Bed Rest With a Short Cervix on Preterm Birth (BEWISE)
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.
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).
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Kirsten Bünemann, Medical Doctor, PhD-student
- 電話番号：+45 40329849
- メール：kirsten.bunemann@clin.au.dk
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Activity Restriction
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.
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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.
他の名前：
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実験的：No Activity Restriction
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. |
Recommendation to continue normal daily activity in pregnant women with a short cervix, without restricting physical activity.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Gestational age at birth
時間枠：At birth (from inclusion until delivery)
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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).
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At birth (from inclusion until delivery)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Birth before 37 weeks of gestation
時間枠：At birth
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At birth
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Gestational age at birth, pooled
時間枠：At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Latency from inclusion to birth (days)
時間枠：At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Onset of birth
時間枠：At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Mode of birth
時間枠：At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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- Non-occipital presentation
時間枠：At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Interventions during birth
時間枠：At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Degree of birth tear
時間枠：At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Maternal serious morbidity
時間枠：From inclusion to 42 days after delivery
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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
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From inclusion to 42 days after delivery
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Umbilical cord arterial pH
時間枠：At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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EPDS depression score
時間枠：From inclusion to 8 weeks after due date
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From inclusion to 8 weeks after due date
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Bone turnover marker level
時間枠：At inclusion and after 4 and 8 weeks.
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At inclusion and after 4 and 8 weeks.
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Lumbar spine Z-score
時間枠：12 months after stopped breastfeeding
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12 months after stopped breastfeeding
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Data from SENS activity tracker
時間枠：At birth (from inclusion until delivery)
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Step count Time in supine position
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At birth (from inclusion until delivery)
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Neonatal mortality
時間枠：At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Fetal loss
時間枠：At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Birth weight
時間枠：At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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Neonatal admission, days
時間枠：From inclusion until discharge or 44 postmenstrual weeks
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From inclusion until discharge or 44 postmenstrual weeks
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CNS morbidity
時間枠：From inclusion until discharge or 44 postmenstrual weeks
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Intraventricular haemorrhage grade III or IV, Periventricular leukomalacia
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From inclusion until discharge or 44 postmenstrual weeks
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Gastrointestinal morbidity
時間枠：From inclusion until discharge or 44 postmenstrual weeks
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Necrotizing enterocolitis (NEC) requiring surgery (Bell's stage 3), Spontaneous intestinal perfo-ration (SIP) requiring surgical treatment
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From inclusion until discharge or 44 postmenstrual weeks
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Respiratory support
時間枠：From inclusion until discharge or 44 postmenstrual weeks
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Mechanical ventilation or non-invasive ventilation (NIV)
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From inclusion until discharge or 44 postmenstrual weeks
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Respiratory distress syndrome (RDS)
時間枠：From inclusion until discharge or 44 postmenstrual weeks
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From inclusion until discharge or 44 postmenstrual weeks
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Early onset infection
時間枠：From inclusion to 5 days after birth
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Definition: >5 days of i.v.
antibiotics where the treatment starts within the first week after delivery.
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From inclusion to 5 days after birth
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Apgar score at 5 minutes
時間枠：At birth (from inclusion until delivery)
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At birth (from inclusion until delivery)
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Julie Glavind, Senior Consultant, MD, PhD、Aarhus Univeristy Hospital, Department of Obstetrics and Gynecology
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 16-0500-15
- 4308-00216B (その他の助成金/資金番号：Independent Research Fund Denmark)
- 1-10-72-96-25 (その他の識別子：De Videnskabsetiske Komitéer For Region Midtjylland)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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