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

3 de maio de 2026 atualizado por: 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).

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

6000

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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.
Comportamental: 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.
Outros nomes:
  • RA
  • Bed Rest
Experimental: 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.
Comportamental: No Activity Restriction
Recommendation to continue normal daily activity in pregnant women with a short cervix, without restricting physical activity.
Outros nomes:
  • Atividade
  • No Bed Rest
  • NAR

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Gestational age at birth
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Birth before 37 weeks of gestation
Prazo: At birth
At birth
Gestational age at birth, pooled
Prazo: 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)
Prazo: At birth (from inclusion until delivery)
At birth (from inclusion until delivery)
Onset of birth
Prazo: At birth (from inclusion until delivery)
  • Spontaneous
  • Induction
  • Caesarean section
At birth (from inclusion until delivery)
Mode of birth
Prazo: 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
Prazo: At birth (from inclusion until delivery)
At birth (from inclusion until delivery)
Interventions during birth
Prazo: At birth (from inclusion until delivery)
  • Oxytocin-infusion
  • Epidural anaesthesia
At birth (from inclusion until delivery)
Degree of birth tear
Prazo: 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
Prazo: 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
Prazo: At birth (from inclusion until delivery)
At birth (from inclusion until delivery)
EPDS depression score
Prazo: From inclusion to 8 weeks after due date
From inclusion to 8 weeks after due date
Bone turnover marker level
Prazo: 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
Prazo: 12 months after stopped breastfeeding
12 months after stopped breastfeeding
Data from SENS activity tracker
Prazo: At birth (from inclusion until delivery)
Step count Time in supine position
At birth (from inclusion until delivery)
Neonatal mortality
Prazo: At birth (from inclusion until delivery)
At birth (from inclusion until delivery)
Fetal loss
Prazo: At birth (from inclusion until delivery)
At birth (from inclusion until delivery)
Birth weight
Prazo: At birth (from inclusion until delivery)
At birth (from inclusion until delivery)
Neonatal admission, days
Prazo: From inclusion until discharge or 44 postmenstrual weeks
From inclusion until discharge or 44 postmenstrual weeks
CNS morbidity
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: From inclusion until discharge or 44 postmenstrual weeks
From inclusion until discharge or 44 postmenstrual weeks
Early onset infection
Prazo: 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
Prazo: At birth (from inclusion until delivery)
At birth (from inclusion until delivery)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Julie Glavind

Colaboradores

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

Investigadores

  • Investigador principal: Julie Glavind, Senior Consultant, MD, PhD, Aarhus Univeristy Hospital, Department of Obstetrics and Gynecology

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de maio de 2026

Conclusão Primária (Estimado)

1 de fevereiro de 2029

Conclusão do estudo (Estimado)

1 de maio de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

3 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de maio de 2026

Primeira postagem (Real)

11 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

11 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 16-0500-15
  • 4308-00216B (Número de outro subsídio/financiamento: Independent Research Fund Denmark)
  • 1-10-72-96-25 (Outro identificador: De Videnskabsetiske Komitéer For Region Midtjylland)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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