Preterm BirthBEWISENCT07577388
Bed Rest With a Short Cervix on Preterm Birth
A study testing Activity Restriction and No Activity Restriction in people with Preterm Birth and Cervical Insufficiency, run by Julie Glavind.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Birth, Cervical Insufficiency, Bed Rest
- What is being tested?
- Activity Restriction and No Activity Restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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).
- Conditions
- Preterm Birth, Cervical Insufficiency, Bed Rest, Pregnancy Complications, Immobilization, Depression, Postpartum
- Being tested
- Activity Restriction, No Activity Restriction
- Medical subject headings
- Premature Birth, Uterine Cervical Incompetence, Pregnancy Complications, Depression, Postpartum, Obstetric Labor, Premature, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activity RestrictionBehavioural
Also called Bed Rest, AR
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.
No Activity RestrictionBehavioural
Also called Activity, No Bed Rest, NAR
Recommendation to continue normal daily activity in pregnant women with a short cervix, without restricting physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Activity Restriction | Active comparator | 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. Receives: Behavioral: Activity Restriction |
| No Activity Restriction | Experimental | 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. Receives: Behavioral: No Activity Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gestational age at birth
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).
Measured: At birth (from inclusion until delivery)
Secondary outcomes (24)
Birth before 37 weeks of gestation
Measured: At birth
Gestational age at birth, pooled
- 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
Measured: At birth (from inclusion until delivery)
Latency from inclusion to birth (days)
Measured: At birth (from inclusion until delivery)
Onset of birth
- Spontaneous
- Induction
- Caesarean section
Measured: At birth (from inclusion until delivery)
Mode of birth
- Vaginal
- Assisted vaginal
- Planned caesarean section
- Non planned caesarean section
Measured: At birth (from inclusion until delivery)
- Non-occipital presentation
Measured: At birth (from inclusion until delivery)
Interventions during birth
- Oxytocin-infusion
- Epidural anaesthesia
Measured: At birth (from inclusion until delivery)
Degree of birth tear
- No tear
- 1. or 2. degree tear
- 3. or 4. degree tear
Measured: At birth (from inclusion until delivery)
Maternal serious morbidity
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
Measured: From inclusion to 42 days after delivery
Umbilical cord arterial pH
Measured: At birth (from inclusion until delivery)
EPDS depression score
Measured: From inclusion to 8 weeks after due date
Bone turnover marker level
- Procollagen type 1 N-propeptide (PINP)
- Carboxy-terminal telopeptide of type I collagen (CTX)
Measured: At inclusion and after 4 and 8 weeks.
Lumbar spine Z-score
Measured: 12 months after stopped breastfeeding
Data from SENS activity tracker
Step count Time in supine position
Measured: At birth (from inclusion until delivery)
Neonatal mortality
Measured: At birth (from inclusion until delivery)
Fetal loss
Measured: At birth (from inclusion until delivery)
Birth weight
Measured: At birth (from inclusion until delivery)
Neonatal admission, days
Measured: From inclusion until discharge or 44 postmenstrual weeks
CNS morbidity
Intraventricular haemorrhage grade III or IV, Periventricular leukomalacia
Measured: From inclusion until discharge or 44 postmenstrual weeks
Gastrointestinal morbidity
Necrotizing enterocolitis (NEC) requiring surgery (Bell's stage 3), Spontaneous intestinal perfo-ration (SIP) requiring surgical treatment
Measured: From inclusion until discharge or 44 postmenstrual weeks
Respiratory support
Mechanical ventilation or non-invasive ventilation (NIV)
Measured: From inclusion until discharge or 44 postmenstrual weeks
Respiratory distress syndrome (RDS)
Measured: From inclusion until discharge or 44 postmenstrual weeks
Early onset infection
Definition: >5 days of i.v. antibiotics where the treatment starts within the first week after delivery.
