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Bed Rest With a Short Cervix on Preterm Birth (BEWISE)

2026年5月3日 更新者：Julie Glavind

BEWISE - Bed Rest With a Short Cervix on Preterm Birth

Maternal AR has long been used to prevent PTB. However, definitions of AR vary widely, ranging from complete bed rest to partial limitation of physical activity for one or more hours daily.

The use of maternal AR to prevent preterm birth is largely based on observational evidence linking strenuous physical activity to an increased risk of preterm birth, and the assumption that reduced activity may decrease myometrial activity. However, the existing evidence on the clinical effects of AR remains limited and has not demonstrated a reduction in preterm birth or a delay in deliv-ery. In contrast, some studies suggest a potential increase in preterm birth following AR and instead significant adverse maternal and fetal effects.

The overall aim of this study is to compare gestational age at birth in women with a short cervix who are prescribed AR compared with women with a short cervix who are not prescribed AR (NAR).

The primary hypothesis is that NAR is non-inferior to AR in prolonging pregnancy in women with a short cervix.

Secondary hypotheses are that, compared with AR, NAR is associated with higher level of physical activity, lower risk of maternal depression, and reduced risk of loss of maternal bone mineral density.

Through the BEWISE study, we wish to implement a change in the Danish national clinical practice regarding AR from recommending AR in risk groups (current practice) to no longer recommending AR as part as routine care (new practice). We will evaluate this change in clinical practice by prospectively collecting data from women both before and after implementation of the new recommendation. The transition from AR to NAR will be implemented sequentially in each Danish region using a randomised stepped-wedge (SW) cluster design, with each region constituting a cluster. The order in which regions transition is determined by randomisation. Each region will adopt the new recommendation at 3-month intervals, resulting in full national transition from AR to NAR within 12 months Eligible participants are pregnant women in gestational age 20+0 to 33+6 and cervical length < 25 mm in singleton pregnancies and < 30 mm in multiple pregnancies. Participants must be above 18 years of age and be able to read and understand Danish or English. There are no exclusion criteria.

The primary outcome is gestational age in days (continuous).

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

6000

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

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

Pregnant women with gestational age 20+0 to 33+6

  • Cervical length < 25 mm in singleton pregnancies and < 30 mm in multiple pregnancies
  • Above 18 years of age
  • Reads and understands Danish or English

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：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Activity Restriction
The comparison arm reflects current Danish clinical practice in each participating region. According to national recommendations, AR is indicated before GA 28+0, with the level of restriction determined by cervical length and clinical context. In singleton pregnancies with a cervix <10 mm in singleton/<15 mm in twins, strict AR is prescribed, defined as bed rest with only toilet allowance. In addition, thrombosis prophylaxis (Low Molecular Weight Heparin and compression stockings) is initiated in cases of strict AR. In women with a cervix of 10-14 mm in singletons/15-20 mm in twins, or in cases of PPROM with a cervix <25 mm, moderate AR is prescribed, defined as 2-8 hours of daily bed rest. The regimen is continued until 28 weeks of gestation.
行为的：Activity Restriction
Recommendation to restrict physical activity in pregnant women with a short cervix. This may include increased rest or bed rest according to local clinical practice.
其他名称：
  • 增强现实
  • Bed Rest
实验性的：No Activity Restriction

The intervention consists of a recommendation of NAR during pregnancy. No general or graded restrictions on daily activities are advised, and cervical length is not an indication for activity limitation, in line with current evidence.

The NAR recommendation is supported by a pragmatic clinical guidance. Women are advised to avoid activities that provoke pain, increase uterine contractions, or worsen pelvic pressure. Decisions regarding hospital admission or sick leave are based on individual clinical assessment rather than cervical length.

Specific advice may be provided when clinically indicated. Women are generally advised to avoid heavy weight-bearing exercise and lifting of objects exceeding approximately 10 kg. Otherwise, no specific restrictions on physical activity are imposed, provided that activities do not provoke symptoms such as pain, increased uterine contractions, or pelvic pressure. Sexual activity may be ad-dressed on an individual basis following clinical assessment.
行为的：No Activity Restriction
Recommendation to continue normal daily activity in pregnant women with a short cervix, without restricting physical activity.
其他名称：
  • 活动
  • No Bed Rest
  • NAR

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 birth
大体时间：At birth (from inclusion until delivery)
Gestational age at birth measured in completed days of pregnancy. This is calculated based on the estimated due date from ultrasound (crown-rump lenght <14weeks).
At birth (from inclusion until delivery)

