Natural History of Sleep Disturbance in Childbearing Women: A Feasibility Study

育龄妇女睡眠障碍的自然史：可行性研究

基本信息

批准号：
9033471
负责人：
JACQUELINE D KLOSS
金额：
$ 24.49万
依托单位：
DREXEL UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-26 至 2016-09-27
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9033471
关键词：
Accounting Address Admission activity Birth Birth Weight Cesarean section Childbirth Collaborations Data Disease Distress Electronic Mail Enrollment Ensure Evaluation Exhibits Exploratory/Developmental Grant Fatigue Feasibility Studies Feedback First Pregnancy Trimester Frequencies Gestational Diabetes Health Hormonal Change Incentives Incidence Infant Infant Health Intervention Intrinsic Sleep Disorders Leadership Literature Longitudinal Studies Low Birth Weight Infant Maternal Health Measures Mental Depression Mental Health Methods Moods Morbidity - disease rate Mothers Natural History Nature Outcome Participant Pathology Pattern Personal Satisfaction Postpartum Depression Postpartum Period Postpartum Women Pre-Eclampsia Pregnancy Pregnancy loss Pregnant Women Premature Birth Probability Prognostic Marker Prospective Studies Qualifying Questionnaires Recruitment Activity Registries Research Research Personnel Resolution Restless Legs Syndrome Risk Sampling Second Pregnancy Trimester Severities Sleep Sleep Apnea Syndromes Sleep Disorders Sleep disturbances Sleeplessness Specific qualifier value Spontaneous abortion Surveys Symptoms System Testing Time Woman Women&apos s Group adverse outcome antepartum depression base child bearing cohort course development design disturbance in affect infant outcome innovation instrument longitudinal design meetings motherhood novel physical conditioning pregnant programs prospective sleep abnormalities web site

项目摘要

PROJECT ABSTRACT/SUMMARY Prospective data on the sleep of women as they transition from pre-pregnancy through pregnancy and to postpartum are needed to predict maternal and infant health outcomes. Sleep disturbance among new mothers is ubiquitous and presents a profound challenge, not only to mothers' health and well-being, but also to that of their infant. While some sleep disruptions may be normative and resolve with childbirth and the adaptation to new motherhood, others may be maladaptive and confer risk for adverse pregnancy and/or poor maternal or infant health outcomes. For example, sleep disturbance, globally measured, has been associated with antenatal depression, preterm birth, longer labors, more C-section deliveries, and postpartum depression. Which sleep disorders specifically confer risk is only now being delineated. Longitudinal studies are needed to determine when, for whom, and under what conditions, sleep disturbance gives rise to pathology. Prospective studies of this nature, however, have been limited, due to challenges in recruiting large, representative samples, maintaining enrolled participants, and ensuring timely completion of study instruments. In keeping with the R21 mechanism, the present study is designed to 1) pilot the feasibility of a novel methodological approach (recruitment via a national polling agency and registry, the use of an online questionnaire system, the provision of regular feedback via email and a study website, and a lottery-based incentive system) aimed to systematically and efficiently cull longitudinal data of this kind; 2) evaluate pregnant and non-pregnant women for differences with respect to cumulative sleep disorder morbidity, and determine which specific sleep disorders account for these differences; and 3) gather pilot data on the association between sleep disturbance and maternal-infant outcomes. Nulliparous women who do not intend to conceive in the next 18 months, who intend to conceive in the next 18 months, and who are currently in their first trimester, will be recruited to participate in a 16-18 month study. Feasibility will be assessed by evaluating recruitment, retention, and compliance rates and whether these meet pre-specified threshold criteria. Both sleep continuity and sleep disorder symptoms will be systematically tracked in relation to maternal and infant outcomes (e.g., fatigue, sleepiness, mood disturbance, gestational diabetes, incidence of pregnancy loss, incidence of pre-term birth, and birth weight). Given data to support the feasibility of these strategies, the methodological package proposed can be applied to numerous longitudinal designs, including, and apart from, the proposed study. Finally, the content of the proposed study will serve to allow an estimation of the overall association between sleep disturbance and maternal and infant health (i.e., an overall association between the two sets of measures) and for the evaluation of specific associations (e.g., OSA-related symptoms and gestational diabetes). Ultimately, if successful, this program of research may help define when sleep disorder interventions are needed to promote both maternal health and good infant outcomes.

项目摘要/总结关于女性从怀孕前到怀孕期间的睡眠的前瞻性数据产后需要预测孕产妇和婴儿的健康结果。新妈妈的睡眠障碍它无处不在，不仅对母亲的健康和福祉，而且对孩子的健康和福祉提出了深刻的挑战。他们的婴儿。虽然一些睡眠中断可能是正常的，并会随着分娩和适应而解决刚当妈妈的人，其他人可能会适应不良，并带来不良妊娠和/或母亲或母亲状况不佳的风险。婴儿健康结果。例如，全球测量的睡眠障碍与产前抑郁症、早产、产程延长、剖腹产次数增多以及产后抑郁症。哪些睡眠障碍具体会带来风险，现在才被描述出来。需要进行纵向研究确定睡眠障碍何时、针对谁以及在什么条件下引起病理。预期然而，由于在招募大规模、有代表性的研究方面存在挑战，这种性质的研究受到限制。样本，维护登记的参与者，并确保及时完成研究工具。为了保持借助 R21 机制，本研究旨在 1) 试点新方法的可行性（通过国家投票机构和登记处进行招募、使用在线调查问卷系统、提供通过电子邮件和研究网站定期反馈，以及基于抽签的激励系统）旨在系统地和有效地剔除此类纵向数据； 2) 评估孕妇和非孕妇在尊重方面的差异累积睡眠障碍发病率，并确定哪些特定的睡眠障碍导致了这些差异；和 3) 收集有关睡眠障碍与母婴结局之间关系的试点数据。未生育过的女性会这样做未来 18 个月内不打算怀孕的人、未来 18 个月内打算怀孕的人以及目前正在怀孕的人他们将被招募参加为期 16-18 个月的研究。可行性将通过评估来评估招聘、保留和合规率，以及这些是否符合预先指定的阈值标准。两个都将系统地跟踪与母婴相关的睡眠连续性和睡眠障碍症状结果（例如，疲劳、嗜睡、情绪障碍、妊娠期糖尿病、流产发生率、早产发生率和出生体重）。鉴于数据支持这些策略的可行性，所提出的方法包可以应用于许多纵向设计，包括但不限于：拟议的研究。最后，拟议研究的内容将有助于对总体情况进行估计睡眠障碍与母婴健康之间的关联（即睡眠障碍与母婴健康之间的总体关联）两组测量）以及评估特定关联（例如 OSA 相关症状和妊娠期糖尿病）。最终，如果成功，这项研究计划可能有助于确定睡眠障碍何时发生需要采取干预措施来促进孕产妇健康和良好的婴儿结局。