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生活方式干预改善双胎妊娠结局 (LIFETWIN)

2026年8月13日 更新者：Universitaire Ziekenhuizen KU Leuven

生活方式干预改善双胎妊娠结局：一项多中心随机对照试验的综合试点研究

这项临床试验旨在评估包括营养、体育活动和正念在内的整体生活方式干预措施的益处，目标是减少双胞胎早产，可能在全球范围内革新双胞胎护理。

将进行一项初步的综合试点研究，以评估和完善干预方法。试点研究的主要目标是评估可行性。如果认为可行，将实施完整研究，并将试点研究参与者的数据纳入主要研究。

完整研究的目标：评估多组分生活方式是否将分娩时的孕周延长一周。附加目标：评估干预措施是否对包括妊娠并发症、新生儿和孕产妇结局以及孕产妇生活质量在内的多个次要结局产生积极影响。

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

81

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 比利时
      • Brussels、比利时、1020
        • 招聘中
        • CHU Brugmann
        • 接触：
        • 首席研究员：
          • Jacques Jani, MD, PhD
      • Genk、比利时、3600
        • 招聘中
        • Ziekenhuis Oost-Limburg
        • 接触：
        • 首席研究员：
          • Tinne Mesens, MD
      • Leuven、比利时、3000
        • 招聘中
        • UZ Leuven
        • 首席研究员：
          • Roland Devlieger, MD, PhD
        • 接触：
      • Liège、比利时、4000
        • 招聘中
        • Hôpital de la Citadelle
        • 接触：
        • 首席研究员：
          • Laure Noël, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  • 在任何随机分组或干预前，参与者必须自愿提供书面知情同意书。
  • 双绒毛膜双胎妊娠的诊断必须符合接受标准。
  • 参与者必须在妊娠第14周前被招募。
  • 需精通荷兰语、英语或法语。

排除标准：

  • 参与者有影响饮食的既往疾病或状况史：

    1. 孕前糖尿病
    2. 严重心脏病，
    3. 慢性肾脏疾病，
    4. 乳糜泻，
    5. 炎症性肠病，
    6. 减肥手术后

  • 参与者有影响身体活动能力的既往疾病或状况史：

    1. 慢性阻塞性肺疾病（COPD）
    2. 严重哮喘。
    3. 纤维肌痛
    4. 骨关节炎
    5. 慢性疼痛综合征
    6. 脊髓损伤。
    7. 多发性硬化症（MS）
    8. 帕金森病
    9. 中风史
    10. 耐药性癫痫
  • 通过Born in Belgium（BIB）或本地筛查工具识别出需要特定护理路径的精神脆弱性参与者。

  • 有精神健康障碍史的参与者

    1. 创伤后应激障碍（PTSD）
    2. 焦虑障碍
    3. 抑郁障碍
    4. 双相情感障碍
    5. 强迫症（OCD）
    6. 精神分裂症或分裂情感性障碍
  • 无法提供知情同意
  • 不懂荷兰语、英语或法语
  • 孕早期诊断出单胎或双胎存在严重先天性异常
  • 孕早期单胎或双胎胎死宫内
  • 招募前胎膜早破
  • 参与任何其他干预性研究

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：控制
护理标准
实验性的：干预
生活方式指导课程
行为的：LIFETWIN
LIFETWIN干预计划为孕期女性提供8次辅导课程，重点包括营养（含复合维生素摄入）、体育锻炼和压力缓解。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Gestational age at delivery (main)
大体时间：Delivery
The primary outcome is gestational age at delivery, measured in weeks and days. This is calculated based on the last menstrual period and confirmed via early ultrasound dating (before 13 weeks and 6 days) for spontaneous pregnancies or based on embryo age at transfer for IVF patients. The study aims to evaluate whether a multi-component lifestyle intervention can delay delivery by at least one week, thereby enhancing pregnancy outcomes. Gestational age data will be collected from medical records to ensure accuracy and consistency.
Delivery

次要结果测量

结果测量
措施说明
大体时间
Birth weight (main)
大体时间：Delivery
Birth weight in grams and percentile.
Delivery
Small for gestational age (main)
大体时间：Delivery
Small for gestational age in at least one twin, defined as below the 10th percentile according to twins' nomograms
Delivery
Offspring mortality (main)
大体时间：24 weeks -28 days postpartum
Offspring mortality- defined as the death of one or both twins occurring at any time from foetal viability (24 weeks' gestation) until 28 days postpartum (neonatal period).
24 weeks -28 days postpartum
Offspring infection (main)
大体时间：within the first 72 hours of delivery
Offspring infection- defined as neonatal sepsis, congenital pneumonia, neonatal meningitis, or necrotizing enterocolitis (NEC) with infection within the first 72 hours of delivery.
within the first 72 hours of delivery
Early neurodevelopmental morbidity (main)
大体时间：6 weeks postpartum
Early neurodevelopmental morbidity- defined as diagnosis of Intraventricular haemorrhage (IVH) Grade III-IV, periventricular leukomalacia (PVL), hypoxic-ischemic encephalopathy (HIE), and neonatal seizures.
6 weeks postpartum
Gastrointestinal morbidity (main)
大体时间：6 weeks postpartum
Gastrointestinal morbidity- defined as diagnosis of NEC and spontaneous perforation.
6 weeks postpartum
Respiratory morbidity (main)
大体时间：6 weeks postpartum
Respiratory morbidity- defined as diagnosis of respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), transient tachypnoea of the newborn (TTN) or persistent pulmonary hypertension of the newborn (PPHN)
6 weeks postpartum
NICU admission (main)
大体时间：within 72 hours of delivery
Any admission to the Neonatal intensive care unit (NICU) within 72 hours of delivery.
within 72 hours of delivery
Number of days in the NICU (main)
大体时间：6 weeks postpartum
Number of days in the NICU
6 weeks postpartum
Gestational weight gain (main)
大体时间：from 14 weeks pregnancy to delivery
Gestational Weight Gain (GWG) corrected to pregnancy duration.
from 14 weeks pregnancy to delivery
Maternal quality of life (main)
大体时间：Before 14 weeks of pregnancy, 32-34 weeks and 6 weeks postpartum
Maternal quality of Life based on questionnaire EQ-5D-5L.
Before 14 weeks of pregnancy, 32-34 weeks and 6 weeks postpartum
Postpartum weight (main)
大体时间：6 weeks postpartum
Postpartum weight recorded 6 weeks postpartum
6 weeks postpartum