次要结果测量

结果测量
措施说明
大体时间
Birth before 37 weeks of gestation
大体时间：At birth
At birth
Gestational age at birth, pooled
大体时间：At birth (from inclusion until delivery)
  • 14+0-21+6 weeks
  • 22+0-27+6 weeks
  • 28+0-31+6 weeks
  • 32+0-36+6 weeks
  • Birth after 37+0 weeks of gestation
At birth (from inclusion until delivery)
Latency from inclusion to birth (days)
大体时间：At birth (from inclusion until delivery)
At birth (from inclusion until delivery)
Onset of birth
大体时间：At birth (from inclusion until delivery)
  • Spontaneous
  • Induction
  • Caesarean section
At birth (from inclusion until delivery)
Mode of birth
大体时间：At birth (from inclusion until delivery)
  • Vaginal
  • Assisted vaginal
  • Planned caesarean section
  • Non planned caesarean section
At birth (from inclusion until delivery)
- Non-occipital presentation
大体时间：At birth (from inclusion until delivery)
At birth (from inclusion until delivery)
Interventions during birth
大体时间：At birth (from inclusion until delivery)
  • Oxytocin-infusion
  • Epidural anaesthesia
At birth (from inclusion until delivery)
Degree of birth tear
大体时间：At birth (from inclusion until delivery)
  • No tear
  • 1. or 2. degree tear
  • 3. or 4. degree tear
At birth (from inclusion until delivery)
Maternal serious morbidity
大体时间：From inclusion to 42 days after delivery
Admission to an intensive care unit or a unit providing 24-hour medical supervision, mechanical ventilation, or continuous vasoactive drug support at any time during pregnancy and postpartum due to pregnancy- or childbirth-related complications
From inclusion to 42 days after delivery
Umbilical cord arterial pH
大体时间：At birth (from inclusion until delivery)
At birth (from inclusion until delivery)
EPDS depression score
大体时间：From inclusion to 8 weeks after due date
From inclusion to 8 weeks after due date
Bone turnover marker level
大体时间：At inclusion and after 4 and 8 weeks.
  • Procollagen type 1 N-propeptide (PINP)
  • Carboxy-terminal telopeptide of type I collagen (CTX)
At inclusion and after 4 and 8 weeks.
Lumbar spine Z-score
大体时间：12 months after stopped breastfeeding
12 months after stopped breastfeeding
Data from SENS activity tracker
大体时间：At birth (from inclusion until delivery)
Step count Time in supine position
At birth (from inclusion until delivery)
Neonatal mortality
大体时间：At birth (from inclusion until delivery)
At birth (from inclusion until delivery)
Fetal loss
大体时间：At birth (from inclusion until delivery)
At birth (from inclusion until delivery)
Birth weight
大体时间：At birth (from inclusion until delivery)
At birth (from inclusion until delivery)
Neonatal admission, days
大体时间：From inclusion until discharge or 44 postmenstrual weeks
From inclusion until discharge or 44 postmenstrual weeks
CNS morbidity
大体时间：From inclusion until discharge or 44 postmenstrual weeks
Intraventricular haemorrhage grade III or IV, Periventricular leukomalacia
From inclusion until discharge or 44 postmenstrual weeks
Gastrointestinal morbidity
大体时间：From inclusion until discharge or 44 postmenstrual weeks
Necrotizing enterocolitis (NEC) requiring surgery (Bell's stage 3), Spontaneous intestinal perfo-ration (SIP) requiring surgical treatment
From inclusion until discharge or 44 postmenstrual weeks
Respiratory support
大体时间：From inclusion until discharge or 44 postmenstrual weeks
Mechanical ventilation or non-invasive ventilation (NIV)
From inclusion until discharge or 44 postmenstrual weeks
Respiratory distress syndrome (RDS)
大体时间：From inclusion until discharge or 44 postmenstrual weeks
From inclusion until discharge or 44 postmenstrual weeks
Early onset infection
大体时间：From inclusion to 5 days after birth
Definition: >5 days of i.v. antibiotics where the treatment starts within the first week after delivery.
From inclusion to 5 days after birth
Apgar score at 5 minutes
大体时间：At birth (from inclusion until delivery)
At birth (from inclusion until delivery)

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

Julie Glavind

合作者

Odense University Hospital
Zealand University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Aalborg University Hospital
University of Aberdeen

调查人员

  • 首席研究员：Julie Glavind, Senior Consultant, MD, PhD、Aarhus Univeristy Hospital, Department of Obstetrics and Gynecology

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 (估计的)

2026年5月1日

初级完成 (估计的)

2029年2月1日

研究完成 (估计的)

2029年5月1日

研究注册日期

首次提交

2026年5月3日

首先提交符合 QC 标准的

2026年5月3日

首次发布 (实际的)

2026年5月11日

研究记录更新

最后更新发布 (实际的)

2026年5月11日

上次提交的符合 QC 标准的更新

2026年5月3日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 16-0500-15
  • 4308-00216B (其他赠款/资助编号：Independent Research Fund Denmark)
  • 1-10-72-96-25 (其他标识符：De Videnskabsetiske Komitéer For Region Midtjylland)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

IPD will be shared if possible according to GDPR and Danish legislation

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

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