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Bed Rest With a Short Cervix on Preterm Birth

BEWISE - Bed Rest With a Short Cervix on Preterm Birth

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07577388
Acronym
BEWISE
Enrollment
6000
Registered
2026-05-11
Start date
2026-05-01
Completion date
2029-05-01
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth, Cervical Insufficiency, Bed Rest, Pregnancy Complications, Immobilization, Depression, Postpartum, Pregnancy Outcome, Infant, Premature, Uterine Cervical Incompetence, Premature Birth, Obstetric Labor, Premature, Physical Activity, Bone Density

Brief summary

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).

Interventions

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.

BEHAVIORALNo Activity Restriction

Recommendation to continue normal daily activity in pregnant women with a short cervix, without restricting physical activity.

Sponsors

Julie Glavind
Lead SponsorOTHER
Aarhus University Hospital
CollaboratorOTHER
University of Aberdeen
CollaboratorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
Odense University Hospital
CollaboratorOTHER
Aalborg University Hospital
CollaboratorOTHER
Zealand University Hospital
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The BEWISE study is designed as a non-inferiority stepped-wedge cluster randomized controlled trial. The transition from activity restriction to no activity restriction is determined by a randomized sequence at cluster level and implemented stepwise across the Danish regions. The recommendation provided to each participant depends solely on the implementation phase of her region and is not influenced by individual participation or consent. Outcomes are measured across regions before and after implementation of the new recommendation.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Gestational age at birthAt 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).

Secondary

MeasureTime frameDescription
Apgar score at 5 minutesAt birth (from inclusion until delivery)
Birth before 37 weeks of gestationAt birth
Gestational age at birth, pooledAt 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
Latency from inclusion to birth (days)At birth (from inclusion until delivery)
Onset of birthAt birth (from inclusion until delivery)* Spontaneous * Induction * Caesarean section
Mode of birthAt birth (from inclusion until delivery)* Vaginal * Assisted vaginal * Planned caesarean section * Non planned caesarean section
- Non-occipital presentationAt birth (from inclusion until delivery)
Interventions during birthAt birth (from inclusion until delivery)* Oxytocin-infusion * Epidural anaesthesia
Degree of birth tearAt birth (from inclusion until delivery)* No tear * 1\. or 2. degree tear * 3\. or 4. degree tear
Maternal serious morbidityFrom inclusion to 42 days after deliveryAdmission 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
Umbilical cord arterial pHAt birth (from inclusion until delivery)
EPDS depression scoreFrom inclusion to 8 weeks after due date
Bone turnover marker levelAt inclusion and after 4 and 8 weeks.* Procollagen type 1 N-propeptide (PINP) * Carboxy-terminal telopeptide of type I collagen (CTX)
Lumbar spine Z-score12 months after stopped breastfeeding
Data from SENS activity trackerAt birth (from inclusion until delivery)Step count Time in supine position
Neonatal mortalityAt birth (from inclusion until delivery)
Fetal lossAt birth (from inclusion until delivery)
Birth weightAt birth (from inclusion until delivery)
Neonatal admission, daysFrom inclusion until discharge or 44 postmenstrual weeks
CNS morbidityFrom inclusion until discharge or 44 postmenstrual weeksIntraventricular haemorrhage grade III or IV, Periventricular leukomalacia
Gastrointestinal morbidityFrom inclusion until discharge or 44 postmenstrual weeksNecrotizing enterocolitis (NEC) requiring surgery (Bell's stage 3), Spontaneous intestinal perfo-ration (SIP) requiring surgical treatment
Respiratory supportFrom inclusion until discharge or 44 postmenstrual weeksMechanical ventilation or non-invasive ventilation (NIV)
Early onset infectionFrom inclusion to 5 days after birthDefinition: \>5 days of i.v. antibiotics where the treatment starts within the first week after delivery.
Respiratory distress syndrome (RDS)From inclusion until discharge or 44 postmenstrual weeks

Contacts

CONTACTKirsten Bünemann, Medical Doctor, PhD-student
kirsten.bunemann@clin.au.dk+45 40329849
PRINCIPAL_INVESTIGATORJulie Glavind, Senior Consultant, MD, PhD

Aarhus Univeristy Hospital, Department of Obstetrics and Gynecology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026