Bed Rest With a Short Cervix on Preterm Birth

NCT07577388 | Not Yet Recruiting

• 3 other identifiers: 16-0500-154308-00216B1-10-72-96-25
• Study Type: interventional
• Target: 6,000
• Locations: 0 countries
• Sites: N/A

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).

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

Outcome Measures

Primary Outcomes (1)

• 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).

  At birth (from inclusion until delivery)

Secondary Outcomes (24)

• Birth before 37 weeks of gestation

  At birth

• Gestational age at birth, pooled

  At birth (from inclusion until delivery)

• Latency from inclusion to birth (days)

  At birth (from inclusion until delivery)

• Onset of birth

  At birth (from inclusion until delivery)

• Mode of birth

  At birth (from inclusion until delivery)

Study Arms (2)

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.

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.

Behavioral: No Activity Restriction

Interventions

Activity Restriction BEHAVIORAL

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.

Also known as: Bed Rest, AR

Activity Restriction

No Activity Restriction BEHAVIORAL

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

Also known as: Activity, No Bed Rest, NAR

No Activity Restriction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Julie Glavind: lead
• Aarhus University Hospital: collaborator
• University of Aberdeen: collaborator
• Rigshospitalet, Denmark: collaborator
• Odense University Hospital: collaborator
• Zealand University Hospital: collaborator
• Aalborg University Hospital: collaborator

MeSH Terms

Conditions

Premature Birth; Uterine Cervical Incompetence; Pregnancy Complications; Depression, Postpartum; Obstetric Labor, Premature; Motor Activity

Interventions

Bed Rest; Exercise

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Genital Diseases; Puerperal Disorders; Depressive Disorder; Mood Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Julie Glavind, Senior Consultant, MD, PhD

  Aarhus Univeristy Hospital, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsten Bünemann, Medical Doctor, PhD-student

CONTACT

+45 40329849; kirsten.bunemann@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Consultant, PhD, Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2026
• First Posted: May 11, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05