Bed Rest With a Short Cervix on Preterm Birth
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Activity Restriction, No Activity Restriction.
- Who it may be relevant to
- Registry conditions: Preterm Birth, Cervical Insufficiency, Bed Rest, Pregnancy Complications. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
BEWISE - Bed Rest With a Short Cervix on Preterm Birth
Overview
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
- Behavioral 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. - Behavioral No Activity Restriction
Recommendation to continue normal daily activity in pregnant women with a short cervix, without restricting physical activity.
Primary outcome measures
- Gestational age at birth [Time frame: At birth (from inclusion until delivery)]
Secondary outcome measures (12)
- 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.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07577388 · 16-0500-15 · 4308-00216B · 1-10-72-96-25