol esters; Female; Fertility; Folate; Folic Acid; Food; Food Supplements; Frequencies; Funding; Gastroesophageal reflux disease; Glucocorticoids; Goals; Infertility; Intake; Intention; Internet; Iron; Length; Life Style; Link; Mails; Maintenance; Medical History; Mental Depression; Methods; Migraine; Occupational Exposure; Occupations; Outcome; Participant; Patient Self-Report; Pharmaceutical Preparations; Physical activity; Pilot Projects; Population; Population Study; Pregnancy; Prevalence; Prospective Studies; Public Health; Questionnaires; Recruitment Activity; Registries; Reporting; Reproductive Health; Reproductive History; Research; Research Design; Research Personnel; Resources; Risk; Risk Factors; Saturated Fatty Acids; Selection Bias; Selective Serotonin Reuptake Inhibitor; Serotonin; Services; Smoking; Source; Spontaneous abortion; Stress; Subfecundity; Telephone Interviews; Time; Time Study; Treatment Effectiveness; Woman; Work; base; cohort; cost; cost effective; data registry; depressive symptoms; design; expectation; follow-up; inhibitor/antagonist; interest; male; modifiable risk; obesity in children; parity; population based; pregnant; prospective; public health relevance; reproductive; reproductive epidemiology; sedentary; success; uptake; volunteer

DESCRIPTION (provided by investigator): We propose to conduct a prospective cohort study of risk factors for delayed time to pregnancy (TTP) among Danish couples. About 10-15 per cent of couples suffer from infertility, and the prevalence may be increasing. Use of infertility services constitutes a major economic burden, and success rates of treatment are relatively low. Thus, identifying risk factors for delayed TTP, especially modifiable factors, is an important public health goal. Most previous studies of delayed TTP have used retrospective designs, which may be particularly subject to selection bias. This prospective cohort study in Denmark will expand a highly successful R21-funded pilot study, using the internet to recruit and follow 10,000 women and their male partners who are planning a pregnancy. Based on results from the pilot study, internet-based methods appear to be an efficient and cost- effective means of recruitment and follow-up in a prospective cohort study, especially for couples planning a pregnancy who are not readily identifiable by other means. The combination of internet-based prospective recruitment and linkage to registry data is a powerful research design that can mitigate biases due to loss to follow-up, recall, and misclassification of exposures and outcomes. Owing to unique registry resources in Denmark, establishment of this cohort will allow, with extended follow-up, the long-term evaluation of other endpoints such as childhood obesity and asthma. In the expanded study, both female and male participants will complete a baseline questionnaire and bi-monthly follow-up questionnaires that collect data on a wide range of factors including alcohol consumption, caffeine intake, body mass index, physical activity and sedentary behavior. In addition, guided by recent research, we will collect exposure data on dietary factors, such as fatty acids, folic acid, dairy foods, and iron intake, using a validated food frequency questionnaire. Other objectives will focus on several common and increasingly used medications, including glucocorticoids, serotonin re-uptake inhibitors, and non-steroidal anti-inflammatory drugs. For these exposures, miscarriage as well as TTP will be evaluated as endpoints. We have given priority to these risk factors because they are common and existing studies of their relation to TTP and miscarriage are inconclusive. Couples will be followed until a pregnancy is reported or for up to twelve months, the standard clinical definition of infertility and the time when fertility treatment is typically sought. We will conduct miscarriage analyses among the majority subset of couples that conceive during the follow-up. We will collect potential confounder data on frequency of intercourse, smoking, parity, cycle regularity, cycle length, last method of contraception, occupation, education, stress and depressive symptoms, among other factors. Registry data will be used to validate self-reported data on prescription medications, medical history, and reproductive history and to ascertain pregnancies and birth outcomes among participants who are lost to follow-up. PUBLIC HEALTH RELEVANCE: Nearly 15 per cent of all couples have difficulty becoming pregnant and approximately 20 per cent of all pregnancies end in miscarriage. Despite their frequent occurrence, few factors have been firmly linked to an increased risk of infertility and miscarriage. Identifying modifiable risk factors for infertility and miscarriage is an important public health goal, especially because the effectiveness of treatments for these conditions is relatively poor.

描述（由研究者提供）：我们建议对丹麦夫妇中妊娠时间延迟 (TTP) 的危险因素进行一项前瞻性队列研究。大约 10-15% 的夫妇患有不孕症，而且患病率可能还在增加。使用不孕不育服务构成了重大的经济负担，并且治疗的成功率相对较低。因此，确定 TTP 延迟的危险因素，尤其是可改变的因素，是一个重要的公共卫生目标。大多数延迟 TTP 的先前研究都采用回顾性设计，这可能特别容易受到选择偏倚的影响。丹麦的这项前瞻性队列研究将扩大 R21 资助的一项非常成功的试点研究，利用互联网招募和跟踪 10,000 名计划怀孕的女性及其男性伴侣。根据试点研究的结果，基于互联网的方法似乎是前瞻性队列研究中一种有效且具有成本效益的招募和随访方式，特别是对于通过其他方式不易识别的计划怀孕的夫妇而言。基于互联网的前瞻性招募和与注册数据的链接相结合是一种强大的研究设计，可以减少由于随访失败、回忆以及暴露和结果错误分类而导致的偏差。由于丹麦独特的注册资源，该队列的建立将允许通过长期随访，对儿童肥胖和哮喘等其他终点进行长期评估。在扩大的研究中，女性和男性参与者都将完成基线调查问卷和每两个月一次的后续调查问卷，收集有关酒精消耗、咖啡因摄入量、体重指数、体力活动和久坐行为等多种因素的数据。此外，在最近研究的指导下，我们将使用经过验证的食物频率问卷收集有关饮食因素的暴露数据，例如脂肪酸、叶酸、乳制品和铁摄入量。其他目标将集中在几种常见且日益使用的药物上，包括糖皮质激素、血清素再摄取抑制剂和非甾体抗炎药。对于这些暴露，流产和 TTP 将作为终点进行评估。我们优先考虑这些风险因素，因为它们很常见，而且现有的关于它们与 TTP 和流产关系的研究尚无定论。将对夫妇进行跟踪直至报告怀孕或长达十二个月，这是不孕症的标准临床定义以及通常寻求生育治疗的时间。我们将对随访期间怀孕的大多数夫妇进行流产分析。我们将收集有关性交频率、吸烟、产次、周期规律、周期长度、最后一种避孕方法、职业、教育、压力和抑郁症状等因素的潜在混杂数据。登记数据将用于验证处方药、病史和生育史的自我报告数据，并确定失访参与者的怀孕和出生结果。 公共卫生相关性：近 15% 的夫妇难以怀孕，约 20% 的怀孕以流产告终。尽管这种情况频繁发生，但很少有因素与不孕和流产风险增加密切相关。识别不孕和流产的可改变风险因素是一个重要的公共卫生目标，特别是因为这些疾病的治疗效果相对较差。