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

Julie Glavind

Status: Not yet enrolling

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

Treatments: Behavioral: No Activity Restriction; Behavioral: Activity Restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT07577388

16-0500-15

1-10-72-96-25 (Other Identifier)

4308-00216B (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment: 6,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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6,000 participants in 2 patient groups

Activity Restriction

Active Comparator group

Description:

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.

Treatment:

Behavioral: Activity Restriction

No Activity Restriction

Experimental group

Description:

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.

Treatment:

Behavioral: No Activity Restriction