其他结果措施

结果测量
措施说明
大体时间
Maternal mortality (main)
大体时间：within 42 days postpartum
Maternal mortality- defined as death of the mother during pregnancy or within 42 days postpartum, due to any cause related to or aggravated by pregnancy or its management.
within 42 days postpartum
Caesarean section delivery (main)
大体时间：delivery
delivery
Premature rupture of the membranes (main)
大体时间：before week 34
before week 34
Maternal number of days in hospitalization after delivery (main)
大体时间：6 weeks postpartum
6 weeks postpartum
Maternal pregnancy related hypertension (main)
大体时间：from 14 weeks of pregnancy to delivery
Maternal pregnancy related hypertension- defines as Pregnancy-induced hypertension or preeclampsia as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP).
from 14 weeks of pregnancy to delivery
Maternal gestational diabetes mellitus (main)
大体时间：from week 20 of pregnancy to delivery
Maternal gestational diabetes mellitus as defined by diagnosis of diabetes after week 20 in a two-step approach according to the Carpenter/Coustan criteria.
from week 20 of pregnancy to delivery
maternal anaemia (main)
大体时间：from 14 weeks of pregnancy to delivery
Maternal anaemia defined by haemoglobin under 10 g/dL during pregnancy.
from 14 weeks of pregnancy to delivery
Food consumption change (main)
大体时间：before 14 weeks, 32-34 weeks of pregnancy and 6 weeks postpartum
Food consumption change based on 32-item semi-quantitative Food Frequency Questionnaire
before 14 weeks, 32-34 weeks of pregnancy and 6 weeks postpartum
Physical activity (main)
大体时间：before 14 weeks, 32-34 weeks, 6 weeks postpartum
Physical activity level based on the Kaiser Physical Activity Survey.
before 14 weeks, 32-34 weeks, 6 weeks postpartum
Change in lifestyle habits (main)
大体时间：before 14 weeks, 32-34 weeks, 6 weeks postpartum
Change in lifestyle habits based on Lifestyle behaviour questionnaire.
before 14 weeks, 32-34 weeks, 6 weeks postpartum
Neonatal number of days in hospitalization after delivery (main)
大体时间：6 weeks after birth
6 weeks after birth
Number of recruited participants (pilot)
大体时间：through pilot study completion, an average of 1.5 years
Recruitment Success (RE-AIM Principle: Reach and Adoption): assessment the ability to recruit participants over the course of the pilot. Recruitment efforts will focus on engaging a diverse demographic, particularly including women from low SES and high-risk backgrounds.
through pilot study completion, an average of 1.5 years
Training and retention of study midwifes (pilot)
大体时间：through pilot study completion, an average of 1.5 years
Midwife Engagement (RE-AIM Principle: Adoption): Midwives at all centres will undergo a two-day training program tailored to the LIFETWIN intervention. Retention and engagement of midwives will be monitored throughout the pilot study.
through pilot study completion, an average of 1.5 years
Consistency of intervention delivery (pilot)
大体时间：through pilot study completion, an average of 1.5 years
Intervention Fidelity (RE-AIM Principle: Implementation): We will assess how consistently the intervention (8 lifestyle sessions) can be delivered during the pilot study, both face-to-face and remotely, ensuring quality and adherence across all pilot centres.
through pilot study completion, an average of 1.5 years
The number of participants retained throughout the pilot study (pilot)
大体时间：through pilot study completion, an average of 1.5 years
Participant Retention (RE-AIM Principle: Maintenance): Monitor retention rates of participants throughout the pilot study period, with reasons for lack of adherence and dropout carefully recorded. This will help us understand both the feasibility of maintaining participant engagement and the practical challenges in long-term implementation
through pilot study completion, an average of 1.5 years
Qualitative feedback on experiences with the intervention (pilot)
大体时间：through pilot study completion, an average of 1.5 years
Qualitative Feedback (RE-AIM Principle: Maintenance): Midwives and participants will be interviewed during/after the pilot phase, to assess how the intervention is perceived, experienced, and sustained over time. Insights from this feedback will be critical for informing the next phase of the study (i.e. the main trial), especially regarding long-term adoption and sustainability.
through pilot study completion, an average of 1.5 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Universitaire Ziekenhuizen KU Leuven

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月5日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年6月1日

研究注册日期

首次提交

2025年11月18日

首先提交符合 QC 标准的

2025年11月25日

首次发布 (实际的)

2025年12月8日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月13日

最后验证

2025年10月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • S68251

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

The datasets generated and/or analysed during the current study will be made available upon completion of the LIFETWIN study project. De-identified research data, together with accompanying metadata and relevant documentation, will be deposited in the KU Leuven Research Data Repository (RDR) and will be accessible in accordance with institutional policies and applicable legal and ethical requirements. Data sharing will occur after publication of the main study results and following the end of the project, subject to protection of participant confidentiality and compliance with the informed consent procedures approved by the relevant ethics committee.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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