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

3 mei 2026 bijgewerkt door: 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).

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

6000

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: 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.
Andere namen:
  • AR
  • Bed Rest
Experimenteel: 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.
Gedragsmatig: No Activity Restriction
Recommendation to continue normal daily activity in pregnant women with a short cervix, without restricting physical activity.
Andere namen:
  • Activiteit
  • No Bed Rest
  • NAR

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gestational age at birth
Tijdsspanne: 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)

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Julie Glavind

Medewerkers

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

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 mei 2026

Primaire voltooiing (Geschat)

1 februari 2029

Studie voltooiing (Geschat)

1 mei 2029

Studieregistratiedata

Eerst ingediend

3 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 mei 2026

Eerst geplaatst (Werkelijk)

11 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

3 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 16-0500-15
  • 4308-00216B (Ander subsidie-/financieringsnummer: Independent Research Fund Denmark)
  • 1-10-72-96-25 (Andere identificatie: De Videnskabsetiske Komitéer For Region Midtjylland)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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