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: 8013944
• 负责人: ELIZABETH E HATCH
• 金额: $ 50.91万
• 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/8013944
• 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（由研究人员提供）：我们建议在丹麦夫妇中对延迟怀孕时间（TTP）进行前瞻性队列研究。约有10-15％的夫妇患有不育，患病率可能正在增加。不育服务的使用构成了重大的经济负担，而治疗的成功率相对较低。因此，确定延迟TTP的危险因素，尤其是可修改的因素，是一个重要的公共卫生目标。大多数对延迟TTP的研究都使用了回顾性设计，这可能特别受到选择偏差的影响。这项在丹麦的前瞻性队列研究将扩大一项非常成功的R21资助的试点研究，使用互联网招募并关注计划怀孕的10,000名妇女及其男性伴侣。根据试点研究的结果，基于互联网的方法似乎是一项前瞻性队列研究中的一种有效且具有成本效益的招聘和随访手段，尤其是对于计划怀孕的夫妻，他们不容易通过其他方式识别。基于Internet的潜在招聘和与注册表数据的链接的结合是一种有力的研究设计，可以减轻偏见，因为对暴露和结果的后续行动，召回和错误分类。由于在丹麦的独特注册表资源，建立该队列将允许进行扩展的随访，对其他终点（例如儿童肥胖和哮喘）进行长期评估。在扩大的研究中，女性和男性参与者都将填写一份基线问卷和双月后续调查表，该问卷收集有关广泛因素的数据，包括饮酒，咖啡因摄入，体重指数，体育活动和久坐行为。此外，在最近的研究的指导下，我们将使用经过验证的食品频率问卷收集有关饮食因素的暴露数据，例如脂肪酸，叶酸，乳制品和铁的摄入量。其他目标将集中于几种常见和日益使用的药物，包括糖皮质激素，5-羟色胺再摄取抑制剂和非类固醇抗炎药。对于这些暴露，流产以及TTP将被评估为终点。我们优先考虑这些风险因素，因为它们是常见的，并且现有的与TTP和流产关系的研究尚无定论。将遵循夫妻，直到报告怀孕或长达12个月，这是不育的标准临床定义以及通常寻求生育治疗的时间。我们将在随访期间构想的大多数夫妇子集中进行流产分析。我们将收集有关性交，吸烟，平价，周期规律性，周期长度，避孕，职业，教育，压力，压力和抑郁症状的最后方法的潜在混杂数据。注册表数据将用于验证有关处方药，病史和生殖史的自我报告数据，并确定失去随访的参与者的怀孕和出生结果。 公共卫生相关性：将近15％的夫妇难以怀孕，大约有20％的所有怀孕终止流产。尽管经常出现，但很少有因素与不育和流产的风险增加有关。确定不育和流产的可修改风险因素是一个重要的公共卫生目标，尤其是因为治疗对这些疾病的有效性相对较差。