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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6,000
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.
Recommendation to continue normal daily activity in pregnant women with a short cervix, without restricting physical activity.
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).
Time frame: At birth (from inclusion until delivery)
Birth before 37 weeks of gestation
Time frame: 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
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
* Spontaneous * Induction * Caesarean section
Time frame: At birth (from inclusion until delivery)
Mode of birth
* Vaginal * Assisted vaginal * Planned caesarean section * Non planned caesarean section
Time frame: At birth (from inclusion until delivery)
- Non-occipital presentation
Time frame: At birth (from inclusion until delivery)
Interventions during birth
* Oxytocin-infusion * Epidural anaesthesia
Time frame: At birth (from inclusion until delivery)
Degree of birth tear
* No tear * 1\. or 2. degree tear * 3\. or 4. degree tear
Time frame: 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
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
* Procollagen type 1 N-propeptide (PINP) * Carboxy-terminal telopeptide of type I collagen (CTX)
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
Step count Time in supine position
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
Intraventricular haemorrhage grade III or IV, Periventricular leukomalacia
Time frame: 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
Time frame: From inclusion until discharge or 44 postmenstrual weeks
Respiratory support
Mechanical ventilation or non-invasive ventilation (NIV)
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
Definition: \>5 days of i.v. antibiotics where the treatment starts within the first week after delivery.
Time frame: From inclusion to 5 days after birth
Apgar score at 5 minutes
Time frame: At birth (from inclusion until delivery)
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