Measured: From inclusion to 5 days after birth
Apgar score at 5 minutes
Measured: At birth (from inclusion until delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Julie Glavind
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aberdeen, Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aalborg University Hospital, Zealand University Hospital
- Responsible party
- Sponsor-investigator, Julie Glavind, University of Aarhus
- Investigators
- Julie Glavind, Senior Consultant, MD, PhD, Principal investigator, Aarhus Univeristy Hospital, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577388
- Sponsor's protocol ID
- 16-0500-15
- Other IDs
- 4308-00216B, 1-10-72-96-25
- Acronym
- BEWISE
- Status last verified
- May 2026
- First submitted
- 3 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be shared if possible according to GDPR and Danish legislation
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEWISE - Bed Rest With a Short Cervix on Preterm Birth
- ClinicalTrials.gov ID
- NCT07577388
- Acronym / sponsor ID
- BEWISE / 16-0500-15
- Conditions
- Preterm Birth, Cervical Insufficiency, Bed Rest, Pregnancy Complications, Immobilization, Depression, Postpartum
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Julie GlavindUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, University of Aberdeen, Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Aalborg University Hospital, Zealand University Hospital
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Activity Restriction | Active comparator | Behavioral: Activity RestrictionThe 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. |
| No Activity Restriction | Experimental | Behavioral: No Activity RestrictionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activity RestrictionAlso: Bed Rest, ARRecommendation to restrict physical activity in pregnant women with a short cervix. This may include increased rest or bed rest according to local clinical practice. | Behavioural | Activity Restriction |
| No Activity RestrictionAlso: Activity, No Bed Rest, NARRecommendation to continue normal daily activity in pregnant women with a short cervix, without restricting physical activity. | Behavioural | No Activity Restriction |
Primary outcome
Gestational age at birth
Time frame: 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).
24 secondary outcomes
Birth before 37 weeks of gestation
Time frame: At birth
Gestational age at birth, pooled
Time frame: At birth (from inclusion until delivery)
Latency from inclusion to birth (days)
Time frame: At birth (from inclusion until delivery)
Onset of birth
Time frame: At birth (from inclusion until delivery)
Mode of birth
Time frame: At birth (from inclusion until delivery)
- Non-occipital presentation
Time frame: At birth (from inclusion until delivery)
Interventions during birth
Time frame: At birth (from inclusion until delivery)
Degree of birth tear
Time frame: At birth (from inclusion until delivery)
Maternal serious morbidity
Time frame: From inclusion to 42 days after delivery
Umbilical cord arterial pH
Time frame: At birth (from inclusion until delivery)
EPDS depression score
Time frame: From inclusion to 8 weeks after due date
Bone turnover marker level
Time frame: At inclusion and after 4 and 8 weeks.
Lumbar spine Z-score
Time frame: 12 months after stopped breastfeeding
Data from SENS activity tracker
Time frame: At birth (from inclusion until delivery)
Neonatal mortality
Time frame: At birth (from inclusion until delivery)
Fetal loss
Time frame: At birth (from inclusion until delivery)
Birth weight
Time frame: At birth (from inclusion until delivery)
Neonatal admission, days
Time frame: From inclusion until discharge or 44 postmenstrual weeks
CNS morbidity
Time frame: From inclusion until discharge or 44 postmenstrual weeks
Gastrointestinal morbidity
Time frame: From inclusion until discharge or 44 postmenstrual weeks
Respiratory support
Time frame: From inclusion until discharge or 44 postmenstrual weeks
Respiratory distress syndrome (RDS)
Time frame: From inclusion until discharge or 44 postmenstrual weeks
Early onset infection
Time frame: From inclusion to 5 days after birth
Apgar score at 5 minutes
Time frame: At birth (from inclusion until delivery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Undecided. IPD will be shared if possible according to GDPR and Danish legislation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Glavind, Senior Consultant, MD, PhD principal investigator
Aarhus Univeristy Hospital, Department of Obstetrics and Gynecology
Questions about this trial
What is this clinical trial studying?
A study testing Activity Restriction and No Activity Restriction in people with Preterm Birth and Cervical Insufficiency, run by Julie Glavind.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kirsten Bünemann, Medical Doctor, PhD-student (+45 40329849, kirsten.bunemann@clin.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational age at birth (time frame: At birth (from inclusion until delivery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.